Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT04525703
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2020-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pathways for Parents After Incarceration Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000987', 'term': 'Antisocial Personality Disorder'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'paja.charles@wisc.edu', 'phone': '608-263-3834', 'title': 'Pajarita Charles, PhD', 'organization': 'University of Wisconsin - Madison'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 21 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Children', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Eligible Fathers and Caregivers Who Consent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': 'The feasibility of this approach will in part be measured by successful recruitment of participants from this population. This is measured by the proportion of eligible fathers and caregivers who consent to study participation and enrollment.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': '43 Fathers were eligible, 23 consented and started the study'}, {'type': 'PRIMARY', 'title': 'Proportion of Enrolled Fathers and Caregivers Who Complete Entire Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000'}, {'value': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 9 weeks', 'description': 'The feasibility of this approach will in part be measured by the retention of participants in this intervention. This is measured by the proportion of enrolled fathers and caregivers who participate in the first intervention class (after baseline) and complete entire intervention.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This combined criteria (enrolled AND participated in the first intervention class) changes the baseline N to something smaller (n=16, not n=21)'}, {'type': 'PRIMARY', 'title': 'Provider Adherence Measured by the Parenting Inside Out Group Observation Feedback Form Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathways for Parents', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'title': 'Overall Fidelity', 'categories': [{'measurements': [{'value': '4.46', 'spread': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'Curriculum Delivery & Fidelity Subscale', 'categories': [{'measurements': [{'value': '4.57', 'spread': '0.14', 'groupId': 'OG000'}]}]}, {'title': 'Facilitation Skills Subscale', 'categories': [{'measurements': [{'value': '4.55', 'spread': '0.04', 'groupId': 'OG000'}]}]}, {'title': 'Behavior Support and Group Management Subscale', 'categories': [{'measurements': [{'value': '4.86', 'spread': '0.14', 'groupId': 'OG000'}]}]}, {'title': 'Interpersonal Skills Subscale', 'categories': [{'measurements': [{'value': '5.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'PIO Specific Skills Subscale', 'categories': [{'measurements': [{'value': '4.17', 'spread': '0.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 9 weeks', 'description': 'Adherence is measured using the Parenting Inside Out (PIO) Group Observation Feedback Form to assess program integrity and fidelity to the model. This is a 35-item survey that assesses 5 domains: curriculum delivery and fidelity; facilitation skills, behavior support and group management; interpersonal skills, and PIO specific items. Each item is scored on a scale of 1-5 where 1 is remediation needed, 2 is growth area, 3 is developing, 4 is effective, and 5 is highly effective. Average scores from each domain are reported for a total possible range of scores 1-5, higher scores indicate better adherence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Team stopped collecting this survey after 3 responses as it was determined to be burdensome for the participant and not useful for the investigation.'}, {'type': 'PRIMARY', 'title': 'Acceptability of Intervention Assessed by Providers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Providers', 'description': 'Providers for the Pathways for Parents after Incarceration Program.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.43', 'spread': '0.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 9 weeks', 'description': 'Acceptability is assessed by interventionists using an overall rating of the content delivered to participants each week.\n\nThe overall score is rated on a scale of 1=poor to 10=excellent, with higher scores indicating greater acceptability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Providers were not consented to the study, but were surveyed for acceptability of the intervention.'}, {'type': 'PRIMARY', 'title': 'Self-Perceived Helpfulness of the Program for the Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.67', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '4.71', 'spread': '0.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 21 weeks', 'description': 'Acceptability and usefulness of the intervention is assessed in part by a series of questions that ascertain perceived helpfulness of program for the participant.\n\nHow helpful was the parenting program for you? 1= Not at all helpful, 2=A little helpful, 3=Somewhat helpful, 4=Quite helpful, 5=Very helpful', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant-Perceived Helpfulness of the Program for the Participant's Child", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks'}, {'id': 'OG001', 'title': 'Caregiver', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.90', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '4.43', 'spread': '0.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 21 weeks', 'description': 'Acceptability and usefulness of the intervention is assessed in part by a series of questions that ascertain perceived helpfulness of program for the participant.