Alcohol DrinkingSMARTNCT00506753
Motivation and Skills for Delta-9-tetrahydrocannabinol/Ethanol (THC/ETOH+) Teens in Jail
A study testing MI/CBT and RT/SU in people with Alcohol Drinking and Marijuana Smoking, run by University of Rhode Island at 1 site in United States.
Trial summary
This study will focus on treating substance abusing incarcerated teens using individually administered Motivational Interviewing (MI) followed by group Cognitive Behavior Therapy (CBT). The control group receives individualized Relaxation Training (RT) followed by group Treatment as Usual (TU). Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Marijuana Smoking
- What is being tested?
- MI/CBT and RT/SU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents will be eligible if in the year prior to incarceration they either a) drank alcohol or used marijuana at least once per month or b) binge-drank (> 5 for boys, > 4 for girls) during any two week period; or they drank or used marijuana in the four weeks before the offense for which they were incarcerated; or they used alcohol or marijuana in the four weeks before they were incarcerated.
Who cannot join
- Those teens sentenced for less than 4 months or greater than 12 months, those who are younger than 14 years or older than 19 years, and those for whom have inability to consent/assent (example, language barrier) are not obtained will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Training School
Cranston, Rhode Island, 02920
About this study
Official title: Prison Study: Motivation and Skills for THC/ETOH+ Teens in Jail
This study will focus on treating substance abusing incarcerated teens using individually administered Motivational Interviewing (MI) followed by group Cognitive Behavior Therapy (CBT). The control group receives individualized Relaxation Training (RT) followed by group Treatment as Usual (TU). Currently, there is little research regarding effective group treatments for incarcerated teens and this study will address this gap in our knowledge base. We seek to reduce substance use and associated risky behaviors post-release (including driving under the influence, risky sexual behaviors, etc.)
Read the detailed description
This proposal is in response to RFA-DA-04-008, Group Treatment for Individuals in Drug Abuse or Alcoholism Treatment. Of particular interest to the agencies are group therapies for Conduct Disordered adolescents, reducing the spread of infectious disease, and mechanisms of action. This proposal targets these areas of interest. This study will focus on treating substance abusing incarcerated teens using 2 individually administered Motivational Interviewing (MI) sessions followed by 10 group sessions of Cognitive Behavior Therapy (CBT). MI is conceptualized as preparation for group CBT. The control group receives individualized Relaxation Training (RT) followed by group Treatment as Usual (TU). Currently, t here is little research regarding effective group treatments for incarcerated teens and this study will address this gap in our knowledge base.
In this proposed randomized trial, a one-way design (MI/CBT vs RT/TU) will be used to determine whether MI/CBT enhances group therapy participation and reduces substance use and related problems (such as crime, injuries and unprotected sex) post discharge in substance-involved juvenile delinquents. RT/TU is based on the 12-step model and includes psycho-educational components. Participant are followed during incarceration and for 6 months post incarceration. Primary outcome variables include alcohol and marijuana use, as well as related behaviors (illegal activities, sex or injuries while drunk or high). It is hypothesized that in comparison to teens in RT/TU, youth receiving MI/CBT will participate more in therapy (according to teen, facility staff, and counselor ratings) and will show lower levels of substance use and related problems after discharge.
Frequently, substance abuse treatment is unavailable to youths in the juvenile justice system, and when treatment is available, it may be provided in group format using untested therapies. A motivation/skills-based intervention (delivered in group format) may prove efficacious in enhancing motivation and in reducing substance abuse and related problems. This study extends previous research by rigorously evaluating group treatment for incarcerated teens. We will examine processes contributing to the efficacy of group MI/CBT, and the influence of race and ethnicity on treatment effects. The development of effective interventions for substance using juvenile offenders has the potential to reduce substance abuse and crime in this population.
- Conditions
- Alcohol Drinking, Marijuana Smoking
- Being tested
- MI/CBT, RT/SU
- Keywords
- substance abuse
- Medical subject headings
- Alcohol Drinking, Marijuana Smoking, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI/CBTBehavioural
Also called Motivation Interviewing,Cognitive Behavior Therapy
Motivational Interviewing followed by Cognitive Behavior Therapy
RT/SUBehavioural
Also called Relaxation Training, Treatment as Usual
Relaxation Training followed by Treatment as Usual
| Study group | Role | What they receive |
|---|---|---|
| MI/CBT | Experimental | Motivational Interviewing followed by Cognitive Behavior Therapy Receives: Behavioral: MI/CBT |
| RT/TU | Experimental | Relaxation Training followed by Treatment as Usual Receives: Behavioral: RT/SU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use, Average # of Drinks Per Week
using Time-Line Follow-back, we collected average # of drinks per week for a 3 month period at Baseline, 3 months and 6 months post release
Measured: Baseline, 3 months post release and 6 months post release
Marijuana Use
using Time-Line Follow-back, we collected average number of joints per smoking day
Measured: Baseline, 3 months post release and 6 month post release
Crime: General Predatory Aggression
using the Misbehaviors Questionnaire, we collect 12 items that assess the average number of times crimes involving predatory aggression were committed at Baseline, 3 months and 6 month post release.
Measured: Baseline, 3 months post release and 6 months post release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startSep 2004
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Lynda Stein, Ph.D., University of Rhode Island
- Investigators
- Lynda Stein, Ph.D., Principal investigator, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506753
- Sponsor's protocol ID
- DA018851-02
- Other IDs
- R01DA018851
- Acronym
- SMART
- Status last verified
- Apr 2019
- First submitted
- 23 Jul 2007
- Last updated
- 15 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: With appropriate request and procedure.
Publications
Martin RA, Stein LA, Clair M, Cancilliere MK, Hurlbut W, Rohsenow DJ. Adolescent Substance Treatment Engagement Questionnaire for Incarcerated Teens. J Subst Abuse Treat. 2015 Oct;57:49-56. doi: 10.1016/j.jsat.2015.04.011. Epub 2015 May 7.
PubMed 26021405Stein LA, Clair M, Martin RA, Soenksen S, Lebeau R, Rohsenow DJ, Kahler CW, Hurlbut W, Monti PM. Measuring behaviors of individual adolescents during group-based substance abuse intervention. Subst Abus. 2014;35(4):408-17. doi: 10.1080/08897077.2014.949337.
PubMed 25127289Bernstein MH, Stein LA. Do bisexual girls report higher rates of substance use than heterosexual girls? A failure to replicate with incarcerated and detained youth. J Bisex. 2015;15(4):498-508. doi: 10.1080/15299716.2015.1057889. Epub 2015 Nov 17.
PubMed 27087787Stein LA, Clair M, Rossi JS, Martin RA, Cancilliere MK, Clarke JG. Gender, ethnicity and race in incarcerated and detained youth: services and policy implications for girls. Psychiatr Rehabil J. 2015 Mar;38(1):65-73. doi: 10.1037/prj0000089. Epub 2014 Sep 1.
PubMed 25180525Stein LA, Clair M, Soenksen S, Martin RA, Clarke JG. Studying Process and Proximal Outcomes of Supervision for Motivational Interviewing. Train Educ Prof Psychol. 2015 May;9(2):175-182. doi: 10.1037/tep0000073. No abstract available.
PubMed 26417395Bassett SS, Stein LA, Rossi JS, Martin RA. Evaluating Measures of Fidelity for Substance Abuse Group Treatment With Incarcerated Adolescents. J Subst Abuse Treat. 2016 Jul;66:9-15. doi: 10.1016/j.jsat.2016.02.011. Epub 2016 Mar 9.
PubMed 27211991
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prison Study: Motivation and Skills for THC/ETOH+ Teens in Jail
- ClinicalTrials.gov ID
- NCT00506753
- Acronym / sponsor ID
- SMART / DA018851-02
- Conditions
- Alcohol Drinking, Marijuana Smoking
- Keywords
- substance abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2004
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Posted 15 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will focus on treating substance abusing incarcerated teens using individually administered Motivational Interviewing (MI) followed by group Cognitive Behavior Therapy (CBT). The control group receives individualized Relaxation Training (RT) followed by group Treatment as Usual (TU). Currently, there is little research regarding effective group treatments for incarcerated teens and this study will address this gap in our knowledge base. We seek to reduce substance use and associated risky behaviors post-release (including driving under the influence, risky sexual behaviors, etc.)
Detailed description
This proposal is in response to RFA-DA-04-008, Group Treatment for Individuals in Drug Abuse or Alcoholism Treatment. Of particular interest to the agencies are group therapies for Conduct Disordered adolescents, reducing the spread of infectious disease, and mechanisms of action. This proposal targets these areas of interest. This study will focus on treating substance abusing incarcerated teens using 2 individually administered Motivational Interviewing (MI) sessions followed by 10 group sessions of Cognitive Behavior Therapy (CBT). MI is conceptualized as preparation for group CBT. The control group receives individualized Relaxation Training (RT) followed by group Treatment as Usual (TU). Currently, t here is little research regarding effective group treatments for incarcerated teens and this study will address this gap in our knowledge base.
In this proposed randomized trial, a one-way design (MI/CBT vs RT/TU) will be used to determine whether MI/CBT enhances group therapy participation and reduces substance use and related problems (such as crime, injuries and unprotected sex) post discharge in substance-involved juvenile delinquents. RT/TU is based on the 12-step model and includes psycho-educational components. Participant are followed during incarceration and for 6 months post incarceration. Primary outcome variables include alcohol and marijuana use, as well as related behaviors (illegal activities, sex or injuries while drunk or high). It is hypothesized that in comparison to teens in RT/TU, youth receiving MI/CBT will participate more in therapy (according to teen, facility staff, and counselor ratings) and will show lower levels of substance use and related problems after discharge.
