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NCT Number: NCT07023367

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

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

Recruiting

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Key information

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location status: Recruiting

Location contact

Emma Salmon, BS

CONTACT

[email protected]

323-361-5103

Nhu Tran, PhD, RN

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Latino/x Infants:

Inclusion criteria

  • Infants born with CHD requiring medical/surgical intervention at less than 30 days of age
  • 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:

Inclusion criteria

  • Identify as Latino/x

Exclusion criteria

  • Not fluent in English or Spanish

Treatment and study plan

Parent Navigator Program

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

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.

Primary outcomes

  1. Total number of Visits to the High Risk Infant Follow Up clinic and Early Intervention between Parent Navigator Program and Standard of Care

    Time frame: Baseline to 6 months

    Each group's number of visits to the High Risk Infant Follow Up clinic will be counted using electronic medical record chart abstraction. Each group's number of Early Intervention visits will be counted using the Medical Abstraction Form, a self-report survey developed by the principal investigator that will be completed by parents. Parents will be asked how frequently they see the early interventionist and when the visits started, allowing for a calculation of the total number of visits.

  2. Group comparison of neurodevelopmental outcomes measured by the Bayley Scales of Infant and Toddler Development

    Time frame: Baseline to 6 months

    Each infant in both arms of the study will be evaluated using the Bayley Scales of Infant and Toddler Development - 4th Edition at 6 months of age. Scores in cognitive, language, and motor domains will be obtained. Separate multiple linear regression analyses to examine group association with standard scores in each of the three domains (cognitive, language, and motor). Standard scores on the Bayley Scales of Infant and Toddler Development - 4th Edition are scaled to a metric with a mean of 100 and a standard deviation of 15. Standard scores range from 45 to 155, with 45 corresponding to a score below the 0.1st percentile and 155 corresponding to a score above the 99.9th percentile.

  3. Average parental stress score over 6 months measured by the Parental Stress Scale

    Time frame: Baseline to 6 months

    Each parent in both arms of the study will complete the Parental Stress Scale at the two visits. Repeated measures analysis of variance or mixed model for repeated measures will be used to compare average parental stress between the groups over time. Scores on the Parental Stress Scale range from 18 to 90, with 18 indicating low stress and 90 indicating high stress.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Salmon, BS

CONTACT

[email protected]

323-361-5103

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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