NCT01544218

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
521

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2015

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

2.9 years

First QC Date

February 15, 2012

Last Update Submit

June 19, 2017

Conditions

Keywords

Alcohol related disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Correlation of HgbA1c level with level of alcohol use

    Baseline

  • Correlation between score on the Asthma Control Test (ACT)and level of alcohol use

    Baseline

  • Correlation of score on The Childhood Health Assessment Questionnaire (CHAQ) with level of alcohol use

    baseline

  • Correlation between The Pediatric Ulcerative Colitis Activity Index (PUCAI)score and level of alcohol use

    Baseline

Study Arms (1)

YCMC

Youth ages 9-18 with one of four chronic medical conditions - asthma, diabetes, rheumatic or gastroenterologic conditions

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

9-18 year old youth with one of four chronic conditions - asthma, diabetes, rheumatic or gastroenterologic conditions

You may qualify if:

  • 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

You may not qualify if:

  • medically or emotionally unstable
  • unable to assent/consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Sharon Levy, MD, MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR
  • Elissa Weitzman, ScD, MSc

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics, Harvard Medical School

Study Record Dates

First Submitted

February 15, 2012

First Posted

March 5, 2012

Study Start

September 1, 2012

Primary Completion

July 20, 2015

Study Completion

June 30, 2016

Last Updated

June 21, 2017

Record last verified: 2017-06

Locations