Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT00603369
Status:
COMPLETED
Last Update Posted:
2009-02-06
First Post:
2008-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HIV, Abuse, and Psychiatric Disorders Among Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-05', 'studyFirstSubmitDate': '2008-01-16', 'studyFirstSubmitQcDate': '2008-01-28', 'lastUpdatePostDateStruct': {'date': '2009-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'condom use', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'scores on HIV knowledge questionnaire', 'timeFrame': '1 year'}, {'measure': 'number of sexual partners', 'timeFrame': '1 year'}, {'measure': 'scores on measure of attitudes toward condom use', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV prevention', 'HIV seronegativity'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '21961780', 'type': 'DERIVED', 'citation': 'Brown LK, Nugent NR, Houck CD, Lescano CM, Whiteley LB, Barker D, Viau L, Zlotnick C. Safe Thinking and Affect Regulation (STAR): human immunodeficiency virus prevention in alternative/therapeutic schools. J Am Acad Child Adolesc Psychiatry. 2011 Oct;50(10):1065-74. doi: 10.1016/j.jaac.2011.06.018. Epub 2011 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'One subgroup of adolescents at particular risk for HIV is those with psychiatric disorders. Furthermore, those with histories of sexual abuse have been found to have riskier attitudes, poorer sexual communication skills, and less consistent condom use than non-abused peers. This study implemented and evaluated interventions for adolescents in intensive psychiatric treatment settings, particularly those with histories of sexual abuse. It is hypothesized that those participating in the intervention that addresses affect management and cognitive monitoring strategies will show fewer HIV-risk related behaviors and attitudes at posttest than peers in an information-based intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescent attending therapeutic school\n\nExclusion Criteria:\n\n* Adolescent is HIV positive\n* Adolescent is developmentally delayed\n* Adolescent is pregnant\n* Adolescent has a history of sexual crime'}, 'identificationModule': {'nctId': 'NCT00603369', 'acronym': 'Project STAR', 'briefTitle': 'HIV, Abuse, and Psychiatric Disorders Among Youth', 'organization': {'class': 'OTHER', 'fullName': 'Rhode Island Hospital'}, 'officialTitle': 'HIV, Abuse, and Psychiatric Disorders Among Youth', 'orgStudyIdInfo': {'id': 'R01MH061149', 'link': 'https://reporter.nih.gov/quickSearch/R01MH061149', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH061149', 'link': 'https://reporter.nih.gov/quickSearch/R01MH061149', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '13 session group intervention including sexual health information, affect management skills, cognitive monitoring, and communication skills training.', 'interventionNames': ['Behavioral: group intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '2 session group intervention including sexual health information training.', 'interventionNames': ['Behavioral: group intervention']}], 'interventions': [{'name': 'group intervention', 'type': 'BEHAVIORAL', 'description': '13-session intervention', 'armGroupLabels': ['1']}, {'name': 'group intervention', 'type': 'BEHAVIORAL', 'description': '2-session intervention', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Larry K. Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rhode Island Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhode Island Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Larry K. Brown/Principal Investigator', 'oldOrganization': 'Rhode Island Hospital'}}}}