Trial of Computerized SBI to Reduce Teen 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:
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
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: 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 Children's Hospital Boston
  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:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced 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 September 18, 2014