Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-29 @ 4:04 PM
Study NCT ID:
NCT03858803
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2019-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving the Reproductive Health of Families
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'janetsstlawrence@gmail.com', 'phone': '971-978-7801', 'title': 'Dr. Janet S. St. Lawrence', 'organization': 'Portland State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'One year follow-up for intervention outcomes was planned; however, the COVID pandemic and associated restrictions interrupted data collection.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'FM2 First, LAST Delayed - Youth', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.', 'otherNumAtRisk': 161, 'deathsNumAtRisk': 161, 'otherNumAffected': 0, 'seriousNumAtRisk': 161, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'FM2 and LAST Simultaneous - Youth', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.', 'otherNumAtRisk': 158, 'deathsNumAtRisk': 158, 'otherNumAffected': 0, 'seriousNumAtRisk': 158, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Comparison Arm - Youth', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 0, 'seriousNumAtRisk': 153, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'FM2 First, LAST Delayed - Parent', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.', 'otherNumAtRisk': 161, 'deathsNumAtRisk': 161, 'otherNumAffected': 0, 'seriousNumAtRisk': 161, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'FM2 and LAST Simultaneous - Parent', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.', 'otherNumAtRisk': 160, 'deathsNumAtRisk': 160, 'otherNumAffected': 0, 'seriousNumAtRisk': 160, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Comparison Arm - Parent', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.', 'otherNumAtRisk': 152, 'deathsNumAtRisk': 152, 'otherNumAffected': 0, 'seriousNumAtRisk': 152, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Frequency of Unprotected Intercourse (Youth)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FM2 First, LAST Delayed', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG001', 'title': 'FM2 and LAST Simultaneous', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG002', 'title': 'Comparison Arm', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.42', 'spread': '3.09', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '1.78', 'groupId': 'OG001'}, {'value': '1.38', 'spread': '2.93', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'MANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Self-reported frequency of unprotected intercourse occasions in past 3 months.', 'unitOfMeasure': 'number of occassions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Reproductive Health Knowledge Test Scores (Youth)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FM2 First, LAST Delayed', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG001', 'title': 'FM2 and LAST Simultaneous', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG002', 'title': 'Comparison Arm', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.79', 'spread': '6.32', 'groupId': 'OG000'}, {'value': '14.66', 'spread': '6.90', 'groupId': 'OG001'}, {'value': '11.37', 'spread': '5.99', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'MANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Measure of knowledge about prevention of STIs, HIV, and pregnancy. Total score range 0-26. No subscales. Higher scores reflect more accurate knowledge.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Condom Barriers Scale(Youth)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FM2 First, LAST Delayed', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG001', 'title': 'FM2 and LAST Simultaneous', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG002', 'title': 'Comparison Arm', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.67', 'spread': '20.08', 'groupId': 'OG000'}, {'value': '57.73', 'spread': '22.30', 'groupId': 'OG001'}, {'value': '66.37', 'spread': '19.12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'MANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Total score range 0 - 140; Higher scores reflect greater perceived barriers to condom use. No subscales', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Attitudes Toward Transactional Sex Scale (Youth)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FM2 First, LAST Delayed', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG001', 'title': 'FM2 and LAST Simultaneous', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG002', 'title': 'Comparison Arm', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.67', 'spread': '12.93', 'groupId': 'OG000'}, {'value': '20.44', 'spread': '13.49', 'groupId': 'OG001'}, {'value': '23.18', 'spread': '14.70', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'MANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Total score range 0 - 120, No subscales, Higher scores reflect more acceptance of transactional sex', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Number of Sex Partners (Youth)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FM2 First, LAST Delayed', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG001', 'title': 'FM2 and LAST Simultaneous', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG002', 'title': 'Comparison Arm', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '2.09', 'groupId': 'OG001'}, {'value': '2.14', 'spread': '3.59', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'MANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change in self-reported numbers of sex partners in past two months', 'unitOfMeasure': 'number of sex partners', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes on Family Communication Scale (Youth)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FM2 First, LAST Delayed', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG001', 'title': 'FM2 and LAST Simultaneous', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG002', 'title': 'Comparison Arm', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.89', 'spread': '14.58', 'groupId': 'OG000'}, {'value': '24.33', 'spread': '14.53', 'groupId': 'OG001'}, {'value': '20.73', 'spread': '13.82', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'MANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Total scale range 0-52, No subscales, Higher scores reflect more frequent communication between parent and child frequency', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Scores on the Condom Attitudes Scale (Youth)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FM2 First, LAST Delayed', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG001', 'title': 'FM2 and LAST Simultaneous', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG002', 'title': 'Comparison Arm', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.40', 'spread': '26.50', 'groupId': 'OG000'}, {'value': '96.65', 'spread': '31.00', 'groupId': 'OG001'}, {'value': '92.09', 'spread': '26.85', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'MANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Total scale score range 0-144, No subscales, Higher scores reflect more positive attitudes toward condom use', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Scores on Self Efficacy Beliefs Scale (Youth)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FM2 First, LAST Delayed', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG001', 'title': 'FM2 and LAST Simultaneous', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG002', 'title': 'Comparison Arm', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.99', 'spread': '47.29', 'groupId': 'OG000'}, {'value': '71.82', 'spread': '52.68', 'groupId': 'OG001'}, {'value': '67.83', 'spread': '52.05', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'MANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Total scale score range 0-160, No subscales, Higher scores reflect endorsement of greater self efficacy beliefs', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes on Parental Responsiveness Scale (Youth)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FM2 First, LAST Delayed', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG001', 'title': 'FM2 and LAST Simultaneous', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG002', 'title': 'Comparison Arm', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.06', 'spread': '3.72', 'groupId': 'OG000'}, {'value': '6.41', 'spread': '3.59', 'groupId': 'OG001'}, {'value': '5.23', 'spread': '3.70', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'MANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Total scale score range 0-11, No subscales, Higher scores reflect reports of greater parental responsiveness', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Parent Use of Positive Reinforcement Scale (Youth)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FM2 First, LAST Delayed', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG001', 'title': 'FM2 and LAST Simultaneous', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG002', 'title': 'Comparison Arm', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.95', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '5.92', 'spread': '3.23', 'groupId': 'OG001'}, {'value': '5.78', 'spread': '3.26', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'MANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Total score range 0-12, No Subscales, Higher score reflect reports of more frequent use of positive reinforcement by parents', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Parental Monitoring Scale (Youth)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FM2 First, LAST Delayed', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG001', 'title': 'FM2 and LAST Simultaneous', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'OG002', 'title': 'Comparison Arm', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.67', 'spread': '3.92', 'groupId': 'OG000'}, {'value': '9.82', 'spread': '4.43', 'groupId': 'OG001'}, {'value': '10.03', 'spread': '3.93', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'MANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 month', 'description': 'Total scale score range 0-16, No subscales, Higher scores reflect report of greater parental monitoring', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FM2 First, LAST Delayed - Youth', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'FG001', 'title': 'FM2 First, LAST Delayed - Parents', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'FG002', 'title': 'FM2 and LAST Simultaneous - Youth', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'FG003', 'title': 'FM2 and LAST Simultaneous - Parents', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'FG004', 'title': 'Comparison Arm - Youth', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'FG005', 'title': 'Comparison Arm - Parents', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '161'}, {'groupId': 'FG002', 'numSubjects': '158'}, {'groupId': 'FG003', 'numSubjects': '160'}, {'groupId': 'FG004', 'numSubjects': '153'}, {'groupId': 'FG005', 'numSubjects': '152'}]}, {'type': 'Post', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '161'}, {'groupId': 'FG002', 'numSubjects': '158'}, {'groupId': 'FG003', 'numSubjects': '160'}, {'groupId': 'FG004', 'numSubjects': '153'}, {'groupId': 'FG005', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '151'}, {'groupId': 'FG002', 'numSubjects': '153'}, {'groupId': 'FG003', 'numSubjects': '155'}, {'groupId': 'FG004', 'numSubjects': '149'}, {'groupId': 'FG005', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}, {'value': '160', 'groupId': 'BG004'}, {'value': '152', 'groupId': 'BG005'}, {'value': '945', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'FM2 First, LAST Delayed - Youth', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'BG001', 'title': 'FM2 and LAST Simultaneous - Youth', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'BG002', 'title': 'Comparison Arm - Youth', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'BG003', 'title': 'FM2 First, LAST Delayed - Parents', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'BG004', 'title': 'FM2 and LAST Simultaneous - Parents', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.\n\nFamilies Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.\n\nLiving as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.'}, {'id': 'BG005', 'title': 'Comparison Arm - Parents', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '477', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}, {'value': '153', 'groupId': 'BG004'}, {'value': '143', 'groupId': 'BG005'}, {'value': '450', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '15.26', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '15.00', 'spread': '1.7', 'groupId': 'BG002'}, {'value': '41.95', 'spread': '9.12', 'groupId': 'BG003'}, {'value': '38.56', 'spread': '9.34', 'groupId': 'BG004'}, {'value': '41.03', 'spread': '9.79', 'groupId': 'BG005'}, {'value': '27.83', 'spread': '12.74', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}, {'value': '139', 'groupId': 'BG005'}, {'value': '689', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '256', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}, {'value': '160', 'groupId': 'BG004'}, {'value': '152', 'groupId': 'BG005'}, {'value': '945', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Botswana', 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}, {'value': '160', 'groupId': 'BG004'}, {'value': '152', 'groupId': 'BG005'}, {'value': '945', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Parental Monitoring', 'classes': [{'categories': [{'measurements': [{'value': '9.51', 'spread': '3.75', 'groupId': 'BG000'}, {'value': '10.03', 'spread': '4.25', 'groupId': 'BG001'}, {'value': '9.62', 'spread': '4.24', 'groupId': 'BG002'}, {'value': '8.35', 'spread': '4.22', 'groupId': 'BG003'}, {'value': '8.38', 'spread': '4.48', 'groupId': 'BG004'}, {'value': '8.20', 'spread': '4.63', 'groupId': 'BG005'}, {'value': '9.02', 'spread': '.72', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Total scale score range 0-16, No subscales, Higher scores reflect report of greater parental monitoring', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-31', 'size': 83385, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-20T15:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Random assignment to one of three experimental arms:\n\nArm 1: Parents complete intervention immediately, adolescents complete intervention 6 month later Arm 2: Both parents and adolescents participate in intervention simultaneously Arm 3: Comparison condition in which both parents and adolescents are offered their respective interventions after the final assessment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 945}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2019-02-21', 'resultsFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2019-02-27', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-30', 'studyFirstPostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Frequency of Unprotected Intercourse (Youth)', 'timeFrame': '6 month', 'description': 'Self-reported frequency of unprotected intercourse occasions in past 3 months.'}, {'measure': 'Changes in Reproductive Health Knowledge Test Scores (Youth)', 'timeFrame': '6 month', 'description': 'Measure of knowledge about prevention of STIs, HIV, and pregnancy. Total score range 0-26. No subscales. Higher scores reflect more accurate knowledge.'}, {'measure': 'Changes in Condom Barriers Scale(Youth)', 'timeFrame': '6 month', 'description': 'Total score range 0 - 140; Higher scores reflect greater perceived barriers to condom use. No subscales'}, {'measure': 'Change in Attitudes Toward Transactional Sex Scale (Youth)', 'timeFrame': '6 month', 'description': 'Total score range 0 - 120, No subscales, Higher scores reflect more acceptance of transactional sex'}, {'measure': 'Change in Number of Sex Partners (Youth)', 'timeFrame': '6 months', 'description': 'Change in self-reported numbers of sex partners in past two months'}, {'measure': 'Changes on Family Communication Scale (Youth)', 'timeFrame': '6 month', 'description': 'Total scale range 0-52, No subscales, Higher scores reflect more frequent communication between parent and child frequency'}, {'measure': 'Changes in Scores on the Condom Attitudes Scale (Youth)', 'timeFrame': '6 month', 'description': 'Total scale score range 0-144, No subscales, Higher scores reflect more positive attitudes toward condom use'}, {'measure': 'Changes in Scores on Self Efficacy Beliefs Scale (Youth)', 'timeFrame': '6 month', 'description': 'Total scale score range 0-160, No subscales, Higher scores reflect endorsement of greater self efficacy beliefs'}, {'measure': 'Changes on Parental Responsiveness Scale (Youth)', 'timeFrame': '6 month', 'description': 'Total scale score range 0-11, No subscales, Higher scores reflect reports of greater parental