- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01779414
STAT-ED: Suicidal Teens Accessing Treatment After an Emergency Department Visit (STAT-ED)
This study looks to implement a novel intervention (STAT-ED) for children who screen positive to suicide ideation. The intervention looks to collect data from several different measures and then randomize participants into one of two groups: a control group where the participant will be set up with a mental health referral from a psychiatric social worker; or if randomized into the STAT-ED intervention, the adolescent and parent will receive a brief motivational interview, barrier reduction discussion, referral and limited case management by the study social worker to enhance outpatient mental health follow up after discharge from the ED.
The hypothesis of the study is patients who are randomized into the STAT-ED intervention group will have a significantly higher rate of initiating mental health treatment and will attend more mental health treatment sessions in the two months after the ED visit compared with adolescents in the control group. Secondary aims of this study look to determine whether the effectiveness of the STAT-ED intervention differs by age, gender, or ethnicity; and evaluate predictors and mediators of mental health treatment engagement.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who arrive in the ED who are between the ages of 12-17 years old
- Screen positive on the Ask Suicide-Screening Questions (ASQ) tool
- Have had no contact with a mental health provider in the 90 days preceding the current ED visit
- Are stable as determined by vital signs and triage criteria (triage levels 2-5)
Exclusion Criteria:
- Patients who present in the ED with a chief complaint of suicidal behavior will be excluded to comply with the requirements of the RFA.
- Those who present in the ED with a primary or secondary psychiatric concern
- Those without access to a telephone/cell phone
- Those unable to adequately understand the study process
- Those families unable to speak or read English adequately to participate in study procedures
- Patients who have altered mental status either due to illness or medication (pain medications)
- Patients who live greater than 100 miles away form the enrolling site
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Enhanced Usual Care
Participants in this arm of the study will receive a standard, usual care psychological risk assessment by a social worker and then recommended to a mental health referral.
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Experimental: STAT-ED Intervention
Participants in this group will receive a motivational interview conducted by a study trained social worker, where the social worker and the family will discuss the participants issues, thoughts and feelings about receiving treatment, barriers to treatment and methods of overcoming those barriers.
The study trained social worker will also make a referral for a mental health follow-up for the patient.
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Participants in this group will receive a motivational interview conducted by a study trained social worker, where the social worker and the family will discuss the participants issues, thoughts and feelings about receiving treatment, barriers to treatment and methods of overcoming those barriers.
The study trained social worker will also make a referral for a mental health follow-up for the patient.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
STAT-ED Intervention Superior to EUC Group
Time Frame: Three years
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Adolescents receiving the STAT-ED intervention will have a significantly higher rate of initiating mental health treatment and will attend more mental health treatment sessions in the two months after the ED visit compared with adolescents in the EUC condition.
STAT-ED will also be superior to the EUC arm in reducing suicidal ideation and depression symptoms at two months and six months.
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Three years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jacqueline Grupp-Phelan, M.D., M.P.H., Children's Hospital Medical Center, Cincinnati
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CINC-2012-3660
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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