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Congenital Heart DiseaseNewbornBehavioralChildren's healthBehavioral

What this study is

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

What's being tested

  • Parent Navigator Program

    Intervention · 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

    Intervention · 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.

Study details

Sponsor
Children's Hospital Los Angeles
Conditions
Congenital Heart Disease
Enrolling
40 people
Starts
2025-10-01
Est. completion
2026-06-30
Design
Open-label, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