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

October 19, 2009
October 19, 2009
December 2007
December 2010   (final data collection date for primary outcome measure)
Time Line Follow Back and urine screen [ Time Frame: Pre and post-treatment, 3 and 6 month follow-ups ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Risk Reduction for Drug Use and Sexual Revictimization
Risk Reduction for Drug Use and Sexual Revictimization

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.

See above summary

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Risk Reduction Through Family Therapy.
  • Usual Care.
Behavioral: Risk Reduction through Family Therapy
Component based intervention based on existing empirically supported treatments
Other Name: RRFT
  • Experimental: 1
    RRFT
    Intervention: Behavioral: Risk Reduction through Family Therapy
  • Active Comparator: 2
    Usual care
    Intervention: Behavioral: Risk Reduction through Family Therapy
Danielson CK, McCart MR, Walsh K, de Arellano MA, White D, Resnick HS. Reducing substance use risk and mental health problems among sexually assaulted adolescents: a pilot randomized controlled trial. J Fam Psychol. 2012 Aug;26(4):628-35. doi: 10.1037/a0028862. Epub 2012 Jun 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • memorable sexual assault

Exclusion Criteria:

  • active psychosis
  • active suicidality
Both
12 Years to 17 Years
No
United States
 
NCT00998153
K23DA018686
Yes
Carla Kmett Danielson, Ph.D., Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Not Provided
Not Provided
National Institute on Drug Abuse (NIDA)
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP