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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Children's Hospital Los Angeles
Study ID
NCT07023367
Status
Recruiting
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Conditions

  • Congenital Heart Disease

Eligibility Criteria

Sex
ALL
Age
0 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Oct 1, 2025
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Parent Navigator Program
  • Active Comparator: Standard of Care

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Emma Salmon, BS
[email protected]
323-361-5103
Nhu Tran, PhD, RN (PRINCIPAL_INVESTIGATOR)

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By research site
Children's Hospital Los Angeles· Los Angeles, CA

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