Pilot Test of Computerized MET to Reduce Adolescent Alcohol Use

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01796158
First received: February 20, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

The goal of this project is to conduct a pilot study evaluating feasibility, acceptability, and estimating the effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescent primary care patients. The investigators hypothesize that 1) cMET, when added to Computerized Alcohol Screening and Brief Intervention (cASBI), (cASBI+cMET) will be feasible and acceptable when used in primary care; and 2) 12- to 18-yr old patients receiving cASBI+cMET will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, than cASBI alone.


Condition Intervention
Alcohol Abuse
Behavioral: cASBI+cMET
Behavioral: cASBI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Test of Computerized MET Intervention to Reduce Adolescent Alcohol Use

Resource links provided by NLM:


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

Primary Outcome Measures:
  • cMET completion [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The investigators will measure the percentages of completed cMET sessions by those referred to cMET.


Secondary Outcome Measures:
  • cMET satisfaction [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The investigators will measure patient satisfaction with the cMET program.


Other Outcome Measures:
  • Alcohol use [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The investigators will measure rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking in the cASBI+cMET group vs the cASBI group.


Estimated Enrollment: 142
Study Start Date: September 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cASBI+cMET
Participants will complete the computerized alcohol screening and brief intervention (cASBI)protocol at the time of an office visit and also complete the 2-session computerized Motivational Enhancement Therapy intervention (cMET).
Behavioral: cASBI+cMET
In the cASBI protocol participants complete a computerized screen for alcohol and drug use, view their screen results on the computer, then see 10 pages of science and true life stories describing the health effects of alcohol and other substance use. The provider receives a report of the screen results and gives brief advice regarding alcohol and drug use during the office visit. The cMET protocol is a 2 session intervention composed of 8 exercises designed to encourage adolescents their alcohol and other substance use and develop a plan to stop or reduce their use.
Behavioral: cASBI
In the cASBI protocol participants complete a computerized screen for alcohol and drug use, view their screen results on the computer, then see 10 pages of science and true life stories describing the health effects of alcohol and other substance use. The provider receives a report of the screen results and gives brief advice regarding alcohol and drug use during the office visit.
Active Comparator: cASBI
Participants will complete the computerized screening and brief intervention protocol at the time of a primary care office visit.
Behavioral: cASBI
In the cASBI protocol participants complete a computerized screen for alcohol and drug use, view their screen results on the computer, then see 10 pages of science and true life stories describing the health effects of alcohol and other substance use. The provider receives a report of the screen results and gives brief advice regarding alcohol and drug use during the office visit.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any alcohol use days in the past 90 days
  • have an email address and internet access at home, school, or library

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 time of 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: NCT01796158

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

Locations
United States, Massachusetts
Boston Children's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: John R Knight, MD         
Sponsors and Collaborators
Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01796158     History of Changes
Other Study ID Numbers: JKR34_PA-13-078
Study First Received: February 20, 2013
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
adolescents
alcohol abuse
drug abuse
substance use

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014