Validating NIAAA Screen Guide in YCMC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01544218
Recruitment Status : Completed
First Posted : March 5, 2012
Last Update Posted : June 21, 2017
Information provided by (Responsible Party):
Sharon Levy, Boston Children’s Hospital

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
Alcohol Related Disorders

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 : September 2012
Actual Primary Completion Date : July 20, 2015
Actual Study Completion Date : June 30, 2016

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Correlation of HgbA1c level with level of alcohol use [ Time Frame: Baseline ]
  2. Correlation between score on the Asthma Control Test (ACT)and level of alcohol use [ Time Frame: Baseline ]
  3. Correlation of score on The Childhood Health Assessment Questionnaire (CHAQ) with level of alcohol use [ Time Frame: baseline ]
  4. Correlation between The Pediatric Ulcerative Colitis Activity Index (PUCAI)score and level of alcohol use [ Time Frame: Baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
9-18 year old youth with one of four chronic conditions - asthma, diabetes, rheumatic or gastroenterologic conditions

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01544218

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Principal Investigator: Sharon Levy, MD, MPH Boston Children’s Hospital
Principal Investigator: Elissa Weitzman, ScD, MSc Boston Children’s Hospital

Responsible Party: Sharon Levy, Assistant Professor of Pediatrics, Harvard Medical School, Boston Children’s Hospital Identifier: NCT01544218     History of Changes
Other Study ID Numbers: SL_NIAAARFA_0212
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017

Keywords provided by Sharon Levy, Boston Children’s Hospital:
Alcohol related disorders

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders