Clinical trial NCT02130479: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Substance Abuse
Delinquency
Mental Health
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2014-05-05
Enrollment: 101
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Change in youths' substance abuse frequency as measured by Urine Drug Screens and the Global Appraisal of Individual Needs Scale
timeFrame: Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
measure: Change in youths' delinquent behavior as measured by Juvenile Justice Archival Records and the Self-Report Delinquency Scale
timeFrame: Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
measure: Change in youths' mental health functioning as measured by the Brief Problem Checklist
timeFrame: Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Secondary outcomes:
measure: 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
timeFrame: Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
measure: Change in family functioning as measured by the Caregiver Supervision Scale, the Discipline Scale, and the Communication Form from the Pittsburgh Youth Study
timeFrame: Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
measure: Change in youths' self-control as measured by the Good Behavioral Self-Control and the Poor Behavioral Regulation Scales
timeFrame: Youth baseline, 3, 6, 9, 12, & 18 months post-baseline
Other outcomes:
measure: Incremental costs associated with CM-FAM as measured by the Drug Abuse Treatment Cost Analysis Program
timeFrame: 6, 18, and 30 months following initiation of CM-FAM delivery
measure: Change in youths' treatment duration and rates of completion as measured by clinic records
timeFrame: 6, 18, and 30 months following initiation of CM-FAM delivery
measure: Change in therapists' perceptions of the functioning of their treatment facility as measured by the Organizational Readiness for Change Scale
timeFrame: Therapist baseline, 6, 12, 18, 24, & 30 months post-baseline
Locations:
city: Florence
country: United States
facility: Circle Park Behavioral Health Services
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Scott Henggeler, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: