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Testing a Promising Treatment for Youth Substance Abuse in a Community Setting

Primary Purpose

Substance Abuse, Delinquency, Mental Health

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Contingency Management-Family Engagement
Treatment as Usual
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age of 12-17 years
  • Meeting criteria for substance use or abuse.

Sites / Locations

  • Circle Park Behavioral Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Contingency Management-Family Engagement

Treatment as Usual

Arm Description

The Contingency Management-Family Engagement or CM-FAM model integrates behavioral (e.g., drug testing linked with consequences) and cognitive behavioral (e.g., functional analyses of drug use, self-management and drug refusal skills training) strategies based on the Community Reinforcement Approach with effective family engagement strategies used in Multisystemic Therapy.

Standard community-based substance abuse treatment services.

Outcomes

Primary Outcome Measures

Change in youths' substance abuse frequency as measured by Urine Drug Screens and the Global Appraisal of Individual Needs Scale
Change in youths' delinquent behavior as measured by Juvenile Justice Archival Records and the Self-Report Delinquency Scale
Change in youths' mental health functioning as measured by the Brief Problem Checklist

Secondary Outcome Measures

Change in youths' peer relations as measured by the Peer Delinquency and Drug Activities Scales, the Conventional Activities of Peers Scale, and the Bad Friends Scale from the Pittsburgh Youth Study
Change in family functioning as measured by the Caregiver Supervision Scale, the Discipline Scale, and the Communication Form from the Pittsburgh Youth Study
Change in youths' self-control as measured by the Good Behavioral Self-Control and the Poor Behavioral Regulation Scales

Full Information

First Posted
May 1, 2014
Last Updated
July 4, 2018
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT02130479
Brief Title
Testing a Promising Treatment for Youth Substance Abuse in a Community Setting
Official Title
Testing a Promising Treatment for Youth Substance Abuse in a Community Setting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to address a serious public health problem (i.e., substance abusing adolescents) by testing the effectiveness of a promising substance abuse treatment implemented in a community-based treatment setting (CM-FAM, a family-based contingency management intervention) in comparison to usual treatment services.
Detailed Description
The overriding purpose of the randomized trial is to examine the effectiveness of a promising and efficient outpatient treatment of adolescent substance abuse delivered in a community-based treatment setting. Although several evidence-based treatments of adolescent substance abuse are emerging, none have experienced widespread adoption in community settings. Thus, as noted by the Institute of Medicine (1998) more than a decade ago and reiterated more recently, a considerable science-service gap exists in regards to treatment of substance abuse in adolescents and adults. For the proposed study, 204 adolescents meeting diagnostic criteria for substance abuse or dependence will be randomized to either the Contingency Management-Family Engagement (CM-FAM) or Treatment as Usual (TAU) conditions. A multimethod, multirespondent approach will be used to track clinical outcomes at 3, 6, 9, 12, and 18 months post recruitment. Clinical level outcomes pertain to youth substance use, criminal behavior, mental health functioning, and key mediators of serious antisocial behavior in adolescents (e.g., self-control, parental supervision, association with deviant peers). In addition, the incremental cost of CM-FAM will be determined for use in cost effectiveness analyses. Aim 1: Over an 18-month post-recruitment follow-up, determine the relative effectiveness of CM-FAM vs. TAU in reducing adolescent participants' substance use, criminal activity (including incarceration), and mental health symptoms; and evaluate the cost effectiveness of CM-FAM in achieving these outcomes. Aim 2: Examine possible moderators and mediators of intervention effectiveness. Moderator variables will include youth demographic and clinical (e.g., co-occurring disorders) characteristics. Mediator variables will include measures of self-control, parenting, and association with deviant peers - constructs targeted by CM-FAM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Delinquency, Mental Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contingency Management-Family Engagement
Arm Type
Experimental
Arm Description
The Contingency Management-Family Engagement or CM-FAM model integrates behavioral (e.g., drug testing linked with consequences) and cognitive behavioral (e.g., functional analyses of drug use, self-management and drug refusal skills training) strategies based on the Community Reinforcement Approach with effective family engagement strategies used in Multisystemic Therapy.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Standard community-based substance abuse treatment services.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management-Family Engagement
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Primary Outcome Measure Information:
Title
Change in youths' substance abuse frequency as measured by Urine Drug Screens and the Global Appraisal of Individual Needs Scale
Time Frame
Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Title
Change in youths' delinquent behavior as measured by Juvenile Justice Archival Records and the Self-Report Delinquency Scale
Time Frame
Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Title
Change in youths' mental health functioning as measured by the Brief Problem Checklist
Time Frame
Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Secondary Outcome Measure Information:
Title
Change in youths' peer relations as measured by the Peer Delinquency and Drug Activities Scales, the Conventional Activities of Peers Scale, and the Bad Friends Scale from the Pittsburgh Youth Study
Time Frame
Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Title
Change in family functioning as measured by the Caregiver Supervision Scale, the Discipline Scale, and the Communication Form from the Pittsburgh Youth Study
Time Frame
Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Title
Change in youths' self-control as measured by the Good Behavioral Self-Control and the Poor Behavioral Regulation Scales
Time Frame
Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Other Pre-specified Outcome Measures:
Title
Incremental costs associated with CM-FAM as measured by the Drug Abuse Treatment Cost Analysis Program
Time Frame
6, 18, and 30 months following initiation of CM-FAM delivery
Title
Change in youths' treatment duration and rates of completion as measured by clinic records
Time Frame
6, 18, and 30 months following initiation of CM-FAM delivery
Title
Change in therapists' perceptions of the functioning of their treatment facility as measured by the Organizational Readiness for Change Scale
Time Frame
Therapist baseline, 6, 12, 18, 24, & 30 months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age of 12-17 years Meeting criteria for substance use or abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Henggeler, Ph.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Circle Park Behavioral Health Services
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States

12. IPD Sharing Statement

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Testing a Promising Treatment for Youth Substance Abuse in a Community Setting

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