Suicide Treatment Alternatives for Teens (START)

July 3, 2024 updated by: Children's Hospital Medical Center, Cincinnati

A Multi-Site Study to Compare the Outcomes of Psychiatric Treatment of Suicidal Adolescents in Different Treatment Settings

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • Glen Oaks, New York, United States, 11004
        • Recruiting
        • Northwell Health
        • Contact:
        • Principal Investigator:
          • Victor Fornari, MD
        • Principal Investigator:
          • Vera Feuer, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital and Medical Center
        • Contact:
        • Contact:
      • Columbus, Ohio, United States, 43205
        • Recruiting
        • Nationwide Children's Hospital
        • Contact:
        • Principal Investigator:
          • Jeffrey Bridge, PhD
        • Principal Investigator:
          • David Axelson, MD
    • Texas
      • Dallas, Texas, United States, 75390
        • Not yet recruiting
        • UT Southwestern Medical Center/Children's Health
        • Contact:
        • Principal Investigator:
          • Graham Emslie, MD
        • Principal Investigator:
          • Beth Kennard, PsyD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Inpatient Psychiatry
Child and adolescent inpatient treatment
Behavioral: Inpatient Psychiatry
Inpatient hospitalization to treat and stabilize suicidal thoughts and behavior.
Active Comparator: Outpatient Crisis Intervention Clinic
OCIC is outpatient crisis intervention clinic
Behavioral: Outpatient Crisis Intervention Clinic
Outpatient psychiatric clinic that provides crisis intervention to treat and stabilize suicidal thoughts and behavior.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to first recurrence of a suicide event
Time Frame: 180 days
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.
Time Frame: 180 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment Satisfaction as assessed using the Client Satisfaction Questionnaire-Adapted (CSQ).
Time Frame: 180 days
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).
180 days
Demographic factors as assessed using the START demographics form.
Time Frame: 180 days
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.
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
Time Frame: 180 days
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.
180 days
Quality of Life Satisfaction as assessed using the PROMIS Pediatric Item Bank v1.0 - Life Satisfaction - Short Form 4a
Time Frame: 180 days
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.
180 days
Quality of Life Satisfaction as assessed using PROMIS Parent Proxy Item Bank v1.0 - Life Satisfaction - Short Form 8a
Time Frame: 180 days
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.
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital Medical Center, Cincinnati

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Drew Barzman, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCS-2018C1-11111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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