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Validating NIAAA Screen Guide in YCMC

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sharon Levy, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT01544218
First received: February 15, 2012
Last updated: June 19, 2017
Last verified: June 2017
  Purpose
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
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 Sharon Levy, 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 ]

Enrollment: 521
Study Start Date: September 2012
Study Completion Date: June 30, 2016
Primary Completion Date: July 20, 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
YCMC
Youth ages 9-18 with one of four chronic medical conditions - asthma, diabetes, rheumatic or gastroenterologic conditions

  Eligibility

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
Criteria

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 ClinicalTrials.gov identifier: NCT01544218

Locations
United States, Massachusetts
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
  More Information

Responsible Party: Sharon Levy, Assistant Professor of Pediatrics, Harvard Medical School, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01544218     History of Changes
Other Study ID Numbers: SL_NIAAARFA_0212
Study First Received: February 15, 2012
Last Updated: June 19, 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

ClinicalTrials.gov processed this record on June 27, 2017