Clinical trial NCT01381133: Adolescent Outpatient and Continuing Care Study
Official title: Adolescent Outpatient and Continuing Care Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Substance Abuse
Substance Dependence
Keywords: Substance abuse
Adolescent outpatient treatment
Continuing care
Outcomes
Lead sponsor: Chestnut Health Systems
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-06-27
Enrollment: 320
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Percentage of days abstinent from any alcohol and drugs
timeFrame: Baseline and 3, 6, 9, and 12 months post-baseline
measure: Change in Days abstinent from alcohol alone
timeFrame: Baseline and 3, 6, 9, and 12 months post-baseline
measure: Change in Substance use problems
timeFrame: Baseline and 3, 6, 9, and 12 months post-baseline
measure: Change in Recovery status
timeFrame: 12 months post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Chestnut Health Systems
state: Illinois
Study officials:
affiliation: Chestnut Health Systems
name: Susan H Godley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.