Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 18, 2013
First Posted Date  ICMJE June 20, 2013
Last Update Posted Date April 20, 2017
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
Alcohol use [ Time Frame: up to 9-months follow-up ]
We will measure the past 90 day alcohol use at 3-, 6-, and 9-months follow-up.
Change History Complete list of historical versions of study NCT01881841 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2013)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
Drinks per drinking day [ Time Frame: up to 9-months follow-up ]
We will measure the number of drinks per drinking day in the past 90 days at 3-, 6-, and 9-months follow-up
Current Other Pre-specified Outcome Measures
 (submitted: June 21, 2013)
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.
Original Other Pre-specified Outcome Measures
 (submitted: June 19, 2013)
Heavy episodic drinking [ Time Frame: up to 9-months follow-up ]
We will measure the occurrences of heavy episodic drinking in the past 90 days at 3-, 6-, and 9-months follow-up.
 
Descriptive Information
Brief Title  ICMJE Computer Adaptation of Screening, Brief MET Intervention to Reduce Teen Drinking
Official Title  ICMJE Computer Adaptation of Screening, Brief MET Intervention to Reduce Teen Drinking
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:

  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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Alcohol Abuse
  • Tobacco Use Disorder
  • Substance Use
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: cMET
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 19, 2013)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01881841
Other Study ID Numbers  ICMJE JRKnightR34PA-13-078
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sion Kim Harris, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John R Knight, MD Boston Children’s Hospital
Principal Investigator: Sion K Harris, PhD Boston Children’s Hospital
PRS Account Boston Children’s Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP