Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-03-27 @ 11:56 PM
Study NCT ID:
NCT01880450
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2011-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project Prepared: Risks, Roles and Relationships
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 397}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-12', 'studyFirstSubmitDate': '2011-07-12', 'studyFirstSubmitQcDate': '2013-06-15', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Intentions to engage in safer sex behavior at 6 months', 'timeFrame': '6 months post baseline', 'description': 'measuring change from baseline to 6 months (as compared to control group)'}, {'measure': 'Change in Intentions to engage in safer sex behavior at 1 year', 'timeFrame': '1 year post baseline', 'description': 'measuring change from baseline to 1 year (as compared to control group)'}], 'secondaryOutcomes': [{'measure': 'Change in Cognitive Factors at 6 months', 'timeFrame': '6 months post baseline', 'description': 'measuring change in HIV/STI knowledge, condom outcome and efficacy expectancies, sexual self-efficacy from baseline to 6 months (compared to control group)'}, {'measure': 'Change in Cognitive Factors at 1 year', 'timeFrame': '1 year post baseline', 'description': 'measuring changes in HIV/STI knowledge, condom outcome and efficacy expectancies, sexual self-efficacy from baseline to 1 year (as compared to control group)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['F01.145.802.845', 'F01.145.802.987']}, 'referencesModule': {'references': [{'pmid': '33606173', 'type': 'DERIVED', 'citation': 'Bauman LJ, Watnick D, Silver EJ, Rivera A, Sclafane JH, Rodgers CRR, Leu CS. Reducing HIV/STI Risk Among Adolescents Aged 12 to 14 Years: a Randomized Controlled Trial of Project Prepared. Prev Sci. 2021 Nov;22(8):1023-1035. doi: 10.1007/s11121-021-01203-0. Epub 2021 Feb 19.'}]}, 'descriptionModule': {'briefSummary': 'Project Prepared is a theoretically based, comprehensive, intensive group intervention that is designed to prepare early adolescents for middle adolescence and its challenges. It emphasizes skills in avoiding risky sexual situations, and provides medically accurate information about sexual development, sexually transmitted infections and pregnancy. Effectiveness is measured by using a randomized control trial design and tracking differences in cognitive factors (HIV/STI (Sexually Transmitted Infections) knowledge, sexual self-efficacy; intention to use a condom); relationship factors (immature romantic beliefs, relationship self-efficacy), gender norms (macho man, powerless female), and resilience.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 12-14 yrs old\n* lives in the Bronx, NY at Baseline\n* Has been seen at some point in one of the Montefiore Medical Center community health clinics.\n\nExclusion Criteria:\n\n* Inability to independently complete the questionnaire/training due to sensory, cognitive or motor disabilities.\n* Reading ability NOT at 5th grade on the reading subtest of the Wide-range Achievement Test.'}, 'identificationModule': {'nctId': 'NCT01880450', 'acronym': 'Prepared', 'briefTitle': 'Project Prepared: Risks, Roles and Relationships', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Longitudinal Intervention Study to Prepare Early Adolescents for Middle Adolescence, Specifically Focusing on Improving Sexual Health Outcomes', 'orgStudyIdInfo': {'id': '2008-551'}, 'secondaryIdInfos': [{'id': '5R01HD062079', 'link': 'https://reporter.nih.gov/quickSearch/5R01HD062079', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Project Prepared', 'interventionNames': ['Behavioral: Project Prepared']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TEEN-Teen Education & Employment Network', 'interventionNames': ['Behavioral: TEEN']}], 'interventions': [{'name': 'Project Prepared', 'type': 'BEHAVIORAL', 'description': 'Behavioral intervention to reduce sexual risk and promote healthy relationships', 'armGroupLabels': ['Project Prepared']}, {'name': 'TEEN', 'type': 'BEHAVIORAL', 'description': 'Control condition the promote communication, decision-making skills etc.', 'armGroupLabels': ['TEEN-Teen Education & Employment Network']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Laurie J Bauman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine, Pediatrics Division'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor; Director, Preventive Intervention Research Center', 'investigatorFullName': 'Laurie Bauman', 'investigatorAffiliation': 'Albert Einstein College of Medicine'}}}}