Parent Navigator Program (PNP) to Improve Outcomes in Latino/x Children and Parents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parent Navigator Program, Standard of Care.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease. Basic parameters: from 0 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Behavioral 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. - Behavioral 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 measures
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Children's Hospital Los Angeles — Los Angeles
Identifiers
NCT: NCT07023367 · CHLA-25-00190