Clinical trial NCT04625686: Observational Study to Compare Outcomes of Different Psychiatric Treatment of Suicidal Adolescents
Official title: A Multi-Site, Non-Interventional Study to Compare the Outcomes of Psychiatric Treatment of Suicidal Adolescents in Different Treatment Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicidal Ideation
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-11-12
Enrollment: 249
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents experiencing suicidal ideation and require a higher level of care.

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.

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.

Primary outcomes:
measure: Number of Recurrent Suicidal Events Measured by Treatment Arm
timeFrame: 6 Months
Secondary outcomes:
measure: Which Treatment Leads to Better Life Satisfaction
timeFrame: 6 Months
Other outcomes:
measure: Treatment Satisfaction Scores Measured by Treatment Arm
timeFrame: 2 weeks
Locations:
city: Queens
country: United States
facility: Northwell Health
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
References:
citation: Curtin SC, Warner M, Hedegaard H. Increase in Suicide in the United States, 1999-2014. NCHS Data Brief. 2016 Apr;(241):1-8.
citation: 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.
citation: 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.