Supporting Caregivers Following Mental Health Emergency Department Visits (SCFMHEDV)

February 11, 2026 updated by: Amanda Burnside, Ann & Robert H Lurie Children's Hospital of Chicago
The investigators plan to conduct a pilot hybrid effectiveness-implementation type 1 randomized controlled trial comparing 3 arms of varying follow-up intervention. Caregivers of youth ages 10-17 who present to the Lurie Children's Hospital ED with suicidal thoughts or behaviors (STBs) and are discharged with a safety plan will be included in the current study. Families will be randomized to receive either 1) treatment as usual, 2) follow-up phone calls, or 3) automatic electronic medical record (EMR) MyChart messages

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants are eligible for participation in the current study if they are parent/guardians of youth ages 10-17 who received a psychiatric evaluation in the ED for suicidal thoughts or behaviors and are being discharged with a safety plan

Exclusion Criteria:

  • Parents/guardians will be excluded from recruitment if the youth is in state custody, if they are not proficient in English or Spanish, if the patient is being admitted or transferred for medical or psychiatric hospital admission, or they are not willing to enroll in MyChart through the EMR. The investigators are also only enrolling one caregiver per patient. In other words, if a patient returns to the ED with a different caregiver, the investigators will not enroll the other caregiver.

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telephone Calls
Parents/guardians are contacted via telephone by a psychiatric social worker within 72 hours of ED discharge, then the family receives weekly phone calls until either they have successfully connected to follow-up mental health services or asks to no longer be contacted. Otherwise phone calls will continue to be made weekly until 60-days post-discharge.
Behavioral: Telephone Calls
Parents/guardians are contacted via telephone by a psychiatric social worker within 72 hours of ED discharge, then the family receives weekly phone calls until either they have successfully connected to follow-up mental health services or asks to no longer be contacted. Otherwise phone calls will continue to be made weekly until 60-days post-discharge.
No Intervention: Standard Treatment
The caregiver receives the standard follow-up protocol once the patient has been discharged from the Emergency Department.
Experimental: Automatic MyChart Messages
Parents/guardians receive automatic MyChart messages that will provide educational content and provide support around utilizing safety plans and restricting lethal means as well as the importance of connecting to follow-up care. These messages are sent within 72 hours of discharge then weekly for the first 60-days post-discharge.
Behavioral: Automatic MyChart Messages
Parents/guardians receive automatic MyChart messages within 72 hours of ED discharge, then the family receives weekly messages until 60-days post-discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ED Return Visits
Time Frame: Between baseline enrollment and 90 day follow-up assessment
Count of return visits to the ED for a mental health chief complaint within 90 days from initial ED encounter
Between baseline enrollment and 90 day follow-up assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Acceptability
Time Frame: 90 Days follow-up
Participant acceptability (using Acceptability of Intervention; AIM measure)
90 Days follow-up
Study feasibility
Time Frame: Baseline
Percentage of eligible and approached patients that consent and are enrolled in the study
Baseline

Collaborators and Investigators

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

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborators

Health Resources and Services Administration (HRSA)

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)

January 26, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000386
  • 25-0364 (Other Grant/Funding Number: Pediatric Pandemic Network Pilot & Emerging Issues Grant)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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