Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD (RRFT)
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Purpose
Adolescents receiving RRFT and their caregivers will report significantly fewer substance use problems (quantity of use, frequency of use, and abuse symptoms) during treatment and follow-up than control adolescents who receive Treatment as Usual (TAU). Adolescents receiving RRFT and their caregivers will report improvement in empirically-demonstrated risk and protective factors for substance use and abuse at the individual level (e.g., coping) and at each level of an adolescent's ecology (e.g., increased number of positive family activities, reduced family conflict, reduced number of peers who use drugs, improved school attendance, increased involvement in pro-social community activities) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will experience less PTSD symptoms (per youth and caregiver reports) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will report engaging in fewer risky sexual behaviors (e.g., increased condom use, fewer partners) during treatment and follow-up than control adolescents who receive TAU. Changes during treatment in family relations (familial cohesiveness and conflict, satisfaction with caregiver-youth relationship) and parenting practices (monitoring) will mediate changes in substance use. Changes during treatment in emotional reactivity will mediate changes in PTSD symptoms.
| Condition | Intervention |
|---|---|
|
PTSD Alcohol Use Disorders Substance Use Disorders |
Behavioral: Risk Reduction through Family Therapy Behavioral: Treatment as Usual |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD |
- change in substance use problems (initiation/continuation, quantity, and abuse symptoms) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- change in PTSD severity and symptoms [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- change in risky sexual behaviors [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 250 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | November 2017 |
| Estimated Primary Completion Date: | November 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Treatment as Usual (TAU)
Treatment as Usual (TAU) will be defined as it already exists within the community child advocacy centers. This could include individual and/or group therapy using a variety of treatment models.
|
Behavioral: Treatment as Usual
Participants assigned to the TAU condition will receive the standard treatment that a CSA victim would typically receive at community advocacy centers. In addition to treatment that is typically offered at the CACs, this will include a referral for substance abuse evaluation and may include referrals to other agencies in the community. TAU has been utilized as a comparison condition for several behavioral treatment evaluations involving adolescent substance abuse.
Other Name: TAU
|
|
Experimental: RRFT
RRFT is an acronym for an experimental intervention named Risk Reduction through Family Therapy. Please see intervention description for more detail about the model.
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Behavioral: Risk Reduction through Family Therapy
RRFT is an integrative, ecologically-based approach to risk reduction and treatment. A Stage 1a feasibility trial and a Stage 1b pilot randomized controlled trial (RCT) evaluating RRFT have been completed. This Stage 1 work has resulted in a treatment manual, a clinician training protocol, and a quality assurance system. Preliminary findings from these studies are promising, indicating that RRFT can be readily learned and implemented with fidelity, and that it can lead to improvements in drug use and drug use-related risk and protective factors, PTSD symptoms, and risky sexual behaviors.
Other Name: RRFT
|
Detailed Description:
See above.
Eligibility| Ages Eligible for Study: | 14 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 1) 14-17 years old;
- 2) Presenting to LCC/HH for evaluation or treatment;
- 3) Experienced CSA in their lifetime, defined as forced or unwanted: (a) vaginal or anal penetration by an object, finger, or penis; (b) oral sex; (c) touching of the respondent's breasts or genitalia; or (d) respondents' touching of another person's genitalia;
- 4) Have a memory of the CSA incident(s);
- 5) Five or more DSM-IV PTSD symptoms;
- 6) Substance use, defined as alcohol or illicit drug use in the past 90 days per self-report and/or urine drug screen or breathalyzer.
Exclusion Criteria:
- 1) Previously identified as having a Pervasive Developmental Disability or Moderate to Severe Mental Retardation;
- 2) Actively suicidal or homicidal;
- 3) Reports active psychotic disorder;
- 4) Currently living with the participant's CSA perpetrator.
Contacts and Locations| Contact: Elizabeth McGuan, MSW | 8437928361 | mcguan@musc.edu |
| Contact: Kathryn Soltis, BA | 8437927067 | soltisk@musc.edu |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Principal Investigator: | Carla K Danielson, PhD | MUSC |
More Information
No publications provided
| Responsible Party: | Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT01751035 History of Changes |
| Other Study ID Numbers: | Pro00009042, R01DA031285-01 |
| Study First Received: | November 15, 2012 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Alcohol Drinking Stress Disorders, Post-Traumatic Substance-Related Disorders Drinking Behavior |
Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013