Clincosm LogoSign in Get a demo

Validating NIAAA Screen Guide in YCMC

Sponsor
Boston Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01544218
Collaborator
(none)
521
Enrollment
1
Location
45.9
Duration (Months)
11.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    521 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Validating NIAAA's Brief Screening Guide in Youth With Chronic Medical Conditions
    Study Start Date :
    Sep 1, 2012
    Actual Primary Completion Date :
    Jul 20, 2015
    Actual Study Completion Date :
    Jun 30, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    YCMC

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

    Outcome Measures

    Primary Outcome Measures

    1. eGuide diagnosis of alcohol use disorder [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.

    Secondary Outcome Measures

    1. Correlation of HgbA1c level with level of alcohol use [Baseline]

    2. Correlation between score on the Asthma Control Test (ACT)and level of alcohol use [Baseline]

    3. Correlation of score on The Childhood Health Assessment Questionnaire (CHAQ) with level of alcohol use [baseline]

    4. Correlation between The Pediatric Ulcerative Colitis Activity Index (PUCAI)score and level of alcohol use [Baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital Boston Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sharon Levy, Assistant Professor of Pediatrics, Harvard Medical School, Boston Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT01544218
    Other Study ID Numbers:
    • SL_NIAAARFA_0212
    First Posted:
    Mar 5, 2012
    Last Update Posted:
    Jun 21, 2017
    Last Verified:
    Jun 1, 2017
    Keywords provided by Sharon Levy, Assistant Professor of Pediatrics, Harvard Medical School, Boston Children's Hospital
    Alcohol related disorders
    Additional relevant MeSH terms:
    Alcohol-Related Disorders

    Study Results

    No Results Posted as of Jun 21, 2017