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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01326195
• Other study ID #: K23MH086328
• Status: Recruiting
• Phase: Phase 1
• First received: March 28, 2011
• Last updated: March 29, 2011
• Start date: May 2009
• Est. completion date: February 2014

Study information

• Verified date: March 2011
• Source: Rhode Island Hospital
• Contact: Christie J. Rizzo, Ph.D.
• Phone: 401-793-8064
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dating Violence
• HIV Infections

Intervention

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
• Psycho-educational Dating Violence and HIV prevention group
Knowledge based intervention matched for time and attention to skills arm

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number (#) of unprotected sex acts		Baseline, 3 months, 6 months, 9 months	No
Secondary	Change in number of acts of dating violence perpetration and victimization		Baseline, 3 months, 6 months, 9 months	No