- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02233946
Computerized Alcohol Screening for Children and Adolescents (cASCA) in Primary Care (cASCA)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts Medical Center
-
Boston, Massachusetts, United States, 02115
- Longwood Pediatrics
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Boston, Massachusetts, United States, 02115
- Boston Childrens Primary Care Center
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East Boston, Massachusetts, United States, 02128
- East Boston Neighborhood Health Center
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Lexington, Massachusetts, United States, 02421
- Lexington Pediatrics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: John R Knight, MD, Boston Children's Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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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