Trial of Computerized SBI to Reduce Teen Alcohol Use

Nicotine Dependence Clinical Trial

Official title:

Randomized Controlled Trial of Computerized SBI to Reduce Teen Alcohol Use

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01784627
• Other study ID #: JK R01 PA-12-031
• Status: Withdrawn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• Status: Withdrawn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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Cannabis Abuse
• Marijuana Abuse
• Nicotine Dependence
• Tobacco Use Disorder

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