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

NCT ID: NCT04625686

Last Updated: 2025-01-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Suicidal Ideation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Inpatient Treatment

Inpatient psychiatric treatment

Mental Health Treatment

Intervention Type BEHAVIORAL

Treatment of suicidal ideation

OCIC Treatment

In-person outpatient crisis intervention

Mental Health Treatment

Intervention Type BEHAVIORAL

Treatment of suicidal ideation

Telehealth Therapy Treatment

Virtual outpatient therapy

Mental Health Treatment

Intervention Type BEHAVIORAL

Treatment of suicidal ideation

No Show Group

Participant who do not attend recommended treatment

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mental Health Treatment

Treatment of suicidal ideation

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northwell Health

Queens, New York, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND
PMID: 27111185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28771461 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18093032 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40922794 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-0686

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.