Risk Reduction for Drug Use and Sexual Revictimization (RRFT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Medical University of South Carolina
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Carla Danielson, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00998153
First received: October 19, 2009
Last updated: March 15, 2016
Last verified: March 2016
  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

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Time Line Follow Back and urine screen [ Time Frame: Pre and post-treatment, 3 and 6 month follow-ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: February 2017
Estimated Primary Completion Date: February 2017 (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   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • memorable sexual assault

Exclusion Criteria:

  • active psychosis
  • active suicidality
  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: NCT00998153

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   
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carla Danielson, Associate Professor, 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: March 15, 2016
Health Authority: United States: Federal Government

Keywords provided by Medical University of South Carolina:
substance use
PTSD
risky behaviors
revictimization

ClinicalTrials.gov processed this record on August 22, 2016