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Completed Not applicable Interventional

Head Start Family Navigator Intervention

ClinicalTrials.gov ID: NCT03499405

Public ClinicalTrials.gov record NCT03499405. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 7:06 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

CIN001-HeadStart Navigator Intervention

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Headstart (HS) is an early childhood education program for low-income children. Preliminary analyses of Hamilton County HS preschoolers with developmental concerns identified 26% with "severe concern" necessitating developmental testing, and only 47% followed-through when some developmental concern was identified. Those less likely to follow-through were African American or Hispanic, lived in larger families, or had asthma. Cultural and economic factors are known barriers to earlier diagnosis of children with developmental disabilities (DD) among African American, Hispanic and low-income children. Given that HS children are low-income and culturally diverse, preschoolers are likely to face barriers to early identification of DD and subsequently kindergarten readiness. Patient navigator programs are effective interventions for vulnerable populations to improve health care access, increase treatment adherence, enhance trust in health care systems, and reduce health care costs. A family (FN) intervention that is culturally-adapted to promote caregiver follow-through, and undergirded by HS's mission of kindergarten success may effectively increase caregiver adherence to developmental testing. The goal of this study is to develop and pilot test a FN intervention in HS that is executed by peer-to-peer navigators to improve adherence with developmental testing in high-risk preschoolers.

Study identification

NCT ID
NCT03499405
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
36 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
3 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2017
Primary completion
Jun 29, 2018
Completion
Jun 29, 2018
Last update posted
Jul 23, 2018

2017 – 2018

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Cincinnati Childrens Hospital Medical Center Cincinnati Ohio 45229

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03499405, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 23, 2018 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03499405 live on ClinicalTrials.gov.

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