Boston, Massachusetts 02115

  • Alcohol Related Disorders

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.


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


Study is Available At:


Original ID:

SL_NIAAARFA_0212


NCT ID:

NCT01544218


Secondary ID:


Study Acronym:


Brief Title:

Validating NIAAA Screen Guide in YCMC


Official Title:

Validating NIAAA's Brief Screening Guide in Youth With Chronic Medical Conditions


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

9 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Boston Children’s Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

521


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sharon Levy, MD, MPH
Principal Investigator
Boston Children’s Hospital

Study Dates

Start Date:September 2012
Completion Date:June 30, 2016
Completion Type:Actual
Primary Completion Date:July 20, 2015
Primary Completion Type:Actual
Verification Date:June 2017
Last Changed Date:June 19, 2017
First Received Date:February 15, 2012

Study Outcomes

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

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:YCMC
Description:Youth ages 9-18 with one of four chronic medical conditions - asthma, diabetes, rheumatic or gastroenterologic conditions

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Boston Children’s Hospital

Samples and Retentions

Study Population: 9-18 year old youth with one of four chronic conditions - asthma, diabetes, rheumatic or gastroenterologic conditions
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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