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

Substance Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130479
• Other study ID #: R01DA034064-01A1
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2014
• Est. completion date: June 2018

Study information

• Verified date: July 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Age of 12-17 years

• Meeting criteria for substance use or abuse.

Related Conditions & MeSH terms

• Delinquency
• Mental Health
• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• Contingency Management-Family Engagement

• Treatment as Usual

Locations

Country	Name	City	State
United States	Circle Park Behavioral Health Services	Florence	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incremental costs associated with CM-FAM as measured by the Drug Abuse Treatment Cost Analysis Program		6, 18, and 30 months following initiation of CM-FAM delivery
Other	Change in youths' treatment duration and rates of completion as measured by clinic records		6, 18, and 30 months following initiation of CM-FAM delivery
Other	Change in therapists' perceptions of the functioning of their treatment facility as measured by the Organizational Readiness for Change Scale		Therapist baseline, 6, 12, 18, 24, & 30 months post-baseline
Primary	Change in youths' substance abuse frequency as measured by Urine Drug Screens and the Global Appraisal of Individual Needs Scale		Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Primary	Change in youths' delinquent behavior as measured by Juvenile Justice Archival Records and the Self-Report Delinquency Scale		Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Primary	Change in youths' mental health functioning as measured by the Brief Problem Checklist		Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Secondary	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		Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Secondary	Change in family functioning as measured by the Caregiver Supervision Scale, the Discipline Scale, and the Communication Form from the Pittsburgh Youth Study		Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Secondary	Change in youths' self-control as measured by the Good Behavioral Self-Control and the Poor Behavioral Regulation Scales		Youth baseline, 3, 6, 9, 12, & 18 months post-baseline