Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Rhode Island Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01326195
First received: March 28, 2011
Last updated: March 29, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Change in number (#) of unprotected sex acts [ Time Frame: Baseline, 3 months, 6 months, 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in number of acts of dating violence perpetration and victimization [ Time Frame: Baseline, 3 months, 6 months, 9 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 100
Study Start Date: May 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   15 Years to 17 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Christie J. Rizzo Ph.D./Principal Investigator, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01326195     History of Changes
Other Study ID Numbers: K23MH086328
Study First Received: March 28, 2011
Last Updated: March 29, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on March 03, 2015