Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-31 @ 7:00 PM
Study NCT ID:
NCT01326195
Status:
UNKNOWN
Last Update Posted:
2011-03-30
First Post:
2011-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D019529', 'term': 'Sexuality'}], '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'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-29', 'studyFirstSubmitDate': '2011-03-28', 'studyFirstSubmitQcDate': '2011-03-29', 'lastUpdatePostDateStruct': {'date': '2011-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in number (#) of unprotected sex acts', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months'}], 'secondaryOutcomes': [{'measure': 'Change in number of acts of dating violence perpetration and victimization', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV Prevention', 'Dating Violence', 'Females', 'Romantic relationships', 'Adolescents', 'Sexuality', 'Underserved youth'], 'conditions': ['Dating Violence', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '29352400', 'type': 'DERIVED', 'citation': 'Rizzo CJ, Joppa M, Barker D, Collibee C, Zlotnick C, Brown LK. Project Date SMART: a Dating Violence (DV) and Sexual Risk Prevention Program for Adolescent Girls with Prior DV Exposure. Prev Sci. 2018 May;19(4):416-426. doi: 10.1007/s11121-018-0871-z.'}]}, 'descriptionModule': {'briefSummary': 'This project is designed to develop and test a group-based preventive intervention to reduce dating violence and sexual risk behavior among adolescent females with prior dating violence exposure.', 'detailedDescription': 'A growing body of research reveals that dating violence (DV) plays a significant role in adolescent girls\' HIV risk. Dating violence has been associated with less condom use, younger age at first intercourse, having multiple sex partners and alcohol use prior to sexual encounters. Thus, prevention strategies that address dating violence and HIV risk may hold promise for reducing sexual risk behavior among a particularly at-risk population. In this study, a cognitive-behaviorally based intervention named "Skills to Manage Aggression in Relationships for Teens" (Date S.M.A.R.T.) is being developed and compared to a psychoeducational program for dating violence and HIV prevention. The program is being implemented with a sample of underserved youth, as economic disadvantage and minority status have been found to be related to increased rates of adolescent dating violence. A primary focus of the intervention is to address mental health problems (i.e. psychological distress and behavioral dysregulation) that underlie the development and maintenance of both dating violence and sexual risk behavior among adolescent girls.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescent must be English-speaking\n* Adolescent must have a lifetime history of physical dating violence perpetration or victimization\n\nExclusion Criteria:\n\n* Current enrollment in an intervention for dating violence or HIV prevention'}, 'identificationModule': {'nctId': 'NCT01326195', 'briefTitle': 'Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Rhode Island Hospital'}, 'officialTitle': 'Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions', 'orgStudyIdInfo': {'id': 'K23MH086328', 'link': 'https://reporter.nih.gov/quickSearch/K23MH086328', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Skills', 'description': 'Cognitive-Behavioral Dating Violence and HIV Prevention Group', 'interventionNames': ['Behavioral: Cognitive-Behavioral Dating Violence and HIV Prevention Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Promotion', 'description': 'Psycho-educational Dating Violence and HIV Prevention group', 'interventionNames': ['Behavioral: Psycho-educational Dating Violence and HIV prevention group']}], 'interventions': [{'name': 'Cognitive-Behavioral Dating Violence and HIV Prevention Group', 'type': 'BEHAVIORAL', 'otherNames': ['Date SMART'], 'description': 'Six, two-hour weekly sessions and one 2-hour booster session 6 weeks later with adolescent females', 'armGroupLabels': ['Skills']}, {'name': 'Psycho-educational Dating Violence and HIV prevention group', 'type': 'BEHAVIORAL', 'description': 'Knowledge based intervention matched for time and attention to skills arm', 'armGroupLabels': ['Health Promotion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christie Rizzo, PhD', 'role': 'CONTACT', 'phone': '401-793-8064'}, {'name': 'Christie J. Rizzo, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'Christie J. Rizzo, Ph.D.', 'role': 'CONTACT', 'phone': '401-793-8064'}], 'overallOfficials': [{'name': 'Christie J. Rizzo, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rhode Island Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhode Island Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Christie J. Rizzo Ph.D./Principal Investigator', 'oldOrganization': 'Rhode Island Hospital'}}}}