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Adolescent Outpatient and Continuing Care Study (AOCCS)

Primary Purpose

Substance Abuse, Substance Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Chestnut Bloomington Outpatient (CBOP)
Motivational Enhancement Therapy/Cognitive Behavior Treatment (MET/CBT 7)
Assertive Continuing Care (ACC)
Sponsored by
Chestnut Health Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Substance abuse, Adolescent outpatient treatment, Continuing care, Outcomes

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chestnut Health Systems

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

CBOP without ACC

CBOP with ACC

MET/CBT 7 without ACC

MET/CBT 7 with ACC

Arm Description

Outcomes

Primary Outcome Measures

Change in Percentage of days abstinent from any alcohol and drugs
Change in Days abstinent from alcohol alone
Change in Substance use problems
Measured using the Substance Problem Scale of the Global Appraisal of Individual Needs
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.

Secondary Outcome Measures

Full Information

First Posted
June 23, 2011
Last Updated
August 13, 2013
Sponsor
Chestnut Health Systems
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01381133
Brief Title
Adolescent Outpatient and Continuing Care Study
Acronym
AOCCS
Official Title
Adolescent Outpatient and Continuing Care Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chestnut Health Systems
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Substance Dependence
Keywords
Substance abuse, Adolescent outpatient treatment, Continuing care, Outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBOP without ACC
Arm Type
Experimental
Arm Title
CBOP with ACC
Arm Type
Experimental
Arm Title
MET/CBT 7 without ACC
Arm Type
Experimental
Arm Title
MET/CBT 7 with ACC
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Chestnut Bloomington Outpatient (CBOP)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy/Cognitive Behavior Treatment (MET/CBT 7)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Assertive Continuing Care (ACC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Percentage of days abstinent from any alcohol and drugs
Time Frame
Baseline and 3, 6, 9, and 12 months post-baseline
Title
Change in Days abstinent from alcohol alone
Time Frame
Baseline and 3, 6, 9, and 12 months post-baseline
Title
Change in Substance use problems
Description
Measured using the Substance Problem Scale of the Global Appraisal of Individual Needs
Time Frame
Baseline and 3, 6, 9, and 12 months post-baseline
Title
Change in Recovery status
Description
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.
Time Frame
12 months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan H Godley, Ph.D.
Organizational Affiliation
Chestnut Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chestnut Health Systems
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20219293
Citation
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.
Results Reference
result
Links:
URL
http://www.chestnut.org/Portals/14/PDF_Documents/Lighthouse/CYT/Products/MCB5_CYT_v1.pdf
Description
MET/CBT 5 manual
URL
http://www.chestnut.org/li/bookstore/categoryid/8/productid/58
Description
CBOP manual
URL
http://www.chestnut.org/Portals/14/PDF_Documents/Lighthouse/CYT/Products/ACRA_CYT_v4.pdf
Description
ACC: A-CRA manual (used in conjunction with case management manual)
URL
http://www.chestnut.org/Portals/14/PDF_Documents/Lighthouse/Manuals/ACC_manual_revised_2nd_ed_111306.pdf
Description
ACC: case management manual (used in conjunction with A-CRA manual)

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Adolescent Outpatient and Continuing Care Study

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