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Trial of Computerized SBI to Reduce Teen Alcohol Use

Primary Purpose

Alcohol Abuse, Cannabis Abuse, Nicotine Dependence

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
c-ASBI
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Abuse focused on measuring substance use, alcohol abuse, cannabis abuse, nicotine dependence, adolescents

Eligibility Criteria

9 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tufts Medical Center
  • Boston Children's Hospital
  • Longwood Pediatrics
  • East Boston Neighborhood Health Center
  • Cambridge Pediatrics
  • Lexington Pediatrics

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment at Usual

c-ASBI

Arm Description

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.

Participants in this group will receive the computerized alcohol screening and brief intervention (c-ASBI).

Outcomes

Primary Outcome Measures

Days of alcohol use
We will compare rates of any alcohol use over the past twelve months between the groups.

Secondary Outcome Measures

Drinking initiation
We will compare rates of drinking initiation over the past 12-months between groups.
Drinking cessation
We will compare rates of drinking cessation over the past 12 months between groups.
Driving/Riding risk
We will compare the rates of driving under the influence or riding with a driver under the influence between groups.

Full Information

First Posted
February 4, 2013
Last Updated
October 6, 2016
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01784627
Brief Title
Trial of Computerized SBI to Reduce Teen Alcohol Use
Official Title
Randomized Controlled Trial of Computerized SBI to Reduce Teen Alcohol Use
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
The Specific Aims are to 1) Test the effects of c-ASBI on any alcohol use; 2) Test the effects of c-ASBI separately as a prevention, therapeutic, and risk-reduction intervention; 3) Test the effects of c-ASBI separately on cannabis and tobacco use; explore its effects on other drug use; and 4) Assess potential moderators (e.g., age, gender, race/ethnicity, substance use history +/-, parent/sibling/peer substance use), mediators (e.g., Youth to Provider Connectedness,20 perceived harmfulness of alcohol and drug use), and explore c-ASBI's mechanism of action.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Cannabis Abuse, Nicotine Dependence
Keywords
substance use, alcohol abuse, cannabis abuse, nicotine dependence, adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment at Usual
Arm Type
No Intervention
Arm Description
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.
Arm Title
c-ASBI
Arm Type
Experimental
Arm Description
Participants in this group will receive the computerized alcohol screening and brief intervention (c-ASBI).
Intervention Type
Behavioral
Intervention Name(s)
c-ASBI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Days of alcohol use
Description
We will compare rates of any alcohol use over the past twelve months between the groups.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Drinking initiation
Description
We will compare rates of drinking initiation over the past 12-months between groups.
Time Frame
12 months
Title
Drinking cessation
Description
We will compare rates of drinking cessation over the past 12 months between groups.
Time Frame
12 months
Title
Driving/Riding risk
Description
We will compare the rates of driving under the influence or riding with a driver under the influence between groups.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Cannabis use
Description
We will compare the rates of cannabis use over the past twelve months between groups.
Time Frame
12 months
Title
Tobacco use
Description
We will compare the rates of tobacco use over the past twelve months between groups.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Knight, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Longwood Pediatrics
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
East Boston Neighborhood Health Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02128
Country
United States
Facility Name
Cambridge Pediatrics
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States
Facility Name
Lexington Pediatrics
City
Lexington
State/Province
Massachusetts
ZIP/Postal Code
02421
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Trial of Computerized SBI to Reduce Teen Alcohol Use

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