## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** R01DA034064-01A1
**Link:** https://reporter.nih.gov/quickSearch/R01DA034064-01A1
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** Medical University of South Carolina
### Status Module
#### Completion Date
**Date:** 2018-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-07-06

**Type:** ACTUAL

**Last Update Submit Date:** 2018-07-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-06

**Type:** ACTUAL

#### Start Date
**Date:** 2014-04

**Status Verified Date:** 2018-07

#### Study First Post Date
**Date:** 2014-05-05
**Type:** ESTIMATED
**Study First Submit Date:** 2014-05-01
**Study First Submit QC Date:** 2014-05-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Medical University of South Carolina

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Substance Abuse

- Delinquency

- Mental Health

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 101

**Type:** ACTUAL

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Behavioral: Contingency Management-Family Engagement

**Label:** Contingency Management-Family Engagement

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Standard community-based substance abuse treatment services.

**Intervention Names:**

- Behavioral: Treatment as Usual

**Label:** Treatment as Usual

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Contingency Management-Family Engagement

**Name:** Contingency Management-Family Engagement

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Treatment as Usual

**Name:** Treatment as Usual

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Measure:** 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

**Measure:** 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

**Measure:** 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

#### Primary Outcomes

**Measure:** 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

**Measure:** 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

**Measure:** 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 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

**Time Frame:** 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

**Time Frame:** 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

**Time Frame:** Youth baseline, 3, 6, 9, 12, & 18 months post-baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

**Healthy Volunteers:** True

**Maximum Age:** 17 Years

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Florence

**Country:** United States

**Facility:** Circle Park Behavioral Health Services

**State:** South Carolina

**Zip:** 29501

#### Overall Officials

**Official 1:**

**Affiliation:** Medical University of South Carolina

**Name:** Scott Henggeler, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: HIGH

- As Found: Substance Abuse

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000019966

- Term: Substance-Related Disorders

### Misc Info Module

- Version Holder: 2024-05-24
