Validating NIAAA Screen Guide in YCMC | NCT01544218

Studies
Validating NIAAA Screen Guide in YCMC

NCT01544218

Sponsor

Boston Children's Hospital

Status

Completed

Last Update Posted

Jun 21, 2017Actual

Enrollment

521Actual

Phase

Not provided

Conditions

Alcohol Related Disorders

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Jul 20, 2015Actual

Completion Date

Jun 30, 2016Actual

First Submitted Date

Feb 15, 2012

First Submission Date that Met QC Criteria

Feb 28, 2012

First Posted Date

Mar 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2017

Last Update Posted Date

Jun 21, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sharon Levy, Assistant Professor of Pediatrics, Harvard Medical School, Boston Children's HospitalPrincipal Investigator

Lead Sponsor

Boston Children's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

521Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
YCMC		Youth ages 9-18 with one of four chronic medical conditions - asthma, diabetes, rheumatic or gastroenterologic conditions

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sharon Levy, MD, MPH	Boston Children's Hospital	Principal Investigator
Elissa Weitzman, ScD, MSc	Boston Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Boston		Boston	Massachusetts	02115	United States

Condition Browse Module

MeSH Terms

ID	Term
D019973	Alcohol-Related Disorders

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided