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NCT03499405 · ClinicalTrials.gov registry record · NA

Head Start Family Navigator Intervention

A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
NA
Development phase
36
Enrollment target

NCT03499405: Completed NA study, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT03499405 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 36 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03499405, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
NA
Development phase
36 participants
Enrollment target

Study Summary

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.

Primary Outcome

The primary outcome is the proportion of children who complete referrals for developmental testing in the intervention group relative to the control group, with the hypothesis that the FN intervention will increase caregiver completion of referrals and time to completion is less than those in the control group (feasibility).

Interventions

  • BEHAVIORAL Family Navigator Intervention

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2017-08-01
Est. Completion 2018-06-30
Phase NA

What the finished NCT03499405 record still lists

NCT03499405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Family Navigator Intervention is the first listed.

NCT03499405 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03499405 about?

NCT03499405 is a clinical study titled "Head Start Family Navigator Intervention". 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 ...

What is the current status of trial NCT03499405?

This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2017-08-01. Estimated completion is 2018-06-30.

What interventions are being tested in trial NCT03499405?

The interventions under investigation include: Family Navigator Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT03499405?

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

How this trial's enrollment target compares

Where NCT03499405's enrollment target sits among peer trials

36 1541st of 2000 higher than 437 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03499405, the US trial registry maintained by the National Library of Medicine. NCT03499405 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.