Risk Reduction for Drug Use and Sexual Revictimization (RRFT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00998153
First received: October 19, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  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 National Institute on Drug Abuse (NIDA):

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: 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
Criteria

Inclusion Criteria:

  • memorable sexual assault

Exclusion Criteria:

  • active psychosis
  • active suicidality
  Contacts and Locations
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
  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 April 17, 2014