\n\n"Overall, do you think your participation in this program has had any effect on your child?" 1=has had a very negative effect, 5=has had a very positive effect.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There are missing data from 2 participants in the Fathers group.'}, {'type': 'PRIMARY', 'title': 'Acceptability of Intervention Assessed by Participant Recommendation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.83', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 21 weeks', 'description': 'Acceptability and usefulness of the intervention is assessed in part by a series of questions that ascertain whether participants would recommend the program to other people.\n\nWould you recommend this program to other parents? 1=Strongly recommend, 2=Recommend, 3=Neutral, 4=Not recommend, 5=Strongly not recommend', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Acceptability of Intervention Assessed by Parent Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.64', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '4.57', 'spread': '0.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 21 weeks', 'description': 'Acceptability and usefulness is assessed by a series of questions that ascertain parent satisfaction.\n\nQ: How much has the Parenting Inside Out classes changed how happy and satisfied you are with being a parent to your child? 1=none, 2=A little, 3=Some, 4=A lot, 5=Very much', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant in the Fathers group did not answer the survey item.'}, {'type': 'SECONDARY', 'title': 'Inventory of Family Feelings Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'title': 'Pre-test', 'categories': [{'measurements': [{'value': '16.0', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '16.14', 'spread': '2.06', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '14.17', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '15.57', 'spread': '0.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': "Family interactions \\& relationships will be assessed with the 38-item Inventory of Family Feelings to assess fathers' and caregivers' perceptions of their relationship with another and with their children. Scores range from 0-38, with higher scores indicating more positive affect toward family members and lower scores reflecting conflicted relationships.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Coparenting Relationship Scale Score: Undermining Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'title': 'Pre-test', 'categories': [{'measurements': [{'value': '6.6', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '6.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'The Undermining subscale of the Coparenting Relationship Scale contains 3-items, scored on a scale of 1=strongly disagree to 5=strongly agree. Change in summed score will be reported (between 3-15) with lower scores indicative of a stronger coparenting relationship.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Coparenting Relationship Scale Score: Alliance Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'title': 'Pre-test', 'categories': [{'measurements': [{'value': '18.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '18.8', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '21.4', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'The Alliance subscale of the Coparenting Relationship Scale contains 5-items, scored on a scale of 1=strongly disagree to 5=strongly agree. Change in summed score will be reported (between 5-25) with higher scores indicative of a stronger coparenting relationship.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Coparenting Relationship Scale Score: Gatekeeping Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'title': 'Pre-test', 'categories': [{'measurements': [{'value': '5.5', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '5.2', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'The Gatekeeping subscale of the Coparenting Relationship Scale contains 3 items, scored on a scale of 1=strongly disagree to 5=strongly agree. Change in summed score will be reported (between 3-15) with lower scores are indicative of a stronger coparenting relationship.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Kansas Parenting Satisfaction Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'title': 'Pre-test', 'categories': [{'measurements': [{'value': '16.8', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '1.45', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '15.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '1.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'Parenting Satisfaction will be assessed with a 3-item scale, Kansas Parenting Satisfaction Scale. Items are scored on a scale of 1=extremely dissatisfied to 7=extremely satisfied. Change in summed score will be reported (between 3-21) with higher scores indicative of higher levels of parenting satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parenting Sense of Competence Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'title': 'Pre-test', 'categories': [{'measurements': [{'value': '78.8', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '74.7', 'spread': '5.12', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '76.4', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '76.7', 'spread': '5.