Trial record 5 of 34 for:    alcohol [CONDITION] AND (adolescent OR teen) [ALL-FIELDS] | Open Studies

Trial of Computerized SBI to Reduce Teen Alcohol Use

This study is not yet open for participant recruitment.
Verified February 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01784627
First received: February 4, 2013
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

The goal of this project is to test the effectiveness of a computer-facilitated alcohol screening and brief intervention (c-ASBI) system for 12- to 18-year-old primary care patients in a multi-site, randomized comparative effectiveness trial. The investigators hypothesize that, among 12- to 18-year olds patients coming for annual well-care, those receiving c-ASBI will have lower rates of any alcohol use at 3-, 6-, and 12-month follow-ups compared to Treatment As Usual (TAU).


Condition Intervention Phase
Alcohol Abuse
Cannabis Abuse
Nicotine Dependence
Behavioral: c-ASBI
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Computerized SBI to Reduce Teen Alcohol Use

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Days of alcohol use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We will compare rates of any alcohol use over the past twelve months between the groups.


Secondary Outcome Measures:
  • Drinking initiation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We will compare rates of drinking initiation over the past 12-months between groups.

  • Drinking cessation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We will compare rates of drinking cessation over the past 12 months between groups.

  • Driving/Riding risk [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    We will compare the rates of driving under the influence or riding with a driver under the influence between groups.


Other Outcome Measures:
  • Cannabis use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We will compare the rates of cannabis use over the past twelve months between groups.

  • Tobacco use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We will compare the rates of tobacco use over the past twelve months between groups.


Estimated Enrollment: 2500
Study Start Date: October 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment at Usual
Participants in this group will receive treatment as usual (TAU) from their provider, which may or may not include screening and brief advice regarding alcohol use.
Experimental: c-ASBI
Participants in this group will receive the computerized alcohol screening and brief intervention (c-ASBI).
Behavioral: c-ASBI
Participants in the c-ASBI group will complete a computerized screen for alcohol, cannabis, tobacco and other drugs, then view their screen score and 10 pages of information about the health effects of substance use and true-life stories on the computer. Their provider will see a report of their screen results and provide advice to stop or decrease their use, or, for those at high risk, referral to complete a computerized motivational enhancement therapy intervention.

  Eligibility

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

Inclusion Criteria:

  • Arriving for well or non-emergent care at one of participating study sites
  • Have an email address
  • Have internet address

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784627

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
Principal Investigator: John R Knight, MD         
Sub-Investigator: Sion K Harris, PhD         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: John R Knight, MD Boston Children's Hospital
  More Information

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01784627     History of Changes
Other Study ID Numbers: JK R01 PA-12-031
Study First Received: February 4, 2013
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
substance use
alcohol abuse
cannabis abuse
nicotine dependence
adolescents

Additional relevant MeSH terms:
Alcohol Drinking
Alcohol-Related Disorders
Marijuana Abuse
Tobacco Use Disorder
Alcoholism
Drinking Behavior
Substance-Related Disorders
Mental Disorders
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 April 17, 2014