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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights

START Trial 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.Check my eligibility
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.See study design
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.

START Trial 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.

START Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of suicide events after treatment.
Time to first recurrence of a suicide event
Secondary outcome measures
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

START 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
815 Previous Clinical Trials
6,530,591 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,996,458 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria to be involved in this medical experiment?

"This trial is accepting 5 participants, who must have suicidal thoughts and range between the ages of twelve to eighteen."

Answered by AI

Is this clinical trial being conducted on a wide scale in Canada?

"Currently, there are 4 different medical centres administering this trial. These locations can be found in Columbus, Cincinnati and Dallas with another unspecified location for enrolment. To reduce disruption to your daily life, it is wise to select the nearest site available if you do join the study."

Answered by AI

What primary goals are being sought by this research endeavor?

"This 180-day trial will evaluate the number of suicide events after treatment and two secondary outcomes: Quality of Life Satisfaction assessed by PROMIS® Parent Proxy Item Bank v1.0 - Life Satisfaction - Short Form 8a, demographic factors determined with START demographics form, as well as general life satisfaction measured via PROMIS® (Patient-Reported Outcomes Measurement Information System) Item Bank v1.0 – General Life Satisfaction – Short Form 5a."

Answered by AI

Is this research initiative accepting senior citizens as participants?

"According to the trial's eligiblity requirements, any patient between 12 and 18 years old can participate."

Answered by AI

Are participants still able to be recruited for this medical experiment?

"This specific trial has been temporarily suspended; it was posted on November 4th 2019, and the last update occurred on January 25th 2021. Despite this, there are still 98 other trials that require participants at present."

Answered by AI

Who else is applying?

What state do they live in?
Texas
New Jersey
How old are they?
18 - 65
What site did they apply to?
Northwell Health
UT Southwestern Medical Center/Children's Health
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
~454 spots leftby Jan 2028