Facilitated Referral for Children Screening Positive for... | NCT00448331

Studies
Facilitated Referral for Children Screening Positive for Mental Illness

NCT00448331

Sponsor

Children's Hospital Medical Center, Cincinnati

Status

Completed

Last Update Posted

Nov 2, 2007Estimated

Enrollment

551Actual

Phase

Not provided

Conditions

Mental Disorders
Mentally Ill Persons
Emergency Medicine

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

ID	Type	Description	Link
MH063916-03

Status Module

Record Verification Date

Oct 2007

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

Jun 2004

Primary Completion Date

Not provided

Completion Date

Aug 2007Actual

First Submitted Date

Mar 14, 2007

First Submission Date that Met QC Criteria

Mar 14, 2007

First Posted Date

Mar 16, 2007Estimated

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

Oct 31, 2007

Last Update Posted Date

Nov 2, 2007Estimated

Name	Class
National Institutes of Health (NIH)	NIH

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

The purpose of this study is to find out how prevalent unidentified Mental Health issues are in the pediatric population that visits the Emergency Department in an urban city.

Detailed Description

The purpose of this research study is to find out how many children in the Emergency Room have emotional issues and how many of them go unnoticed. In particular the study looks at how well a questionnaire for children and teenagers, the DISC Predictive Scales, Version IV (DPS-IV) works and what is the best way to ask the questions. In addition, for children aged 9-17 this study will look at families' readiness to seek care when a problem is indicated.

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

551Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
positive screen, negative screen		Positive screens are those who received positive feedback regarding their answers to a mental illness screening assessment. Negative screens received feedback stating that they did not screen positive for any mental illness.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Child Must be With Biological Mother
Child Presenting to Emergency Department with an Urgent But Stable condition
Child must be between the ages of 6 years and 18 years
Child must have no prior history of Behavioral Health concerns or diagnoses

Exclusion Criteria:

Child has prior Behavioral Health history, diagnosis, or concerns
Child not between ages of 6 years and 18 years of ages
Child presenting without Biological Mother present
Child acuity level outside of Urgent But Stable for presenting complaints

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Emergency Department patients ages 6-18 who present without any history of mental health issues.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jackie Grupp-Phelan, MD, MPH	Children's Hospital Medical Center, Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Children's Hospital Medical Center Emergency Department		Cincinnati	Ohio	45229	United States

Condition Browse Module

MeSH Terms

ID	Term
D001523	Mental Disorders
D004630	Emergencies

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided