NCT01539954

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 28, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

February 16, 2012

Last Update Submit

October 6, 2016

Conditions

Keywords

Alcohol related disorders

Outcome Measures

Primary Outcomes (1)

  • Specificity and sensitivity of cASCA

    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).

    Baseline

Secondary Outcomes (2)

  • Test-retest reliability of cASCA

    baseline

  • Validity of "number of drinking days" item in c-ASCA

    Baseline

Study Arms (1)

Youth 9-18 years of age

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Youth 9-18 years old

You may qualify if:

  • nine- to 18-years old
  • arriving for non-emergent care
  • have an email address and internet access
  • provide informed assent/consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Links

MeSH Terms

Conditions

Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • John R Knight, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics, Harvard Medical School; Senior Associate in Medicine; Associate in Psychiatry, Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 28, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 7, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations