Alcoholic, Marijuana MisusePhase 2NCT00227890
Skills and Motivation at the Rhode Island Training School (Project SMART) - 1
A Phase 2 study testing MI/CBT and RT/TU in people with Alcoholic, Marijuana Misuse, run by University of Rhode Island at 2 sites 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
- Alcoholic, Marijuana Misuse
- What is being tested?
- MI/CBT and RT/TU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2005to Sep 2011
- Phase
- Phase 2
- 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 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
2 sites in 1 country.
United States2 sites
Rhode Island Training School
Cranston, Rhode Island, 02920
University of Rhode Island, Social Sciences Research Center
Kingston, Rhode Island, 02881
About this study
Official title: 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, there 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. Participants are followed during incarceration and for 6 months post incarceration. Primary outcome variables include alcohol and marijuana use, as well as related behaviors (illegal activity, 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
- Alcoholic, Marijuana Misuse
- Being tested
- MI/CBT, RT/TU
- Keywords
- substance abuse
- 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.
MI/CBTBehavioural
RT/TUBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Motivational Interviewing followed by Cognitive Behavior Therapy (MI/CBT) Receives: Behavioral: MI/CBT |
| 2 | Experimental | Relaxation Training followed by Treatment as Usual (RT/TU) Receives: Behavioral: RT/TU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use, using Time-Line Followback, aggregated into quantity and frequency
Measured: 6 months post release
Marijuana use, using Time-Line Followback, aggregated into quantity and frequency
Measured: 6 months post release
Crime, using Misbehaviors Questionnaire, aggregated into type and frequency
Measured: 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 posted28 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alcoholic, Marijuana MisuseStudies 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 2
- 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
- NCT00227890
- Sponsor's protocol ID
- NIDA-18851-1
- Other IDs
- R01DA018851, R01-18851-1
- Status last verified
- Mar 2017
- First submitted
- 27 Sep 2005
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: With appropriate request and procedure.
Publications
Stein 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 27087787Martin 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, 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 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivation and Skills for THC/ETOH+ Teens in Jail
- ClinicalTrials.gov ID
- NCT00227890
- Acronym / sponsor ID
- NIDA-18851-1
- Conditions
- Alcoholic, Marijuana Misuse
- Keywords
- substance abuse
- Phase
- Phase 2
- 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
- Mar 2005
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Sep 2005 (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 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, there 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. Participants are followed during incarceration and for 6 months post incarceration. Primary outcome variables include alcohol and marijuana use, as well as related behaviors (illegal activity, 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 |
|---|---|---|
| 1 | Experimental | Behavioral: MI/CBTMotivational Interviewing followed by Cognitive Behavior Therapy (MI/CBT) |
| 2 | Experimental | Behavioral: RT/TURelaxation Training followed by Treatment as Usual (RT/TU) |
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/CBT | Behavioural | 1 |
| RT/TU | Behavioural | 2 |
Primary outcome
Alcohol use, using Time-Line Followback, aggregated into quantity and frequency
Time frame: 6 months post release
Marijuana use, using Time-Line Followback, aggregated into quantity and frequency
Time frame: 6 months post release
Crime, using Misbehaviors Questionnaire, aggregated into type and frequency
Time frame: 6 months post release
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 3 Mar 2017.
- 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 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 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.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MI/CBT and RT/TU in people with Alcoholic, Marijuana Misuse, run by University of Rhode Island at 2 sites 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Alcohol use, using Time-Line Followback, aggregated into quantity and frequency (time frame: 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 NCT00227890, 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 3 Mar 2017.