Parent Navigator Program (PNP) to Improve Outcomes in Latino/x Children and Parents

NCT ID: NCT07023367

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-06-30

Brief Summary

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The goal of this clinical trial is to see if a Parent Navigator Program (PNP) is helpful for Latino/x parents of babies with congenital heart disease (CHD) to get connected to developmental follow-up services. The main question it aims to answer are:

* Do families assigned to the Parent Navigator Program (PNP) have higher rates of connection to High-Risk Infant Follow-Up (HRIF)/Early Intervention (EI) compared to the standard care group 6 months after randomization?
* Do children assigned to the Parent Navigator Program (PNP) have better neurodevelopmental outcomes (NDOs) compared to the standard care group 6 months after randomization?
* Do parents assigned to the Parent Navigator Program (PNP) have decreased parental stress compared to the standard care group?

Researchers will compare the Parent Navigator group to the standard care group to see if parent navigator group is helpful in connecting families to High-Risk Infant Follow-Up (HRIF)/Early Intervention (EI), improving neurodevelopmental outcomes (NDOs), and lowering parental stress.

Participants will:

* Undergo developmental assessments and survey at newborn stage and at 6 months
* Participants randomly assigned to the Parent Navigator group will have weekly (at least) phone calls with the parent navigator
* Participants randomly assigned to the Parent Navigator group will complete a 30-minute phone interview about their experience with the parent navigator program 6 months after random assignment

Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Parent Navigator Program

Group Type EXPERIMENTAL

Parent Navigator Program

Intervention Type BEHAVIORAL

Participants in this group will be connected with a parent with lived experience to help get them obtain developmental follow up services and early intervention.

Standard of Care

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type BEHAVIORAL

The families in the standard care group will have their connections to neurodevelopmental (ND) follow-up and support delivered in the standard fashion which consists of a referral to high-risk infant follow-up (HRIF) by discharge coordinator.

Interventions

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Parent Navigator Program

Participants in this group will be connected with a parent with lived experience to help get them obtain developmental follow up services and early intervention.

Intervention Type BEHAVIORAL

Standard of Care

The families in the standard care group will have their connections to neurodevelopmental (ND) follow-up and support delivered in the standard fashion which consists of a referral to high-risk infant follow-up (HRIF) by discharge coordinator.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Infants born with CHD requiring medical/surgical intervention at less than 30 days of age
* Identify as Latino/x


* Identify as Latino/x

Exclusion Criteria

* Presence of a major genetic syndrome
* Intraventricular hemorrhage or other major structural brain lesion
* Undergoing end of life care

Parents of Latino/x Infants:


* Not fluent in English or Spanish
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Nhu Tran

Assistant Professor of Clinical Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nhu Tran, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emma Salmon, BS

Role: CONTACT

323-361-5103

Facility Contacts

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Emma Salmon, BS

Role: primary

323-361-5103

Other Identifiers

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CHLA-25-00190

Identifier Type: -

Identifier Source: org_study_id

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