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Outpatient vs Inpatient Care for Suicidal Thoughts (START Trial)

N/A
Recruiting
Led By Drew Barzman, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adolescents (12 to 18 years old) who were brought to the ED due to suicidal thoughts or behaviors and require a higher level of care (OCIC or inpatient)
Be younger than 65 years old
Must not have
Adolescents who require 24 hour/day supervision but no adult can provide 24 hour/day supervision outside of the hospital
Adolescents without the ability to read and answer survey questions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare inpatient care to outpatient crisis intervention clinics to see which is more effective. Up to 1,000 participants will be enrolled at 4 sites over 5 years.

Who is the study for?
This trial is for adolescents aged 12-17 who arrive at the Emergency Department with suicidal thoughts or behaviors and need more care. They must have a guardian present, score 15-52 on the CHRT-SR scale, and be able to consent to the study. Non-English speakers, those unable to read/respond to surveys, lacking constant adult supervision outside of a hospital, or at immediate risk of suicide are excluded.
What is being tested?
The trial compares two types of care for teens with suicidal thoughts: staying in an inpatient psychiatry unit versus visiting an outpatient crisis intervention clinic. It's quasi-randomized across four sites over five years aiming for up to 1,000 participants.
What are the potential side effects?
While not explicitly listed here, potential side effects may include emotional distress due to therapy sessions or changes in environment from inpatient settings. Close monitoring will be necessary to manage any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a teenager who went to the ER for suicidal thoughts and need more intensive care.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am a teenager who needs round-the-clock supervision but cannot get it at home.
Select...
I am a teenager who cannot read or answer survey questions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of suicide events after treatment.
Time to first recurrence of a suicide event
Secondary study objectives
Demographic factors as assessed using the START demographics form.
Quality of Life Satisfaction as assessed using PROMIS Parent Proxy Item Bank v1.0 - Life Satisfaction - Short Form 8a
Quality of Life Satisfaction as assessed using the PROMIS Pediatric Item Bank v1.0 - Life Satisfaction - Short Form 4a
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Outpatient Crisis Intervention ClinicActive Control1 Intervention
OCIC is outpatient crisis intervention clinic
Group II: Inpatient PsychiatryActive Control1 Intervention
Child and adolescent inpatient treatment

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
839 Previous Clinical Trials
6,564,603 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
580 Previous Clinical Trials
27,104,259 Total Patients Enrolled
Drew Barzman, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Media Library

Inpatient Psychiatry Clinical Trial Eligibility Overview. Trial Name: NCT04089254 — N/A
Suicidal Thoughts Research Study Groups: Outpatient Crisis Intervention Clinic, Inpatient Psychiatry
Suicidal Thoughts Clinical Trial 2023: Inpatient Psychiatry Highlights & Side Effects. Trial Name: NCT04089254 — N/A
Inpatient Psychiatry 2023 Treatment Timeline for Medical Study. Trial Name: NCT04089254 — N/A
~361 spots leftby Jan 2028
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