Adolescent Outpatient and Continuing Care Study (AOCCS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Chestnut Health Systems
ClinicalTrials.gov Identifier:
NCT01381133
First received: June 23, 2011
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Substance Abuse
Substance Dependence
Behavioral: Chestnut Bloomington Outpatient (CBOP)
Behavioral: Motivational Enhancement Therapy/Cognitive Behavior Treatment (MET/CBT 7)
Behavioral: Assertive Continuing Care (ACC)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adolescent Outpatient and Continuing Care Study

Further study details as provided by Chestnut Health Systems:

Primary Outcome Measures:
  • Change in Percentage of days abstinent from any alcohol and drugs [ Time Frame: Baseline and 3, 6, 9, and 12 months post-baseline ] [ Designated as safety issue: No ]
  • Change in Days abstinent from alcohol alone [ Time Frame: Baseline and 3, 6, 9, and 12 months post-baseline ] [ Designated as safety issue: No ]
  • Change in Substance use problems [ Time Frame: Baseline and 3, 6, 9, and 12 months post-baseline ] [ Designated as safety issue: No ]
    Measured using the Substance Problem Scale of the Global Appraisal of Individual Needs

  • Change in Recovery status [ Time Frame: 12 months post-baseline ] [ Designated as safety issue: No ]
    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.


Enrollment: 320
Study Start Date: September 2002
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBOP without ACC Behavioral: Chestnut Bloomington Outpatient (CBOP)
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.
Experimental: CBOP with ACC Behavioral: Chestnut Bloomington Outpatient (CBOP)
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.
Behavioral: Assertive Continuing Care (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.
Experimental: MET/CBT 7 without ACC Behavioral: Motivational Enhancement Therapy/Cognitive Behavior Treatment (MET/CBT 7)
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.
Experimental: MET/CBT 7 with ACC Behavioral: Motivational Enhancement Therapy/Cognitive Behavior Treatment (MET/CBT 7)
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.
Behavioral: Assertive Continuing Care (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.

Detailed Description:

This study evaluated 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. All study conditions attained high rates of participant engagement and retention. Follow-up interviews were completed with over 90% of the adolescents at three, six, nine, and 12 months after treatment admission. There was a significant time by condition effect over 12 months, with CBOP having a slight advantage for average percentage of days abstinent. Unlike previous findings that ACC provided incremental effectiveness following residential treatment, there were no statistically significant findings with regard to the incremental effectiveness of ACC following outpatient treatment. Analysis of the costs of each intervention combined with its outcomes revealed that the most cost-effective condition was MET/CBT7 without ACC.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 12-18 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

Exclusion Criteria:

  • "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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381133

Locations
United States, Illinois
Chestnut Health Systems
Bloomington, Illinois, United States, 61701
Sponsors and Collaborators
Chestnut Health Systems
Investigators
Principal Investigator: Susan H Godley, Ph.D. Chestnut Health Systems
  More Information

Additional Information:
Publications:
Responsible Party: Chestnut Health Systems
ClinicalTrials.gov Identifier: NCT01381133     History of Changes
Other Study ID Numbers: 1022-0602, R01DA018183, U79TI13356
Study First Received: June 23, 2011
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Chestnut Health Systems:
Substance abuse
Adolescent outpatient treatment
Continuing care
Outcomes

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 15, 2014