Viewing Study NCT03779204


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Study NCT ID: NCT03779204
Status: COMPLETED
Last Update Posted: 2025-01-13
First Post: 2018-09-23
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Effect of a Rent Subsidy and Mentoring on Youth Transitioning Out of Homelessness
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012934', 'term': 'Social Isolation'}, {'id': 'D012933', 'term': 'Social Identification'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'naomi.thulien@unityhealth.to', 'phone': '647-460-0781', 'title': 'Dr. Naomi Thulien', 'organization': 'Unity Health Toronto'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 months', 'eventGroups': [{'id': 'EG000', 'title': 'Rent Subsidies + Mentorship', 'description': "Participants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners.\n\nMentorship: The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months.", 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Rent Subsidies Only', 'description': "Participants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months.", 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Community Integration Scale Score at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rent Subsidies + Mentorship', 'description': "Participants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners.\n\nMentorship: The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}, {'id': 'OG001', 'title': 'Rent Subsidies Only', 'description': "Participants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '11.3', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '11.2', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '1.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 18 months', 'description': 'This outcome is a measure of behavioural (e.g., participation in activities) and psychological (e.g., sense of belonging) aspects of community integration. This will be measured using the Community Integration Scale (CIS), an 11-item scale. The CIS includes a psychological subscale (possible score range is from 4-20, 4 being low psychological community integration and 20 being high integration), and a physical subscale (total score range is 0-7, 0 being low physical community integration, and 7 being high integration). Only the psychological subscale has been reported here.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Rosenberg Self-Esteem Scale Score at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rent Subsidies + Mentorship', 'description': "Participants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners.\n\nMentorship: The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}, {'id': 'OG001', 'title': 'Rent Subsidies Only', 'description': "Participants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '16.0', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '18.1', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '2.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 18 months.', 'description': 'This outcome is a measure of global self-worth and will be measured using the Rosenberg Self-Esteem Scale, a 10-item scale, internal consistency α = .77 - .88. The total scoring range is 0-30, a score of \\<15 is categorized as low self-esteem, and 15-30 is categorized as normal self-esteem.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Social Connectedness Scale Score at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rent Subsidies + Mentorship', 'description': "Participants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners.\n\nMentorship: The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}, {'id': 'OG001', 'title': 'Rent Subsidies Only', 'description': "Participants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '67.0', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '77.0', 'spread': '15.9', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '74.2', 'spread': '21.3', 'groupId': 'OG000'}, {'value': '77.0', 'spread': '25.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.38', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.3', 'ciLowerLimit': '-9.7', 'ciUpperLimit': '24.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 18 months.', 'description': 'This outcome is a measure of belongingness - the degree to which people feel connected to others. It is measured using the Social Connected Scale, a 20-item scale, internal consistency α = .92. The total scoring range is 20-120, 20 being low social connectedness and 120 being high social connectedness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Hopelessness Scale Score at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rent Subsidies + Mentorship', 'description': "Participants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners.\n\nMentorship: The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}, {'id': 'OG001', 'title': 'Rent Subsidies Only', 'description': "Participants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.5', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '4.6', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '4.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 18 months.', 'description': "This outcome is a measure of motivation, expectations, and feelings about the future and will be measured using Beck's Hopelessness Scale, a 20-item scale, internal consistency α = .93. The total scoring range is 0-20, 0-3 = None or minimal, 4-8 = Mild, 9-14 = Moderate - requires monitoring, 15+ = Severe - suicide risk.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Academic/Vocational Participation as Assessed by a Questionnaire at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rent Subsidies + Mentorship', 'description': "Participants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners.\n\nMentorship: The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}, {'id': 'OG001', 'title': 'Rent Subsidies Only', 'description': "Participants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.68', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Change from baseline to 18 months.', 'description': 'Participant engagement with school or a training program will be assessed. Participants will be prompted to answer questions about their current educational pursuit every 6 months in a questionnaire, including whether the individual is pursuing education, and the type of education.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Modified Engulfment Scale Score at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rent Subsidies + Mentorship', 'description': "Participants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners.\n\nMentorship: The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}, {'id': 'OG001', 'title': 'Rent Subsidies Only', 'description': "Participants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '81.6', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '83.8', 'spread': '28.1', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '70.4', 'spread': '15.3', 'groupId': 'OG000'}, {'value': '79.5', 'spread': '27.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.2', 'ciLowerLimit': '-16.4', 'ciUpperLimit': '2.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 18 months.', 'description': 'This is an exploratory outcome. This outcome is a measure of the degree to which an individual\'s self-concept is defined by their experience of homelessness. It will be assessed using the Modified Engulfment Scale, a 30-item scale, internal consistency α = .91. The total scoring range is 30-150, 30 being low engulfment, 150 being high engulfment. The scale was adapted for use in this study, substituting "experience of homelessness" for "illness". Increased levels of engulfment indicate that the individual was more likely to have an earlier age of onset (of homelessness), to have experienced a longer period of homelessness, with a greater number of homelessness/shelter contact, and a decreased level of social adjustment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Modified Colorado Symptom Index Score at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rent Subsidies + Mentorship', 'description': "Participants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners.\n\nMentorship: The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}, {'id': 'OG001', 'title': 'Rent Subsidies Only', 'description': "Participants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '40.9', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '36.8', 'spread': '15.4', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '32.9', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '34.9', 'spread': '16.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-13.7', 'ciUpperLimit': '5.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 18 months.', 'description': 'This is an exploratory outcome; it is the measurement of the presence and frequency of psychiatric symptoms experienced in the past month. Measured using the Modified Colorado Symptom Index, a 14-item questionnaire, internal consistency α = .90 - .92. The total scoring range is 0-56, 0 being a low frequency of psychiatric symptoms, and 56 being a high frequency of psychiatric symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Income as Assessed by a Questionnaire at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rent Subsidies + Mentorship', 'description': "Participants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners.\n\nMentorship: The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}, {'id': 'OG001', 'title': 'Rent Subsidies Only', 'description': "Participants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}], 'classes': [{'title': 'Receiving Employment Income at Baseline', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Receiving Employment Income at 18 Months', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Change from baseline to 18 months.', 'description': 'This is an exploratory outcome. Participants will be prompted to answer questions about their current income every 6 months in a questionnaire. This outcome is assessed using a repeated measures analysis and changes in income will be assessed for change over time at the aggregate level.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Perceived Housing Quality Scale Score at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rent Subsidies + Mentorship', 'description': "Participants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners.\n\nMentorship: The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}, {'id': 'OG001', 'title': 'Rent Subsidies Only', 'description': "Participants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '24.6', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '23.5', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '23.8', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '24.6', 'spread': '6.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '4.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 18 months.', 'description': 'This is an exploratory outcome and is assessed by participant perception of housing choice and quality. Measured using the Perceived Housing Quality Scale.This scale was used extensively in the Chez Soi/At Home study, but psychometric properties have yet to be reported. It has been shortened it from 10 items (Chez Soi/At Home) to seven relevant items. The total scoring range is 7-35, 7 being very dissatisfied with current housing quality, and 35 being very satisfied with housing quality.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Barriers and Facilitators of Social and Economic Inclusion: Key Themes and Subthemes as Informed by Individual Interviews With Youth Participants at 30 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Analysis of Intervention and Control Groups', 'description': 'Data for the intervention and control groups were pooled.'