Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2019-11-04
2029-01-31
Brief Summary
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Detailed Description
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SA1: Measure the differences between OCIC and inpatient treatment in the time to first recurrence of a suicidal event (a suicide attempt, interrupted attempt, hospitalization because of suicidal risk, an emergency/urgent evaluation because of suicidal risk, and a death by suicide) and the number of suicidal events over 30 days, 90 days and 180 days for suicidal adolescents after their baseline Emergency Department (ED) visits.
Hypothesis (H) 1.1: Assignment with randomization to OCIC from the ED will lead to a longer time to the first recurrence of a suicidal event compared to inpatient treatment after 30 days, 90 days and 180 days from the baseline ED visit for suicidality. H1.2 Assignment with randomization to OCIC will lead to a lower number suicidal events over 30 days, 90 days and 180 days when compared to inpatient treatment. H1.3 Heterogeneity of Treatment Effects \[HTE\]: The investigators will examine to what degree the following specific clinical features and sociodemographic features differ for patients who respond to OCIC or inpatient psychiatry treatment. Response is defined by a delay in first recurrence of a suicidal event and a lower number of suicidal events over 30 days, 90 days and 180 days. Clinical features: 1) Severity of suicidal ideation at baseline and over 180 days; 2) number of suicidal events at baseline only; 3) Substance use at baseline and over 180 days. Sociodemographic features at baseline: 1) Age 2) Gender 3) Gender Identity 4) Type of Insurance (public insurance/no insurance/private) 5) Ethnicity (Hispanic/Non); 6) Race (African-American (AA) versus non-African American); 7) Living with one biological parent, two biological parents, a stepparent, a relative, or other SA2: Assess the treatment satisfaction (TS) and satisfaction with life (SL) across OCIC and inpatient treatment.
H2.1: Overall, patients and legal guardians/parents in the OCIC group will have higher TS (at the completion of treatment in OCIC or inpatient psychiatry) and better SL than the inpatient treatment group over30 days, 90 and 180 days.
SA3: As an exploratory aim, assess the demographics and potential barriers to treatment for a third comparator of the "no show" group who were randomized to OCIC or inpatient treatment but never showed up or left the inpatient unit against medical advice (AMA).
H3.1: The no show group (the third comparator) who did not arrive for any OCIC appointments or left AMA from inpatient treatment will differ from the other comparators with respect to the following barriers to treatment: 1) Age 2) Gender 3) Type of Insurance (public insurance/no insurance/private) 4) Ethnicity (Hispanic/Non) 64; 5) Race (African-American (AA) versus non-African American) ; 6) Living with one biological parent, two biological parents, a stepparent, a relative, or other H3.2: The no show group will have significantly shorter time to first recurrence of a suicidal event and a larger number of suicidal events over 30 days, 90 days and 180 days in comparison to the other patients.
SA4: As a secondary aim, evaluate the difference of outcomes (see outcomes in SA1 and SA2) in week-by-week treatment allocation followers and treatment switchers.
SA 5: As a secondary aim, evaluate the difference in outcomes between in-person OCIC services and telehealth OCIC services.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Inpatient Psychiatry
Child and adolescent inpatient treatment
Inpatient Psychiatry
Inpatient hospitalization to treat and stabilize suicidal thoughts and behavior.
Outpatient Crisis Intervention Clinic
OCIC is outpatient crisis intervention clinic
Outpatient Crisis Intervention Clinic
Outpatient psychiatric clinic that provides crisis intervention to treat and stabilize suicidal thoughts and behavior.
Interventions
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Inpatient Psychiatry
Inpatient hospitalization to treat and stabilize suicidal thoughts and behavior.
Outpatient Crisis Intervention Clinic
Outpatient psychiatric clinic that provides crisis intervention to treat and stabilize suicidal thoughts and behavior.
Eligibility Criteria
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Inclusion Criteria
2. Are brought to the Emergency Department (ED) due to suicidal thoughts or behaviors
3. Require a higher level of care (OCIC or Inpatient) indicated by clinician determination and a CHRT-SR score of 15 to 52.
4. The presence of a legal guardian
5. Capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria
2. Adolescents who require 24 hour/day supervision but no adult can provide 24 hour/day supervision outside of the hospital
3. Adolescents without the ability to read and answer survey questions
4. Adolescents that are non-English speaking due to the scales and surveys that are used for this study only being available in English.
12 Years
18 Years
ALL
Yes
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Drew Barzman, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Northwell Health
Glen Oaks, New York, United States
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
UT Southwestern Medical Center/Children's Health
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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CDC, Web-based Injury Statistics Query and Reporting System
Other Identifiers
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PCS-2018C1-11111
Identifier Type: -
Identifier Source: org_study_id
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