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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01784627
Other study ID # JK R01 PA-12-031
Secondary ID
Status Withdrawn
Phase Phase 1
First received February 4, 2013
Last updated October 6, 2016
Start date January 2015
Est. completion date October 2017

Study information

Verified date October 2016
Source Boston Children’s Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender Both
Age group 9 Years to 20 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

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.

Locations

Country Name City State
United States Boston Children's Hospital Boston Massachusetts
United States East Boston Neighborhood Health Center Boston Massachusetts
United States Longwood Pediatrics Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Cambridge Pediatrics Cambridge Massachusetts
United States Lexington Pediatrics Lexington Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Cannabis use We will compare the rates of cannabis use over the past twelve months between groups. 12 months No
Other Tobacco use We will compare the rates of tobacco use over the past twelve months between groups. 12 months No
Primary Days of alcohol use We will compare rates of any alcohol use over the past twelve months between the groups. 12 months No
Secondary Drinking initiation We will compare rates of drinking initiation over the past 12-months between groups. 12 months No
Secondary Drinking cessation We will compare rates of drinking cessation over the past 12 months between groups. 12 months No
Secondary Driving/Riding risk We will compare the rates of driving under the influence or riding with a driver under the influence between groups. 12 months Yes
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