Observational Study to Compare Outcomes of Different Psychiatric Treatment of Suicidal Adolescents (Pre-START)

April 26, 2021 updated by: Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

244

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Inpatient Treatment
Inpatient psychiatric treatment
Behavioral: Mental Health Treatment
Treatment of suicidal ideation
OCIC Treatment
In-person outpatient crisis intervention
Behavioral: Mental Health Treatment
Treatment of suicidal ideation
Telehealth Therapy Treatment
Virtual outpatient therapy
Behavioral: Mental Health Treatment
Treatment of suicidal ideation
No Show Group
Participant who do not attend recommended treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Which Treatment Leads to a Lower Risk of a Suicidal Event
Time Frame: 6 Months
Observe which treatment leads to a lower risk of a suicidal event
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Which Treatment Leads to Higher Treatment Satisfaction and Higher Satisfaction of Life
Time Frame: 6 Months
Which Treatment Leads to Higher Treatment Satisfaction and Higher Satisfaction of Life
6 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Which Clinical and Socioeconomic Factors at Baseline May Affect Treatment Outcomes
Time Frame: 6 Months
Which Clinical and Socioeconomic Factors at Baseline May Affect Treatment Outcomes
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Patient-Centered Outcomes Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

November 6, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0686 (Other Identifier: M D Anderson Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Suicidal Ideation

Clinical Trials on Mental Health Treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe