Marijuana UseNCT01329315
Project Chill: Tailored Youth Drug Intervention In Primary Care
A study testing BMI-T and BMI-C in people with Marijuana Use, run by University of Michigan.
Trial summary
This study examines the impact of tailored computer-delivered and therapist-delivered brief motivations prevention/interventions both for adolescents who have not initiated marijuana use (prevention), and those who use marijuana (intervention). Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Use
- What is being tested?
- BMI-T and BMI-C
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,141 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Nov 2012
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- adolescents (ages 12-18) presenting to the approved health clinics (except exclusions as noted below)
- ability to provide informed assent
- access to a parent or guardian for parental consent
Who cannot join
- adolescents who do not understand English
- adolescents deemed unable to provide informed consent by research staff (e.g., cognitive issues)
- adolescents who come to the clinic because of sexual assault or suicide attempt, or are presenting with high psychological distress requiring intensive attention
- prisoners
- adolescents who are deaf
- adolescents with a sibling or other household member in the study will be excluded from Phase II
About this study
Official title: Tailored Youth Drug Intervention In Primary Care
This study examines the impact of tailored computer-delivered and therapist-delivered brief motivations prevention/interventions both for adolescents who have not initiated marijuana use (prevention), and those who use marijuana (intervention). Key moderators of prevention/intervention effectiveness will be examined, including behavioral intentions, self-efficacy, stage of change, school involvement, susceptibility to peer pressure, and potential health consequences such as STD/HIV risk behaviors. This project will provide the critical first step toward the development and implementation of marijuana use prevention/intervention programs that have the potential to be delivered to a large segment of youth who seek care in our nation's primary care settings.
Read the detailed description
The primary care setting represents an underutilized venue for prevention interventions addressing drug use/abuse among youth. The purpose of the study is to: (1) develop and refine promising, empirically-derived, BMI prevention/intervention modules delivered by a clinician or a computer to target marijuana use, and (2) test the effectiveness of BMI in preventing initiation/escalation of marijuana use among youth in community health clinics. This randomized controlled trial screened adolescents in primary care clinics in Flint, MI. A random sample of those who screened negative for past year marijuana use were selected to participate in the study and all subjects who screened positive for past year use were enrolled in the study. These subjects were stratified by gender, age, and past year marijuana use and randomized to one of three conditions: 1) computer-delivered brief motivational approach (BMI-C); 2) therapist-delivered brief motivational approach (BMI-T); or 3) a NIDA drug education booklet. Primary outcomes are evaluated at 3-, 6- and 12-months and include marijuana, alcohol, tobacco and other drug use. Key moderators of effectiveness will be examined, including behavioral intentions, self-efficacy, stage of change, school involvement, susceptibility to peer pressure, and potential health consequences (e.g., STD/HIV risk behaviors). This project will provide the critical first step toward the implementation of tailored marijuana prevention and intervention in primary care clinics.
- Conditions
- Marijuana Use
- Being tested
- BMI-T, BMI-C
- Medical subject headings
- Marijuana Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMI-TBehavioural
Brief Motivational Intervention (BMI-T): social worker/therapist-delivered intervention (25-minute tailored structured module).
BMI-CBehavioural
Computer-delivered intervention (BMI-C): computerized tailored 25-minute intervention.
| Study group | Role | What they receive |
|---|---|---|
| BMI-T | Active comparator | Brief Motivational Intervention (BMI-T): social worker/therapist-delivered intervention (25-minute tailored structured module). Receives: Behavioral: BMI-T |
| BMI-C | Active comparator | Computer-delivered intervention (BMI-C): computerized tailored 25-minute intervention. Receives: Behavioral: BMI-C |
| DPB | No intervention | Drug Prevention Booklet (DPB)- National Institute on Drug Abuse (NIDA)-developed drug prevention booklet to address preventing marijuana initiation, and marijuana use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
marijuana use
initiation of marijuana use or escalation of use
Measured: 12 months
Secondary outcomes (2)
alcohol, tobacco, and illicit drug use
initiation of drug use (defined as tobacco, alcohol, marijuana, or other drugs), escalation of substance use within substances (e.g., increased frequency of use), escalation of drug use to other substances (movement from tobacco to alcohol, or alcohol to marijuana, or marijuana to other "harder" drugs
Measured: 12 months
risk involvement
delinquency, peer affiliation and social context influences
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startSep 2005
- Primary completionNov 2010
- Study completionNov 2012
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 Marijuana UseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Frederic C. Blow, University of Michigan
- Investigators
- Frederic C Blow, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329315
- Sponsor's protocol ID
- DA020075
- Other IDs
- R01DA020075-01
- Status last verified
- Apr 2014
- First submitted
- 29 Mar 2011
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Walton MA, Bohnert K, Resko S, Barry KL, Chermack ST, Zucker RA, Zimmerman MA, Booth BM, Blow FC. Computer and therapist based brief interventions among cannabis-using adolescents presenting to primary care: one year outcomes. Drug Alcohol Depend. 2013 Oct 1;132(3):646-53. doi: 10.1016/j.drugalcdep.2013.04.020. Epub 2013 May 25.