Frequently, substance abuse treatment is unavailable to youths in the juvenile justice system, and when treatment is available, it may be provided in group format using untested therapies. A motivation/skills-based intervention (delivered in group format) may prove efficacious in enhancing motivation and in reducing substance abuse and related problems. This study extends previous research by rigorously evaluating group treatment for incarcerated teens. We will examine processes contributing to the efficacy of group MI/CBT, and the influence of race and ethnicity on treatment effects. The development of effective interventions for substance using juvenile offenders has the potential to reduce substance abuse and crime in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI/CBT | Experimental | Behavioral: MI/CBTMotivational Interviewing followed by Cognitive Behavior Therapy |
| RT/TU | Experimental | Behavioral: RT/SURelaxation Training followed by Treatment as Usual |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents will be eligible if in the year prior to incarceration they either a) drank alcohol or used marijuana at least once per month or b) binge-drank (> 5 for boys, > 4 for girls) during any two week period; or they drank or used marijuana in the four weeks before the offense for which they were incarcerated; or they used alcohol or marijuana in the four weeks before they were incarcerated.
Key exclusion criteria (1 listed)
- Those teens sentenced for less than 4 months or greater than 12 months, those who are younger than 14 years or older than 19 years, and those for whom have inability to consent/assent (example, language barrier) are not obtained will be excluded from participation.
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 |
|---|---|---|
| MI/CBTAlso: Motivation Interviewing,Cognitive Behavior TherapyMotivational Interviewing followed by Cognitive Behavior Therapy | Behavioural | MI/CBT |
| RT/SUAlso: Relaxation Training, Treatment as UsualRelaxation Training followed by Treatment as Usual | Behavioural | RT/TU |
Primary outcome
Alcohol Use, Average # of Drinks Per Week
Time frame: Baseline, 3 months post release and 6 months post release
using Time-Line Follow-back, we collected average # of drinks per week for a 3 month period at Baseline, 3 months and 6 months post release
Marijuana Use
Time frame: Baseline, 3 months post release and 6 month post release
using Time-Line Follow-back, we collected average number of joints per smoking day
Crime: General Predatory Aggression
Time frame: Baseline, 3 months post release and 6 months post release
using the Misbehaviors Questionnaire, we collect 12 items that assess the average number of times crimes involving predatory aggression were committed at Baseline, 3 months and 6 month post release.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26021405Martin RA, Stein LA, Clair M, Cancilliere MK, Hurlbut W, Rohsenow DJ. Adolescent Substance Treatment Engagement Questionnaire for Incarcerated Teens. J Subst Abuse Treat. 2015 Oct;57:49-56. doi: 10.1016/j.jsat.2015.04.011. Epub 2015 May 7.
- Background: PubMed 25127289Stein LA, Clair M, Martin RA, Soenksen S, Lebeau R, Rohsenow DJ, Kahler CW, Hurlbut W, Monti PM. Measuring behaviors of individual adolescents during group-based substance abuse intervention. Subst Abus. 2014;35(4):408-17. doi: 10.1080/08897077.2014.949337.
- Background: PubMed 27087787Bernstein MH, Stein LA. Do bisexual girls report higher rates of substance use than heterosexual girls? A failure to replicate with incarcerated and detained youth. J Bisex. 2015;15(4):498-508. doi: 10.1080/15299716.2015.1057889. Epub 2015 Nov 17.
- Background: PubMed 25180525Stein LA, Clair M, Rossi JS, Martin RA, Cancilliere MK, Clarke JG. Gender, ethnicity and race in incarcerated and detained youth: services and policy implications for girls. Psychiatr Rehabil J. 2015 Mar;38(1):65-73. doi: 10.1037/prj0000089. Epub 2014 Sep 1.
- Background: PubMed 26417395Stein LA, Clair M, Soenksen S, Martin RA, Clarke JG. Studying Process and Proximal Outcomes of Supervision for Motivational Interviewing. Train Educ Prof Psychol. 2015 May;9(2):175-182. doi: 10.1037/tep0000073. No abstract available.
- Background: PubMed 27211991Bassett SS, Stein LA, Rossi JS, Martin RA. Evaluating Measures of Fidelity for Substance Abuse Group Treatment With Incarcerated Adolescents. J Subst Abuse Treat. 2016 Jul;66:9-15. doi: 10.1016/j.jsat.2016.02.011. Epub 2016 Mar 9.
- Individual participant dataSharing planned: Yes. With appropriate request and procedure.
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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.
Lynda Stein, Ph.D. principal investigator
University of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI/CBT and RT/SU in people with Alcohol Drinking and Marijuana Smoking, run by University of Rhode Island 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 1 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 15 May 2019. 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?
Yes. Results are posted in the registry (first posted 15 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Alcohol Use, Average # of Drinks Per Week (time frame: Baseline, 3 months post release and 6 months post release). The study lists 3 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 NCT00506753, which also lists 6 linked publications.
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 15 May 2019.