Suicide Treatment Alternatives for Teens

NCT04089254 | Recruiting DMC

• 1 other identifier: PCS-2018C1-11111
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Suicidal Ideation

Keywords

Suicide; Suicidal; Adolescent

Outcome Measures

Primary Outcomes (2)

• 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).

  180 days

• 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.

  180 days

Secondary Outcomes (5)

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

  180 days

• Demographic factors as assessed using the START demographics form.

  180 days

• 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

  180 days

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

  180 days

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

  180 days

Study Arms (2)

Inpatient Psychiatry

ACTIVE COMPARATOR

Child and adolescent inpatient treatment

Behavioral: Inpatient Psychiatry

Outpatient Crisis Intervention Clinic

ACTIVE COMPARATOR

OCIC is outpatient crisis intervention clinic

Behavioral: Outpatient Crisis Intervention Clinic

Interventions

Inpatient Psychiatry BEHAVIORAL

Inpatient hospitalization to treat and stabilize suicidal thoughts and behavior.

Inpatient Psychiatry

Outpatient Crisis Intervention Clinic BEHAVIORAL

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

Outpatient Crisis Intervention Clinic

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents that are 12 through 17 years old (including 17 year olds who will turn 18 years old during the course of the study).
• Are brought to the Emergency Department (ED) due to suicidal thoughts or behaviors
• Require a higher level of care (OCIC or Inpatient) indicated by clinician determination and a CHRT-SR score of 15 to 52.
• The presence of a legal guardian
• 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.

You may not qualify if:

• Adolescents with suicidal thoughts that place themselves at a serious imminent risk of suicide based on clinical judgment.
• 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
• Adolescents that are non-English speaking due to the scales and surveys that are used for this study only being available in English.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (4)

Northwell Health

Glen Oaks, New York, 11004, United States

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

NOT YET RECRUITING

Related Links

• CDC, Web-based Injury Statistics Query and Reporting System

MeSH Terms

Conditions

Suicidal Ideation; Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Drew Barzman, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Drew Barzman, MD

CONTACT

(513) 636-0807; drew.barzman@cchmc.org

Jennifer Combs, MSSA

CONTACT

(513) 803-0007; jennifer.combs@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Quasi-Randomized Design

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: September 13, 2019
• Study Start: November 4, 2019
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)