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'Parenting competence assessed with the 17-item Parenting Sense of Competence Scale. Items are scored on a scale of 1=strongly disagree to 6=strongly agree. Scores range from 17-102, with higher scores indicative of a stronger sense of competence, satisfaction and efficacy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Alliance Measure Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'title': 'Pre-test', 'categories': [{'measurements': [{'value': '80.1', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '87.1', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '82.4', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '83.4', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'Parenting alliance is assessed with the 20-items self-report Parenting Alliance Measure. Items are scored on a 5-point rating scale ranging from 1=strongly disagree to 5=strongly agree. Change in summed score will be reported (between 20-100), with higher scores reflecting stronger coparenting alliances between people.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Child-Parent Relationship Scale (CPRS) Score: Conflict Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'title': 'Pre-test', 'categories': [{'measurements': [{'value': '19.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '17.86', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '18.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': "Assessed with the 15-item Child-Parent Relationship Scale-Short Form to assess perceptions of participants' relationship with their children. The Conflict subscale contains 8-items, scored on a scale of 1=definitely does not apply to 5=definitely applies. Change in summed scores (between 8 and 40) for each subscale over time will be reported, higher scores on each subscale (closeness, conflict) indicative of higher levels of each dimension.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Child-Parent Relationship Scale (CPRS) Score: Closeness Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'title': 'Pre-test', 'categories': [{'measurements': [{'value': '30.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '31.1', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '30.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '29.43', 'spread': '2.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': "Assessed with the 15-item Child-Parent Relationship Scale-Short Form to assess perceptions of participants' relationship with their children. The Closeness subscale contains 7-items, scored on a scale of 1=definitely does not apply to 5=definitely applies. Change in summed scores (between 7 and 35) for each subscale over time will be reported, higher scores on each subscale (closeness, conflict) indicative of higher levels of each dimension.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohen Perceived Stress Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'title': 'Pre-test', 'categories': [{'measurements': [{'value': '34.2', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '33.57', 'spread': '2.99', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '32.0', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '33.71', 'spread': '2.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'Stress will be assessed with the 10-item Cohen Perceived Stress Scale. Items are scored on a scale of 0=never to 4=very often. Change in summed score (between 0-40) will be reported, with higher scores reflecting higher levels of stress experienced by the participant.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Center for Epidemiologic Studies Depression (CESD) Depression Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'OG001', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}], 'classes': [{'title': 'Pre-test', 'categories': [{'measurements': [{'value': '15.0', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '9.71', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '12.8', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '10.86', 'spread': '3.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'Depression will be assessed with the CESD Depression Scale. Items are scored on a scale of 0=rarely or none of the time (or less than 1 day) to 3=most or all of the time (5-7 days). Change in summed score (between 0-60) will be reported, with higher scores indicating the presence of more depression symptomology.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'FG001', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks'}, {'id': 'FG002', 'title': 'Children', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Completed Baseline Interview', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Attended Any of the P4P Program', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Completed P4P Program', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Completed Post Intervention Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Completed 3-month Follow up Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'The Pathways for Parents after Incarceration Program study was conducted between September 2020 and March 2022 during the COVID-19 pandemic.', 'preAssignmentDetails': '51 Fathers were assessed for eligibility, 43 were eligible, 21 consented and started the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Caregivers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'BG001', 'title': 'Fathers', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'BG002', 'title': 'Children', 'description': 'Pathways for Parents after Incarceration: The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time Since Incarceration', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Caregivers Not Incarcerated', 'groupId': 'BG000'}, {'value': '8', 