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Clinical Trials/NCT04625686
NCT04625686
Completed
Not Applicable

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

Children's Hospital Medical Center, Cincinnati4 sites in 1 country249 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicidal Ideation
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
249
Locations
4
Primary Endpoint
Number of Recurrent Suicidal Events Measured by Treatment Arm
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
December 15, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Number of Recurrent Suicidal Events Measured by Treatment Arm

Time Frame: 6 Months

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

Secondary Outcomes

  • Which Treatment Leads to Better Life Satisfaction(6 Months)

Study Sites (4)

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