Validating NIAAA Screen Guide in YCMC

June 19, 2017 updated by: Sharon Levy, Boston Children's Hospital

Validating NIAAA's Brief Screening Guide in Youth With Chronic Medical Conditions

Alcohol use is a serious health threat to the 26% youth in the US with chronic medical conditions. While alcohol use can significantly impact an underlying illness and its safe/effective management, medical specialists rarely screen their adolescent patients for alcohol use. The investigators will validate a new, brief alcohol- screening tool with 9-18 year old youth with chronic medical conditions. Comprehensive assessment information will be collected and analyzed to describe relationships between youth alcohol use, other substance use, and chronic disease outcomes and findings integrated into the validated screen as actionable clinician guidance and health advice.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

521

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston

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

9-18 year old youth with one of four chronic conditions - asthma, diabetes, rheumatic or gastroenterologic conditions

Description

Inclusion Criteria:

  • 9-18 years of age
  • duration of chronic illness of at least one year
  • ability to speak/read English and use a computer keyboard and/or complete an interviewer-assisted questionnaire

Exclusion Criteria:

  • medically or emotionally unstable
  • unable to assent/consent

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
YCMC
Youth ages 9-18 with one of four chronic medical conditions - asthma, diabetes, rheumatic or gastroenterologic conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eGuide diagnosis of alcohol use disorder
Time Frame: Baseline
We will evaluate the sensitivity and specificity of the eGuide to correctly identify the group of YCMC who have problem use/abuse or dependence, using the CIDI-SAM as the criterion standard.
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of HgbA1c level with level of alcohol use
Time Frame: Baseline
Baseline
Correlation between score on the Asthma Control Test (ACT)and level of alcohol use
Time Frame: Baseline
Baseline
Correlation of score on The Childhood Health Assessment Questionnaire (CHAQ) with level of alcohol use
Time Frame: baseline
baseline
Correlation between The Pediatric Ulcerative Colitis Activity Index (PUCAI)score and level of alcohol use
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Sharon Levy, MD, MPH, Boston Children's Hospital
  • Principal Investigator: Elissa Weitzman, ScD, MSc, Boston Children's Hospital

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 (Actual)

July 20, 2015

Study Completion (Actual)

June 30, 2016

Study Registration Dates

First Submitted

February 15, 2012

First Submitted That Met QC Criteria

February 28, 2012

First Posted (Estimate)

March 5, 2012

Study Record Updates

Last Update Posted (Actual)

June 21, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL_NIAAARFA_0212

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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