Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-04-22 @ 6:53 PM
Study NCT ID:
NCT02723292
Status:
COMPLETED
Last Update Posted:
2018-02-12
First Post:
2016-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
City of Rochester Teen Outreach Program (TOP™) Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012725', 'term': 'Sexual Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-08', 'studyFirstSubmitDate': '2016-02-04', 'studyFirstSubmitQcDate': '2016-03-23', 'lastUpdatePostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who become pregnant', 'timeFrame': '21 months'}, {'measure': 'Number of youth who report ever having had sexual intercourse', 'timeFrame': '21 months', 'description': 'For youth who were sexually naive at baseline, the outcome is the number of youth who report ever having had sexual intercourse at the 21 month assessment point.'}, {'measure': 'Amount of sexual intercourse in preceding 3 months without an effective means of birth control', 'timeFrame': '21 months', 'description': 'The number of times a youth reports having had sexual intercourse without using an effective means of birth control measured at the 21 month assessment point.'}], 'secondaryOutcomes': [{'measure': 'Number of failing grades on report card', 'timeFrame': '21 months', 'description': 'This is a self-report measure of the number of courses failed on the last report card received, measured at the 21 month assessment point.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adolescent Problems', 'Sex Behavior', 'Academic Underachievement Disorder of Childhood or Adolescence']}, 'descriptionModule': {'briefSummary': "As part of a 5-year national effort to reduce teen pregnancy, the University of Rochester is partnering with the City of Rochester Department of Recreation and Youth Services to evaluate the City's replication of the Teen Outreach Program (TOP™) for 11-14 year old youth registered at 11 selected Recreation Centers (RCs). A youth development program with demonstrated efficacy to reduce teen pregnancy, school failure and drop-out rates, TOP™ has never been studied in RCs. Advancing from efficacy to effectiveness, the investigators will also measure program fidelity obtained in RCs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must be registered at a participating RC\n* age 11 through 14 years\n* participants must assent and parent(s) or legal guardian(s) provide permission to participate\n* basic understanding of the English language\n\nExclusion Criteria:\n\n* age at enrollment of less than 11 or greater than 14 years\n* for facilitators, age less than 21 is an exclusion criterion'}, 'identificationModule': {'nctId': 'NCT02723292', 'briefTitle': 'City of Rochester Teen Outreach Program (TOP™) Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'City of Rochester Teen Outreach Program (TOP™) Evaluation', 'orgStudyIdInfo': {'id': '36508'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group services', 'description': 'This study will replicate the evidence-based TOP™ in after-school sessions held during RC hours. The primary components of TOP™ include: Comprehensive age-appropriate sexuality education; 90-minute sessions, once a week after-school, during the school year for nine months, using the Changing Scenes© curriculum, and at least twenty hours of youth-led service learning, which involves youth in planning, implementing and reflecting on, community service and leadership.', 'interventionNames': ['Behavioral: TOP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group services', 'description': 'Youth in the control arm will receive a work readiness training curriculum focused on competencies to secure employment. This will include such topics as building customer service skills, clear and direct communication, and creating a work portfolio.', 'interventionNames': ['Behavioral: Control intervention']}], 'interventions': [{'name': 'TOP', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Experimental group services']}, {'name': 'Control intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control group services']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'State University of New York at Binghamton, Decker School of Nursing', 'class': 'UNKNOWN'}, {'name': 'City of Rochester Department of Recreation and Youth Services', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hugh Crean', 'investigatorAffiliation': 'University of Rochester'}}}}