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Alcohol Related DisorderscASCANCT01539954

Computerized Alcohol Screening for Children and Adolescents

An observational study of Alcohol Related Disorders, run by Boston Children's Hospital at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 9 to 18 years
Conditions the study is for
Alcohol Related Disorders
How many people
0 participants
Where
1 siteUnited States
Study dates
Sep 2012to Sep 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Youth 9-18 years old

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Hospital Boston

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: 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.

Keywords
Alcohol related disorders
Medical subject headings
Alcohol-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01539954
Study groupRoleWhat they receive
Youth 9-18 years of ageNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline

Secondary outcomes (2)
  1. Test-retest reliability of cASCA

    We will calculate Cohen's kappas to evaluate 1-2 week test-retest agreement on c-ASCA responses

    Measured: baseline

  2. Validity of "number of drinking days" item in c-ASCA

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionSep 2015 (estimated)
  4. Study completionSep 2015 (estimated)

Why it stopped: The project was not funded.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01539954
Sponsor's protocol ID
JK_NIAAA_02-12
Acronym
cASCA
Status last verified
Oct 2016
First submitted
16 Feb 2012
Last updated
7 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Alcohol Related Disorders, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Specificity and sensitivity of cASCA (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.

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