Enhancing Adolescent Substance Abuse Treatment

Not Applicable

Completed

• Conditions: Substance Use Disorders

• Registration Number: NCT03249350
• Lead Sponsor: Oregon Social Learning Center

Brief Summary

The ultimate goal of this research is to facilitate rapid enhancement of youth substance abuse treatments by determining the key mechanisms of change (i.e., what to target more intensely to generate better outcomes). This work is critical because current outpatient adolescent substance abuse treatments yield only small to medium effects that diminish once treatment has ended. The proposed modern mediation study will address this serious public health problem by experimentally evaluating the most critical factors causing change in client outcomes during adolescent substance abuse treatment, directing the field to focus treatment efforts on those factors.

Detailed Description

Adolescents with substance use disorders (SUD) are at high risk for significant deleterious outcomes. Although several evidence-based practices for adolescent SUD exist, they yield only small to medium effects that rapidly diminish (30-70% 6-month relapse rates). A promising approach for determining how to enhance treatment is experimental mediation research. In contrast to traditional correlational mediation approaches, experimental mediation permits causal inference and is comprised of key steps: (A) Identify the putative mediating variable for a treatment. (B) Enhance the treatment to target that mediator more intensely. (C) Randomize youth to conditions, with the standard and enhanced versions of the treatment targeting different "levels" of the same mediator. (D) Measure the mediator and outcomes longitudinally. (E) Perform modern mediation analyses, coupled with analyses evaluating causal inference, to determine if changes in the mediator are responsible for changes in outcomes. This experimental test of mediation, focused on causality, facilitates rapid improvement of treatments by specifying change mechanisms to target in order to improve outcomes. These steps will be followed to elucidate the mediating processes in treatment for adolescent SUD, with the ultimate goal of enhancing the strength and durability of SUD treatments. The three most common putative mediating variables in adolescent SUD treatments are parent management, behavioral regulation, and peer relations. For this study, parent management was chosen as the target because it has evidenced the most potential for yielding generalizable change in youth outcomes and also has been shown to indirectly improve youths' behavioral regulation and peer relations. Of existing treatments for adolescent SUD, family-based Contingency Management (CM) was chosen as the treatment to enhance because it is highly amenable to an augmented focus on parenting, is less complex relative to other SUD treatments, and has amassed considerable support in terms of efficacy and dissemination potential. Thus, following experimental mediation steps, youth with SUD will be randomized to receive either standard CM or enhanced CM (i.e., CM+) that targets parenting more intensely. Repeated assessments for 12 months and longitudinal analyses will allow testing of mediating processes. The investigators will examine whether parent management skills mediate the effect of treatment on youth substance use and behavior problems (Aim 1). In addition, the investigators will determine whether parent management skills mediate the effect of treatment on youth behavioral regulation and deviant peer relations (Aim 2). Finally, the investigators will test whether behavioral regulation and deviant peer relations mediate the effect of parent management on youth substance use and behavior problems (Aim 3). Findings could have broad impact across multiple adolescent SUD treatments.

Study Timeline

• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-15
• Study Start: 2018-04-23
• Primary Completion: 2024-03-29
• Study Completion: 2024-07-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Age 12 to 18 years
• Presence of current substance use disorder
• Availability of a parent/guardian willing to participate

Exclusion Criteria

• Actively psychotic, suicidal, or homicidal
• Pervasive developmental disorder or metal retardation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes from Baseline scores compared to 12 months post-Baseline Youth Urine Drug/Alcohol Screens (measured at 0, 2, 4, 6, 9, & 12 months).	Baseline to 12 months	The number of positive urine screens for tetrahydrocannabinol (THC), synthetic THC, amphetamines, opiates, phencyclidine (PCP), cocaine, and alcohol metabolites (ethyl glucuronide, ethyl sulfate).

Secondary Outcome Measures

Name	Time	Method
Changes from Baseline scores compared to 12 months post-Baseline Youth Substance Use and Problems (measured at 0, 2, 4, 6, 9, & 12 months).	Baseline to 12 months	Frequency of substance use and substance-related problems as measured by the Global Appraisal of Individual Needs (youth-report).
Changes from Baseline scores compared to 12 months post-Baseline Youth Problem Behaviors (measured at 0, 2, 4, 6, 9, & 12 months).	Baseline to 12 months	Youth problem behaviors as measured by the Child Behavior Checklist (parent-report) and the Youth Self Report.
Changes from Baseline scores compared to 12 months post-Baseline Parent Contingency Management (CM) Adherence (measured at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, & 12 months).	Baseline to 12 months	Parents' implementation of CM as measured by the CM Adherence Measure (youth- and parent-report).
Changes from Baseline scores compared to 12 months post-Baseline Parent Management (measured at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, & 12 months).	Baseline to 12 months	Parent management practices (monitoring/supervision, positive parenting, and consistent discipline) as measured by the Alabama Parenting Questionnaire (youth- and parent-report).
Changes from Baseline scores compared to 12 months post-Baseline Youth Behavioral Regulation - Inhibitory Control (measured at 0, 2, 4, 6, 9, & 12 months).	Baseline to 12 months	Behavioral regulation - inhibitory control as measured by the Early Adolescent Temperament Questionnaire-Revised (youth- and parent-report) and the Go/No Go Task.
Changes from Baseline scores compared to 12 months post-Baseline Youth Behavioral Regulation - Risk Taking (measured at 0, 2, 4, 6, 9, & 12 months).	Baseline to 12 months	Behavioral regulation - risk taking as measured by the Behavioral Inhibition System (youth- and parent-report), the Behavioral Activation System (youth- and parent-report), and the Balloon Analogue Risk Task.
Changes from Baseline scores compared to 12 months post-Baseline Peer Relations (measured at 0, 2, 4, 6, 9, & 12 months).	Baseline to 12 months	Peer relations (association with peers who engage in delinquent behaviors \& prosocial activities) as measured by the Peer Relations Questionnaire (youth- and parent-report).

Trial Locations

Locations (1)

Adolescent and Family Clinic, OSLC Developments, Inc.; 🇺🇸 Eugene, Oregon, United States