NCT02130479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

4.2 years

First QC Date

May 1, 2014

Last Update Submit

July 4, 2018

Conditions

Substance AbuseDelinquencyMental Health

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Change in youths' mental health functioning as measured by the Brief Problem Checklist

    Youth baseline, 3, 6, 9, 12, & 18 months post-baseline

Secondary Outcomes (3)

  • 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

  • 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

  • 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

Other Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Contingency Management-Family Engagement

EXPERIMENTAL

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

Treatment as Usual

ACTIVE COMPARATOR

Standard community-based substance abuse treatment services.

Behavioral: Treatment as Usual

Interventions

Contingency Management-Family EngagementBEHAVIORAL
Contingency Management-Family Engagement
Treatment as UsualBEHAVIORAL
Treatment as Usual

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Circle Park Behavioral Health Services

Florence, South Carolina, 29501, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersPsychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPersonal SatisfactionBehavior

Study Officials

  • Scott Henggeler, Ph.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2014

First Posted

May 5, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

US(1)