Clinical trial NCT07023367: Parent Navigator Program (PNP) to Improve Outcomes in Latino/x Children and Parents
Official title: Parent Navigator Program (PNP) to Improve Outcomes in Latino/x Children and Parents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Keywords: Congenital Heart Disease
Parent Navigator Program
Latino/x Children
High-Risk Infant Follow-up (HRIF)
Early Intervention (EI)
Neurodevelopmental Outcomes
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility 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

Primary outcomes:
measure: Total number of Visits to the High Risk Infant Follow Up clinic and Early Intervention between Parent Navigator Program and Standard of Care
timeFrame: Baseline to 6 months
measure: Group comparison of neurodevelopmental outcomes measured by the Bayley Scales of Infant and Toddler Development
timeFrame: Baseline to 6 months
measure: Average parental stress score over 6 months measured by the Parental Stress Scale
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Nhu Tran, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: