Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-03-05 @ 2:32 PM
Study NCT ID:
NCT00535704
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2007-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Substance Use and Risky Behavior Among Rural African American Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 502}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-10', 'studyFirstSubmitDate': '2007-09-24', 'studyFirstSubmitQcDate': '2007-09-24', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual behavior', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Substance Use', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Risky Sexual Behavior']}, 'descriptionModule': {'briefSummary': 'The Rural African American Families Health (RAAFH) Project is a federally funded research study designed to evaluate the effectiveness two prevention programs designed for rural African American families. One program, FUEL, helps teens develop lifestyles that prevent health problems such as heart disease, diabetes, and being overweight. This program deals with diet and exercise, the influence of TV and magazines on eating habits, and handling stress. The second program, the Strong African American Families Teen Program (SAAF-T), helps teens learn how to develop plans for the future and to avoid drug use and unsafe sex. The sessions deal with goal setting, peer pressure, and staying in school.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African American student in 10th grade\n* Agree to randomization and assessment\n* Resides in targeted county\n* Target and parent speak English\n\nExclusion Criteria:\n\n* Active psychoses'}, 'identificationModule': {'nctId': 'NCT00535704', 'briefTitle': 'Preventing Substance Use and Risky Behavior Among Rural African American Youth', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Preventing Substance Use and Risky Behavior Among Rural African American Youth', 'orgStudyIdInfo': {'id': '1R01DA021736-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA021736-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'The Strong AFrican American FAmilies-Teen program is a five part educational program has been designed to help teens and their parents create successful futures and avoid the risky behaviors that sometimes keep teens from reaching their goals.', 'interventionNames': ['Behavioral: Strong African American Families-Teen Program']}, {'type': 'OTHER', 'label': '2', 'description': 'The FUEL program is a family-based adaptation of a curriculum designed to assist teens to develop lifestyles that prevent health problems such as heart disease, diabetes, and being overweight. This program deals with diet and exercise, the influence of TV and magazines on eating habits, and handling stress.', 'interventionNames': ['Behavioral: FUEL']}], 'interventions': [{'name': 'Strong African American Families-Teen Program', 'type': 'BEHAVIORAL', 'description': '5 week educational program for teens and their caregivers.Each meeting lasts approximately 2 hours.', 'armGroupLabels': ['1']}, {'name': 'FUEL', 'type': 'BEHAVIORAL', 'description': '5 week educational program for teens and caregivers. Each weekly session lasts approximately 2 hours', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30605', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Center for Family Research', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}], 'overallOfficials': [{'name': 'Gene H Brody', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Georgia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}