NCT04625686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

January 27, 2025

Completed
Last Updated

January 27, 2025

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

November 6, 2020

Results QC Date

June 1, 2023

Last Update Submit

December 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Recurrent Suicidal Events Measured by Treatment Arm

    Compare the number of recurrent suicidal event across three treatment groups. Suicidal events were measured by hospitalizations during the study time frame in analysis.

    6 Months

Secondary Outcomes (1)

  • Which Treatment Leads to Better Life Satisfaction

    6 Months

Other Outcomes (1)

  • Treatment Satisfaction Scores Measured by Treatment Arm

    2 weeks

Study Arms (4)

Inpatient Treatment

Inpatient psychiatric treatment

Behavioral: Mental Health Treatment

OCIC Treatment

In-person outpatient crisis intervention

Behavioral: Mental Health Treatment

Telehealth Therapy Treatment

Virtual outpatient therapy

Behavioral: Mental Health Treatment

No Show Group

Participant who do not attend recommended treatment

Interventions

Treatment of suicidal ideation

Inpatient TreatmentOCIC TreatmentTelehealth Therapy Treatment

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescents experiencing suicidal ideation and require a higher level of care.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Northwell Health

Queens, New York, 11004, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (4)

  • Curtin SC, Warner M, Hedegaard H. Increase in Suicide in the United States, 1999-2014. NCHS Data Brief. 2016 Apr;(241):1-8.

    PMID: 27111185BACKGROUND
  • QuickStats: Suicide Rates*,dagger for Teens Aged 15-19 Years, by Sex - United States, 1975-2015. MMWR Morb Mortal Wkly Rep. 2017 Aug 4;66(30):816. doi: 10.15585/mmwr.mm6630a6. No abstract available.

    PMID: 28771461BACKGROUND
  • Green J, Jacobs B, Beecham J, Dunn G, Kroll L, Tobias C, Briskman J. Inpatient treatment in child and adolescent psychiatry--a prospective study of health gain and costs. J Child Psychol Psychiatry. 2007 Dec;48(12):1259-67. doi: 10.1111/j.1469-7610.2007.01802.x.

    PMID: 18093032BACKGROUND
  • Combs J, Lin PI, DelBello MP, Carle AC, Bridge JA, Axelson DA, Fornari V, Feuer V, Emslie GJ, Kennard BD, Porter SC, Sorter MT, Barzman D. Examining Alternative Treatment Settings for Adolescents With Suicidal Thoughts During the COVID-19 Pandemic. JAACAP Open. 2024 Nov 8;3(3):567-575. doi: 10.1016/j.jaacop.2024.10.005. eCollection 2025 Sep.

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Limitations and Caveats

This study is an observational study, which is limited in comparison to an interventional study.

Results Point of Contact

Title
Rosalie Hemphill LSW
Organization
Cincinnati Children's Hospital Medical Center

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 12, 2020

Study Start

October 1, 2020

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

January 27, 2025

Results First Posted

January 27, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

All data will be de-identified from individual data. Data will only be shared with researchers within the research team.

Locations