Risk Reduction for Drug Use and Sexual Revictimization (RRFT)

June 15, 2018 updated by: Medical University of South Carolina
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See above summary

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • National Crime Victims Research and Treatment Center

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

12 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • memorable sexual assault

Exclusion Criteria:

  • active psychosis
  • active suicidality

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
RRFT
Behavioral: Risk Reduction through Family Therapy
Component based intervention based on existing empirically supported treatments
Other Names:
  • RRFT
ACTIVE_COMPARATOR: 2
Usual care
Behavioral: Risk Reduction through Family Therapy
Component based intervention based on existing empirically supported treatments
Other Names:
  • RRFT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time Line Follow Back and urine screen
Time Frame: Pre and post-treatment, 3 and 6 month follow-ups
Pre and post-treatment, 3 and 6 month follow-ups

Secondary Outcome Measures

Outcome Measure
Time Frame
YRBS
Time Frame: Pre and post-treatment, 3 and 6 month follow-ups
Pre and post-treatment, 3 and 6 month follow-ups
FES
Time Frame: Pre and post-treatment, 3 and 6 month follow-ups
Pre and post-treatment, 3 and 6 month follow-ups
UCLA PTSD Reaction Index
Time Frame: Pre, post, and 3 and 6 month follow-up
Pre, post, and 3 and 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute on Drug Abuse (NIDA)

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.

General Publications

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 (ACTUAL)

July 1, 2006

Primary Completion (ACTUAL)

June 30, 2011

Study Completion (ACTUAL)

June 30, 2012

Study Registration Dates

First Submitted

October 19, 2009

First Submitted That Met QC Criteria

October 19, 2009

First Posted (ESTIMATE)

October 20, 2009

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2018

Last Update Submitted That Met QC Criteria

June 15, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • K23DA018686 (NIH)

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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