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Can peer navigators get preschoolers the mental health care they need?

NCT ID NCT07054554

Disease control Sponsor: Children's Hospital Medical Center, Cincinnati Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Many young children show signs of mental health problems, but few get evaluated or treated early. This study tests a program called NTRI-MH that trains peer family navigators to help caregivers of Head Start preschoolers find and engage with mental health services. Researchers will first adapt the program with input from families, teachers, and doctors, then run a small pilot with about 106 caregivers to see whether the navigator approach improves access to care and family outcomes compared with standard child behavior training.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a training and navigation program called NTRI-MH that pairs families with peer navigators to connect preschoolers to mental health services
What this could lead to
If it works, this approach could give Head Start families a trusted guide through the mental health system and get young children into care sooner.
What could go wrong
This is an early feasibility and pilot study with a small number of families at two Head Start sites, so it may not show clear benefits or translate to other communities.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 106 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Family Navigators: Having experience working as family navigator and/or community health worker; Latinx, Black or White; \> 18 years old. * Caregivers: current caregiver of a HStart preschooler at-risk for MH disorders (ASQ-SE above threshold score) * Teachers: Current Head Start (HStart) teacher from one of the 2 HStart site;\> 18 years old; Any race/ethnicity. * PCPs: Currently providing primary care for HStart preschool age children at risk for MH disorders; \> 18 years old; Any race/ethnicity. Exclusion Criteria: * Unable to read/speak either English or Spanish.

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Conditions

The condition(s) this trial relates to.

psychiatric disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Family navigation Mental health disorder Minoritized population Preschool age children

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

    Contact Email: •••••@•••••

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