Mental DisordersMINCT00448331
Facilitated Referral for Children Screening Positive for Mental Illness
An observational study of Mental Disorders and Mentally Ill Persons, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders, Mentally Ill Persons, Emergency Medicine
- How many people
- 551 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Emergency Department patients ages 6-18 who present without any history of mental health issues.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center Emergency Department
Cincinnati, Ohio, 45229
About this study
Official title: Facilitated Referral for Children Screening Positive for Mental Illness in the Pediatric Emergency Department and Readiness to Seek Care
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.
Read the 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.
- Conditions
- Mental Disorders, Mentally Ill Persons, Emergency Medicine
- Keywords
- Mental Disorders, Mentally Ill Persons, Emergency Medicine, Emergency Department, Screening
- Medical subject headings
- Mental Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2007 (estimated)
- Study startJun 2004
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 551 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Jackie Grupp-Phelan, MD, MPH, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448331
- Sponsor's protocol ID
- 02-9-27
- Other IDs
- MH063916-03
- Acronym
- MI
- Status last verified
- Oct 2007
- First submitted
- 14 Mar 2007
- Last updated
- 2 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitated Referral for Children Screening Positive for Mental Illness in the Pediatric Emergency Department and Readiness to Seek Care
- ClinicalTrials.gov ID
- NCT00448331
- Acronym / sponsor ID
- MI / 02-9-27
- Conditions
- Mental Disorders, Mentally Ill Persons, Emergency Medicine
- Keywords
- Mental Disorders, Mentally Ill Persons, Emergency Medicine, Emergency Department, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2004
- Study completion
- Aug 2007 (actual)
- First posted
- 16 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Emergency Department patients ages 6-18 who present without any history of mental health issues.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackie Grupp-Phelan, MD, MPH principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorders and Mentally Ill Persons, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2007.