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Observational Study to Compare Outcomes of Different Psychiatric Treatment of Suicidal Adolescents (Pre-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: NCT04625686
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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Brief Summary:
To address the unmet need of optimizing the treatment and management for adolescent suicidality, the investigators propose to evaluate the effectiveness and safety of telehealth services compared to inpatient and OCIC for suicidal adolescents in target population. To achieve this goal, the investigators propose a multi- site study to compare telehealth, OCIC, and inpatient care, and see which 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.

Condition or disease Intervention/treatment
Suicidal Ideation Behavioral: Mental Health Treatment

Detailed Description:
The investigators have proposed an observational design. Eligible individuals will be identified during a crisis assessment, either in the emergency department or during an emergency phone or telehealth assessment. Once the individual has been assessed and assigned to the clinician for treatment, study staff will assess if the patient is appropriate for the study using the study eligibility criteria. Individuals who receive treatment in one of the following treatment arms will be eligible for this observation study: inpatient, in-person OCIC or telehealth crisis intervention service. Eligible individuals will be contacted by study staff to introduce and offer the study. If patient and guardian agree, they will complete surveys at baseline and every 2 weeks for 6 months to evaluate outcomes.
Study Design
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Study Type : Observational
Estimated Enrollment : 244 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Site, Non-Interventional Study to Compare the Outcomes of Psychiatric Treatment of Suicidal Adolescents in Different Treatment Settings
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Groups and Cohorts
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Group/Cohort Intervention/treatment
Inpatient Treatment
Inpatient psychiatric treatment
 Behavioral: Mental Health Treatment
Treatment of suicidal ideation
OCIC Treatment
In-person outpatient crisis intervention
 Behavioral: Mental Health Treatment
Treatment of suicidal ideation
Telehealth Therapy Treatment
Virtual outpatient therapy
 Behavioral: Mental Health Treatment
Treatment of suicidal ideation
No Show Group
Participant who do not attend recommended treatment


Outcome Measures
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Primary Outcome Measures :
  1. Which Treatment Leads to a Lower Risk of a Suicidal Event [ Time Frame: 6 Months ]
    Observe which treatment leads to a lower risk of a suicidal event


Secondary Outcome Measures :
  1. Which Treatment Leads to Higher Treatment Satisfaction and Higher Satisfaction of Life [ Time Frame: 6 Months ]
    Which Treatment Leads to Higher Treatment Satisfaction and Higher Satisfaction of Life


Other Outcome Measures:
  1. Which Clinical and Socioeconomic Factors at Baseline May Affect Treatment Outcomes [ Time Frame: 6 Months ]
    Which Clinical and Socioeconomic Factors at Baseline May Affect Treatment Outcomes


Eligibility Criteria
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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.


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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adolescents experiencing suicidal ideation and require a higher level of care.
Criteria

Inclusion Criteria:

  • Adolescents that are 12 through 18 years old.
  • Adolescents that are brought to the Emergency Department for crisis evaluation due to suicidal thoughts or behaviors.
  • Require a higher level of care.
  • The presence of a legal guardian for consent.
  • 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 who had prior OCIC treatment in the past 12 months.
  • Adolescents without the ability to 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.
Contacts and Locations
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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): NCT04625686


Contacts
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Contact: Jennifer Combs, LISW 513-803-0007 jennifer.combs@cchmc.org
Contact: Rosalie Hemphill, MSW 513-803-0007 rosalie.hemphill@cchmc.org

Locations
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United States, New York
Northwell Health Recruiting
Queens, New York, United States, 11004
Contact: Nandita Mathur       nmathur@northwell.edu   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Jennifer Combs, LISW    513-803-0007    jennifer.combs@cchmc.org   
Contact: Rosalie Hemphill, MSW    (513) 517-7126    rosalie.hemphill@cchmc.org   
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Jaclyn Tissue    614-355-1529    jaclyn.tissue@nationwidechildrens.org   
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Molly Michaels       molly.michaels@utsouthwestern.edu   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Patient-Centered Outcomes Research Institute
More Information
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Publications:

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04625686    
Other Study ID Numbers: 2020-0686
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be de-identified from individual data. Data will only be shared with researchers within the research team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suicidal Ideation
Suicide
Self-Injurious Behavior
Behavioral Symptoms