NCT07350161

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Dec 2025Sep 2026

Study Start

First participant enrolled

December 26, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

January 13, 2026

Last Update Submit

January 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    From time of intervention until the follow-up interviews 3-4 months later.

  • Clinicians' incorporation of SITB Screen in Child Treatment Plans

    From time of intervention until the follow-up interviews 3-4 months later.

Study Arms (2)

information group

EXPERIMENTAL

receives additional information about childhood SITBs

Other: SITB information

no information group

NO INTERVENTION

does not receive additional information about childhood SITBs

Interventions

childhood SITB information

information group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 20, 2026

Study Start

December 26, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

This is a very small pilot study with minimal resources for data sharing.

Locations