}], 'classes': [{'title': 'Themes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Subthemes', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed every 6 months for 30 months, starting at baseline.', 'description': 'This is an exploratory outcome. Using one-on-one, semi-structured interviews with young people from both the control and intervention arms, we examined and compared their experiences of social and economic inclusion. Additionally, we explored how mentorship, provided to youth in the intervention arm, influenced this experience.', 'unitOfMeasure': 'Key themes and sub-themes', 'reportingStatus': 'POSTED', 'populationDescription': "Participants from both groups were included to explore factors beyond the intervention impacting socioeconomic inclusion. The path to inclusion is complex, with factors like informal mentorship (from non-study mentors) proving more influential than formal study mentorship. Thus, analyzing the groups as a cohort provided a more comprehensive understanding of participants' experiences."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Barriers and Facilitators of Mentorship Intervention: Key Themes and Subthemes as Informed by Focus Groups With Mentors at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mentors', 'description': 'Data from study mentors.'}], 'classes': [{'title': 'Themes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Sub-themes', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed at 12 and 24 months.', 'description': 'This is an exploratory outcome. We conducted focus groups with study mentors to explore their perception of barriers and facilitators to mentorship engagement.', 'unitOfMeasure': 'Key themes and sub-themes', 'reportingStatus': 'POSTED', 'populationDescription': 'Mentors that were matched with youth in the intervention arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rent Subsidies + Mentorship', 'description': "Participants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners.\n\nMentorship: The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}, {'id': 'FG001', 'title': 'Rent Subsidies Only', 'description': "Participants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rent Subsidies + Mentorship', 'description': "Participants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners.\n\nMentorship: The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}, {'id': 'BG001', 'title': 'Rent Subsidies Only', 'description': "Participants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship.\n\nRent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '22.2', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '21.8', 'spread': '2.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Woman', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Man', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Indigenous', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Different choice', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'First time became homeless, age', 'classes': [{'categories': [{'measurements': [{'value': '18', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '17.5', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '17.8', 'spread': '3.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Born in Canada', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Immigration Status', 'classes': [{'title': 'Canadian citizen', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Permanent resident', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Refugee', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Child welfare involvement', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Participants were asked in the baseline survey whether the Children's Aid Society had ever been involved with them or their family. Participants who answered 'yes' have been reported here.", 'unitOfMeasure': 'Participants'}, {'title': 'No. of attempts to live on own after being homeless', 'classes': [{'title': '1-2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': '≥3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were asked in the baseline survey how many times they have tried to live on their own or with others after being homeless. Participant answers were grouped into 1-2 attempts or 3 or more attempts.', 'unitOfMeasure': 'Participants'}, {'title': 'No. of attempts to exit homelessness', 'classes': [{'title': '1-2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': '3-4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': '≥5', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were asked in the baseline survey how many times they have attempted to exit homelessness. Participant answers were grouped into 1-2 attempts, 3-4 attempts, or 5 or more attempts.', 'unitOfMeasure': 'Participants'}, {'title': 'Highest educational level', 'classes': [{'title': 'Less than high school', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Completed high school', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Some or completed postsecondary education', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Regular contact with adult relative', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Participants were asked in the baseline survey if they are in regular contact with an adult relative (e.g., parent, grandparent, or aunt). Participants who answered 'yes' have been reported here.", 'unitOfMeasure': 'Participants'}, {'title': 'Informal adult mentor', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Participants were asked in the baseline survey if they have an adult in their life whom they consider a mentor, and this mentor is not a relative and is outside of the social service sector. Participants who answered 'yes' have been reported here.", 'unitOfMeasure': 'Participants'}, {'title': 'Employed', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Social assistance', 'classes': [{'title': 'Ontario Works', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Ontario Disability Support Program', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were asked in the baseline survey if they are receiving social assistance through Ontario Works or through the Ontario Disability Support Program.', 'unitOfMeasure': 'Participants'}, {'title': 'ACEs, adverse childhood experiences', 'classes': [{'title': '1-3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': '4-9', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants completed an adverse childhood experiences (ACEs) self-report questionnaire. A score of 4 or more is considered being at high risk for toxic stress. A score of 0 to 3 is considered being at a lower risk for toxic stress.