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
Recruitment status was Recruiting
Sponsor:
Rhode Island Hospital
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01326195
First received: March 28, 2011
Last updated: March 29, 2011
Last verified: March 2011
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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:
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 (Child) |
| 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
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
| 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 |
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 |
ClinicalTrials.gov processed this record on September 30, 2016