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

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ClinicalTrials.gov Identifier: NCT01881841
Recruitment Status : Unknown
Verified April 2017 by Sion Kim Harris, Boston Children’s Hospital.
Recruitment status was:  Recruiting
First Posted : June 20, 2013
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Sion Kim Harris, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Alcohol Abuse Tobacco Use Disorder Substance Use Behavioral: cMET Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computer Adaptation of Screening, Brief MET Intervention to Reduce Teen Drinking
Study Start Date : January 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   14 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881841


Contacts
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Contact: John R Knight, MD 617-355-5433 john.knight@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: John R Knight, MD    617-355-5433    john.knight@childrens.harvard.edu   
Contact: Melissa M Weiksnar, MS, MBA    857-218-4311    melissa.weiksnar@childrens.harvard.edu   
Principal Investigator: John R Knight, MD         
Principal Investigator: Sion K Harris, PhD         
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: John R Knight, MD Boston Children’s Hospital
Principal Investigator: Sion K Harris, PhD Boston Children’s Hospital

Additional Information:
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Responsible Party: Sion Kim Harris, Assistant Professor of Pediatrics, Harvard Medical School; Co-Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT01881841     History of Changes
Other Study ID Numbers: JRKnightR34PA-13-078
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sion Kim Harris, Boston Children’s Hospital:
Alcohol abuse
Substance use
Tobacco use disorder
Motivational Enhancement Therapy
Adolescents
Additional relevant MeSH terms:
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Alcoholism
Tobacco Use Disorder
Underage Drinking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol Drinking
Drinking Behavior