Risk Reduction for Drug Use and Sexual Revictimization (RRFT)
Recruitment status was Recruiting
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Purpose
The investigator proposes to evaluate Risk Reduction through Family Therapy (RRFT), which integrates: 1) an ecologically-based intervention for treatment of substance abuse behaviors in high risk adolescents, 2) exposure-based cognitive-behavioral therapy for sexually assaulted youth, and 3) psychoeducation strategies for prevention of risky sexual behaviors and revictimization. The principal purpose of this research proposal is to evaluate the efficacy of RRFT in reducing the risk of drug abuse and other risky behaviors, PTSD, and revictimization among adolescents who have been sexually assaulted. The Research Plan will be conducted based on Stage 1a and Stage 1b from NIDA's Behavioral Therapies Development Program as described in Rounsaville, Carroll, & Onken (2001). The final phase of the research will involve conducting a pilot randomized controlled trial of RRFT in a sample of adolescents, comparing primary outcome measures of youth receiving RRFT to youth receiving usual care in the community. Participants will be adolescents (12-17 years) who have experienced a sexual assault. Assessment of substance use and other risk behaviors, trauma-related psychopathology, and incidents of revictimization will be collected at pre- and post- treatment, as well as 6-week and 3-month follow-ups. Hierarchical Linear Modeling will be the primary method used to test study hypotheses. Development and evaluation of the proposed intervention will have significant implications for addressing public health problems in adolescent substance abuse and related high risk behaviors.
| Condition | Intervention | Phase |
|---|---|---|
|
Risk Reduction Through Family Therapy. Usual Care. |
Behavioral: Risk Reduction through Family Therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Risk Reduction for Drug Use and Sexual Revictimization |
- Time Line Follow Back and urine screen [ Time Frame: Pre and post-treatment, 3 and 6 month follow-ups ] [ Designated as safety issue: No ]
- YRBS [ Time Frame: Pre and post-treatment, 3 and 6 month follow-ups ] [ Designated as safety issue: No ]
- FES [ Time Frame: Pre and post-treatment, 3 and 6 month follow-ups ] [ Designated as safety issue: No ]
- UCLA PTSD Reaction Index [ Time Frame: Pre, post, and 3 and 6 month follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
RRFT
|
Behavioral: Risk Reduction through Family Therapy
Component based intervention based on existing empirically supported treatments
Other Name: RRFT
|
|
Active Comparator: 2
Usual care
|
Behavioral: Risk Reduction through Family Therapy
Component based intervention based on existing empirically supported treatments
Other Name: RRFT
|
Detailed Description:
See above summary
Eligibility| Ages Eligible for Study: | 12 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- memorable sexual assault
Exclusion Criteria:
- active psychosis
- active suicidality
Contacts and Locations| United States, South Carolina | |
| National Crime Victims Research and Treatment Center | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Carla K Danielson, Ph.D. danielso@musc.edu | |
| Contact: Deni L White, B.S. dew36@musc.edu | |
More Information
No publications provided by National Institute on Drug Abuse (NIDA)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Carla Kmett Danielson, Ph.D., Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00998153 History of Changes |
| Other Study ID Numbers: | K23DA018686 |
| Study First Received: | October 19, 2009 |
| Last Updated: | October 19, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Drug Abuse (NIDA):
|
substance use PTSD risky behaviors revictimization |
ClinicalTrials.gov processed this record on May 19, 2013