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-15', 'size': 438375, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-30T15:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will employ a convergent mixed methods design (i.e., quantitative and qualitative data are collected concurrently, and the findings combined) embedded within a RCT and a CBPAR framework. 24 participants will be assessed for eligibility, and then randomized into 1 of 2 arms using covariate adaptive randomization. 12 are allocated to the intervention group (rent subsidies + mentoring), while 12 are allocated to the control group (rent subsidies only). Participants in the intervention group (n = 12) will be matched with an adult mentor recruited by one of the community partners. Mentors are selected and matched through one-on-one interviews with someone in a leadership role within the organization. A common mentoring guide will be used for all sites; these booklets cover information ranging from ideal mentor characteristics to mentor code of conduct.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2018-09-23', 'resultsFirstSubmitDate': '2023-03-22', 'studyFirstSubmitQcDate': '2018-12-14', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-22', 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Modified Engulfment Scale Score at 18 Months', 'timeFrame': 'Change from baseline to 18 months.', 'description': 'This is an exploratory outcome. This outcome is a measure of the degree to which an individual\'s self-concept is defined by their experience of homelessness. It will be assessed using the Modified Engulfment Scale, a 30-item scale, internal consistency α = .91. The total scoring range is 30-150, 30 being low engulfment, 150 being high engulfment. The scale was adapted for use in this study, substituting "experience of homelessness" for "illness". Increased levels of engulfment indicate that the individual was more likely to have an earlier age of onset (of homelessness), to have experienced a longer period of homelessness, with a greater number of homelessness/shelter contact, and a decreased level of social adjustment.'}, {'measure': 'Modified Colorado Symptom Index Score at 18 Months', 'timeFrame': 'Change from baseline to 18 months.', 'description': 'This is an exploratory outcome; it is the measurement of the presence and frequency of psychiatric symptoms experienced in the past month. Measured using the Modified Colorado Symptom Index, a 14-item questionnaire, internal consistency α = .90 - .92. The total scoring range is 0-56, 0 being a low frequency of psychiatric symptoms, and 56 being a high frequency of psychiatric symptoms.'}, {'measure': 'Income as Assessed by a Questionnaire at 18 Months', 'timeFrame': 'Change from baseline to 18 months.', 'description': 'This is an exploratory outcome. Participants will be prompted to answer questions about their current income every 6 months in a questionnaire. This outcome is assessed using a repeated measures analysis and changes in income will be assessed for change over time at the aggregate level.'}, {'measure': 'Perceived Housing Quality Scale Score at 18 Months', 'timeFrame': 'Change from baseline to 18 months.', 'description': 'This is an exploratory outcome and is assessed by participant perception of housing choice and quality. Measured using the Perceived Housing Quality Scale.This scale was used extensively in the Chez Soi/At Home study, but psychometric properties have yet to be reported. It has been shortened it from 10 items (Chez Soi/At Home) to seven relevant items. The total scoring range is 7-35, 7 being very dissatisfied with current housing quality, and 35 being very satisfied with housing quality.'}, {'measure': 'Barriers and Facilitators of Social and Economic Inclusion: Key Themes and Subthemes as Informed by Individual Interviews With Youth Participants at 30 Months', 'timeFrame': 'Assessed every 6 months for 30 months, starting at baseline.', 'description': 'This is an exploratory outcome. Using one-on-one, semi-structured interviews with young people from both the control and intervention arms, we examined and compared their experiences of social and economic inclusion. Additionally, we explored how mentorship, provided to youth in the intervention arm, influenced this experience.'}, {'measure': 'Barriers and Facilitators of Mentorship Intervention: Key Themes and Subthemes as Informed by Focus Groups With Mentors at 24 Months', 'timeFrame': 'Assessed at 12 and 24 months.', 'description': 'This is an exploratory outcome. We conducted focus groups with study mentors to explore their perception of barriers and facilitators to mentorship engagement.'}], 'primaryOutcomes': [{'measure': 'Community Integration Scale Score at 18 Months', 'timeFrame': 'Change from baseline to 18 months', 'description': 'This outcome is a measure of behavioural (e.g., participation in activities) and psychological (e.g., sense of belonging) aspects of community integration. This will be measured using the Community Integration Scale (CIS), an 11-item scale. The CIS includes a psychological subscale (possible score range is from 4-20, 4 being low psychological community integration and 20 being high integration), and a physical subscale (total score range is 0-7, 0 being low physical community integration, and 7 being high integration). Only the psychological subscale has been reported here.'}, {'measure': 'Rosenberg Self-Esteem Scale Score at 18 Months', 'timeFrame': 'Change from baseline to 18 months.', 'description': 'This outcome is a measure of global self-worth and will be measured using the Rosenberg Self-Esteem Scale, a 10-item scale, internal consistency α = .77 - .88. The total scoring range is 0-30, a score of \\<15 is categorized as low self-esteem, and 15-30 is categorized as normal self-esteem.'}], 'secondaryOutcomes': [{'measure': 'Social Connectedness Scale Score at 18 Months', 'timeFrame': 'Change from baseline to 18 months.', 'description': 'This outcome is a measure of belongingness - the degree to which people feel connected to others. It is measured using the Social Connected Scale, a 20-item scale, internal consistency α = .92. The total scoring range is 20-120, 20 being low social connectedness and 120 being high social connectedness.'