Mental HealthNCT00750412
An Assessment of Voluntary Adolescent Mental Health Screening and Referral in a Children's Hospital Emergency Department
A study testing TeenScreen Program in people with Mental Health, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to compare the TeenScreen intervention to usual care for adolescents who screen positive for mental health problems in a pediatric emergency department. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- TeenScreen Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jun 2010
- Phase
- Interventional
- 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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients between 11 and 17 years old
- Medically stable and presenting with a non-psychiatric complaint
- English speaking
- Parent/guardian present for consent
- Insurance coverage by Medicaid
- Hamilton County residents
- Not currently receiving mental health treatment
Who cannot join
- Less than 11 years or greater than 17 years old
- Parent/guardian not present at time of visit
- Medically unstable
- Non-English speaking
- Insurance other than Medicaid
- Presenting complaint is a mental health problem
- Currently receiving mental health treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center Division of Emergency Medicine
Cincinnati, Ohio, 45229
About this study
The purpose of this study is to compare the TeenScreen intervention to usual care for adolescents who screen positive for mental health problems in a pediatric emergency department. It is anticipated that adolescents receiving the TeenScreen intervention will be more likely to attend a first session of outpatient mental health services within 60 days of the initial screening than those receiving the usual care.
- Conditions
- Mental Health
- Being tested
- TeenScreen Program
- Keywords
- TeenScreen, Mental Health, Adolescent Mental Health, Social Work
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeenScreen ProgramBehavioural
Adolescents who are randomized into the TeenScreen program and their parent/guardian will receive post-screening information, a facilitated referral, and case management services from a research social worker.
| Study group | Role | What they receive |
|---|---|---|
| TeenScreen | Experimental | Not described Receives: Behavioral: TeenScreen Program |
| Treatment As Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verified mental health service use through clinical administrative data
Measured: 60 days after the initial mental health screening
Secondary outcomes (1)
Measurement of depressive symptoms and impairment of functioning utilizing the Center for Epidemiological Studies-Depressions Scale and Sheehan Disability Score
Measured: 60 days after the initial mental health screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startMar 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Jacqueline Grupp-Phelan, MD, MPH, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750412
- Sponsor's protocol ID
- CCHMC 2008-0987
- Status last verified
- Oct 2011
- First submitted
- 9 Sep 2008
- Last updated
- 18 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Grupp-Phelan J, McGuire L, Husky MM, Olfson M. A randomized controlled trial to engage in care of adolescent emergency department patients with mental health problems that increase suicide risk. Pediatr Emerg Care. 2012 Dec;28(12):1263-8. doi: 10.1097/PEC.0b013e3182767ac8.
PubMed 23187979
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of Voluntary Adolescent Mental Health Screening and Referral in a Children's Hospital Emergency Department
- ClinicalTrials.gov ID
- NCT00750412
- Acronym / sponsor ID
- CCHMC 2008-0987
- Conditions
- Mental Health
- Keywords
- TeenScreen, Mental Health, Adolescent Mental Health, Social Work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- Mar 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Sep 2008 (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 compare the TeenScreen intervention to usual care for adolescents who screen positive for mental health problems in a pediatric emergency department. It is anticipated that adolescents receiving the TeenScreen intervention will be more likely to attend a first session of outpatient mental health services within 60 days of the initial screening than those receiving the usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TeenScreen | Experimental | Behavioral: TeenScreen Program |
| Treatment As Usual | No intervention | – |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients between 11 and 17 years old
- Medically stable and presenting with a non-psychiatric complaint
- English speaking
- Parent/guardian present for consent
- Insurance coverage by Medicaid
Key exclusion criteria (7 listed)
- Less than 11 years or greater than 17 years old
- Parent/guardian not present at time of visit
- Medically unstable
- Non-English speaking
- Insurance other than Medicaid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeenScreen ProgramAdolescents who are randomized into the TeenScreen program and their parent/guardian will receive post-screening information, a facilitated referral, and case management services from a research social worker. | Behavioural | TeenScreen |
Primary outcome
Verified mental health service use through clinical administrative data
Time frame: 60 days after the initial mental health screening
1 secondary outcome
Measurement of depressive symptoms and impairment of functioning utilizing the Center for Epidemiological Studies-Depressions Scale and Sheehan Disability Score
Time frame: 60 days after the initial mental health screening
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 18 Oct 2011.
- Derived from this study: PubMed 23187979Grupp-Phelan J, McGuire L, Husky MM, Olfson M. A randomized controlled trial to engage in care of adolescent emergency department patients with mental health problems that increase suicide risk. Pediatr Emerg Care. 2012 Dec;28(12):1263-8. doi: 10.1097/PEC.0b013e3182767ac8.
- Columbia University TeenScreen ProgramLink provided by the sponsor.
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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.
Jacqueline 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?
A study testing TeenScreen Program in people with Mental Health, 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 7 inclusion and 7 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 18 Oct 2011. 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.
What does the primary outcome measure?
Verified mental health service use through clinical administrative data (time frame: 60 days after the initial mental health screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00750412, which also lists 1 linked publication.
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 18 Oct 2011.