Testing a Promising Treatment for Youth Substance Abuse in a Community Setting

Phase 1

Completed

• Conditions: Mental Health; Substance Abuse; Delinquency
• Interventions: Behavioral: Contingency Management-Family Engagement; Behavioral: Treatment as Usual

• Registration Number: NCT02130479
• Lead Sponsor: Medical University of South Carolina

Brief Summary

This study aims to address a serious public health problem (i.e., substance abusing adolescents) by testing the effectiveness of a promising substance abuse treatment implemented in a community-based treatment setting (CM-FAM, a family-based contingency management intervention) in comparison to usual treatment services.

Detailed Description

The overriding purpose of the randomized trial is to examine the effectiveness of a promising and efficient outpatient treatment of adolescent substance abuse delivered in a community-based treatment setting. Although several evidence-based treatments of adolescent substance abuse are emerging, none have experienced widespread adoption in community settings. Thus, as noted by the Institute of Medicine (1998) more than a decade ago and reiterated more recently, a considerable science-service gap exists in regards to treatment of substance abuse in adolescents and adults.

For the proposed study, 204 adolescents meeting diagnostic criteria for substance abuse or dependence will be randomized to either the Contingency Management-Family Engagement (CM-FAM) or Treatment as Usual (TAU) conditions. A multimethod, multirespondent approach will be used to track clinical outcomes at 3, 6, 9, 12, and 18 months post recruitment. Clinical level outcomes pertain to youth substance use, criminal behavior, mental health functioning, and key mediators of serious antisocial behavior in adolescents (e.g., self-control, parental supervision, association with deviant peers). In addition, the incremental cost of CM-FAM will be determined for use in cost effectiveness analyses.

Aim 1: Over an 18-month post-recruitment follow-up, determine the relative effectiveness of CM-FAM vs. TAU in reducing adolescent participants' substance use, criminal activity (including incarceration), and mental health symptoms; and evaluate the cost effectiveness of CM-FAM in achieving these outcomes.

Aim 2: Examine possible moderators and mediators of intervention effectiveness. Moderator variables will include youth demographic and clinical (e.g., co-occurring disorders) characteristics. Mediator variables will include measures of self-control, parenting, and association with deviant peers - constructs targeted by CM-FAM.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-01
• Study First Submitted QC: 2014-05-01
• Study First Posted: 2014-05-05
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-04
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Age of 12-17 years
• Meeting criteria for substance use or abuse.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contingency Management-Family Engagement	Contingency Management-Family Engagement	The Contingency Management-Family Engagement or CM-FAM model integrates behavioral (e.g., drug testing linked with consequences) and cognitive behavioral (e.g., functional analyses of drug use, self-management and drug refusal skills training) strategies based on the Community Reinforcement Approach with effective family engagement strategies used in Multisystemic Therapy.
Treatment as Usual	Treatment as Usual	Standard community-based substance abuse treatment services.

Primary Outcome Measures

Name	Time	Method
Change in youths' substance abuse frequency as measured by Urine Drug Screens and the Global Appraisal of Individual Needs Scale	Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Change in youths' delinquent behavior as measured by Juvenile Justice Archival Records and the Self-Report Delinquency Scale	Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Change in youths' mental health functioning as measured by the Brief Problem Checklist	Youth baseline, 3, 6, 9, 12, & 18 months post-baseline

Secondary Outcome Measures

Name	Time	Method
Change in youths' peer relations as measured by the Peer Delinquency and Drug Activities Scales, the Conventional Activities of Peers Scale, and the Bad Friends Scale from the Pittsburgh Youth Study	Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Change in family functioning as measured by the Caregiver Supervision Scale, the Discipline Scale, and the Communication Form from the Pittsburgh Youth Study	Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Change in youths' self-control as measured by the Good Behavioral Self-Control and the Poor Behavioral Regulation Scales	Youth baseline, 3, 6, 9, 12, & 18 months post-baseline

Trial Locations

Locations (1)

Circle Park Behavioral Health Services; 🇺🇸 Florence, South Carolina, United States