responsiveness'}, {'measure': 'Changes in Parent Use of Positive Reinforcement Scale (Youth)', 'timeFrame': '6 month', 'description': 'Total score range 0-12, No Subscales, Higher score reflect reports of more frequent use of positive reinforcement by parents'}, {'measure': 'Changes in Parental Monitoring Scale (Youth)', 'timeFrame': '6 month', 'description': 'Total scale score range 0-16, No subscales, Higher scores reflect report of greater parental monitoring'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'STI', 'Unplanned pregnancy', 'Reproductive health of families', 'Adolescents'], 'conditions': ['Reproductive Health']}, 'descriptionModule': {'briefSummary': 'This research will assess the effectiveness of a parent- and an adolescent- intervention in lowering risk of STIs, HIV, and unintended pregnancies among Batswana youth.', 'detailedDescription': "Youth in Botswana face extraordinary challenges as they transition through adolescence. High rates of teen pregnancy force girls to drop out of school after which few resume their education. Sexually transmitted infections (STIs) are prevalent and the country has the 3rd highest Human Immunodeficiency Virus (HIV) prevalence in the world, with incidence increasing rapidly among adolescents 15-19, peaking at 40.2% HIV seroprevalence at ages 30-34. Traditional methods for sex education through village initiation schools are no longer available and parents are not comfortable with discussions addressing reproductive health within the family. As a result, adolescents have no conduit to educate them about healthy sexual development. This study will recruit 456 families, ½ with a male and ½ with a female adolescent. Families will be randomized to one of three intervention arms. Parents will participate in Families Matter 2! (FM2) and adolescents in Living as a Safer Teen (LAST), both evidence-based interventions that were adapted and pilot tested in Botswana during an earlier R34 award. In Arm 1, the parent will participate in FM2 immediately and the youth will participate in LAST six months later. In Arm 2, both the parent and youth will participant in their respective interventions simultaneously. In Arm 3, the comparison condition, participants will be offered the interventions immediately after the final assessment. Each adolescent and parent will complete assessments in English or Setswana at baseline, post-intervention, and 6- and 12-month follow-ups. Results from a pilot trial of the adapted interventions suggest that these interventions may result in improved family communications, child management skills, knowledge of sexual development, more favorable attitudes toward contraception, less tolerance for intergenerational transactional sex, greater rejection of gender violence, and lower rates of sexual risk behavior by both parents and adolescents. It is further anticipated that youths who are abstinent upon entering the intervention will delay sexual debut to a greater extent than youth in the comparison arm. This proposed study addresses the highest priority in Botswana's current national strategic plan: preventing early pregnancy, STIs and HIV in adolescents. If the proposed randomized controlled trial (RCT) provides strong evidence of effectiveness, the investigators will work with the Ministries of Education, Health, Youth \\& Culture and the Office of the President to disseminate the intervention throughout Botswana."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescent 13-18 in or near Gaborone Botswana and parent/guardian\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03858803', 'briefTitle': 'Improving the Reproductive Health of Families', 'organization': {'class': 'OTHER', 'fullName': 'Portland State University'}, 'officialTitle': 'Improving the Reproductive Health of Families', 'orgStudyIdInfo': {'id': 'Botswana Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FM2 first, LAST delayed', 'description': 'Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months', 'interventionNames': ['Behavioral: Families Matter 2', 'Behavioral: Living as a Safer Teen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FM2 and LAST simultaneous', 'description': 'Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment.', 'interventionNames': ['Behavioral: Families Matter 2', 'Behavioral: Living as a Safer Teen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison arm', 'description': 'Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service.', 'interventionNames': ['Behavioral: Families Matter 2', 'Behavioral: Living as a Safer Teen']}], 'interventions': [{'name': 'Families Matter 2', 'type': 'BEHAVIORAL', 'otherNames': ['FM2'], 'description': 'Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.', 'armGroupLabels': ['Comparison arm', 'FM2 and LAST simultaneous', 'FM2 first, LAST delayed']}, {'name': 'Living as a Safer Teen', 'type': 'BEHAVIORAL', 'otherNames': ['LAST'], 'description': 'Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.', 'armGroupLabels': ['Comparison arm', 'FM2 and LAST simultaneous', 'FM2 first, LAST delayed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97206', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Janet S. St. Lawrence', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Janet S St. Lawrence, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Portland State University'}, {'name': 'Esther S Seloilwe, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Botswana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Anonymized data will be made available upon study completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Portland State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}