NCT07411300

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Jan 2026Aug 2026

Study Start

First participant enrolled

January 26, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

February 13, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

January 29, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

pediatricrandomizedcaregiverssuicideemergency department

Outcome Measures

Primary Outcomes (1)

  • ED Return Visits

    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 Outcomes (2)

  • Intervention Acceptability

    90 Days follow-up

  • Study feasibility

    Baseline

Study Arms (3)

Telephone Calls

EXPERIMENTAL

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

Standard Treatment

NO INTERVENTION

The caregiver receives the standard follow-up protocol once the patient has been discharged from the Emergency Department.

Automatic MyChart Messages

EXPERIMENTAL

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

Interventions

Telephone CallsBEHAVIORAL

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.

Telephone Calls

Parents/guardians receive automatic MyChart messages within 72 hours of ED discharge, then the family receives weekly messages until 60-days post-discharge.

Automatic MyChart Messages

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60640, United States

RECRUITING

MeSH Terms

Conditions

SuicideEmergencies

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Amanda Burnside, PhD

CONTACT

Danielle Cory, MENG

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The investigators are comparing three parent/guardian/caregiver follow-up modalities to support families with a youth discharging from the ED who has experienced suicidal thoughts or behaviors. Caregivers may be randomized to receive automatic MyChart messages that provide educational content and support around utilizing safety plans and restricting lethal means as well as the importance of connecting to follow-up care. Caregivers may be randomized to a series of telephone calls from a psychiatric social worker. Caregivers may be randomized to standard of care (standard procedures for a patient being discharged from our ED, no intervention).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Principal Investigator, Pediatric Psychologist

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 13, 2026

Study Start

January 26, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

February 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations