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NCT07054554 · ClinicalTrials.gov registry record · NA

Engaging Mental Health Services for Preschoolers at Risk

A NA study of Mental Health Disorder and Family Navigation, sponsored by Children's Hospital Medical Center, Cincinnati.

Recruiting
Registry status
NA
Development phase
106
Enrollment target
1
Study location

NCT07054554 is a NA study of Mental Health Disorder and Family Navigation that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 106 participants, below the 268-participant average among 16 other Mental Health Disorder trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07054554, a NA study of Mental Health Disorder and Family Navigation, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.

RECRUITING
Registry status
NA
Development phase
106 participants
Enrollment target
1
Study location

Study Summary

Most mental health (MH) disorders develop in early childhood but are not clinically identified or treated until later-delaying treatment services that could prevent the enduring effects of long-term MH problems. Moreover, low income, ethno-racial minoritized children who exhibit higher rates of persistent MH disorders, are at greater risk for lags in identification and treatment. Head Start (HStart) has shown early school success for low-income children, aged 3-5 years, who are disproportionately Black or Latinx. HStart monitors early childhood MH symptoms, yet studies have found that when detected, only those most impaired are referred for treatment. In our research, the investigators learned that system and individual level barriers preclude early treatment among HStart preschoolers with developmental concern. The investigators showed that caregivers encountered system barriers of HStart teachers and primary care providers (PCPs) falling behind in referrals for intervention, and caregiver beliefs about stigma, their limited knowledge and distrust of healthcare hindered early engagement in services. Studies on MH treatment obstacles for low-income, ethno-racial minoritized people illustrate similar barriers to those found among HStart preschoolers with developmental concern. We developed and tested an ethno-racially matched, peer-based family navigator program for HStart preschoolers with developmental concern. Navigators used trust and empowerment to increase caregiver advocacy thereby leading to improved professional alliances and treatment. A navigator program for those with primary MH concerns has not been trialed. For Aim 1, the investigators aim to tailor and trial in a case series the Navigate-Train-Referral-Intervention Mental Health (NTRI-MH) intervention to promote access, engagement, coordination, and optimization of services for preschoolers with MH symptoms. The investigators have used focus group feedback from caregiver, navigator, HStart teacher, and

Interventions

  • OTHER NTRI-MH

Study Locations (1)

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2025-07-01
Est. Completion 2027-07-31
Phase NA

What the Registry Record Tells You About NCT07054554

The ClinicalTrials.gov registry entry for NCT07054554 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 268-participant average among 16 other Mental Health Disorder trials with a reported enrollment target (60% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Mental Health Disorder appearing as the primary indexed condition, and to 1 intervention - of which NTRI-MH is the first listed.

NCT07054554 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT07054554 about?

NCT07054554 is a clinical study titled "Engaging Mental Health Services for Preschoolers at Risk". Most mental health (MH) disorders develop in early childhood but are not clinically identified or treated until later-delaying treatment services that could prevent the enduring effects of long-term MH problems. Moreover, low income, ethno-racial minoritized children who exhibit higher rates of pers...

What is the current status of trial NCT07054554?

This trial is currently recruiting. It is a NA study. The enrollment target is 106 participants. The study started on 2025-07-01. Estimated completion is 2027-07-31.

What conditions does trial NCT07054554 study?

This clinical trial studies the following conditions: Mental Health Disorder, Family Navigation, Minoritized Population, Preschool Age Children.

What interventions are being tested in trial NCT07054554?

The interventions under investigation include: NTRI-MH (OTHER).

Who is sponsoring clinical trial NCT07054554?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07054554 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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