'spread': '13.94', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Children Not Incarcerated', 'groupId': 'BG002'}, {'value': '8', 'spread': '13.94', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-31', 'size': 445549, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-31T14:25', 'hasProtocol': True}, {'date': '2021-09-10', 'size': 138688, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-05-19T10:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2020-08-20', 'resultsFirstSubmitDate': '2023-03-31', 'studyFirstSubmitQcDate': '2020-08-20', 'lastUpdatePostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-15', 'studyFirstPostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Eligible Fathers and Caregivers Who Consent', 'timeFrame': 'baseline', 'description': 'The feasibility of this approach will in part be measured by successful recruitment of participants from this population. This is measured by the proportion of eligible fathers and caregivers who consent to study participation and enrollment.'}, {'measure': 'Proportion of Enrolled Fathers and Caregivers Who Complete Entire Intervention', 'timeFrame': 'up to 9 weeks', 'description': 'The feasibility of this approach will in part be measured by the retention of participants in this intervention. This is measured by the proportion of enrolled fathers and caregivers who participate in the first intervention class (after baseline) and complete entire intervention.'}, {'measure': 'Provider Adherence Measured by the Parenting Inside Out Group Observation Feedback Form Score', 'timeFrame': 'up to 9 weeks', 'description': 'Adherence is measured using the Parenting Inside Out (PIO) Group Observation Feedback Form to assess program integrity and fidelity to the model. This is a 35-item survey that assesses 5 domains: curriculum delivery and fidelity; facilitation skills, behavior support and group management; interpersonal skills, and PIO specific items. Each item is scored on a scale of 1-5 where 1 is remediation needed, 2 is growth area, 3 is developing, 4 is effective, and 5 is highly effective. Average scores from each domain are reported for a total possible range of scores 1-5, higher scores indicate better adherence.'}, {'measure': 'Acceptability of Intervention Assessed by Providers', 'timeFrame': 'up to 9 weeks', 'description': 'Acceptability is assessed by interventionists using an overall rating of the content delivered to participants each week.\n\nThe overall score is rated on a scale of 1=poor to 10=excellent, with higher scores indicating greater acceptability.'}, {'measure': 'Self-Perceived Helpfulness of the Program for the Participant', 'timeFrame': 'up to 21 weeks', 'description': 'Acceptability and usefulness of the intervention is assessed in part by a series of questions that ascertain perceived helpfulness of program for the participant.\n\nHow helpful was the parenting program for you? 1= Not at all helpful, 2=A little helpful, 3=Somewhat helpful, 4=Quite helpful, 5=Very helpful'}, {'measure': "Participant-Perceived Helpfulness of the Program for the Participant's Child", 'timeFrame': 'up to 21 weeks', 'description': 'Acceptability and usefulness of the intervention is assessed in part by a series of questions that ascertain perceived helpfulness of program for the participant.\n\n"Overall, do you think your participation in this program has had any effect on your child?" 1=has had a very negative effect, 5=has had a very positive effect.'}, {'measure': 'Acceptability of Intervention Assessed by Participant Recommendation', 'timeFrame': 'up to 21 weeks', 'description': 'Acceptability and usefulness of the intervention is assessed in part by a series of questions that ascertain whether participants would recommend the program to other people.\n\nWould you recommend this program to other parents? 1=Strongly recommend, 2=Recommend, 3=Neutral, 4=Not recommend, 5=Strongly not recommend'}, {'measure': 'Acceptability of Intervention Assessed by Parent Satisfaction', 'timeFrame': 'up to 21 weeks', 'description': 'Acceptability and usefulness is assessed by a series of questions that ascertain parent satisfaction.\n\nQ: How much has the Parenting Inside Out classes changed how happy and satisfied you are with being a parent to your child? 1=none, 2=A little, 3=Some, 4=A lot, 5=Very much'}], 'secondaryOutcomes': [{'measure': 'Inventory of Family Feelings Score', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': "Family interactions \\& relationships will be assessed with the 38-item Inventory of Family Feelings to assess fathers' and caregivers' perceptions of their relationship with another and with their children. Scores range from 0-38, with higher scores indicating more positive affect toward family members and lower scores reflecting conflicted relationships."}, {'measure': 'Coparenting Relationship Scale Score: Undermining Subscale', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'The Undermining subscale of the Coparenting Relationship Scale contains 3-items, scored on a scale of 1=strongly disagree to 5=strongly agree. Change in summed score will be reported (between 3-15) with lower scores indicative of a stronger coparenting relationship.'}, {'measure': 'Coparenting Relationship Scale Score: Alliance Subscale', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'The Alliance subscale of the Coparenting Relationship Scale contains 5-items, scored on a scale of 1=strongly disagree to 5=strongly agree. Change in summed score will be reported (between 5-25) with higher scores indicative of a stronger coparenting relationship.'