Substance AbusePhase 3AOCCSNCT01381133
Adolescent Outpatient and Continuing Care Study
A Phase 3 study testing Chestnut Bloomington Outpatient (CBOP), Motivational Enhancement Therapy/Cognitive Behavior Treatment (MET/CBT 7) and Assertive Continuing Care (ACC) in people with Substance Abuse and Substance Dependence, run by Chestnut Health Systems at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Substance Abuse, Substance Dependence
- What is being tested?
- Chestnut Bloomington Outpatient (CBOP), Motivational Enhancement Therapy/Cognitive Behavior Treatment (MET/CBT 7) and Assertive Continuing Care (ACC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- "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
Trial locations and contacts
1 site in 1 country.
United States1 site
Chestnut Health Systems
Bloomington, Illinois, 61701
About this study
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.
Read the 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
- Being tested
- Chestnut Bloomington Outpatient (CBOP), Motivational Enhancement Therapy/Cognitive Behavior Treatment (MET/CBT 7), Assertive Continuing Care (ACC)
- Keywords
- Substance abuse, Adolescent outpatient treatment, Continuing care, Outcomes
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chestnut Bloomington Outpatient (CBOP)Behavioural
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.
Motivational Enhancement Therapy/Cognitive Behavior Treatment (MET/CBT 7)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBOP without ACC | Experimental | Not described Receives: Behavioral: Chestnut Bloomington Outpatient (CBOP) |
| CBOP with ACC | Experimental | Not described Receives: Behavioral: Chestnut Bloomington Outpatient (CBOP); Behavioral: Assertive Continuing Care (ACC) |
| MET/CBT 7 without ACC | Experimental | Not described Receives: Behavioral: Motivational Enhancement Therapy/Cognitive Behavior Treatment (MET/CBT 7) |
| MET/CBT 7 with ACC | Experimental | Not described Receives: Behavioral: Motivational Enhancement Therapy/Cognitive Behavior Treatment (MET/CBT 7); Behavioral: Assertive Continuing Care (ACC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage of days abstinent from any alcohol and drugs
Measured: Baseline and 3, 6, 9, and 12 months post-baseline
Change in Days abstinent from alcohol alone
Measured: 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
Measured: 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.
Measured: 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startSep 2002
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chestnut Health Systems
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Susan H Godley, Ph.D., Principal investigator, Chestnut Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381133
- Sponsor's protocol ID
- 1022-0602
- Other IDs
- R01DA018183, U79TI13356
- Acronym
- AOCCS
- Status last verified
- Aug 2013
- First submitted
- 23 Jun 2011
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20219293
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Outpatient and Continuing Care Study
- ClinicalTrials.gov ID
- NCT01381133
- Acronym / sponsor ID
- AOCCS / 1022-0602
- Conditions
- Substance Abuse, Substance Dependence
- Keywords
- Substance abuse, Adolescent outpatient treatment, Continuing care, Outcomes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Chestnut Health SystemsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2002
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- "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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CBOP with ACC, CBOP without ACC |
| 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. | Behavioural | MET/CBT 7 with ACC, MET/CBT 7 without ACC |
| 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. | Behavioural | CBOP with ACC, MET/CBT 7 with ACC |
Primary outcome
Change in Percentage of days abstinent from any alcohol and drugs
Time frame: Baseline and 3, 6, 9, and 12 months post-baseline
Change in Days abstinent from alcohol alone
Time frame: Baseline and 3, 6, 9, and 12 months post-baseline
Change in Substance use problems
Time frame: Baseline and 3, 6, 9, and 12 months post-baseline
Measured using the Substance Problem Scale of the Global Appraisal of Individual Needs
Change in Recovery status
Time frame: 12 months post-baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
- Results publication: PubMed 20219293Godley 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.
- MET/CBT 5 manualLink provided by the sponsor.
- ACC: A-CRA manual (used in conjunction with case management manual)Link provided by the sponsor.
- ACC: case management manual (used in conjunction with A-CRA manual)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan H Godley, Ph.D. principal investigator
Chestnut Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chestnut Bloomington Outpatient (CBOP), Motivational Enhancement Therapy/Cognitive Behavior Treatment (MET/CBT 7) and Assertive Continuing Care (ACC) in people with Substance Abuse and Substance Dependence, run by Chestnut Health Systems at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percentage of days abstinent from any alcohol and drugs (time frame: Baseline and 3, 6, 9, and 12 months post-baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01381133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2013.