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Risk Reduction for Drug Use and Sexual Revictimization (RRFT)

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ClinicalTrials.gov Identifier: NCT00998153
Recruitment Status : Recruiting
First Posted : October 20, 2009
Last Update Posted : March 17, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Carla Danielson, Medical University of South Carolina

Brief 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.

Condition or disease Intervention/treatment Phase
Risk Reduction Through Family Therapy. Usual Care. Behavioral: Risk Reduction through Family Therapy Phase 1

Detailed Description:
See above summary

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Risk Reduction for Drug Use and Sexual Revictimization
Study Start Date : December 2007
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Time Line Follow Back and urine screen [ Time Frame: Pre and post-treatment, 3 and 6 month follow-ups ]

Secondary Outcome Measures :
  1. YRBS [ Time Frame: Pre and post-treatment, 3 and 6 month follow-ups ]
  2. FES [ Time Frame: Pre and post-treatment, 3 and 6 month follow-ups ]
  3. UCLA PTSD Reaction Index [ Time Frame: Pre, post, and 3 and 6 month follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • memorable sexual assault

Exclusion Criteria:

  • active psychosis
  • active suicidality

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

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 ( U.S. NIH Grant/Contract )
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016

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