Enhancing Adolescent Substance Abuse Treatment

Substance Use Disorders Clinical Trial

Official title:

Experimental Mediation Research Aimed at Enhancing Adolescent Substance Abuse Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03249350
• Other study ID #: R01DA043578-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 23, 2018
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: Oregon Social Learning Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Adolescent and Family Clinic, OSLC Developments, Inc.	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Social Learning Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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