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

PTSD Clinical Trial

— RRFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751035
• Other study ID #: Pro00009042
• Secondary ID: R01DA031285-01
• Status: Completed
• Phase: N/A
• Start date: November 1, 2012
• Est. completion date: July 12, 2018

Study information

• Verified date: August 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: July 12, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorders
• Disease
• PTSD
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in substance use problems (initiation/continuation, quantity, and abuse symptoms)		18 months
Secondary	change in PTSD severity and symptoms		18 months
Secondary	change in risky sexual behaviors		18 months