- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01881841
Computer Adaptation of Screening, Brief MET Intervention to Reduce Teen Drinking
April 18, 2017 updated by: Sion Kim Harris, Boston Children's Hospital
The goal of this project is to evaluate the feasibility, acceptability, and effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescents in primary care.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The study aims are to:
- Assess cMET feasibility and acceptability and estimate its effect size on underage drinking. Hypothesis: Among 14- to 20-yr-old primary care patients, those receiving cMET will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, than those receiving treatment as usual.
- Estimate effect sizes for tobacco, cannabis, and other drug use, and other substance-related risks and outcomes including substance-related driving/riding, and experience of substance-related problems.
- Identify potential moderators and mediators of cMET's effect.
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Boston Children's Hospital
-
Contact:
- John R Knight, MD
- Phone Number: 617-355-5433
- Email: john.knight@childrens.harvard.edu
-
Contact:
- Melissa M Weiksnar, MS, MBA
- Phone Number: 857-218-4311
- Email: melissa.weiksnar@childrens.harvard.edu
-
Principal Investigator:
- John R Knight, MD
-
-
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
14 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 14- to 20- yr-olds
- arriving for routine care to one of our participating pediatric practices (Lexington Pediatrics, Lexington, MA; East Boston Community Health Center, Longwood Pediatrics, Tufts Medical Center Adolescent Clinic, Boston, MA; Cambridge Health Alliance Dept. of Pediatrics, Cambridge, MA)
- any alcohol use days in the past 90 days,
- have an email address and internet access at home, school, or library
- provide informed assent/consent.
Exclusion Criteria:
- unable to read or understand English,
- living away at college at the time of the recruitment visit,
- not available for computer/telephone follow-ups,
- judged by the provider to be medically or emotionally unstable at the time of the visit.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Treatment As Usual
Those randomized to Treatment as Usual (TAU) will not complete cMET but will receive standard treatment from the doctor.
|
|
|
Experimental: cMET
Those randomized to cMET will complete a 2-session computerized Motivational Enhancement Therapy (cMET) intervention.
|
Those in cMET complete the 2-session self-administered computerized intervention which includes 8 exercises designed to encourage adolescents to evaluate the impact of alcohol and other substance use on their health and well-being and consider changing their use.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol use
Time Frame: up to 9-months follow-up
|
The study investigators will measure the past 90 day alcohol use at 3-, 6-, and 9-months follow-up.
|
up to 9-months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Drinks per drinking day
Time Frame: up to 9-months follow-up
|
The study investigators will measure the number of drinks per drinking day in the past 90 days at 3-, 6-, and 9-months follow-up
|
up to 9-months follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heavy episodic drinking
Time Frame: up to 9-months follow-up
|
The study investigators will measure the occurrences of heavy episodic drinking in the past 90 days at 3-, 6-, and 9-months follow-up.
|
up to 9-months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John R Knight, MD, Boston Children's Hospital
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
January 1, 2015
Primary Completion (Anticipated)
August 1, 2017
Study Completion (Anticipated)
August 1, 2017
Study Registration Dates
First Submitted
June 18, 2013
First Submitted That Met QC Criteria
June 19, 2013
First Posted (Estimate)
June 20, 2013
Study Record Updates
Last Update Posted (Actual)
April 20, 2017
Last Update Submitted That Met QC Criteria
April 18, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JRKnightR34PA-13-078
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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