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

NCT01751035 | Completed DMC

• 2 other identifiers: Pro00009042R01DA031285-01
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD; Alcohol Use Disorders; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• change in substance use problems (initiation/continuation, quantity, and abuse symptoms)

  18 months

Secondary Outcomes (2)

• change in PTSD severity and symptoms

  18 months

• change in risky sexual behaviors

  18 months

Study Arms (2)

Treatment as Usual (TAU)

PLACEBO COMPARATOR

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

RRFT

EXPERIMENTAL

RRFT is an acronym for an experimental intervention named Risk Reduction through Family Therapy. Please see intervention description for more detail about the model.

Behavioral: Risk Reduction through Family Therapy

Interventions

Risk Reduction through Family Therapy BEHAVIORAL

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.

Also known as: RRFT

RRFT

Treatment as Usual BEHAVIORAL

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.

Also known as: TAU

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \) 13-18 years old;
• \) Presenting to LCC/HH for evaluation or treatment;
• \) 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.
• \) Have a memory of the incident(s);
• \) Five or more DSM-IV PTSD symptoms;
• \) Substance use, defined as alcohol or illicit drug use in the past 90 days per self-report and/or urine drug screen or breathalyzer.

You may not qualify if:

• \) Previously identified as having a Pervasive Developmental Disability or Moderate to Severe Mental Retardation;
• \) Actively suicidal or homicidal;
• \) Reports active psychotic disorder

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Danielson CK, Adams Z, McCart MR, Chapman JE, Sheidow AJ, Walker J, Smalling A, de Arellano MA. Safety and Efficacy of Exposure-Based Risk Reduction Through Family Therapy for Co-occurring Substance Use Problems and Posttraumatic Stress Disorder Symptoms Among Adolescents: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jun 1;77(6):574-586. doi: 10.1001/jamapsychiatry.2019.4803.

  PMID: 32022827 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Alcoholism; Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Alcohol-Related Disorders; Chemically-Induced Disorders

Study Officials

• Carla K Danielson, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: December 17, 2012
• Study Start: November 1, 2012
• Primary Completion: July 12, 2018
• Study Completion: July 12, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

US (1)