NCT06616701

Brief Summary

The goal of this clinical trial is to learn if a social work led follow up program helps caregivers of youths with suicide risk access mental health resources. Primary aims include:

  1. 1.To formalize a mental health follow up protocol that assists youths with engagement of mental health services after a hospital visit.
  2. 2.To evaluate and standardize the optimal timing for the follow up phone calls.
  3. 3.To assess the proportion of patients with suicide risk who connect with community mental health care within a month after a pediatric emergency department (ED) visit at Johns Hopkins Hospital.
  4. 4.To assess the proportion of patients with suicide risk who have repeat ED visits within 3 and 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
401

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 20, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

September 25, 2024

Last Update Submit

July 22, 2025

Conditions

Keywords

Suicidal thoughtsSuicidal behaviorsSuicidal risk

Outcome Measures

Primary Outcomes (1)

  • Proportion of youths accessing community mental health resources

    The primary outcome of interest is the proportion of youths referred to a community provider who successfully connect to community mental health resources 5 to 10 business days after an ED visit.

    From enrollment up to 6 months

Secondary Outcomes (1)

  • Emergency department revisits

    From enrollment up to 6 months

Study Arms (2)

Follow up call within 5 days

EXPERIMENTAL

Follow up call within 5 days

Behavioral: Follow up call

Follow up call within 10 days

NO INTERVENTION

Follow up call within 10 days

Interventions

Follow up callBEHAVIORAL

As part of the standard of care, caregivers of youths who present to the hospital with suicidal risk receive a follow up call approximately 5-10 business days after the hospital discharge to assist them with any challenges they may encounter in accessing mental health care, including medication access. The intervention group will receive a call 5 days after discharge. The non-intervention group will receive a call 10 days after discharge.

Follow up call within 5 days

Eligibility Criteria

Age8 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients ages 8 to 21 years old;
  • Who present to the emergency department (ED) and are assessed with suicide risk;
  • Who are discharged from the Johns Hopkins Hospital (Pediatric inpatient psychiatric unit, Pediatric Day Hospital, or Pediatric ED) with a mental health referral

You may not qualify if:

  • Patients who were directly transferred to the inpatient psychiatry unit or the Day Hospital from an outside hospital, bypassing the hospital's ED
  • Direct admissions, bypassing the hospital's ED

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Hanae Fujii-Rios, MD MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2024

First Posted

September 27, 2024

Study Start

November 20, 2023

Primary Completion

November 20, 2024

Study Completion

May 20, 2025

Last Updated

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations