A Phase 1/2 interventional study of Contingency Management-Family Engagement and Treatment as Usual in Substance Abuse, Delinquency and Mental Health, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-06.
Sponsored by Medical University of South Carolina · Phase 1/2, Interventional, and Treatment
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.
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.
2,181 studies on the registry are indexed under Substance-Related Disorders; 399 are open to participants now.
This study's enrollment of 101 is close to the median of 108 across 1,770 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Medical University of South Carolina is the lead sponsor of 871 studies on the registry; 163 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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.
Behavioral: Contingency Management-Family Engagement
Standard community-based substance abuse treatment services.
Behavioral: Treatment as Usual
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
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
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
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
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
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
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
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
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
The record gives a start of Apr 2014, a primary completion of Jun 2018 and a completion of Jun 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of South Carolina →