Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Suicide Treatment Alternatives for Teens (START)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04089254
Recruitment Status : Not yet recruiting
First Posted : September 13, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 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
Estimated Study Start Date : November 4, 2019
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089254


Contacts
Layout table for location contacts
Contact: Drew Barzman, MD (513) 636-0807 drew.barzman@cchmc.org
Contact: Jennifer Combs, MSSA (513) 803-0007 jennifer.combs@cchmc.org

Locations
Layout table for location information
United States, New York
Northwell Health Not yet recruiting
Glen Oaks, New York, United States, 11004
Contact: Victor Fornari, MD    718-470-3510    vfornari@northwell.edu   
Principal Investigator: Victor Fornari, MD         
Principal Investigator: Vera Feuer, MD         
United States, Ohio
Cincinnati Children's Hospital and Medical Center Not yet recruiting
Cincinnati, Ohio, United States, 45229
Contact: Drew Barzman, MD    513-636-0807    drew.barzman@cchmc.org   
Contact: Jennifer Combs, MSSA    513-803-0007    jennifer.combs@cchmc.org   
Nationwide Children's Hospital Not yet recruiting
Columbus, Ohio, United States, 43205
Contact: Jeffrey Bridge, PhD    614-722-3066    jeff.bridge@nationwidechildrens.org   
Principal Investigator: Jeffrey Bridge, PhD         
Principal Investigator: David Axelson, MD         
United States, Texas
UT Southwestern Medical Center/Children's Health Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Graham Emslie, MD    844-424-4537    graham.emslie@utsouthwestern.edu   
Principal Investigator: Graham Emslie, MD         
Principal Investigator: Beth Kennard, PsyD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Patient-Centered Outcomes Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Drew Barzman, MD Children's Hospital Medical Center, Cincinnati

Additional Information:
Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04089254     History of Changes
Other Study ID Numbers: PCS-2018C1-11111
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Suicidal Ideation
Suicide
Self-Injurious Behavior
Behavioral Symptoms