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Completed

NCT Number: NCT03249350

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.

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Key information

Conditions

Substance Use Disorders Behavior Chemically-Induced Disorders Communication Mental Disorders Negotiating Substance-Related Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adolescent and Family Clinic, OSLC Developments, Inc.

Eugene, Oregon, 97401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Contingency Management (CM)

Behavioral

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+)

Behavioral

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.

Primary outcomes

  1. Changes From Baseline Scores Compared to Post-Treatment Scores, Any Positive Youth Urine Drug/Alcohol Screens (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    Any positive urine screens for tetrahydrocannabinol (THC), synthetic THC, amphetamines, opiates, phencyclidine (PCP), cocaine, and/or alcohol metabolites (ethyl glucuronide, ethyl sulfate).

Secondary outcomes

  1. Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Problem Behaviors (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    Youth problem behaviors as measured by the Child Behavior Checklist (parent-report) and the Youth Self Report.

    This is a 35-item Subscale of the Child Behavior Checklist (CBCL) measuring externalizing behaviors from the youth's self-report. It assesses outward-directed behaviors such as aggression, defiance, hyperactivity, and rule-breaking. Scores range from 0 to 70, where higher scores indicate the presence of more externalizing behavior problems.

  2. Youth Receipt of Required Contingency Management (CM) Treatment Components.

    Time frame: Course of treatment (length varied by participant)

    All treatment sessions were audio-recorded. A random selection of tapes was coded by trained raters to indicate the presence or absence of CM treatment components. Scores on this outcome reflect the proportion of components delivered, with higher scores indicating the presence of more treatment components.

  3. Changes From Baseline Scores Compared to Post-Treatment Scores for Parent Management - Inconsistent Discipline Subscale - Parent Report(Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    A 6-item subscale of the Alabama Parenting Questionnaire (APQ) that measures parents' discipline activity and the variability in rule enforcement and consequences. Scores range from 6-30. High scores suggest unpredictable enforcement of rules, which can undermine authority and increase behavioral issues. This is measured through parents' self-reports of their own behaviors.

  4. Changes From Baseline Scores Compared to Post-Treatment Scores for Parent Management - Positive Parenting Subscale - Parent Report (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    A 6-item subscale of the Alabama Parenting Questionnaire (APQ) that measures positive parenting through the frequency of praise and reinforcement. Scores range from 6-30. High scores reflect the frequent use of praise and rewards, which are associated with better child compliance and emotional well-being. This is measured through parents' self-reports of their own behaviors.

  5. Changes From Baseline Scores Compared to Post-Treatment Scores for Parent Management - Poor Monitoring Subscale - Parent Report (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    Parent management practices as measured by the Alabama Parenting Questionnaire (APQ) (parent-report).

    A 10-item subscale of the Alabama Parenting Questionnaire (APQ) that measures parents' monitoring and supervision of their child's activities and whereabouts. Scores range from 10-50. Higher scores indicate less parental awareness of the child's activities. Elevated scores are associated with an increased risk of delinquency and externalizing behaviors. This is measured through parents' self-reports of their own behaviors.

  6. Changes From Baseline Scores Compared to Post-Treatment Scores for Parent Management - Inconsistent Discipline Subscale (Youth Report) (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    A 6-item subscale of the Alabama Parenting Questionnaire (APQ) that measures parents' discipline activity and the variability in rule enforcement and consequences. Scores range from 6 -30. High scores suggest unpredictable enforcement of rules, which can undermine authority and increase behavioral issues. This is measured through youths' reports on parents' behaviors.

  7. Changes From Baseline Scores Compared to Post-Treatment Scores for Parent Management - Positive Parenting Subscale - Youth Report (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    A 6-item subscale of the Alabama Parenting Questionnaire (APQ) that measures positive parenting through the frequency of praise and reinforcement. Scores range from 6-30. High scores reflect the frequent use of praise and rewards, which are associated with better child compliance and emotional well-being. This is measured through youths' report on parents' behaviors.

  8. Changes From Baseline Scores Compared to Post-Treatment Scores for Parent Management - Poor Monitoring Subscale - Youth Report (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    A 10-item subscale of the Alabama Parenting Questionnaire (APQ) that measures parents' monitoring and supervision of their child's activities and whereabouts. Scores range from 10-50. Higher scores indicate less parental awareness of the child's activities. Elevated scores are associated with an increased risk of delinquency and externalizing behaviors. This is measured through youths' reports on parents' behaviors.

  9. Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Substance Use Frequency (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    Frequency of substance use as measured by the Global Appraisal of Individual Needs (youth-report).

    The Global Appraisal of Individual Needs (GAIN) Frequency Subscale measures the frequency of substance use of 16 different substances over the past 30 days. Scores range from 0 to 100, where higher scores indicate higher frequency of use.

  10. Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Substance Problems (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    The Global Appraisal of Individual Needs (GAIN) Substance Problems Subscale measures the presence of each DSM-V criterion for a substance use disorder and lower severity symptoms. Scores range from 0 to 16, where higher scores indicate the presence of more criterion/symptoms.

  11. Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Risk Taking - Drive - Youth Report (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    Behavioral regulation - risk taking as measured by the Behavioral Inhibition System and Behavioral Activation System (youth report) scales.

