Risk Reduction for Drug Use and Sexual Revictimization

Usual Care Clinical Trial

— RRFT  

Official title:

Risk Reduction for Drug Use and Sexual Revictimization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998153
• Other study ID #: K23DA018686
• Secondary ID: K23DA018686
• Status: Completed
• Phase: N/A
• Start date: July 1, 2006
• Est. completion date: June 30, 2012

Study information

• Verified date: May 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

See above summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: June 30, 2012
• Est. primary completion date: June 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• memorable sexual assault

Exclusion Criteria:

• active psychosis

• active suicidality

Related Conditions & MeSH terms

• Risk Reduction Through Family Therapy
• Usual Care

Intervention

Behavioral:
• Risk Reduction through Family Therapy
Component based intervention based on existing empirically supported treatments

Locations

Country	Name	City	State
United States	National Crime Victims Research and Treatment Center	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Line Follow Back and urine screen		Pre and post-treatment, 3 and 6 month follow-ups
Secondary	YRBS		Pre and post-treatment, 3 and 6 month follow-ups
Secondary	FES		Pre and post-treatment, 3 and 6 month follow-ups
Secondary	UCLA PTSD Reaction Index		Pre, post, and 3 and 6 month follow-up