Computerized Alcohol Screening for Children and Adolescents (cASCA) in Primary Care (cASCA)

February 18, 2021 updated by: Sion Kim Harris, Boston Children's Hospital
The purpose of this study is to assess the psychometric properties of a brief screening questionnaire for alcohol problems among 9- to 18-year-old patients in pediatricians' offices, and to pilot test a personalized, computer-facilitated brief intervention delivered on a tablet computer and by the provider based on screening results.

Study Overview

Status

Completed

Detailed Description

The primary goal of this project is to develop a computerized screening program for primary care offices that is based on the NIAAA's new Alcohol Screening Guide for Children and Adolescents and assess its psychometric properties among nine- to 18-yr-old primary care patients. There is substantial evidence supporting the effectiveness of screening and brief intervention among adult primary care patients, primarily in the reduction of harmful drinking. However, there have been few studies of alcohol screening and brief intervention conducted among adolescents seen in busy primary care settings. This project will develop and validate a new computerized Alcohol Screening for Children and Adolescents (cASCA) program which incorporates the age-specific screening questions of the NIAAA Guide and includes the CRAFFT and AUDIT as secondary risk/problem assessments. We will add tobacco screening because tobacco use is the leading cause of cancer-related mortality in the US as well as screening for marijuana and other drug use so as to create a comprehensive screening instrument that includes all major substances that adolescents use.

Additionally, the NIAAA guide recommends that providers deliver a brief intervention in response to the screening results. Therefore, a secondary aim of this project will be to pilot-test a computer-facilitated Brief Intervention component using a randomized design comparing three groups: 1) screening with treatment as usual [cASCA/TAU]; 2) screening with the computer-facilitated brief intervention [cASCA/BI]. The BI component consists of patients viewing on the computer, immediately after the screening, their score and level of risk for a substance use problem, as well as several interactive pages of science and true-life stories about the health risks of substance use. Clinicians are then given the screen results and suggested talking points for a few minutes of brief counseling during the visit.

Hypothesis: Among 9- to 18-year-old primary care patients, those receiving cASCA/BI will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, at 3, 6, 9 and 12-months follow-up than those receiving treatment as usual.

Study Type

Interventional

Enrollment (Actual)

871

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02115
        • Longwood Pediatrics
      • Boston, Massachusetts, United States, 02115
        • Boston Childrens Primary Care Center
      • East Boston, Massachusetts, United States, 02128
        • East Boston Neighborhood Health Center
      • Lexington, Massachusetts, United States, 02421
        • Lexington Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • access to computer and email address
  • available and willing to complete all follow ups by email or phone
  • medically and emotionally stable
  • can read and understand English

Exclusion Criteria:

  • Patient has already participated in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: screening w/ computer brief intervention
screening with computer-facilitated brief intervention
Immediate feedback to patient of screening results and risk for substance use problem, followed by 11 pages of science and true-life stories about health risks of adolescent substance use. Screening results then go to provider who reviews them with patient and gives brief counseling, and refers to an online motivational enhancement therapy intervention for patients at moderate/high risk for substance use problems.
No Intervention: Screening with Treatment as Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Post-visit Drinking Day
Time Frame: 12-months follow-up
Median (and interquartile range) for times to first use for the cSBI and Treatment As Usual (TAU) groups
12-months follow-up
Time to First Post-visit Heavy Episodic Drinking Day
Time Frame: 12-months follow-up
The number of days post-visit to first reported heavy episodic drinking day
12-months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Post-visit Cannabis Use Day
Time Frame: 12-months follow-up
The number of days post-visit to first reported cannabis use day.
12-months follow-up
Past-3-month Riding Risk
Time Frame: 12 months follow-up
Self-reported riding in the past 3 months with a driver who had been drinking or using other drugs, stratified by reported riding risk in the past 3 months at baseline
12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John R Knight, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

September 4, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • P00004862
  • 1R01AA021904-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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