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Substance Use DisordersNCT03249350

Enhancing Adolescent Substance Abuse Treatment

A study testing Standard Contingency Management (CM) and Enhanced Contingency Management (CM+) in people with Substance Use Disorders, run by Oregon Social Learning Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Substance Use Disorders
What is being tested?
Standard Contingency Management (CM) and Enhanced Contingency Management (CM+)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
1 siteUnited States
Study dates
23 Apr 2018to 31 Jul 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Adolescent and Family Clinic, OSLC Developments, Inc.

    Eugene, Oregon, 97401

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Standard Contingency Management (CM), Enhanced Contingency Management (CM+)
Keywords
Substance Use Disorders, Adolescents, Treatment, Mediation
Medical subject headings
Substance-Related Disorders, Negotiating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Contingency Management (CM)Behavioural

    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+)Behavioural

    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.

Study groups in NCT03249350
Study groupRoleWhat they receive
Standard Contingency Management (CM)Active comparatorThis group will receive standard CM for adolescent substance abuse.
Receives: Behavioral: Standard Contingency Management (CM)
Enhanced Contingency Management (CM+)ExperimentalThis group will receive an enhanced CM protocol for adolescent substance abuse that targets parenting more intensely.
Receives: Behavioral: Enhanced Contingency Management (CM+)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

    Measured: Baseline to 12 months

Secondary outcomes (23)
  1. Changes From Baseline Scores Compared to Post-Treatment Scores for 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.

    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.

    Measured: Baseline to 12 months

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

    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.

    Measured: Course of treatment (length varied by participant)

  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).

    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.

    Measured: Baseline to 12 months

  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).

    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.

    Measured: Baseline to 12 months

  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).

    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.

    Measured: Baseline to 12 months

  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).

    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.

    Measured: Baseline to 12 months

  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).

    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.

    Measured: Baseline to 12 months

  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).

    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.

    Measured: Baseline to 12 months

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

    Measured: Baseline to 12 months

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

    Measured: Baseline to 12 months

  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).

    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).

    Measured: Baseline to 12 months

  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).

    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).

    Measured: Baseline to 12 months

  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).

    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).

    Measured: Baseline to 12 months

  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).

    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).

    Measured: Baseline to 12 months

  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).

    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).

    Measured: Baseline to 12 months

  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).

    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).

    Measured: Baseline to 12 months

  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).

    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.

    Measured: Baseline to 12 months

  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).

    Behavioral regulation - inhibitory control as measured by the Early Adolescent Temperament Questionnaire-Revised (youth- and parent-report) and the Go/No Go Task.

    Measured: Baseline to 12 months

  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).

    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.

    Measured: Baseline to 12 months

  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).

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

    Measured: Baseline to 12 months

  21. Changes From Baseline Scores Compared to Post-Treatment Scores for Peer Relations - Peer Delinquency (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).

    Measured: Baseline to 12 months

  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).

    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.

    Measured: Baseline to 12 months

  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).

    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.

    Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2017
  2. Study start23 Apr 2018
  3. Primary completion29 Mar 2024
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03249350
Sponsor's protocol ID
R01DA043578-01A1
Status last verified
Oct 2025
First submitted
10 Aug 2017
Last updated
14 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Standard Contingency Management (CM) and Enhanced Contingency Management (CM+) in people with Substance Use Disorders, run by Oregon Social Learning Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.

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Enhancing Adolescent Substance Abuse Treatment | AzTrials