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RecruitingNCT04089254STARTUpdated Jul 5, 2024

Suicide Treatment Alternatives for Teens

An interventional study of Inpatient Psychiatry and Outpatient Crisis Intervention Clinic in Suicidal Ideation, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 4 sites in United States. Open to participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-05.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2019; still recruiting 6 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study summary

Quasi-Randomized trial to compare inpatient care versus outpatient crisis intervention clinic. This study plans to enroll up to 1,000 participants across 4 sites in a 5 years period.

Read the detailed description

To address the unmet need of optimizing the treatment and management for adolescent suicidality, the investigators propose to evaluate if Outpatient Crisis Intervention Clinic (OCIC) leads to better treatment outcomes than inpatient treatment. To achieve this goal, the investigators propose a multi- site study to evaluate if OCIC, compared with inpatient care, can lead to a lower risk of a suicidal event (primary outcome) as well as higher treatment satisfaction (TS) and satisfaction with life (SL) (secondary outcomes) of both the legal guardians/parents and patients. Furthermore, the investigators will assess which clinical and socioeconomic factors at baseline may affect the treatment outcomes. With the results from the proposed study, the investigators will be able to reduce the family and clinician decisional uncertainty about the best treatment setting for suicidal adolescents in the target population. The results will significantly help patients, families, and clinicians with this decision-making process and improve outcomes for suicidal adolescents. The study has been designed to accomplish the following Specific Aims (SA):

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.

02

Conditions studied

  • Suicidal Ideation

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Keywords

  • Suicide
  • Suicidal
  • Adolescent
03

In context

Suicidal Ideation

515 studies on the registry are indexed under Suicidal Ideation; 195 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 80 across 426 interventional studies indexed under Suicidal Ideation.

Browse Suicidal Ideation studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Adolescents that are 12 through 17 years old (including 17 year olds who will turn 18 years old during the course of the study).
  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

Exclusion Criteria:

  1. Adolescents with suicidal thoughts that place themselves at a serious imminent risk of suicide based on clinical judgment.
  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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Active comparator
    Inpatient Psychiatry

    Child and adolescent inpatient treatment

    Behavioral: Inpatient Psychiatry

  • Active comparator
    Outpatient Crisis Intervention Clinic

    OCIC is outpatient crisis intervention clinic

    Behavioral: Outpatient Crisis Intervention Clinic

Interventions

  • BehavioralInpatient Psychiatry

    Inpatient hospitalization to treat and stabilize suicidal thoughts and behavior.

  • BehavioralOutpatient Crisis Intervention Clinic

    Outpatient psychiatric clinic that provides crisis intervention to treat and stabilize suicidal thoughts and behavior.

06

What researchers measure

Primary outcomes

  1. Time to first recurrence of a suicide event

    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).

    Time frame: 180 days

  2. Number of suicide events after treatment.

    Measure the difference between OCIC and inpatient treatment in the number of suicidal events (a suicide attempt, interrupted attempt, hospitalization because of suicidal risk, an emergency/urgent evaluation because of suicidal risk, and a death by suicide) over 180 days for suicidal adolescents after their baseline ED visit.

    Time frame: 180 days

Secondary outcomes

  1. Treatment Satisfaction as assessed using the Client Satisfaction Questionnaire-Adapted (CSQ).

    Assess the rate of client treatment satisfaction (TS) across OCIC and inpatient treatment. This will be measured by patient completing the Client Satisfaction Questionnaire-Adapted (CSQ).

    Time frame: 180 days

  2. Demographic factors as assessed using the START demographics form.

    As an exploratory aim, assess the demographic influences that may impact treatment outcomes for all groups (inpatient, OCIC, and no show group).This will be measured by the patient and parent completing the START demographics form, including information on race, ethnicity, patient sexual orientation, patient sexual identify, household education level and income, family makeup (number of parents and/or guardians in the home), and other socio-economic factors.

    Time frame: 180 days

  3. Quality of Life Satisfaction as assessed using the PROMIS® (Patient-Reported Outcomes Measurement Information System) Item Bank v1.0 - General Life Satisfaction - Short Form 5a

    Assess and compare the patient's life satisfaction following treatment in either OCIC or inpatient using the PROMIS® (Patient-Reported Outcomes Measurement Information System) Item Bank v1.0 - General Life Satisfaction - Short Form 5a.

    Time frame: 180 days

  4. Quality of Life Satisfaction as assessed using the PROMIS Pediatric Item Bank v1.0 - Life Satisfaction - Short Form 4a

    Assess and compare the patient's life satisfaction following treatment in either OCIC or inpatient using the Quality of Life Satisfaction as assessed using the PROMIS Pediatric Item Bank v1.0 - Life Satisfaction - Short Form 4a.

    Time frame: 180 days

  5. Quality of Life Satisfaction as assessed using PROMIS Parent Proxy Item Bank v1.0 - Life Satisfaction - Short Form 8a

    Assess and compare the patient's life satisfaction following treatment in either OCIC or inpatient using the : Quality of Life Satisfaction as assessed using PROMIS Parent Proxy Item Bank v1.0 - Life Satisfaction - Short Form 8a.

    Time frame: 180 days

07

Study locations

3 of 4 sites recruiting
  • Northwell Health
    Glen Oaks, New York 11004, United States
    • Victor Fornari, MD · Contact · vfornari@northwell.edu · 718-470-3510
    • Victor Fornari, MD · Principal investigator
    • Vera Feuer, MD · Principal investigator
    Recruiting
  • Cincinnati Children's Hospital and Medical Center
    Cincinnati, Ohio 45229, United States
    Recruiting
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
    Recruiting
  • UT Southwestern Medical Center/Children's Health
    Dallas, Texas 75390, United States
    • Graham Emslie, MD · Contact · graham.emslie@utsouthwestern.edu · 844-424-4537
    • Graham Emslie, MD · Principal investigator
    • Beth Kennard, PsyD · Principal investigator
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04089254
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Patient-Centered Outcomes Research Institute
Responsible party
Sponsor
First posted
Sep 13, 2019
Start date
Nov 4, 2019
Primary completion
Jan 2028 (estimated)
Completion
Jan 2029 (estimated)
Last update
Jul 5, 2024

Study contacts

Drew Barzman, MD
Contact
drew.barzman@cchmc.org
(513) 636-0807
Jennifer Combs, MSSA
Contact
jennifer.combs@cchmc.org
(513) 803-0007
Drew Barzman, MD
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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