Alcohol AbuseNCT01449981
Development and Testing of Adolescent Twelve-Step Facilitation
A study testing Integrated Twelve-Step Facilitation and Cognitive Behavioral Therapy in people with Alcohol Abuse and Alcohol Dependence, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study is the first to develop and test in a randomized experimental design the efficacy of an integrated 12-step facilitation intervention tailored for young people. In the first phase of the study, the investigators are developing and revising a preliminary manual for the two sessions individually-delivered… Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Alcohol Abuse, Alcohol Dependence, Drug Abuse
- What is being tested?
- Integrated Twelve-Step Facilitation and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jan 2016
- Phase
- Interventional
- 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 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Young people between the ages of 14 and 21 that meet criteria for alcohol or other drug abuse or dependence.
Who cannot join
- with an active psychotic disorders
- who are in another substance use disorder (SUD) treatment program or receiving SUD related psychotherapy that could conflict with our treatment
- with a history of severe or complicated withdrawal (e.g., alcohol seizure history)
- who may be using alcohol/drugs prior to study entry at levels likely to result in severe withdrawal complications, in the absence of any history
- taking addiction treatment medications (e.g., Buprenorphine)
- who cannot speak English because the treatment and assessment instruments will be conducted in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Addiction Medicine 60 Staniford Street
Boston, Massachusetts, 02114
About this study
This study is the first to develop and test in a randomized experimental design the efficacy of an integrated 12-step facilitation intervention tailored for young people. In the first phase of the study, the investigators are developing and revising a preliminary manual for the two sessions individually-delivered Motivational Enhancement Therapy (MET) component and subsequent 8 session group-delivered Cognitive-Behavioral Therapy (CBT) component which will integrate Twelve-step Facilitation (TSF). Forty adolescents each will complete the preliminary integrated TSF protocol. In the second phase of the study, the investigators will compare integrated TSF (iTSF) to standard treatment (MET/CBT) in a randomized experimental design for adolescent substance use disorder with 60 adolescents. As a result, the investigators will examine potential mechanisms that may underlie the efficacy of iTSF in improving alcohol and other drug use outcomes. The investigators will test group differences on potential mechanisms of change (e.g., Alcoholics Anonymous/Narcotics Anonymous attendance and involvement) and whether these variables are associated with substance use outcomes.
- Conditions
- Alcohol Abuse, Alcohol Dependence, Drug Abuse, Drug Dependence
- Being tested
- Integrated Twelve-Step Facilitation, Cognitive Behavioral Therapy
- Keywords
- Adolescents, Alcohol Abuse, Alcohol Dependence, Drug Abuse, Drug Dependence, Substance Use Disorder, Alcoholics Anonymous, Motivational Enhancement Therapy, Cognitive Behavioral Therapy
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Twelve-Step FacilitationBehavioural
Also called iTSF
The iTSF condition will include review of treatment goals and overall review of progress, coping skills, real life practices, emotions/mood management, how to make changes in one's social network and discussions about how 12-step meetings can be helpful in one's recovery efforts. In addition, speakers from 12-step fellowships such as Alcoholics Anonymous (AA) and Narcotics Anonymous (NA) will be invited to share their experiences and discuss myths and facts related to attendance at 12-step meetings as well as answer any questions participants have about these fellowships.
Cognitive Behavioral TherapyBehavioural
Also called CBT
The CBT condition will include review of progress, coping skills, group exercises, real life practice, and emotions/mood management.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Twelve-Step Facilitation | Experimental | Not described Receives: Behavioral: Integrated Twelve-Step Facilitation |
| Cognitive Behavioral Therapy | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Days Abstinent (PDA)
Given the goals of both treatments will be abstinence, the main outcome analyses and effect size estimates will be based upon biochemically verified 90 day point-prevalence of PDA. These will be captured using Form-90 (Miller \& Del Boca, 1994) which will be used to examine substance use (including number of days used and first and last dates of use within the time period), as well as other treatment experiences in the past 90 days.
