- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01539954
Computerized Alcohol Screening for Children and Adolescents (cASCA)
October 6, 2016 updated by: John R Knight, MD, Boston Children's Hospital
Computerized Alcohol Screening for Children and Adolescents (cASCA) in Primary Care
The goal of this project is to develop a computerized screening program for primary care offices that is based on the NIAAA's Alcohol Screening Guide for Children and Adolescents and assess its psychometric properties among nine- to 18-yr-old primary care patients.
There have been few studies of alcohol screening and brief intervention conducted among adolescents receiving primary medical care.
This project will develop and validate a new computerized Alcohol Screening for Children and Adolescents (cASCA) system based on the two age-specific screening questions of the NIAAA Guide and includes the CRAFFT and AUDIT as secondary risk and problem assessments.
The system will yield a provider report with the screening results, level of risk, and recommended brief advice, counseling, or referral strategies.
The Specific Aims of this project are to: 1)Assess the sensitivity, specificity, positive and negative predictive values of the 'any drinking/number of drinking days' and 'friends' questions of the cASCA in identifying past-year use as determined by the Timeline Follow-Back Calendar (TLFB), and for identifying any problem use, abuse or dependence as determined by the AUDIT, CRAFFT and a structured psychiatric diagnostic interview (computerized DISC-IV, Youth Version) at baseline (criterion validity); 2)Assess the test-retest reliability of the cASCA in measuring drinking frequency categories and in classifying patients into Low, Medium and High risk categories; 3)Assess the predictive validity of the 'any drinking/number of drinking days' and 'friends' questions in predicting drinking, "binge" drinking, and any problem use, abuse or dependence at 12-mos follow-up; 4)Assess the degree to which the 'any drinking/number of drinking days' item of the cASCA predicts drug use risk as measured by the TLFB (any use and frequency), tobacco use as measured by the Hooked on Nicotine Checklist (screen for potential nicotine dependence), drug use disorders as measured by the Drug Abuse Screening Test for Adolescents, and the degree to which it predicts other mental health problems as measured by the Youth DISC Predictive Scales at baseline and 12-month follow-up; 5)Compare the psychometric properties of the cASCA across subgroups, including: age, gender, race/ethnicity, practice type, provider type, and patient risks (e.g., those with/without friends who drink); and explore the possible effects of the cASCA system on drinking at 3-, 6-, 9-, and 12-month follow-ups.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
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
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
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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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Youth 9-18 years old
Description
Inclusion Criteria:
- nine- to 18-years old
- arriving for non-emergent care
- have an email address and internet access
- provide informed assent/consent.
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 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
Cohorts and Interventions
Group / Cohort |
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Youth 9-18 years of age
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Specificity and sensitivity of cASCA
Time Frame: Baseline
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We will examine validity of the lifetime "any drinking" item by comparing participant responses on the c-ASCA to responses on the Brief Substance Use History (BSUH) questionnaire (lifetime use and age of initiation of use, if any).
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Test-retest reliability of cASCA
Time Frame: baseline
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We will calculate Cohen's kappas to evaluate 1-2 week test-retest agreement on c-ASCA responses
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baseline
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Validity of "number of drinking days" item in c-ASCA
Time Frame: Baseline
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For middle and high school-aged youth (12-18 yrs), we will examine validity of the c-ASCA past-year "number of drinking days" by computing the intra-class correlation coefficients (ICC) assessing agreement between the two continuous variables of total past-year number of days reported on c-ASCA and on the TLFB.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
Helpful Links
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
September 1, 2012
Primary Completion (Anticipated)
September 1, 2015
Study Completion (Anticipated)
September 1, 2015
Study Registration Dates
First Submitted
February 16, 2012
First Submitted That Met QC Criteria
February 22, 2012
First Posted (Estimate)
February 28, 2012
Study Record Updates
Last Update Posted (Estimate)
October 7, 2016
Last Update Submitted That Met QC Criteria
October 6, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JK_NIAAA_02-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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