}, {'measure': 'Coparenting Relationship Scale Score: Gatekeeping Subscale', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'The Gatekeeping subscale of the Coparenting Relationship Scale contains 3 items, scored on a scale of 1=strongly disagree to 5=strongly agree. Change in summed score will be reported (between 3-15) with lower scores are indicative of a stronger coparenting relationship.'}, {'measure': 'Kansas Parenting Satisfaction Scale Score', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'Parenting Satisfaction will be assessed with a 3-item scale, Kansas Parenting Satisfaction Scale. Items are scored on a scale of 1=extremely dissatisfied to 7=extremely satisfied. Change in summed score will be reported (between 3-21) with higher scores indicative of higher levels of parenting satisfaction.'}, {'measure': 'Parenting Sense of Competence Scale Score', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'Parenting competence assessed with the 17-item Parenting Sense of Competence Scale. Items are scored on a scale of 1=strongly disagree to 6=strongly agree. Scores range from 17-102, with higher scores indicative of a stronger sense of competence, satisfaction and efficacy.'}, {'measure': 'Alliance Measure Score', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'Parenting alliance is assessed with the 20-items self-report Parenting Alliance Measure. Items are scored on a 5-point rating scale ranging from 1=strongly disagree to 5=strongly agree. Change in summed score will be reported (between 20-100), with higher scores reflecting stronger coparenting alliances between people.'}, {'measure': 'Child-Parent Relationship Scale (CPRS) Score: Conflict Subscale', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': "Assessed with the 15-item Child-Parent Relationship Scale-Short Form to assess perceptions of participants' relationship with their children. The Conflict subscale contains 8-items, scored on a scale of 1=definitely does not apply to 5=definitely applies. Change in summed scores (between 8 and 40) for each subscale over time will be reported, higher scores on each subscale (closeness, conflict) indicative of higher levels of each dimension."}, {'measure': 'Child-Parent Relationship Scale (CPRS) Score: Closeness Subscale', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': "Assessed with the 15-item Child-Parent Relationship Scale-Short Form to assess perceptions of participants' relationship with their children. The Closeness subscale contains 7-items, scored on a scale of 1=definitely does not apply to 5=definitely applies. Change in summed scores (between 7 and 35) for each subscale over time will be reported, higher scores on each subscale (closeness, conflict) indicative of higher levels of each dimension."}, {'measure': 'Cohen Perceived Stress Scale Score', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'Stress will be assessed with the 10-item Cohen Perceived Stress Scale. Items are scored on a scale of 0=never to 4=very often. Change in summed score (between 0-40) will be reported, with higher scores reflecting higher levels of stress experienced by the participant.'}, {'measure': 'Center for Epidemiologic Studies Depression (CESD) Depression Scale Score', 'timeFrame': 'Baseline (pre-test), 9 weeks (post-test)', 'description': 'Depression will be assessed with the CESD Depression Scale. Items are scored on a scale of 0=rarely or none of the time (or less than 1 day) to 3=most or all of the time (5-7 days). Change in summed score (between 0-60) will be reported, with higher scores indicating the presence of more depression symptomology.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['incarceration', 'antisocial behavior', 'family', 'child development'], 'conditions': ['Parenting', 'Development, Child', 'Behavior']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn how to better support fathers and their families after incarceration. It will test an intervention that promotes healthy development for children of previously incarcerated fathers and the caregivers of their children for empirical promise through a pilot feasibility trial. The aims of the pilot are to demonstrate: a) client acceptance of the treatment (e.g., retention), b) ability to recruit sufficient numbers of participants, and c) feasibility of delivery with the clients and therapists in the designated treatment settings. About 15 families (15 fathers, 15 caregivers, and 15-20 children, totaling 45-50 participants) will be in the study.', 'detailedDescription': "The purpose of the overall study, Promoting Healthy Development among Children of Fathers with Antisocial Behavior, is to build and test a preventive family-focused intervention in a feasibility study that promotes healthy development for children of previously incarcerated fathers and the caregivers of their children. The study has three specific aims, two of which have already been completed. The first was to conduct secondary data analyses to explore a series of questions that explored topics including fathers' history of antisocial behavior and criminality, children's psycho-social and behavioral health outcomes, father engagement and parenting behavior, maternal parenting practices, quality of parental relationship, and extended family involvement. The second aim included conducting semi-structured interviews with fathers, mothers, and relatives to improve understanding of the barriers to father engagement and challenges that families face as fathers return to the community following incarceration.