}, {'measure': 'Beck Hopelessness Scale Score at 18 Months', 'timeFrame': 'Change from baseline to 18 months.', 'description': "This outcome is a measure of motivation, expectations, and feelings about the future and will be measured using Beck's Hopelessness Scale, a 20-item scale, internal consistency α = .93. The total scoring range is 0-20, 0-3 = None or minimal, 4-8 = Mild, 9-14 = Moderate - requires monitoring, 15+ = Severe - suicide risk."}, {'measure': 'Academic/Vocational Participation as Assessed by a Questionnaire at 18 Months', 'timeFrame': 'Change from baseline to 18 months.', 'description': 'Participant engagement with school or a training program will be assessed. Participants will be prompted to answer questions about their current educational pursuit every 6 months in a questionnaire, including whether the individual is pursuing education, and the type of education.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Social Isolation', 'Self-Esteem', 'Hope', 'Psychiatric Problem', 'Education', 'Employment', 'Income', 'Housing Problems', 'Identity, Social', 'Youth', 'Rent Subsidy', 'Mentorship'], 'conditions': ['Homeless Persons']}, 'referencesModule': {'references': [{'pmid': '20494240', 'type': 'BACKGROUND', 'citation': 'Altena AM, Brilleslijper-Kater SN, Wolf JL. Effective interventions for homeless youth: a systematic review. Am J Prev Med. 2010 Jun;38(6):637-45. doi: 10.1016/j.amepre.2010.02.017.'}, {'pmid': '4436473', 'type': 'BACKGROUND', 'citation': 'Beck AT, Weissman A, Lester D, Trexler L. The measurement of pessimism: the hopelessness scale. J Consult Clin Psychol. 1974 Dec;42(6):861-5. doi: 10.1037/h0037562. No abstract available.'}, {'type': 'BACKGROUND', 'citation': "Brueckner, M., Green, M., & Saggers, S. (2011). The trappings of home: Young homeless people's transitions towards independent living. Housing Studies, 26(1), 1-16. doi:10.1080/02673037.2010.512751."}, {'type': 'BACKGROUND', 'citation': 'Chenail. R. J., St. Goerge, S., Wulff, D., & Cooper, R. (2012). Action research: The methodologies. In P. L. Munhall (Ed.), Nursing research: A qualitative perspective (5th ed.) (pp. 455-470). Sudbury, MS: Jones & Bartlett.'}, {'type': 'BACKGROUND', 'citation': 'Ciarolo, J. A., Edwards, D. W., Kiresuk, T. J., Newman, F. L., & Brown, T. R. (1981). Colorado symptom index. Washington, DC: National Institute of Mental Health.'}, {'pmid': '26760047', 'type': 'BACKGROUND', 'citation': 'Coren E, Hossain R, Pardo Pardo J, Bakker B. 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American Behavioral Scientist, 51(6), 772-788. doi:10.1177/0002764207311987."}, {'type': 'BACKGROUND', 'citation': 'Karabanow, J., Carson, A., & Clement, P. (2010). Leaving the streets: Stories of Canadian youth. Halifax, NS: Fernwood Publishing.'}, {'type': 'BACKGROUND', 'citation': 'Karabanow, J., Kidd, S., Frederick, T., & Hughes, J. (2016). Toward housing stability: Exiting homelessness as an emerging adult. Journal of Sociology & Social Welfare, 43(1), 121- 148. Retrieved from https://wmich.edu/socialworkjournal'}, {'type': 'BACKGROUND', 'citation': 'Kawabata, M., & Gastaldo, D. (2015). The less said, the better: Interpreting silence in qualitative research. International Journal of Qualitative Research Methods, 14(4), 1-9. doi:10.1177/1609406915618123.'}, {'type': 'BACKGROUND', 'citation': 'Kidd, S.A., Frederick, T., Karabanow, J., Hughes, J., Naylor, T., & Barbic, S. (2016). A mixed methods study of recently homeless youth efforts to sustain housing and stability. 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Supporting young people's transitions from care: Reflections on doing participatory action research with youth from care. In L. Brown & S. Strega (Eds.), Research as resistance: Critical, Indigenous, & anti-oppressive approaches (pp. 153-179). Toronto, ON: Canadian Scholars' Press/Women's Press."}, {'pmid': '20161294', 'type': 'BACKGROUND', 'citation': 'Slesnick N, Dashora P, Letcher A, Erdem G, Serovich J. A Review of Services and Interventions for Runaway and Homeless Youth: Moving Forward. Child Youth Serv Rev. 2009 Jul;31(7):732-742. doi: 10.1016/j.childyouth.2009.01.006.'}, {'type': 'BACKGROUND', 'citation': 'SocioCultural Research Consultants, LLC. (2018). Dedoose (Version 8.0.35) [web application]. Retrieved from http://www.dedoose.com'}, {'type': 'BACKGROUND', 'citation': 'Solar, O., & Irwin, A. (2010). A conceptual framework for action on the social determinants of health: Social determinants of health discussion paper 2. Geneva, Switzerland: World Health Organization Press. Retrieved from http://www.who.int/sdhconference/resources/ConceptualframeworkforactiononS DH_eng.pdf'}, {'type': 'BACKGROUND', 'citation': 'Solomon, P., Cavanaugh, M.M., & Draine, J. (2009). Randomized controlled trials: Design and implementation for community-based psychosocial interventions. New York, NY: Oxford University Press.'}, {'pmid': '24725374', 'type': 'BACKGROUND', 'citation': "Stergiopoulos V, Gozdzik A, O'Campo P, Holtby AR, Jeyaratnam J, Tsemberis S. Housing First: exploring participants' early support needs. BMC Health Serv Res. 2014 Apr 13;14:167. doi: 10.1186/1472-6963-14-167."}, {'type': 'BACKGROUND', 'citation': "Strega, B. (2005). The view from the poststructural margins: Epistemology and methodology reconsidered. In L. Brown & S. Strega (Eds.), Research as resistance: Critical, Indigenous, & anti-oppressive approaches (pp. 199-235). Toronto, ON: Canadian Scholars' Press/Women's Press."}, {'pmid': '21772732', 'type': 'BACKGROUND', 'citation': 'Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.'}, {'type': 'BACKGROUND', 'citation': 'Thompson, A. E., Greeson, J. K., & Brunsink, A. M. (2016). Natural mentoring among older youth in and aging out of foster care: A systematic review. Children and Youth Services Review, 61, 40-50. doi: 10.1016/j.childyouth.2015.12.006.'}, {'pmid': '29981071', 'type': 'BACKGROUND', 'citation': 'Thulien NS, Gastaldo D, Hwang SW, McCay E. The elusive goal of social integration: A critical examination of the socio-economic and psychosocial consequences experienced by homeless young people who obtain housing. Can J Public Health. 