NCT01381133

Brief Summary

The purpose of this study was to evaluate the effectiveness and cost-effectiveness of two types of outpatient treatment with and without Assertive Continuing Care (ACC) for 320 adolescents with substance use disorders. Study participants were randomly assigned to one of four conditions: (a) Chestnut's Bloomington Outpatient Treatment (CBOP) without ACC; (b) CBOP with ACC; (c) Motivational Enhancement Therapy/Cognitive Behavior Therapy-7 session model (MET/CBT7) without ACC; and (d) MET/CBT7 with ACC. Based on prior quasi and experimental studies, the investigators hypothesized that MET/CBT would be more effective and cost-effective than CBOP in terms of increasing days abstinent and decreasing substance abuse problems. Additionally, the investigators hypothesized that the groups receiving ACC would have significantly better outcomes than the groups without ACC. Lastly, the investigators hypothesized that adding ACC to MET/CBT would be the most cost-effective option in terms of days abstinent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
Last Updated

August 14, 2013

Status Verified

August 1, 2013

Enrollment Period

6.3 years

First QC Date

June 23, 2011

Last Update Submit

August 13, 2013

Conditions

Keywords

Substance abuseAdolescent outpatient treatmentContinuing careOutcomes

Outcome Measures

Primary Outcomes (4)

  • Change in Percentage of days abstinent from any alcohol and drugs

    Baseline and 3, 6, 9, and 12 months post-baseline

  • Change in Days abstinent from alcohol alone

    Baseline and 3, 6, 9, and 12 months post-baseline

  • Change in Substance use problems

    Measured using the Substance Problem Scale of the Global Appraisal of Individual Needs

    Baseline and 3, 6, 9, and 12 months post-baseline

  • Change in Recovery status

    Being in recovery at the end of the study was defined as living in the community (vs. being incarcerated, or residing in inpatient treatment or other controlled environment) and reporting no past month substance use, abuse, or dependence problems at the 12 month interview. Urine samples were collected as described above in Section 2.4.2, and when an adolescent reported being in recovery but the urine test result suggested a false-negative self-report, data were re-coded to show the adolescent as not being in recovery.

    12 months post-baseline

Study Arms (4)

CBOP without ACC

EXPERIMENTAL
Behavioral: Chestnut Bloomington Outpatient (CBOP)

CBOP with ACC

EXPERIMENTAL
Behavioral: Chestnut Bloomington Outpatient (CBOP)Behavioral: Assertive Continuing Care (ACC)

MET/CBT 7 without ACC

EXPERIMENTAL
Behavioral: Motivational Enhancement Therapy/Cognitive Behavior Treatment (MET/CBT 7)

MET/CBT 7 with ACC

EXPERIMENTAL
Behavioral: Motivational Enhancement Therapy/Cognitive Behavior Treatment (MET/CBT 7)Behavioral: Assertive Continuing Care (ACC)

Interventions

CBOP is an evidence-informed intervention that has developed over 20 years and been shaped by treatment research. The underlying theory of change is that the combination of multiple evidence-based and best-practice treatment components will increase the adolescent's desire to change, provide the necessary skills, and create an environment supportive for this change. The intervention is based on a manual and is primarily delivered through skill and therapy groups, combined with a limited number of family and individual sessions for treatment planning and progress reviews.

CBOP with ACCCBOP without ACC

A manual-based 5-session MET/CBT model was supplemented with 2 family sessions. First was a family session to provide parents with an overview. Next was an individual adolescent MET session that focused on building rapport, explaining treatment, building motivation, and reviewing personalized feedback. In the third session, the therapist helped the adolescent complete a functional analysis of substance use and a personal goal worksheet. During sessions 4-6, the adolescent joined a closed group of 6 for 90-min CBT skills groups focusing on substance refusal skills, enhancing social support, planning for high-risk situations, and coping with relapse. The last session was a family session to review progress, relapse signs, and continuing care plans. Treatment lasted about 12 weeks.

MET/CBT 7 with ACCMET/CBT 7 without ACC

ACC is a home-based continuing care approach that takes place over a 12-14 week period and has shown promise in a randomized clinical trial of adolescents discharged from residential treatment. Following an operant reinforcement and skills training model, ACC combines the Adolescent Community Reinforcement Approach and case management services to help adolescents and their caregivers engage in prosocial activities, skills, and needed community services during weekly home visits.

CBOP with ACCMET/CBT 7 with ACC

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old
  • met ASAM's (2001) Patient Placement Criteria for Level I outpatient treatment based on a substance abuse or dependence diagnosis and six dimensional admission criteria (i.e., severity of intoxication/withdrawal, physical health, emotional/behavioral health, treatment readiness, relapse potential, and recovery environment)
  • attended an admission appointment

You may not qualify if:

  • "stepped-down" from residential treatment and were therefore more severe than adolescents who entered outpatient treatment from the community
  • were recommended only for individual counseling, as both outpatient treatment conditions had group components
  • were a ward of the state
  • did not have a parent/guardian present during admission to outpatient treatment
  • appeared to have insufficient mental capacity to provide informed consent
  • did not speak English with sufficient ability to understand study procedures and instruments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chestnut Health Systems

Bloomington, Illinois, 61701, United States

Location

Related Publications (1)

  • Godley SH, Garner BR, Passetti LL, Funk RR, Dennis ML, Godley MD. Adolescent outpatient treatment and continuing care: main findings from a randomized clinical trial. Drug Alcohol Depend. 2010 Jul 1;110(1-2):44-54. doi: 10.1016/j.drugalcdep.2010.02.003. Epub 2010 Mar 9.

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Susan H Godley, Ph.D.

    Chestnut Health Systems

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2011

First Posted

June 27, 2011

Study Start

September 1, 2002

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 14, 2013

Record last verified: 2013-08

Locations