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CompletedNCT06616701Updated Jul 25, 2025

The Impact of Routine Follow-up Contacts After a Pediatric ED Visit for Youth With Suicide Risk

An interventional study of Follow up call in Suicidal Ideation, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 8 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-07-25.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Nov 2023, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
401
Allocation
Randomized
Ages
8 Years to 21 Years
Sex
All
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Study 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. To formalize a mental health follow up protocol that assists youths with engagement of mental health services after a hospital visit.
  2. To evaluate and standardize the optimal timing for the follow up phone calls.
  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. To assess the proportion of patients with suicide risk who have repeat ED visits within 3 and 6 months.

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. The secondary outcome will involve repeat ED visits within 3 and 6 months.

Read the detailed description

The month following an ED discharge is a high-risk period for suicide for patients recovering from a suicide attempt and/or experiencing suicidal ideation, making referrals and follow up critically important. Very few hospital systems, if any, have been able to implement policies and practices that ensure patients at risk for suicide are getting the follow up care they need. Patient navigator interventions have demonstrated success in improving health outcomes across a range of conditions including mental health, and moreover, they have been effective in providing practical support and encouragement to aid patients in accessing community mental health services. Navigators are trained and supervised frontline public health personnel who are hired from the same communities as patients and aid patients in accessing health care and social services. They have shared experiences and nuanced understanding of the communities they serve to help facilitate developing rapport and trust with families, which can help mitigate health care inequities. To the investigator's knowledge, there are no published studies that have evaluated the implementation of patient navigators in the pediatric ED to help caregivers of suicidal youths access community mental health resources after an ED visit.

In the pediatric ED at Johns Hopkins, an ad hoc clinical initiative led by social work (SW) was started in September 2022 with efforts focused on following up with caregivers of patients with mental health emergencies who are discharged from the hospital. SW staff have been calling caregivers a few days after an ED visit or hospitalization to assist with barriers such as challenges in connecting with community mental health resources and accessing prescribed medications.

For this research, this follow up program will be standardized and consistent data collection will be implemented. A randomized controlled trial will be conducted to evaluate the efficacy of this intervention. If the results are promising, evaluation of this program would provide preliminary data for a future study for implementation of a patient navigation program to improve mental health service engagement for youths with suicide risk who are discharged from the pediatric ED.

02

Conditions studied

  • Suicidal Ideation

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Keywords

  • Suicidal thoughts
  • Suicidal behaviors
  • Suicidal risk
03

In context

Suicidal Ideation

515 studies on the registry are indexed under Suicidal Ideation; 195 are open to participants now.

This study's enrollment of 401 is above the median of 80 across 426 interventional studies indexed under Suicidal Ideation.

Browse Suicidal Ideation studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
401 participants (actual)

Study arms

  • Experimental
    Follow up call within 5 days

    Follow up call within 5 days

    Behavioral: Follow up call

  • No intervention
    Follow up call within 10 days

    Follow up call within 10 days

Interventions

  • BehavioralFollow up call

    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.

06

What researchers measure

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.

    Time frame: From enrollment up to 6 months

Secondary outcomes

  1. Emergency department revisits

    The secondary outcome will involve repeat ED visits within 3 and 6 months.

    Time frame: From enrollment up to 6 months

07

Study locations

1 site
  • Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06616701
Lead sponsor
Johns Hopkins University
Responsible party
Sponsor
First posted
Sep 27, 2024
Start date
Nov 20, 2023
Primary completion
Nov 20, 2024
Completion
May 20, 2025
Last update
Jul 25, 2025

Study contacts

Hanae Fujii-Rios, MD MPH
principal investigator · Johns Hopkins University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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