2018 Feb;109(1):89-98. doi: 10.17269/s41997-018-0029-6.'}, {'pmid': '9170771', 'type': 'BACKGROUND', 'citation': 'Toro PA, Passero Rabideau JM, Bellavia CW, Daeschler CV, Wall DD, Thomas DM, Smith SJ. Evaluating an intervention for homeless persons: results of a field experiment. J Consult Clin Psychol. 1997 Jun;65(3):476-84. doi: 10.1037//0022-006x.65.3.476.'}, {'type': 'BACKGROUND', 'citation': 'Urbaniak, G.C., & Plous,S. (2013). Research Randomizer (Version 4.0) [Computer software]. Retrieved from https://www.randomizer.org'}, {'pmid': '29691865', 'type': 'BACKGROUND', 'citation': 'Van Dam L, Smit D, Wildschut B, Branje SJT, Rhodes JE, Assink M, Stams GJJM. Does Natural Mentoring Matter? A Multilevel Meta-analysis on the Association Between Natural Mentoring and Youth Outcomes. Am J Community Psychol. 2018 Sep;62(1-2):203-220. doi: 10.1002/ajcp.12248. Epub 2018 Apr 25.'}, {'pmid': '16760238', 'type': 'BACKGROUND', 'citation': 'Wallerstein NB, Duran B. Using community-based participatory research to address health disparities. Health Promot Pract. 2006 Jul;7(3):312-23. doi: 10.1177/1524839906289376. Epub 2006 Jun 7.'}, {'pmid': '20147663', 'type': 'BACKGROUND', 'citation': 'Wallerstein N, Duran B. Community-based participatory research contributions to intervention research: the intersection of science and practice to improve health equity. Am J Public Health. 2010 Apr 1;100 Suppl 1(Suppl 1):S40-6. doi: 10.2105/AJPH.2009.184036. Epub 2010 Feb 10.'}, {'type': 'BACKGROUND', 'citation': 'Wallerstein, N., Duran, B., Oetzel, J.G., & Minkler, M. (2018). Community-based participatory research for health: Advancing social and health equity (3rd ed.). San Francisco, CA: Jossey-Bass.'}, {'pmid': '21318011', 'type': 'BACKGROUND', 'citation': 'Efird J. Blocked randomization with randomly selected block sizes. Int J Environ Res Public Health. 2011 Jan;8(1):15-20. doi: 10.3390/ijerph8010015. Epub 2010 Dec 23.'}, {'pmid': '36301546', 'type': 'RESULT', 'citation': 'Thulien NS, Amiri A, Hwang SW, Kozloff N, Wang A, Akdikmen A, Roglich J, Nisenbaum R. Effect of Portable Rent Subsidies and Mentorship on Socioeconomic Inclusion for Young People Exiting Homelessness: A Community-Based Pilot Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2238670. doi: 10.1001/jamanetworkopen.2022.38670.'}, {'pmid': '37462842', 'type': 'RESULT', 'citation': 'Thulien NS, Hwang SW, Kozloff N, Nisenbaum R, Akdikmen A, Fambegbe OP, Feraday R, Mathewson C, Mutamiri M, Roglich J, Wang A, Zagala M, Amiri A. "When I think about my future, I just see darkness": How youth exiting homelessness navigate the hazy, liminal space between socioeconomic exclusion and inclusion. Can J Public Health. 2023 Dec;114(6):893-905. doi: 10.17269/s41997-023-00804-2. Epub 2023 Jul 18.'}, {'pmid': '31859688', 'type': 'DERIVED', 'citation': 'Thulien NS, Kozloff N, McCay E, Nisenbaum R, Wang A, Hwang SW. Evaluating the Effects of a Rent Subsidy and Mentoring Intervention for Youth Transitioning Out of Homelessness: Protocol for a Mixed Methods, Community-Based Pilot Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 20;8(12):e15557. doi: 10.2196/15557.'}]}, 'descriptionModule': {'briefSummary': 'Compared to the vast amount of literature about the risk factors associated with young people entering and becoming entrenched in homelessness, much less is known about how to facilitate and sustain transitions off the streets.\n\nCurrent evidence indicates that while structural supports such as subsidized housing and social service providers are important, these things alone are insufficient to help young people integrate into mainstream society. Connecting these young people with an adult who exhibits the relationship-based components of mentoring that young people value most (e.g., genuine interest in their well-being and belief in their ability to succeed, a non-judgmental attitude and a willingness to listen, the provision of advice, guidance, affirmation and encouragement) may be key to helping them move forward and integrate into the mainstream.\n\nThis intervention will provide 24 young people (ages 18-26) who have transitioned out of homelessness and into market rent housing within the past year with rent subsidies for 24 months. Half of the young people will be randomized to receive regular mentorship from an adult mentor, tasked with helping their mentee bridge the gap between homelessness and mainstream living.\n\nIt is hypothesized that, for the primary outcome measures of community integration and self-esteem:\n\n1\\. Better mean scores (community integration and self-esteem) in the participants who receive rent subsidies plus mentorship (intervention group) will be observed compared to the participants who receive rent subsidies only (control group) by the primary endpoint of 18 months of study participation.\n\nIt is hypothesized that, for the secondary outcome measures of social connectedness, hope, and academic and vocational participation:\n\n1. Better mean scores (social connectedness and hope) in the intervention group relative to participants in the control group will be observed by 18 months of study participation.\n2. Participants in the intervention group will be more likely than the control group to demonstrate sustained engagement in academic and vocational activities (education, employment, and/or skills training) by 18 months of study participation.\n\nThis pilot will be the first to test the impact of economic and social supports on meaningful social integration for formerly homeless young people living in market rent housing.', 'detailedDescription': 'The overarching aim of this mixed methods study is to assess whether and how rent subsidies and mentorship influence social integration outcomes for formerly homeless young people living in market rent housing in three urban settings.\n\nSpecifically, the objectives of this study are to:\n\n1. Determine whether rent subsidies plus mentorship results in better social integration outcomes than only receiving rent subsidies with respect to: a) community integration (psychological and physical); and b) self-esteem at the primary endpoint of 18 months.\n2. Determine whether rent subsidies plus mentorship results in better social integration outcomes than only receiving rent subsidies with respect to: a) social connectedness; b) hope; and c) sustained academic and vocational participation at 18 months.\n3. Explore whether rent subsidies plus mentorship results in better social integration outcomes than only receiving rent subsidies with respect to: a) income; b) perceived housing quality; c) psychiatric symptoms; and d) sense of engulfment at 18 months.\n4. Integrate qualitative data to facilitate a fuller understanding of the quantitative data and deepen understanding of what the study participants (young people and mentors) found most beneficial about the intervention and how it could be improved.\n\nThis study will employ a convergent mixed methods design (i.e., quantitative and qualitative data are collected concurrently, and the findings combined) embedded within a randomized controlled trial (RCT) and a community-based participatory action research (CBPAR) framework. A mixed methods RCT is appropriate given the complex explanatory pathways (i.e., social and behavioral processes that may act independently and interdependently) of this intervention. In addition, the qualitative data will provide insights on contextual factors that may impact the external validity of the findings. Most importantly, this design provides a crucial (and under utilized) youth-informed perspective on social integration.\n\nThe study will be conducted in three Canadian cities: Toronto, Ontario (pop. 2.8 million); Hamilton, Ontario (pop. 552,000); and St. Catharines, Ontario (pop. 133,000). All of the study participants (n = 24) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as a part of the intervention. This study includes funding for the rent subsidies and will be paid directly to the landlords by the community partners. St. Michael\'s Hospital will establish a service provider agreement with each of the community partners for this purpose. Participants in the intervention group (n = 12) will be matched with an adult mentor recruited by one of the community partners.\n\nThe mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a \'coach\' or \'cheerleader\' role) to assist with mainstream integration. To facilitate more of an organic, natural mentor-mentee relationship, the mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. For example, they will not be mandated to attend shelter-based social events. Instead, mentors will be encouraged to initiate activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus, touring a local library, or visiting the mentor\'s place of employment during business hours). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.\n\nCommunity partners will match all participants with an outreach worker (already employed by each agency) who will communicate regularly with the research team, help ensure the rent subsidies are being distributed appropriately, maintain an ongoing relationship with the study participants, and monitor for \'red flags\' in participants matched in mentor-mentee relationships (e.g., mentee reluctant to meet with their mentor). Matching all of the study participants with a worker will also help ensure that everyone is receiving a fairly equal level of social support from community partners, making it easier for the research team to discern whether the outcomes of interest are more likely attributable to mentorship rather than to varied levels of agency-based support. Moreover, a review of services and interventions designed to reduce "problem behaviors" (e.g., substance use and risky sexual practices) among street-involved and homeless young people (ages 12 - 24) found that researchers who had strong relationships with outreach workers and the community had more effective interventions and lower attrition rates than those who did not.\n\nFollowing the baseline interview, participants at each of the three study sites (Toronto (n=12), Hamilton (n=6), and St. Catharine\'s (n=6)) will be randomized using block randomization to either the intervention (rent subsidies plus mentoring) or control (rent subsidies only) group. Randomization will be balanced by site based on random block sizes of two and four. The advantage of using block randomization is to uniformly distribute participants into treatment groups within each site. Because small block sizes may increase the risk of guessing the allocation procedure and subsequently introducing bias into the enrolment procedure, random block sizes will be used to avoid this potential selection bias. A unique randomization schedule will be produced for each site using SAS. A research coordinator not affiliated with the study will be the only person with access to the randomization schedule. The research coordinator will prepare sealed, opaque and sequentially numbered envelopes with the randomization results of participants. After assessing for eligibility and obtaining consent of each participant, research personnel responsible for enrolling participants will open the next randomization envelope from the sequentially ordered randomization envelope file to obtain the participant\'s randomized group assignment.\n\nQuantitative data will be collected at six points in time over the course of 30 months: baseline, month six, month 12, month 18, month 24, and month 30. Qualitative measures are an important feature of this study and will consist of: 1) semi-structured individual interviews (study participants) and 2) focus groups (mentors). At baseline, twelve participants (six from each arm of the study) will be invited to participate in six semi-structured individual interviews, which will take place at the same time as the quantitative data collection: baseline, month six, month 12, month 18, month 24, and month 30. Participants will be purposively selected with a goal of having input from each of the three communities and a fairly equal gender and ethno-racial representation. All of the mentors (n = 12) will be invited to participate in two focus groups, which will take place at month 12 and month 24.