Recruiting

Parent Navigator Program

Sponsor:

Children's Hospital Los Angeles

Code:

NCT07023367

Conditions

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Parent Navigator Program

Standard of Care

Study Details

Brief summary:

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

Conditions

Congenital Heart Disease

Study ID

NCT07023367

Start date

Oct 1, 2025

Status verified date

Jun, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Parent Navigator Program

active comparator: Standard of Care

Interventions

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.

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.

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 ]
  • Group comparison of neurodevelopmental outcomes measured by the Bayley Scales of Infant and Toddler Development [ Time Frame: Baseline to 6 months ]
  • Average parental stress score over 6 months measured by the Parental Stress Scale [ Time Frame: Baseline to 6 months ]

Central Contacts and Locations

Central contacts

Emma Salmon, BS

323-361-5103esalmon@chla.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Emma Salmon, BS

323-361-5103esalmon@chla.usc.edu

Principal Investigator:

Nhu Tran, PhD, RN

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Sep 12, 2025

Last verified

Jun, 2025

Keywords

  • Congenital Heart Disease
  • Parent Navigator Program
  • Latino/x Children
  • High-Risk Infant Follow-up (HRIF)
  • Early Intervention (EI)
  • Neurodevelopmental Outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2025-09-12.