Enhancing Adolescent Substance Abuse Treatment

Experimental Mediation Research Aimed at Enhancing Adolescent Substance Abuse Treatment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Substance Use Disorders
• Intervention / Treatment: Behavioral: Standard Contingency Management (CM); Behavioral: Enhanced Contingency Management (CM+)

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Adolescent and Family Clinic, OSLC Developments, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 12 to 17 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Contingency Management (CM); This group will receive standard CM for adolescent substance abuse.	Behavioral: Standard Contingency Management (CM); CM utilizes behavior modification & cognitive behavioral strategies to target adolescent substance use. Protocol components are as follows: (a) The provider introduces CM to the youth and caregiver and engages them in the intervention; (b) The provider conducts Antecedent-Behavior-Consequence (ABC) assessments of the youth's AOD use with the youth and caregiver; (c) Based on the results of the ABC assessments, self-management planning and drug refusal skills training are implemented by the provider in collaboration with the youth and caregiver; (d) Concurrently, a point and level system contract is established with the family, which provides the youth with rewards/privileges for negative drug and alcohol tests and disincentives (e.g., extra chores) for positive tests. Until continued abstinence is achieved, components "b" through "d" are repeated; (e) The provider collaborates with the family to develop plans for sustaining long-term abstinence. Typical duration of CM is 12-16 weeks.
Experimental: Enhanced Contingency Management (CM+); This group will receive an enhanced CM protocol for adolescent substance abuse that targets parenting more intensely.	Behavioral: Enhanced Contingency Management (CM+); The CM+ protocol adds the behavioral assessment and teaching system from Parent Management Training Oregon (PMTO) to standard CM to enhance parent's skill acquisition more intensely. PMTO's behavioral assessment and teaching system uses three processes to bring about changes in parenting: daily parent reports on youth behavior, anti-coercive problem-solving, and structured learning and in vivo practice of new parenting techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from Baseline scores compared to 12 months post-Baseline Youth Urine Drug/Alcohol Screens (measured at 0, 2, 4, 6, 9, & 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).	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from Baseline scores compared to 12 months post-Baseline Youth Problem Behaviors (measured at 0, 2, 4, 6, 9, & 12 months).	Youth problem behaviors as measured by the Child Behavior Checklist (parent-report) and the Youth Self Report.	Baseline to 12 months
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).	Parent management practices (monitoring/supervision, positive parenting, and consistent discipline) as measured by the Alabama Parenting Questionnaire (youth- and parent-report).	Baseline to 12 months
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).	Parents' implementation of CM as measured by the CM Adherence Measure (youth- and parent-report).	Baseline to 12 months
Changes from Baseline scores compared to 12 months post-Baseline Youth Substance Use and Problems (measured at 0, 2, 4, 6, 9, & 12 months).	Frequency of substance use and substance-related problems as measured by the Global Appraisal of Individual Needs (youth-report).	Baseline to 12 months
Changes from Baseline scores compared to 12 months post-Baseline Youth Behavioral Regulation - Risk Taking (measured at 0, 2, 4, 6, 9, & 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.	Baseline to 12 months
Changes from Baseline scores compared to 12 months post-Baseline Youth Behavioral Regulation - Inhibitory Control (measured at 0, 2, 4, 6, 9, & 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.	Baseline to 12 months
Changes from Baseline scores compared to 12 months post-Baseline Peer Relations (measured at 0, 2, 4, 6, 9, & 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).	Baseline to 12 months

Collaborators and Investigators

• Sponsor: Oregon Social Learning Center

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2018
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; Treatment; Substance Use Disorders; Mediation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: R01DA043578-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No