- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03249350
Enhancing Adolescent Substance Abuse Treatment
Experimental Mediation Research Aimed at Enhancing Adolescent Substance Abuse Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Oregon
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Eugene, Oregon, United States, 97401
- Adolescent and Family Clinic, OSLC Developments, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Standard Contingency Management (CM)
This group will receive standard CM for adolescent substance abuse.
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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.
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Experimental: Enhanced Contingency Management (CM+)
This group will receive an enhanced CM protocol for adolescent substance abuse that targets parenting more intensely.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline to 12 months
|
|
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.
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Course of treatment (length varied by participant)
|
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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.
|
Baseline to 12 months
|
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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.
|
Baseline to 12 months
|
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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. |
Baseline to 12 months
|
|
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.
|
Baseline to 12 months
|
|
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.
|
Baseline to 12 months
|
|
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.
|
Baseline to 12 months
|
|
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. |
Baseline to 12 months
|
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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
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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.
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Baseline to 12 months
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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). |
Baseline to 12 months
|
|
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). |
Baseline to 12 months
|
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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). |
Baseline to 12 months
|
|
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). |
Baseline to 12 months
|
|
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). |
Baseline to 12 months
|
|
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). |
Baseline to 12 months
|
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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.
|
Baseline to 12 months
|
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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
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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
|
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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.
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Baseline to 12 months
|
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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
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Youth performance of youth inhibitory control as assessed by the percent correct on no go trials on computerized go/no-go task.
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Baseline to 12 months
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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
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Peer relations (association with peers who engage in delinquent behaviors & prosocial activities) as measured by the Peer Relations Questionnaire (youth- and parent-report).
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Baseline to 12 months
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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.
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Baseline to 12 months
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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.
|
Baseline to 12 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA043578-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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