search
Back to results

Suicide Treatment Alternatives for Teens (START)

Primary Purpose

Suicidal Ideation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inpatient Psychiatry
Outpatient Crisis Intervention Clinic
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation focused on measuring Suicide, Suicidal, Adolescent

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)
  • The presence of a legal guardian

Exclusion Criteria:

  • Adolescents with suicidal thoughts that place themselves at a serious imminent risk of suicide based on clinical judgment and/or responses on the Concise Health Risk Tracking Self-Report (CHRT-SR) (a score of 23 or higher on the 14 item CHRT-SR) 70-72
  • Adolescents who require 24 hour/day supervision but no adult can provide 24 hour/day supervision outside of the hospital
  • Adolescents with suicidal thoughts who had prior OCIC treatment in the past 12 months will be excluded
  • Adolescents without the ability to answer survey questions will be excluded

Sites / Locations

  • Northwell HealthRecruiting
  • Cincinnati Children's Hospital and Medical CenterRecruiting
  • Nationwide Children's HospitalRecruiting
  • UT Southwestern Medical Center/Children's Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Inpatient Psychiatry

Outpatient Crisis Intervention Clinic

Arm Description

Child and adolescent inpatient treatment

OCIC is outpatient crisis intervention clinic

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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).
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.
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.
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.
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.

Full Information

First Posted
July 9, 2019
Last Updated
June 1, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Patient-Centered Outcomes Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT04089254
Brief Title
Suicide Treatment Alternatives for Teens
Acronym
START
Official Title
A Multi-Site Study to Compare the Outcomes of Psychiatric Treatment of Suicidal Adolescents in Different Treatment Settings
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
January 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation
Keywords
Suicide, Suicidal, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Quasi-Randomized Design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inpatient Psychiatry
Arm Type
Active Comparator
Arm Description
Child and adolescent inpatient treatment
Arm Title
Outpatient Crisis Intervention Clinic
Arm Type
Active Comparator
Arm Description
OCIC is outpatient crisis intervention clinic
Intervention Type
Behavioral
Intervention Name(s)
Inpatient Psychiatry
Intervention Description
Inpatient hospitalization to treat and stabilize suicidal thoughts and behavior.
Intervention Type
Behavioral
Intervention Name(s)
Outpatient Crisis Intervention Clinic
Intervention Description
Outpatient psychiatric clinic that provides crisis intervention to treat and stabilize suicidal thoughts and behavior.
Primary Outcome Measure Information:
Title
Time to first recurrence of a suicide event
Description
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
Title
Number of suicide events after treatment.
Description
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 Outcome Measure Information:
Title
Treatment Satisfaction as assessed using the Client Satisfaction Questionnaire-Adapted (CSQ).
Description
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
Title
Demographic factors as assessed using the START demographics form.
Description
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
Title
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
Description
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
Title
Quality of Life Satisfaction as assessed using the PROMIS Pediatric Item Bank v1.0 - Life Satisfaction - Short Form 4a
Description
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
Title
Quality of Life Satisfaction as assessed using PROMIS Parent Proxy Item Bank v1.0 - Life Satisfaction - Short Form 8a
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Drew Barzman, MD
Phone
(513) 636-0807
Email
drew.barzman@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Combs, MSSA
Phone
(513) 803-0007
Email
jennifer.combs@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drew Barzman, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwell Health
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Fornari, MD
Phone
718-470-3510
Email
vfornari@northwell.edu
First Name & Middle Initial & Last Name & Degree
Victor Fornari, MD
First Name & Middle Initial & Last Name & Degree
Vera Feuer, MD
Facility Name
Cincinnati Children's Hospital and Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Drew Barzman, MD
Phone
513-636-0807
Email
drew.barzman@cchmc.org
First Name & Middle Initial & Last Name & Degree
Jennifer Combs, MSSA
Phone
513-803-0007
Email
jennifer.combs@cchmc.org
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Bridge, PhD
Phone
614-722-3066
Email
jeff.bridge@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Jeffrey Bridge, PhD
First Name & Middle Initial & Last Name & Degree
David Axelson, MD
Facility Name
UT Southwestern Medical Center/Children's Health
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Graham Emslie, MD
Phone
844-424-4537
Email
graham.emslie@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Graham Emslie, MD
First Name & Middle Initial & Last Name & Degree
Beth Kennard, PsyD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.cdc.gov/injury/wisqars/index.html
Description
CDC, Web-based Injury Statistics Query and Reporting System

Learn more about this trial

Suicide Treatment Alternatives for Teens

We'll reach out to this number within 24 hrs