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Validating NIAAA Screen Guide in YCMC

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Boston Children’s Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Boston Children’s Hospital Identifier:
First received: February 15, 2012
Last updated: January 2, 2013
Last verified: January 2013
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.

Alcohol Related Disorders

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Validating NIAAA's Brief Screening Guide in Youth With Chronic Medical Conditions

Further study details as provided by Boston Children’s Hospital:

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

Estimated Enrollment: 460
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Youth ages 9-18 with one of four chronic medical conditions - asthma, diabetes, rheumatic or gastroenterologic conditions


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Boston Children’s Hospital Identifier: NCT01544218     History of Changes
Other Study ID Numbers: SL_NIAAARFA_0212 
Study First Received: February 15, 2012
Last Updated: January 2, 2013

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

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders processed this record on February 17, 2017