Suicidal IdeationNCT06616701
The Impact of Routine Follow-up Contacts After a Pediatric ED Visit for Youth With Suicide Risk
A study testing Follow up call in people with Suicidal Ideation, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Follow up call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 20 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Routine Follow-up Contacts After a Pediatric ED Visit for Youth With Suicide Risk: a Randomized Controlled Trial
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:
Read more
- To formalize a mental health follow up protocol that assists youths with engagement of mental health services after a hospital visit.
- To evaluate and standardize the optimal timing for the follow up phone calls.
- 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.
- 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.
- Conditions
- Suicidal Ideation
- Being tested
- Follow up call
- Keywords
- Suicidal thoughts, Suicidal behaviors, Suicidal risk
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up callBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Follow up call within 5 days | Experimental | Follow up call within 5 days Receives: Behavioral: Follow up call |
| Follow up call within 10 days | No intervention | Follow up call within 10 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start20 Nov 2023
- Primary completion20 Nov 2024
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanae Fujii-Rios, MD MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616701
- Sponsor's protocol ID
- IRB00396477
- Status last verified
- Jul 2025
- First submitted
- 25 Sep 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Routine Follow-up Contacts After a Pediatric ED Visit for Youth With Suicide Risk: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06616701
- Acronym / sponsor ID
- IRB00396477
- Conditions
- Suicidal Ideation
- Keywords
- Suicidal thoughts, Suicidal behaviors, Suicidal risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To formalize a mental health follow up protocol that assists youths with engagement of mental health services after a hospital visit.
- To evaluate and standardize the optimal timing for the follow up phone calls.
- 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.
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow up call within 5 days | Experimental | Behavioral: Follow up callFollow up call within 5 days |
| Follow up call within 10 days | No intervention | –Follow up call within 10 days |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow up callAs 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. | Behavioural | Follow up call within 5 days |
Primary outcome
Proportion of youths accessing community mental health resources
Time frame: From enrollment up to 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.
1 secondary outcome
Emergency department revisits
Time frame: From enrollment up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanae Fujii-Rios, MD MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow up call in people with Suicidal Ideation, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of youths accessing community mental health resources (time frame: From enrollment up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.