Caregiver ParticipationSCFMHEDVNCT07411300
Supporting Caregivers Following Mental Health Emergency Department Visits
A study testing Telephone Calls and Automatic MyChart Messages in people with Caregiver Participation and Emergency Department Presentation, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Caregiver Participation, Emergency Department Presentation, Safety Plan
- What is being tested?
- Telephone Calls and Automatic MyChart Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60640
Amanda Burnside, PhD, 312-227-2785, aburnside@luriechildrens.org
Danielle Cory, MENG, dcory@luriechildrens.org
About this study
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
- Being tested
- Telephone Calls, Automatic MyChart Messages
- Keywords
- pediatric, randomized, caregivers, suicide, emergency department
- Medical subject headings
- Suicide, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone CallsBehavioural
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.
Automatic MyChart MessagesBehavioural
Parents/guardians receive automatic MyChart messages within 72 hours of ED discharge, then the family receives weekly messages until 60-days post-discharge.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Automatic MyChart Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED Return Visits
Count of return visits to the ED for a mental health chief complaint within 90 days from initial ED encounter
Measured: Between baseline enrollment and 90 day follow-up assessment
Secondary outcomes (2)
Intervention Acceptability
Participant acceptability (using Acceptability of Intervention; AIM measure)
Measured: 90 Days follow-up
Study feasibility
Percentage of eligible and approached patients that consent and are enrolled in the study
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start26 Jan 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver ParticipationStudies of the same condition, open and under way.
- 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
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, Amanda Burnside, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411300
- Sponsor's protocol ID
- STUDY00000386
- Other IDs
- 25-0364
- Acronym
- SCFMHEDV
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Caregivers Following Mental Health Emergency Department Visits
- ClinicalTrials.gov ID
- NCT07411300
- Acronym / sponsor ID
- SCFMHEDV / STUDY00000386
- Keywords
- pediatric, randomized, caregivers, suicide, emergency department
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 13 Feb 2026 (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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Telephone Calls | Experimental | Behavioral: Telephone CallsParents/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. |
| 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 | Behavioral: Automatic MyChart MessagesParents/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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Telephone CallsParents/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. | Behavioural | Telephone Calls |
| Automatic MyChart MessagesParents/guardians receive automatic MyChart messages within 72 hours of ED discharge, then the family receives weekly messages until 60-days post-discharge. | Behavioural | Automatic MyChart Messages |
Primary outcome
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
2 secondary outcomes
Intervention Acceptability
Time frame: 90 Days follow-up
Study feasibility
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Calls and Automatic MyChart Messages in people with Caregiver Participation and Emergency Department Presentation, run by Ann & Robert H Lurie Children's Hospital of Chicago 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Burnside, PhD (312-227-2785, aburnside@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED Return Visits (time frame: Between baseline enrollment and 90 day follow-up assessment). 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 13 Feb 2026.