Suicide Treatment Alternatives for Teens (START)

• ClinicalTrials.gov Identifier: NCT04089254
• Recruitment Status: Active, not recruiting
• First Posted: September 13, 2019
• Last Update Posted: January 26, 2021
• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Children's Hospital Medical Center, Cincinnati

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Suicidal Ideation	Behavioral: Inpatient Psychiatry; Behavioral: Outpatient Crisis Intervention Clinic	Not Applicable

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 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 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 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 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 over 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 90 days and 180 days in comparison to the other patients.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Design
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-Site Study to Compare the Outcomes of Psychiatric Treatment of Suicidal Adolescents in Different Treatment Settings
• Actual Study Start Date: November 4, 2019
• Estimated Primary Completion Date: November 30, 2024
• Estimated Study Completion Date: October 1, 2025

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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).
2. 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.

Secondary Outcome Measures :

1. 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).
2. 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.
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 [ 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.
4. 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.
5. 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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, New York

Northwell Health

Glen Oaks, New York, United States, 11004

United States, Ohio

Cincinnati Children's Hospital and Medical Center

Cincinnati, Ohio, United States, 45229

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

United States, Texas

UT Southwestern Medical Center/Children's Health

Dallas, Texas, United States, 75390

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Drew Barzman, MD; Children's Hospital Medical Center, Cincinnati

More Information

Additional Information:

CDC, Web-based Injury Statistics Query and Reporting System 

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT04089254
• Other Study ID Numbers: PCS-2018C1-11111
• First Posted: September 13, 2019
• Last Update Posted: January 26, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Hospital Medical Center, Cincinnati:

Suicide; Suicidal; Adolescent

Additional relevant MeSH terms:

Suicidal Ideation; Suicide; Self-Injurious Behavior; Behavioral Symptoms