Computer Adaptation of Screening, Brief MET Intervention to Reduce Teen Drinking
Primary Purpose
Alcohol Abuse, Tobacco Use Disorder, Substance Use
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cMET
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Abuse focused on measuring Alcohol abuse, Substance use, Tobacco use disorder, Motivational Enhancement Therapy, Adolescents
Eligibility Criteria
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.
Sites / Locations
- Boston Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Treatment As Usual
cMET
Arm Description
Those randomized to Treatment as Usual (TAU) will not complete cMET but will receive standard treatment from the doctor.
Those randomized to cMET will complete a 2-session computerized Motivational Enhancement Therapy (cMET) intervention.
Outcomes
Primary Outcome Measures
Alcohol use
The study investigators will measure the past 90 day alcohol use at 3-, 6-, and 9-months follow-up.
Secondary Outcome Measures
Drinks per drinking day
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
Full Information
NCT ID
NCT01881841
First Posted
June 18, 2013
Last Updated
April 18, 2017
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01881841
Brief Title
Computer Adaptation of Screening, Brief MET Intervention to Reduce Teen Drinking
Official Title
Computer Adaptation of Screening, Brief MET Intervention to Reduce Teen Drinking
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Tobacco Use Disorder, Substance Use
Keywords
Alcohol abuse, Substance use, Tobacco use disorder, Motivational Enhancement Therapy, Adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
Those randomized to Treatment as Usual (TAU) will not complete cMET but will receive standard treatment from the doctor.
Arm Title
cMET
Arm Type
Experimental
Arm Description
Those randomized to cMET will complete a 2-session computerized Motivational Enhancement Therapy (cMET) intervention.
Intervention Type
Behavioral
Intervention Name(s)
cMET
Other Intervention Name(s)
Computerized Motivational Enhancement Therapy intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Alcohol use
Description
The study investigators will measure the past 90 day alcohol use at 3-, 6-, and 9-months follow-up.
Time Frame
up to 9-months follow-up
Secondary Outcome Measure Information:
Title
Drinks per drinking day
Description
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
Time Frame
up to 9-months follow-up
Other Pre-specified Outcome Measures:
Title
Heavy episodic drinking
Description
The study investigators will measure the occurrences of heavy episodic drinking in the past 90 days at 3-, 6-, and 9-months follow-up.
Time Frame
up to 9-months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John R Knight, MD
Phone
617-355-5433
Email
john.knight@childrens.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Knight, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sion K Harris, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John R Knight, MD
Phone
617-355-5433
Email
john.knight@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Melissa M Weiksnar, MS, MBA
Phone
857-218-4311
Email
melissa.weiksnar@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
John R Knight, MD
First Name & Middle Initial & Last Name & Degree
Sion K Harris, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.ceasar.org
Description
Web site of the Center for Adolescent Substance Abuse Research at Boston Children's Hospital
Learn more about this trial
Computer Adaptation of Screening, Brief MET Intervention to Reduce Teen Drinking
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