Risk Reduction for Drug Use and Sexual Revictimization (RRFT)
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| ClinicalTrials.gov Identifier: NCT00998153 |
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Recruitment Status :
Completed
First Posted : October 20, 2009
Last Update Posted : June 18, 2018
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Sponsor:
Medical University of South Carolina
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Medical University of South Carolina
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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 | Not Applicable |
See above summary
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 135 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Risk Reduction for Drug Use and Sexual Revictimization |
| Actual Study Start Date : | July 1, 2006 |
| Actual Primary Completion Date : | June 30, 2011 |
| Actual Study Completion Date : | June 30, 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
RRFT
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Behavioral: Risk Reduction through Family Therapy
Component based intervention based on existing empirically supported treatments
Other Name: RRFT |
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Active Comparator: 2
Usual care
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Behavioral: Risk Reduction through Family Therapy
Component based intervention based on existing empirically supported treatments
Other Name: RRFT |
Primary Outcome Measures :
- Time Line Follow Back and urine screen [ Time Frame: Pre and post-treatment, 3 and 6 month follow-ups ]
Secondary Outcome Measures :
- YRBS [ Time Frame: Pre and post-treatment, 3 and 6 month follow-ups ]
- FES [ Time Frame: Pre and post-treatment, 3 and 6 month follow-ups ]
- 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 | |
| Charleston, South Carolina, United States, 29425 | |
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: | Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00998153 History of Changes |
| Other Study ID Numbers: |
K23DA018686 ( U.S. NIH Grant/Contract ) K23DA018686 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 20, 2009 Key Record Dates |
| Last Update Posted: | June 18, 2018 |
| Last Verified: | May 2018 |
Keywords provided by Medical University of South Carolina:
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substance use PTSD risky behaviors revictimization |