Computer Adaptation of Screening, Brief MET Intervention to Reduce Teen Drinking

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01881841
First received: June 18, 2013
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.

The study aims are to:

  1. 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.
  2. 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.
  3. Identify potential moderators and mediators of cMET's effect.

Condition Intervention Phase
Alcohol Abuse
Tobacco Use
Substance Use
Behavioral: cMET
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Computer Adaptation of Screening, Brief MET Intervention to Reduce Teen Drinking

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Alcohol use [ Time Frame: up to 9-months follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 9-months follow-up ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • Heavy episodic drinking [ Time Frame: up to 9-months follow-up ] [ Designated as safety issue: No ]
    The study investigators will measure the occurrences of heavy episodic drinking in the past 90 days at 3-, 6-, and 9-months follow-up.


Estimated Enrollment: 150
Study Start Date: April 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: TAU
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.
Behavioral: cMET
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 Name: Computerized Motivational Enhancement Therapy intervention

  Eligibility

Ages Eligible for Study:   14 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 14- to 20- yr-olds
  • arriving for routine care,
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881841

Contacts
Contact: John R Knight, MD 617-355-5433 john.knight@childrens.harvard.edu
Contact: Shari Van Hook, MPH 857-218-4317 shari.vanhook@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: John R Knight, MD    617-355-5433    john.knight@childrens.harvard.edu   
Contact: Shari Van Hook, MPH    857-218-4317    shari.vanhook@childrens.harvard.edu   
Principal Investigator: John R Knight, MD         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: John R Knight, MD Children's Hospital Boston
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01881841     History of Changes
Other Study ID Numbers: JRKnightR34PA-13-078
Study First Received: June 18, 2013
Last Updated: June 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Alcohol abuse
Substance use
Tobacco use
Motivational Enhancement Therapy
Adolescents

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014