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Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions

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ClinicalTrials.gov Identifier: NCT01326195
Recruitment Status : Unknown
Verified March 2011 by Rhode Island Hospital.
Recruitment status was:  Recruiting
First Posted : March 30, 2011
Last Update Posted : March 30, 2011
Sponsor:
Information provided by:
Rhode Island Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dating Violence HIV Infections Behavioral: Cognitive-Behavioral Dating Violence and HIV Prevention Group Behavioral: Psycho-educational Dating Violence and HIV prevention group Phase 1

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions
Study Start Date : May 2009
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Skills
Cognitive-Behavioral Dating Violence and HIV Prevention Group
 Behavioral: Cognitive-Behavioral Dating Violence and HIV Prevention Group
Six, two-hour weekly sessions and one 2-hour booster session 6 weeks later with adolescent females
Other Name: Date SMART
Active Comparator: Health Promotion
Psycho-educational Dating Violence and HIV Prevention group
 Behavioral: Psycho-educational Dating Violence and HIV prevention group
Knowledge based intervention matched for time and attention to skills arm


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in number (#) of unprotected sex acts [ Time Frame: Baseline, 3 months, 6 months, 9 months ]

Secondary Outcome Measures :
  1. Change in number of acts of dating violence perpetration and victimization [ Time Frame: Baseline, 3 months, 6 months, 9 months ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   15 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adolescent must be English-speaking
  • Adolescent must have a lifetime history of physical dating violence perpetration or victimization

Exclusion Criteria:

  • Current enrollment in an intervention for dating violence or HIV prevention
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326195


Contacts
Contact: Christie J. Rizzo, Ph.D. 401-793-8064

Locations
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Christie Rizzo, PhD    401-793-8064      
Principal Investigator: Christie J. Rizzo, Ph.D.         
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Christie J. Rizzo, Ph.D. Rhode Island Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christie J. Rizzo Ph.D./Principal Investigator, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01326195     History of Changes
Other Study ID Numbers: K23MH086328 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: March 30, 2011
Last Verified: March 2011

Keywords provided by Rhode Island Hospital:
HIV Prevention
Dating Violence
Females
Romantic relationships
 Adolescents
Sexuality
Underserved youth

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases