- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07350161
Implementation of a Caregiver-Report Suicide-Risk Screener in Children Under Age 8 in a Behavioral Health Center
January 15, 2026 updated by: Washington University School of Medicine
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
St Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Contact:
- Laura Hennefield Hennefield, PhD
- Phone Number: 314-286-2705
- Email: lhennefield@wustl.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: information group
receives additional information about childhood SITBs
|
childhood SITB information
|
|
No Intervention: no information group
does not receive additional information about childhood SITBs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From time of intervention until the follow-up interviews 3-4 months later.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician report of hesitancies regarding use of SITB screen
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 hesitancies with including the screen in the intake packet.
|
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.
|
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.
|
From time of intervention until the follow-up interviews 3-4 months later.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 26, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 30, 2026
Study Registration Dates
First Submitted
January 13, 2026
First Submitted That Met QC Criteria
January 15, 2026
First Posted (Actual)
January 20, 2026
Study Record Updates
Last Update Posted (Actual)
January 20, 2026
Last Update Submitted That Met QC Criteria
January 15, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 202501012
- UL1TR002345 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This is a very small pilot study with minimal resources for data sharing.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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