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Enhancing Adolescent Substance Abuse Treatment

Primary Purpose

Substance Use Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Contingency Management (CM)
Enhanced Contingency Management (CM+)
Sponsored by
Oregon Social Learning Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Substance Use Disorders, Adolescents, Treatment, Mediation

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Adolescent and Family Clinic, OSLC Developments, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Contingency Management (CM)

Enhanced Contingency Management (CM+)

Arm Description

This group will receive standard CM for adolescent substance abuse.

This group will receive an enhanced CM protocol for adolescent substance abuse that targets parenting more intensely.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
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).
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).
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.
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.
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).

Full Information

First Posted
August 10, 2017
Last Updated
May 11, 2022
Sponsor
Oregon Social Learning Center
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1. Study Identification

Unique Protocol Identification Number
NCT03249350
Brief Title
Enhancing Adolescent Substance Abuse Treatment
Official Title
Experimental Mediation Research Aimed at Enhancing Adolescent Substance Abuse Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Social Learning Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Substance Use Disorders, Adolescents, Treatment, Mediation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Contingency Management (CM)
Arm Type
Active Comparator
Arm Description
This group will receive standard CM for adolescent substance abuse.
Arm Title
Enhanced Contingency Management (CM+)
Arm Type
Experimental
Arm Description
This group will receive an enhanced CM protocol for adolescent substance abuse that targets parenting more intensely.
Intervention Type
Behavioral
Intervention Name(s)
Standard Contingency Management (CM)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Contingency Management (CM+)
Intervention Description
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 Outcome Measure Information:
Title
Changes from Baseline scores compared to 12 months post-Baseline Youth Urine Drug/Alcohol Screens (measured at 0, 2, 4, 6, 9, & 12 months).
Description
The number of positive urine screens for tetrahydrocannabinol (THC), synthetic THC, amphetamines, opiates, phencyclidine (PCP), cocaine, and alcohol metabolites (ethyl glucuronide, ethyl sulfate).
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Changes from Baseline scores compared to 12 months post-Baseline Youth Problem Behaviors (measured at 0, 2, 4, 6, 9, & 12 months).
Description
Youth problem behaviors as measured by the Child Behavior Checklist (parent-report) and the Youth Self Report.
Time Frame
Baseline to 12 months
Title
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).
Description
Parent management practices (monitoring/supervision, positive parenting, and consistent discipline) as measured by the Alabama Parenting Questionnaire (youth- and parent-report).
Time Frame
Baseline to 12 months
Title
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).
Description
Parents' implementation of CM as measured by the CM Adherence Measure (youth- and parent-report).
Time Frame
Baseline to 12 months
Title
Changes from Baseline scores compared to 12 months post-Baseline Youth Substance Use and Problems (measured at 0, 2, 4, 6, 9, & 12 months).
Description
Frequency of substance use and substance-related problems as measured by the Global Appraisal of Individual Needs (youth-report).
Time Frame
Baseline to 12 months
Title
Changes from Baseline scores compared to 12 months post-Baseline Youth Behavioral Regulation - Risk Taking (measured at 0, 2, 4, 6, 9, & 12 months).
Description
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.
Time Frame
Baseline to 12 months
Title
Changes from Baseline scores compared to 12 months post-Baseline Youth Behavioral Regulation - Inhibitory Control (measured at 0, 2, 4, 6, 9, & 12 months).
Description
Behavioral regulation - inhibitory control as measured by the Early Adolescent Temperament Questionnaire-Revised (youth- and parent-report) and the Go/No Go Task.
Time Frame
Baseline to 12 months
Title
Changes from Baseline scores compared to 12 months post-Baseline Peer Relations (measured at 0, 2, 4, 6, 9, & 12 months).
Description
Peer relations (association with peers who engage in delinquent behaviors & prosocial activities) as measured by the Peer Relations Questionnaire (youth- and parent-report).
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael McCart, PhD
Phone
541-485-2711
Email
MikeM@oslc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ashli Sheidow, PhD
Phone
541-485-2711
Email
ashlis@oslc.org
Facility Information:
Facility Name
Adolescent and Family Clinic, OSLC Developments, Inc.
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Marchini, MS
Phone
541-284-7560
Email
juliem@oslc.org
First Name & Middle Initial & Last Name & Degree
Mike McCart, PhD
Phone
541-284-7560
Email
mikem@oslc.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhancing Adolescent Substance Abuse Treatment

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