- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01329315
Project Chill: Tailored Youth Drug Intervention In Primary Care
April 3, 2014 updated by: Frederic C. Blow, University of Michigan
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
1141
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: BMI-T
Brief Motivational Intervention (BMI-T): social worker/therapist-delivered intervention (25-minute tailored structured module).
|
Brief Motivational Intervention (BMI-T): social worker/therapist-delivered intervention (25-minute tailored structured module).
|
|
Active Comparator: BMI-C
Computer-delivered intervention (BMI-C): computerized tailored 25-minute intervention.
|
Computer-delivered intervention (BMI-C): computerized tailored 25-minute intervention.
|
|
No Intervention: DPB
Drug Prevention Booklet (DPB)- National Institute on Drug Abuse (NIDA)-developed drug prevention booklet to address preventing marijuana initiation, and marijuana use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
marijuana use
Time Frame: 12 months
|
initiation of marijuana use or escalation of use
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
alcohol, tobacco, and illicit drug use
Time Frame: 12 months
|
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
|
12 months
|
|
risk involvement
Time Frame: 12 months
|
delinquency, peer affiliation and social context influences
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
March 29, 2011
First Submitted That Met QC Criteria
April 1, 2011
First Posted (Estimate)
April 5, 2011
Study Record Updates
Last Update Posted (Estimate)
April 7, 2014
Last Update Submitted That Met QC Criteria
April 3, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA020075
- R01DA020075-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Marijuana Use
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Michael SofisDartmouth CollegeRecruitingTobacco Use | Marijuana Use | Alcohol Use, Unspecified | Marijuana DependenceUnited States
-
Indiana UniversityNational Institute on Drug Abuse (NIDA)RecruitingMarijuana Abuse | Marijuana Use | Addiction | Substance Use | Cannabis Dependence | Substance Use Disorders | Cannabis Use | Substance Abuse | Addiction, Substance | Marijuana Dependence | Substance Dependence | Marijuana Smoking | Cannabis Abuse | Cannabis Use Disorder | Marijuana | Cannabis Intoxication | Substance Related... and other conditionsUnited States
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)CompletedMarijuana Use DisorderUnited States
-
Shanna Babalonis, PhDNational Institute on Drug Abuse (NIDA)Completed
-
Western University, CanadaRecruitingCannabis Use | Marijuana Smoking | Cannabis Smoking | Marijuana UsageCanada
-
Brown UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)RecruitingTobacco Smoking | Behavioral Economics | Cannabis SmokingUnited States
-
Northwestern UniversityNational Institute on Drug Abuse (NIDA); Brown University; Rhode Island HospitalCompletedAdolescent | Cannabis UseUnited States
-
Brown UniversityCompleted
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA); Research Foundation for Mental Hygiene...CompletedMarijuana SmokingUnited States
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)Completed
Clinical Trials on BMI-T
-
Mansoura UniversityUnknown
-
HealthPartners InstituteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruiting
-
University of California, BerkeleyNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
University of Texas Southwestern Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)CompletedOverweight | Childhood ObesityUnited States
-
University of MinnesotaCompleted
-
Nationwide Children's HospitalCompleted
-
University of RochesterNational Institute on Drug Abuse (NIDA)Completed
-
University of Split, School of MedicineClinical Hospital Centre ZagrebUnknownApnea | Obesity | Respiratory Insufficiency | Sedation Complication | Hypoxic Respiratory Failure | Airway Obstruction, NasalCroatia
-
Saglik Bilimleri UniversitesiCompletedSleeve Gastrectomy | Adipokines | Obesity & OverweightTurkey (Türkiye)
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University of PittsburghCompletedBipolar Disorder | Medication AdherenceUnited States