PubMed 23711998
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Youth Drug Intervention In Primary Care
- ClinicalTrials.gov ID
- NCT01329315
- Acronym / sponsor ID
- DA020075
- Conditions
- Marijuana Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,141 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2005
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 5 Apr 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 examines the impact of tailored computer-delivered and therapist-delivered brief motivations prevention/interventions both for adolescents who have not initiated marijuana use (prevention), and those who use marijuana (intervention). Key moderators of prevention/intervention effectiveness will be examined, including behavioral intentions, self-efficacy, stage of change, school involvement, susceptibility to peer pressure, and potential health consequences such as STD/HIV risk behaviors. This project will provide the critical first step toward the development and implementation of marijuana use prevention/intervention programs that have the potential to be delivered to a large segment of youth who seek care in our nation's primary care settings.
Detailed description
The primary care setting represents an underutilized venue for prevention interventions addressing drug use/abuse among youth. The purpose of the study is to: (1) develop and refine promising, empirically-derived, BMI prevention/intervention modules delivered by a clinician or a computer to target marijuana use, and (2) test the effectiveness of BMI in preventing initiation/escalation of marijuana use among youth in community health clinics. This randomized controlled trial screened adolescents in primary care clinics in Flint, MI. A random sample of those who screened negative for past year marijuana use were selected to participate in the study and all subjects who screened positive for past year use were enrolled in the study. These subjects were stratified by gender, age, and past year marijuana use and randomized to one of three conditions: 1) computer-delivered brief motivational approach (BMI-C); 2) therapist-delivered brief motivational approach (BMI-T); or 3) a NIDA drug education booklet. Primary outcomes are evaluated at 3-, 6- and 12-months and include marijuana, alcohol, tobacco and other drug use. Key moderators of effectiveness will be examined, including behavioral intentions, self-efficacy, stage of change, school involvement, susceptibility to peer pressure, and potential health consequences (e.g., STD/HIV risk behaviors). This project will provide the critical first step toward the implementation of tailored marijuana prevention and intervention in primary care clinics.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMI-T | Active comparator | Behavioral: BMI-TBrief Motivational Intervention (BMI-T): social worker/therapist-delivered intervention (25-minute tailored structured module). |
| BMI-C | Active comparator | Behavioral: BMI-CComputer-delivered intervention (BMI-C): computerized tailored 25-minute intervention. |
| DPB | No intervention | –Drug Prevention Booklet (DPB)- National Institute on Drug Abuse (NIDA)-developed drug prevention booklet to address preventing marijuana initiation, and marijuana use. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- adolescents (ages 12-18) presenting to the approved health clinics (except exclusions as noted below)
- ability to provide informed assent
- access to a parent or guardian for parental consent
Key exclusion criteria (6 listed)
- adolescents who do not understand English
- adolescents deemed unable to provide informed consent by research staff (e.g., cognitive issues)
- adolescents who come to the clinic because of sexual assault or suicide attempt, or are presenting with high psychological distress requiring intensive attention
- prisoners
- adolescents who are deaf
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 |
|---|---|---|
| BMI-TBrief Motivational Intervention (BMI-T): social worker/therapist-delivered intervention (25-minute tailored structured module). | Behavioural | BMI-T |
| BMI-CComputer-delivered intervention (BMI-C): computerized tailored 25-minute intervention. | Behavioural | BMI-C |
Primary outcome
marijuana use
Time frame: 12 months
initiation of marijuana use or escalation of use
2 secondary outcomes
alcohol, tobacco, and illicit drug use
Time frame: 12 months
risk involvement
Time frame: 12 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 7 Apr 2014.
- Derived from this study: PubMed 23711998Walton MA, Bohnert K, Resko S, Barry KL, Chermack ST, Zucker RA, Zimmerman MA, Booth BM, Blow FC. Computer and therapist based brief interventions among cannabis-using adolescents presenting to primary care: one year outcomes. Drug Alcohol Depend. 2013 Oct 1;132(3):646-53. doi: 10.1016/j.drugalcdep.2013.04.020. Epub 2013 May 25.
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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.
Frederic C Blow, PhD principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
A study testing BMI-T and BMI-C in people with Marijuana Use, run by University of Michigan.
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 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
marijuana use (time frame: 12 months). 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 NCT01329315, 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 7 Apr 2014.