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A helping hand for new families: could navigators prevent child maltreatment?

NCT ID NCT04438031

Prevention Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial tests a program called Community Navigation, where trained navigators meet with pregnant women and new mothers to assess family needs and connect them with healthcare and community resources. The program aims to improve maternal and child health, well-being, and development, and to reduce the risk of child maltreatment. Researchers will compare outcomes for families who receive navigation support versus those who do not.

What this could mean

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

Active substance
Community Navigation program (behavioral intervention)
What this could lead to
If effective, this program could reduce child maltreatment and improve maternal and child health, development, and school readiness.
What could go wrong
This is an early-stage trial focused on implementation and impact, so results may not be conclusive or generalizable. Success depends on families engaging with navigators and community services.

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

815 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Jun 2030

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

0 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: 1. Pregnant individuals residing in Durham County, NC who are receiving prenatal care from a Duke University OB/GYN clinic, the Durham County Health Department, or the local Fetal Diagnostic Center. 2. Primary language is English or Spanish 3. Recruited into the study at or before 28 weeks gestation. Exclusion Criteria: * Families residing outside of Durham County * Families that are planning to move out of either county within the next 2 months at the time of recruitment * Families will also be ineligible if the parent has a cognitive impairment that impairs their ability to consent/participate.

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As listed by the trial registrant

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

Prenatal; postnatal

Contacts and locations

Locations

  • Duke University

    Durham, North Carolina, 27708, United States