Observational Study to Compare Outcomes of Different Psychiatric Treatment of Suicidal Adolescents

Suicidal Ideation Clinical Trial

— Pre-START  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04625686
• Other study ID #: 2020-0686
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: September 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Jennifer Combs, LISW
• Phone: 513-803-0007
• Email: jennifer.combs[@]cchmc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

Behavioral:
• Mental Health Treatment
Treatment of suicidal ideation

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Northwell Health	Queens	New York

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

QuickStats: Suicide Rates*(,†) 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Which Clinical and Socioeconomic Factors at Baseline May Affect Treatment Outcomes	Which Clinical and Socioeconomic Factors at Baseline May Affect Treatment Outcomes	6 Months
Primary	Which Treatment Leads to a Lower Risk of a Suicidal Event	Observe which treatment leads to a lower risk of a suicidal event	6 Months
Secondary	Which Treatment Leads to Higher Treatment Satisfaction and Higher Satisfaction of Life	Which Treatment Leads to Higher Treatment Satisfaction and Higher Satisfaction of Life	6 Months