- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01326195
Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions
March 29, 2011 updated by: Rhode Island Hospital
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.
Study Overview
Status
Unknown
Conditions
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 Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christie J. Rizzo, Ph.D.
- Phone Number: 401-793-8064
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Recruiting
- Rhode Island Hospital
-
Contact:
- Christie Rizzo, PhD
- Phone Number: 401-793-8064
-
Principal Investigator:
- Christie J. Rizzo, Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Skills
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 Names:
|
Active Comparator: Health Promotion
Psycho-educational Dating Violence and HIV Prevention group
|
Knowledge based intervention matched for time and attention to skills arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in number (#) of unprotected sex acts
Time Frame: Baseline, 3 months, 6 months, 9 months
|
Baseline, 3 months, 6 months, 9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in number of acts of dating violence perpetration and victimization
Time Frame: Baseline, 3 months, 6 months, 9 months
|
Baseline, 3 months, 6 months, 9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christie J. Rizzo, Ph.D., Rhode Island Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Anticipated)
February 1, 2014
Study Completion (Anticipated)
February 1, 2014
Study Registration Dates
First Submitted
March 28, 2011
First Submitted That Met QC Criteria
March 29, 2011
First Posted (Estimate)
March 30, 2011
Study Record Updates
Last Update Posted (Estimate)
March 30, 2011
Last Update Submitted That Met QC Criteria
March 29, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23MH086328 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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