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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01544218
Other study ID # SL_NIAAARFA_0212
Secondary ID
Status Completed
Phase N/A
First received February 15, 2012
Last updated June 19, 2017
Start date September 2012
Est. completion date June 30, 2016

Study information

Verified date June 2017
Source Boston Children’s Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 521
Est. completion date June 30, 2016
Est. primary completion date July 20, 2015
Accepts healthy volunteers No
Gender All
Age group 9 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Children's Hospital Boston Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary eGuide diagnosis of alcohol use disorder 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. Baseline
Secondary Correlation of HgbA1c level with level of alcohol use Baseline
Secondary Correlation between score on the Asthma Control Test (ACT)and level of alcohol use Baseline
Secondary Correlation of score on The Childhood Health Assessment Questionnaire (CHAQ) with level of alcohol use baseline
Secondary Correlation between The Pediatric Ulcerative Colitis Activity Index (PUCAI)score and level of alcohol use Baseline
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