\n\nTo that end, this protocol situates itself within the third and final aim, that of specifying treatment procedures (e.g., develop manuals, select measures, specify therapist training and adherence procedures) and establishing feasibility of the intervention (e.g., recruitment, enrollment, fidelity, adherence, retention, and safety). Specifically, this protocol is in regard to the feasibility of the intervention. The purpose is to test the intervention for empirical promise through a pilot feasibility trial. The aims of the pilot are to demonstrate: a) client acceptance of the treatment (e.g., retention), b) ability to recruit sufficient numbers of participants, and c) feasibility of delivery with the clients and therapists in the designated treatment settings.\n\nThe family intervention is based in a family systems model that includes all members of the family. Multiple family groups are used because previous research has found they are efficient forms of service delivery, build social support among participants, and improve parent-child interactions. Feasibility of the pilot must include all participants anticipated in the program model to test strategies, logistics, and measures. Drawing from the framework of dissemination and implementation science, another central purpose of the pilot is to refine the operational methods that will facilitate translation and implementation in the future should the intervention be found efficacious and effective. This pilot will answer questions that are pertinent to intervention development, as well as the success of dissemination and implementation in the future.\n\nThe Intervention:\n\nPathways for Parents after Incarceration (P4P) is a community-based program that seeks to equip fathers with the skills both for positive father engagement and reentry success. It uses a manualized curriculum that is adapted from a prison-based program, Parenting Inside Out (PIO). PIO is an evidence-based, cognitive-behavioral parent management skills training program created for incarcerated parents through a six-year collaboration of scientists, policy makers, practitioners, and instructional designers. Both the information in the program and the way that information is presented were informed by knowledge derived from research and practice. Extracted from the full 90-hour version, the Pathways for Parents after Incarceration program uses eight key lessons from the original version that have been identified by the research team and those with lived experience as being most beneficial to them. These include topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The course is led by 2 parent coaches who will be interviewed by program leaders and formally trained to deliver PIO by the PIO parent organization, The Pathfinder Network. The classroom-based PIO sessions will be delivered over 8 weeks in two-hour sessions.\n\nIn addition to the classroom component that PIO provides, the program will offer a therapeutic component. Weekly, those receiving services from Pathways for Parents after Incarceration will be invited to take part in a peer support group-style group session led by an esteemed provider within the community, Anesis Family Therapy. This component of the program is rooted in systems therapy and uses narrative therapy, trauma focused cognitive therapy, and motivational interviewing techniques. This aspect promotes fathers' and caregivers' ability to identify their values and skills so they can effectively confront the challenges (both instrumental and relational) that they face during their reentry period and as family members working to support the fathers. These sessions run for 45 minutes following the classroom portion.\n\nThe program (both classroom and therapeutic peer support) will be offered weekly on a weekday evening for 8 continuous weeks (the 9th week will be a class graduation/celebration). The sessions will be offered virtually to accommodate safety protocols related to the COVID-19 pandemic."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (fathers):\n\n* being able to speak and read English\n* having at least one child between the ages of 3 and 17-years-old\n* having been released from incarceration within the last 5 years (from county jail or state/federal prison)\n* play a parenting role in at least some way (e.g., residence, contact, phone, etc.)\n\nInclusion Criteria (caregivers):\n\n* able to speak and read English\n* at least 18-years-old\n\nExclusion Criteria:\n\n* have been convicted of a crime against any of his children\n* are prevented from having contact with their child'}, 'identificationModule': {'nctId': 'NCT04525703', 'briefTitle': 'Pathways for Parents After Incarceration Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Intervention Feasibility Study - Fatherhood After Prison: Healthy Children and Families', 'orgStudyIdInfo': {'id': '2020-0144'}, 'secondaryIdInfos': [{'id': 'A488200', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'L&S/SOCIAL WORK/SOC WORK', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '4R00HD081273-03', 'link': 'https://reporter.nih.gov/quickSearch/4R00HD081273-03', 'type': 'NIH'}, {'id': 'Protocol Version 7/8/2021', 'type': 'OTHER', 'domain': 'HSIRB, UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pathways for Parents', 'interventionNames': ['Behavioral: Pathways for Parents after Incarceration']}], 'interventions': [{'name': 'Pathways for Parents after Incarceration', 'type': 'BEHAVIORAL', 'description': 'The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.', 'armGroupLabels': ['Pathways for Parents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53706', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Pajarita Charles, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}