\n\nAll analyses will be performed using the intention-to-treat principle; that is, all participants will be included and analyzed in the groups they were originally randomized. Baseline characteristics of the intervention and control groups will be summarized using descriptive statistics (i.e., mean, standard deviation, median and interquartile range for continuous variables, and frequencies and proportions for categorical variables). The descriptive statistics for outcomes at each study time point will be calculated, and differences in trajectories from baseline to 30 months follow-up between intervention and control groups using scatterplots and box-plots will be explored. Differences with 95% confidence intervals in continuous outcomes at 18 months (psychological community integration, self-esteem, social connectedness, hope, perceived housing quality, psychiatric symptoms, and sense of engulfment) between participants who received rent subsidies plus mentorship and participants who only received rent subsidies will be estimated using Analysis of Covariance (i.e., linear regression models), including an indicator of intervention group and the baseline value of the outcome. Regression diagnostics will be performed and analyses using the non-parametric Wilcoxon rank-sum test will be repeated if there are extreme outliers or influential observations. Groups will be compared with respect to count outcomes at 18 months (physical community integration) using graphical tools and the non-parametric Wilcoxon rank-sum test. For binary outcomes at 18 months (sustained academic and vocational participation, and income above low income cut-off ), differences in proportions with 95% confidence intervals will be estimated and tested using the chi-square or Fisher\'s exact test. Given the small sample size of this pilot randomized trial, all results will be interpreted with caution and with the intention of generating data and hypotheses for conducting a larger trial.\n\nGiven the emergent, iterative nature of research using a qualitative design, data analysis and interpretation will begin immediately after the first qualitative data generation session (at baseline). The semi-structured individual interviews and focus groups will be audio recorded and transcribed verbatim. In order to conduct a more nuanced analysis of the data, the transcriptionist will be instructed to note short responses, uncooperative tones, and literal silence. Prior to each subsequent qualitative data generation session, members of the research team will conduct a preliminary data analysis, reading the interview transcripts multiple times, separating the data into coded segments, making analytic memos beside sections of the transcripts, identifying emerging themes (and comparing/contrasting these between respondents), and compiling new questions. Those participating in the individual interviews and the focus groups will be asked for their perspectives on the emerging interpretations at each visit and these perspectives will play a key role in helping shape the data analysis and help ensure the trustworthiness of the data. The web-based application Dedoose will be utilized to assist with sorting and coding the qualitative data.\n\nIn keeping with CBPAR methodology, disseminating evidence with community partners is key in building community capacity and improving the lives of the young people participating in this study. Moreover, given the use of Critical Social Theory, the study findings will not only be presented, but will also be used to expose and explicate the relational processes (e.g., subjective experience of low socioeconomic position and low social class) that may be preventing formerly homeless young people from achieving meaningful social integration. With an emphasis on \'actionable\' data, the findings will be disseminated broadly to both academic and community-based audiences in a variety of formats ranging from scientific journal papers to oral presentations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between ages 18-26\n* Left homelessness within the past year\n* Living in market rent housing\n* Plan on staying in or nearby the community in which they were recruited (Toronto, Hamilton, or St. Catharines) for the duration of the 24-month study\n* Be willing to be matched with an adult mentor who has been screened and chosen by one of the community partners\n\nExclusion Criteria:\n\n* In imminent danger of losing their housing (e.g., facing jail time or impending eviction)\n* Enrolled in another study with enhanced financial and social supports\n* Unable to provide free and informed consent\n* Unable to communicate fluently in English'}, 'identificationModule': {'nctId': 'NCT03779204', 'briefTitle': 'Effect of a Rent Subsidy and Mentoring on Youth Transitioning Out of Homelessness', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Transitioning Youth Out of Homelessness: A Mixed Methods Community-Based Pilot Randomized Controlled Trial of a Rent Subsidy and Mentoring Intervention in Three Canadian Cities', 'orgStudyIdInfo': {'id': '18-251'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rent subsidies + Mentorship', 'description': 'Participants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners.', 'interventionNames': ['Behavioral: Mentorship', 'Behavioral: Rent Subsidies']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rent subsidies only', 'description': 'Participants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship.', 'interventionNames': ['Behavioral: Rent Subsidies']}], 'interventions': [{'name': 'Mentorship', 'type': 'BEHAVIORAL', 'description': "The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.", 'armGroupLabels': ['Rent subsidies + Mentorship']}, {'name': 'Rent Subsidies', 'type': 'BEHAVIORAL', 'description': "Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months.", 'armGroupLabels': ['Rent subsidies + Mentorship', 'Rent subsidies only']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Naomi S Thulien, RN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Covenant House Toronto', 'class': 'OTHER'}, {'name': 'Living Rock Ministries', 'class': 'OTHER'}, {'name': 'Resource Association for Teens', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}