    Youth report of youth risk-taking as assessed by the sum score on the Drive subscale from the Behavioral Inhibition System and Behavioral Activation System scales. Scores on individual items and subscale range from 1=Strongly agree to 4=Strongly disagree and scores range from 4 to 16. Higher scores equal higher youth behavioral activation (drive).

  12. Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Risk Taking - Fun Seeking - Youth Report (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    Behavioral regulation - risk taking as measured by the Behavioral Inhibition System and Behavioral Activation System (youth report) scales.

    Youth report of youth risk taking as assessed by the sum score on the Fun Seeking subscale from the Behavioral Inhibition System and Behavioral Activation System scales. Scores on individual items and subscale range from 1=Strongly agree to 4=Strongly disagree and scores range from 4 to 16. Higher scores equal higher youth behavioral activation (fun seeking).

  13. Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Risk Taking - Reward Responsiveness - Youth Report (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    Behavioral regulation - risk taking as measured by the Behavioral Inhibition System and Behavioral Activation System (youth report) scales.

    Youth report of youth risk taking as assessed by the sum score on the Reward Responsiveness subscale from the Behavioral Inhibition System and Behavioral Activation System. Scores on individual items and subscale range from 1=Strongly agree to 4=Strongly disagree and scores range from 5 to 20. Higher scores equal higher youth behavioral activation (reward responsiveness).

  14. Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Risk Taking - Drive - Parent Report (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    Behavioral regulation - risk taking as measured by the Behavioral Inhibition System and Behavioral Activation System (parent report) scales.

    Parent report of youth risk-taking as assessed by the sum score on the Drive subscale from the Behavioral Inhibition System and Behavioral Activation System scales. Scores on individual items and subscale range from 1=Strongly agree to 4=Strongly disagree and scores range from 4 to 16. Higher scores equal higher youth behavioral activation (drive).

  15. Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Risk Taking - Fun Seeking - Parent Report (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    Behavioral regulation - risk taking as measured by the Behavioral Inhibition System and Behavioral Activation System (parent report) scales.

    Parent report of youth risk taking as assessed by the sum score on the Fun Seeking subscale from the Behavioral Inhibition System and Behavioral Activation System scales. Scores on individual items and subscale range from 1=Strongly agree to 4=Strongly disagree and scores range from 4 to 16. Higher scores equal higher youth behavioral activation (fun seeking).

  16. Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Risk Taking - Reward Responsiveness - Parent Report (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    Behavioral regulation - risk taking as measured by the Behavioral Inhibition System and Behavioral Activation System (parent report) scales.

    Parent report of youth risk-taking as assessed by the sum score on the Reward Responsiveness subscale from the Behavioral Inhibition System and Behavioral Activation System. Scores on individual items and subscale range from 1=Strongly agree to 4=Strongly disagree and scores range from 5 to 20. Higher scores equal higher youth behavioral activation (reward responsiveness).

  17. Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Risk Taking - BART (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    Youth performance on computerized Balloon Analogue Risk Task (automatic version) that requires participants to enter the number of times that they want to pump to inflate a computer-generated balloon, with participants earning a point for each pump but losing all of the points if the balloon pops before the selected number of pumps. The mean number of pumps on all trials is reported. Scores range from 0 to 126. Higher scores equal higher youth risk taking behavior.

  18. Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Inhibitory Control - EATQ - Youth (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: 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.

  19. Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Inhibitory Control - EATQ - Parent Report (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    Parent report of youth inhibitory control as assessed by the mean score on the Effortful Control factor from the Early Adolescent Temperament Questionnaire. Scores on individual items and factor range from 1=Very false to 5=Very true. Higher scores equal higher youth effortful control.

  20. Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Inhibitory Control - Go No Go Performance (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    Youth performance of youth inhibitory control as assessed by the percent correct on no go trials on computerized go/no-go task.

  21. Changes From Baseline Scores Compared to Post-Treatment Scores for Peer Relations - Peer Delinquency (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: 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).

  22. Changes From Baseline Scores Compared to Post-Treatment Scores for Peer Relations - Positive Peer Activity - Youth Report (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    The Positive Peer Activity Scale of the Pittsburgh Youth Study Interview comprises 10 questions rated on a 4-point scale (0 = none to 4 = all) concerning the proportion of friends of the subject that have engaged in a variety of prosocial activities over the past 30 days. Scores range from 0 to 40, where higher scores indicate a higher proportion of prosocial friends. This is measured from the youth's self-report.

  23. Changes From Baseline Scores Compared to Post-Treatment Scores for Peer Relations - Positive Peer Activity - Parent Report (Measured at 0, 2, 4, 6, 9, & 12 Months).

    Time frame: Baseline to 12 months

    The Positive Peer Activity Scale of the Pittsburgh Youth Study Interview comprises 10 questions rated on a 4-point scale (0 = none to 4 = all) concerning the proportion of friends of the subject that have engaged in a variety of prosocial activities over the past 30 days. Scores range from 0 to 40, where higher scores indicate a higher proportion of prosocial friends. This is measured from the parent's report on youth's friends.

Sponsors and collaborators

Lead sponsor

Oregon Social Learning Center

Other

Registry information

Official study title

Experimental Mediation Research Aimed at Enhancing Adolescent Substance Abuse Treatment

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2017
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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