Trial of Computerized SBI to Reduce Teen Alcohol Use

NCT ID: NCT01784627

Last Updated: 2016-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Alcohol Abuse Cannabis Abuse Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

c-ASBI

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

Group Type EXPERIMENTAL

c-ASBI

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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John R Knight, MD

Associate Professor of Pediatrics, Harvard Medical School; Senior Associate in Medicine; Associate in Psychiatry, Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John R Knight, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Longwood Pediatrics

Boston, Massachusetts, United States

Site Status

East Boston Neighborhood Health Center

Boston, Massachusetts, United States

Site Status

Cambridge Pediatrics

Cambridge, Massachusetts, United States

Site Status

Lexington Pediatrics

Lexington, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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JK R01 PA-12-031

Identifier Type: -

Identifier Source: org_study_id

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