Information DisseminationNCT07350161
Implementation of a Caregiver-Report Suicide-Risk Screener in Children Under Age 8 in a Behavioral Health Center
A study testing SITB information in people with Information Dissemination, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This project addresses the pressing need for tools to identify suicidal thoughts and behaviors in children aged 4-7. Although young children can experience STBs, current screening tools and guidelines often overlook this age group, partly due to challenges in directly assessing young children. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Information Dissemination
- What is being tested?
- SITB information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2025to 30 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- licensed mental health clinician (e.g., LPC, LMSW, LCSW, MD) in the Hermann Center
- provides care to children 4-7 years of age
- provides care through the Early Child Intervention, Early Psychiatric Care, or Trauma Response program
- must be currently seeing and/or accepting new patients
Who cannot join
- none
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
Washington University School of Medicine
St Louis, Missouri, 63110
Laura Hennefield Hennefield, PhD, 314-286-2705, lhennefield@wustl.edu
About this study
Official title: Implementation of a Caregiver-Report Suicide-Risk Screener in Children Under Age 8 in a Behavioral Health Center: A Pilot Study
This project addresses the pressing need for tools to identify suicidal thoughts and behaviors in children aged 4-7. Although young children can experience STBs, current screening tools and guidelines often overlook this age group, partly due to challenges in directly assessing young children. The investigators developed a promising caregiver-report screener that identified at-risk children. This study will evaluate the screener's feasibility and effectiveness in clinical settings, gather feedback from clinicians and caregivers, and refine the screening process. The goal is to facilitate early intervention, improving mental health care and outcomes for young children.
Read the detailed description
This project aims to evaluate the feasibility, acceptability, and efficacy of a caregiver-report suicide risk (STB) screening tool for children under age 8. Despite the rising rates of STBs in young children, tools for identifying at-risk individuals in this age group are limited, and significant resistance remains to screening children for STBs. Given the challenges in directly assessing young children and the lack of validated tools, the investigators developed a caregiver-report screener to detect early signs of STBs. Preliminary data indicate that this screener is both sensitive and specific, showing promise in identifying at-risk children. The proposed study will evaluate the implementation of this screener in a child behavioral health clinic, obtaining qualitative and quantitative feedback from both clinicians and caregivers to refine the screener and its integration into clinical workflows. Additionally, the investigators will assess how clinicians use the screener results in diagnostic and treatment planning. This study will provide critical insights into barriers and best practices for STB screening in young children, ultimately improving early identification and clinical care for at-risk youth.
- Conditions
- Information Dissemination
- Being tested
- SITB information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SITB informationOther
childhood SITB information
| Study group | Role | What they receive |
|---|---|---|
| information group | Experimental | receives additional information about childhood SITBs Receives: Other: SITB information |
| no information group | No intervention | does not receive additional information about childhood SITBs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician report of SITB screen acceptability
Interview data from clinicians will be qualitatively analyzed to identify patterns in feedback related to acceptability of the screen.
Measured: From time of intervention until the follow-up interviews 3-4 months later.
Secondary outcomes (2)
Clinician report of hesitancies regarding use of SITB screen
Interview data from clinicians will be qualitatively analyzed to identify patterns in feedback related to hesitancies with including the screen in the intake packet.
Measured: From time of intervention until the follow-up interviews 3-4 months later.
Clinicians' incorporation of SITB Screen in Child Treatment Plans
Interview data from clinicians will be qualitatively analyzed to identify patterns in feedback related clinician's incorporation of the SITB screen results into their treatment plans.
Measured: From time of intervention until the follow-up interviews 3-4 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start26 Dec 2025
- Primary completionSep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Information DisseminationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350161
- Sponsor's protocol ID
- 202501012
- Other IDs
- UL1TR002345
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a very small pilot study with minimal resources for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Caregiver-Report Suicide-Risk Screener in Children Under Age 8 in a Behavioral Health Center: A Pilot Study
- ClinicalTrials.gov ID
- NCT07350161
- Acronym / sponsor ID
- 202501012
- Conditions
- Information Dissemination
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Jan 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.
This project addresses the pressing need for tools to identify suicidal thoughts and behaviors in children aged 4-7. Although young children can experience STBs, current screening tools and guidelines often overlook this age group, partly due to challenges in directly assessing young children. The investigators developed a promising caregiver-report screener that identified at-risk children. This study will evaluate the screener's feasibility and effectiveness in clinical settings, gather feedback from clinicians and caregivers, and refine the screening process. The goal is to facilitate early intervention, improving mental health care and outcomes for young children.
Detailed description
This project aims to evaluate the feasibility, acceptability, and efficacy of a caregiver-report suicide risk (STB) screening tool for children under age 8. Despite the rising rates of STBs in young children, tools for identifying at-risk individuals in this age group are limited, and significant resistance remains to screening children for STBs. Given the challenges in directly assessing young children and the lack of validated tools, the investigators developed a caregiver-report screener to detect early signs of STBs. Preliminary data indicate that this screener is both sensitive and specific, showing promise in identifying at-risk children. The proposed study will evaluate the implementation of this screener in a child behavioral health clinic, obtaining qualitative and quantitative feedback from both clinicians and caregivers to refine the screener and its integration into clinical workflows. Additionally, the investigators will assess how clinicians use the screener results in diagnostic and treatment planning. This study will provide critical insights into barriers and best practices for STB screening in young children, ultimately improving early identification and clinical care for at-risk youth.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| information group | Experimental | Other: SITB informationreceives additional information about childhood SITBs |
| no information group | No intervention | –does not receive additional information about childhood SITBs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- licensed mental health clinician (e.g., LPC, LMSW, LCSW, MD) in the Hermann Center
- provides care to children 4-7 years of age
- provides care through the Early Child Intervention, Early Psychiatric Care, or Trauma Response program
- must be currently seeing and/or accepting new patients
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| SITB informationchildhood SITB information | Other | information group |
Primary outcome
Clinician report of SITB screen acceptability
Time frame: From time of intervention until the follow-up interviews 3-4 months later.
Interview data from clinicians will be qualitatively analyzed to identify patterns in feedback related to acceptability of the screen.
2 secondary outcomes
Clinician report of hesitancies regarding use of SITB screen
Time frame: From time of intervention until the follow-up interviews 3-4 months later.
Clinicians' incorporation of SITB Screen in Child Treatment Plans
Time frame: From time of intervention until the follow-up interviews 3-4 months later.
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 20 Jan 2026.
- Individual participant dataSharing planned: No. This is a very small pilot study with minimal resources for data sharing.
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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 SITB information in people with Information Dissemination, run by Washington University School of Medicine 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 4 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 20 Jan 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician report of SITB screen acceptability (time frame: From time of intervention until the follow-up interviews 3-4 months later.). 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 20 Jan 2026.