Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions
Primary Purpose
Dating Violence, HIV Infections
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Dating Violence and HIV Prevention Group
Psycho-educational Dating Violence and HIV prevention group
Sponsored by
About this trial
This is an interventional prevention trial for Dating Violence focused on measuring HIV Prevention, Dating Violence, Females, Romantic relationships, Adolescents, Sexuality, Underserved youth
Eligibility 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
Sites / Locations
- Rhode Island HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Skills
Health Promotion
Arm Description
Cognitive-Behavioral Dating Violence and HIV Prevention Group
Psycho-educational Dating Violence and HIV Prevention group
Outcomes
Primary Outcome Measures
Change in number (#) of unprotected sex acts
Secondary Outcome Measures
Change in number of acts of dating violence perpetration and victimization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01326195
Brief Title
Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions
Official Title
Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Rhode Island Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dating Violence, HIV Infections
Keywords
HIV Prevention, Dating Violence, Females, Romantic relationships, Adolescents, Sexuality, Underserved youth
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Skills
Arm Type
Experimental
Arm Description
Cognitive-Behavioral Dating Violence and HIV Prevention Group
Arm Title
Health Promotion
Arm Type
Active Comparator
Arm Description
Psycho-educational Dating Violence and HIV Prevention group
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Dating Violence and HIV Prevention Group
Other Intervention Name(s)
Date SMART
Intervention Description
Six, two-hour weekly sessions and one 2-hour booster session 6 weeks later with adolescent females
Intervention Type
Behavioral
Intervention Name(s)
Psycho-educational Dating Violence and HIV prevention group
Intervention Description
Knowledge based intervention matched for time and attention to skills arm
Primary Outcome Measure Information:
Title
Change in number (#) of unprotected sex acts
Time Frame
Baseline, 3 months, 6 months, 9 months
Secondary Outcome Measure Information:
Title
Change in number of acts of dating violence perpetration and victimization
Time Frame
Baseline, 3 months, 6 months, 9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christie J. Rizzo, Ph.D.
Phone
401-793-8064
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christie J. Rizzo, Ph.D.
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christie Rizzo, PhD
Phone
401-793-8064
First Name & Middle Initial & Last Name & Degree
Christie J. Rizzo, Ph.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
29352400
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.
Results Reference
derived
Learn more about this trial
Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions
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