Adolescent Outpatient and Continuing Care Study

NCT ID: NCT01381133

Last Updated: 2013-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2008-12-31

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.

Conditions

Substance Abuse; Substance Dependence

Keywords

Substance abuse; Adolescent outpatient treatment; Continuing care; Outcomes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBOP without ACC

Group Type: EXPERIMENTAL

Chestnut Bloomington Outpatient (CBOP)

Intervention Type: BEHAVIORAL

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 ACC

Group Type: EXPERIMENTAL

Chestnut Bloomington Outpatient (CBOP)

Intervention Type: BEHAVIORAL

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.

Assertive Continuing Care (ACC)

Intervention Type: BEHAVIORAL

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.

MET/CBT 7 without ACC

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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 ACC

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Assertive Continuing Care (ACC)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Chestnut Health Systems

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan H Godley, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chestnut Health Systems

Locations

Chestnut Health Systems

Bloomington, Illinois, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20219293 (View on PubMed)

Related Links

http://www.chestnut.org/Portals/14/PDF_Documents/Lighthouse/CYT/Products/MCB5_CYT_v1.pdf

MET/CBT 5 manual

http://www.chestnut.org/Portals/14/PDF_Documents/Lighthouse/CYT/Products/ACRA_CYT_v4.pdf

ACC: A-CRA manual (used in conjunction with case management manual)

http://www.chestnut.org/Portals/14/PDF_Documents/Lighthouse/Manuals/ACC_manual_revised_2nd_ed_111306.pdf

ACC: case management manual (used in conjunction with A-CRA manual)

Other Identifiers

R01DA018183

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U79TI13356

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1022-0602

Identifier Type: -

Identifier Source: org_study_id