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

Children's Hospital Los Angeles

Status: Enrolling

Conditions: Congenital Heart Disease

Treatments: Behavioral: Parent Navigator Program; Behavioral: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07023367

CHLA-25-00190

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Parent Navigator Program

Experimental group

Treatment:

Behavioral: Parent Navigator Program

Standard of Care

Active Comparator group

Treatment:

Behavioral: Standard of Care