Trial record 15 of 34 for:    alcohol [CONDITION] AND (adolescent OR teen) [ALL-FIELDS] | Open Studies

Validating NIAAA Screen Guide in YCMC

This study is currently recruiting participants.
Verified January 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01544218
First received: February 15, 2012
Last updated: January 2, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • eGuide diagnosis of alcohol use disorder [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Correlation between score on the Asthma Control Test (ACT)and level of alcohol use [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Correlation of score on The Childhood Health Assessment Questionnaire (CHAQ) with level of alcohol use [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Correlation between The Pediatric Ulcerative Colitis Activity Index (PUCAI)score and level of alcohol use [ Time Frame: Baseline ] [ Designated as safety issue: No ]

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)
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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544218

Contacts
Contact: Sharon Levy, MD 857-218-4308 sharon.levy@childrens.harvard.edu
Contact: Elissa Weitzman, ScD 617-355-3538 elissa.weitzman@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sharon Levy, MD    857-218-4308    sharon.levy@childrens.harvard.edu   
Contact: Elissa Weitzman, ScD    617-355-3538    elissa.weitzman@childrens.harvard.edu   
Principal Investigator: Sharon Levy, MD, MPH         
Principal Investigator: Elissa Weitzman, ScD, MSc         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Sharon Levy, MD, MPH Children's Hospital Boston
Principal Investigator: Elissa Weitzman, ScD, MSc Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01544218     History of Changes
Other Study ID Numbers: SL_NIAAARFA_0212
Study First Received: February 15, 2012
Last Updated: January 2, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014