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

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

National Institute on Drug Abuse (NIDA)

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):

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.


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 February 27, 2015

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