Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD

Not Applicable

Completed

• Conditions: PTSD; Alcohol Use Disorders; Substance Use Disorders
• Interventions: Behavioral: Treatment as Usual; Behavioral: Risk Reduction through Family Therapy

• Registration Number: NCT01751035
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

See above.

Study Timeline

• Study Start: 2012-11-01
• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-17
• Primary Completion: 2018-07-12
• Study Completion: 2018-07-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• 1. 13-18 years old;
• 2. Presenting to LCC/HH for evaluation or treatment;
• 3. Report having experienced IPV in their lifetime, including: CSA, 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; CPA, defined as having been (a) attacked or threatened with a gun, knife, or some other weapon; (b) attacked by another person with perceived intent to kill or seriously injure; (c) beaten and injured (i.e., "hurt pretty badly") by another person; (d) spanked so forcefully that it resulted in sustained welts or bruises or required medical care; or (e) cut, burned, or tied up by a caregiver as a punitive consequence; Exposure to Domestic Violence; and being victim of or bearing witness to Community Violence.
• 4. Have a memory of the 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as Usual (TAU)	Treatment as Usual	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.
RRFT	Risk Reduction through Family Therapy	RRFT is an acronym for an experimental intervention named Risk Reduction through Family Therapy. Please see intervention description for more detail about the model.

Primary Outcome Measures

Name	Time	Method
change in substance use problems (initiation/continuation, quantity, and abuse symptoms)	18 months

Secondary Outcome Measures

Name	Time	Method
change in PTSD severity and symptoms	18 months
change in risky sexual behaviors	18 months

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States