Measured: Up to 9 months
Secondary outcomes (1)
Treatment Acceptability
Participants will also complete weekly treatment feedback measures to inform the treatment manual.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John F. Kelly, Massachusetts General Hospital
- Investigators
- John F. Kelly, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449981
- Sponsor's protocol ID
- NIAAA R01AA019664
- Status last verified
- Sep 2016
- First submitted
- 4 Oct 2011
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of Adolescent Twelve-Step Facilitation
- ClinicalTrials.gov ID
- NCT01449981
- Acronym / sponsor ID
- NIAAA R01AA019664
- Conditions
- Alcohol Abuse, Alcohol Dependence, Drug Abuse, Drug Dependence
- Keywords
- Adolescents, Alcohol Abuse, Alcohol Dependence, Drug Abuse, Drug Dependence, Substance Use Disorder, Alcoholics Anonymous, Motivational Enhancement Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Oct 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.
This study is the first to develop and test in a randomized experimental design the efficacy of an integrated 12-step facilitation intervention tailored for young people. In the first phase of the study, the investigators are developing and revising a preliminary manual for the two sessions individually-delivered Motivational Enhancement Therapy (MET) component and subsequent 8 session group-delivered Cognitive-Behavioral Therapy (CBT) component which will integrate Twelve-step Facilitation (TSF). Forty adolescents each will complete the preliminary integrated TSF protocol. In the second phase of the study, the investigators will compare integrated TSF (iTSF) to standard treatment (MET/CBT) in a randomized experimental design for adolescent substance use disorder with 60 adolescents. As a result, the investigators will examine potential mechanisms that may underlie the efficacy of iTSF in improving alcohol and other drug use outcomes. The investigators will test group differences on potential mechanisms of change (e.g., Alcoholics Anonymous/Narcotics Anonymous attendance and involvement) and whether these variables are associated with substance use outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Twelve-Step Facilitation | Experimental | Behavioral: Integrated Twelve-Step Facilitation |
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Young people between the ages of 14 and 21 that meet criteria for alcohol or other drug abuse or dependence.
Key exclusion criteria (6 listed)
- with an active psychotic disorders
- who are in another substance use disorder (SUD) treatment program or receiving SUD related psychotherapy that could conflict with our treatment
- with a history of severe or complicated withdrawal (e.g., alcohol seizure history)
- who may be using alcohol/drugs prior to study entry at levels likely to result in severe withdrawal complications, in the absence of any history
- taking addiction treatment medications (e.g., Buprenorphine)
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 |
|---|---|---|
| Integrated Twelve-Step FacilitationAlso: iTSFThe iTSF condition will include review of treatment goals and overall review of progress, coping skills, real life practices, emotions/mood management, how to make changes in one's social network and discussions about how 12-step meetings can be helpful in one's recovery efforts. In addition, speakers from 12-step fellowships such as Alcoholics Anonymous (AA) and Narcotics Anonymous (NA) will be invited to share their experiences and discuss myths and facts related to attendance at 12-step meetings as well as answer any questions participants have about these fellowships. | Behavioural | Integrated Twelve-Step Facilitation |
| Cognitive Behavioral TherapyAlso: CBTThe CBT condition will include review of progress, coping skills, group exercises, real life practice, and emotions/mood management. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Percent Days Abstinent (PDA)
Time frame: Up to 9 months
Given the goals of both treatments will be abstinence, the main outcome analyses and effect size estimates will be based upon biochemically verified 90 day point-prevalence of PDA. These will be captured using Form-90 (Miller \& Del Boca, 1994) which will be used to examine substance use (including number of days used and first and last dates of use within the time period), as well as other treatment experiences in the past 90 days.
1 secondary outcome
Treatment Acceptability
Time frame: Up to 3 months
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 13 Sep 2016.
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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.
John F. Kelly, Ph.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Twelve-Step Facilitation and Cognitive Behavioral Therapy in people with Alcohol Abuse and Alcohol Dependence, run by Massachusetts General Hospital 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 1 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 13 Sep 2016. 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.
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?
Percent Days Abstinent (PDA) (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2016.