Parent Navigator Program for Latino/x Children with Congenital Heart Disease
This study is looking at whether a Parent Navigator Program (PNP) can help Latino/x parents of babies with congenital heart disease (CHD) connect with important developmental follow-up services. You might be able to join if your baby is Latino/x, under 30 days old, and has CHD requiring medical or surgical help. The study wants to see if families in the PNP group visit High-Risk Infant Follow-Up (HRIF) clinics and Early Intervention more often, if their children have better neurodevelopmental outcomes, and if parents experience less stress compared to those receiving standard care. The goal is to enroll 40 families.
- Study design
- This is an interventional study with 40 planned participants. It compares a Parent Navigator Program to standard care.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months to measure visits, neurodevelopmental outcomes, and parental stress.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Parent Navigator Program (PNP) to Improve Outcomes in Latino/x Children and Parents
At a glance
Conditions
NCT07023367
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Children's Hospital Los Angeles
Los Angeles, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Nhu Tran, PhD, RN · PRINCIPAL_INVESTIGATOR · Children's Hospital Los Angeles
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Total number of Visits to the High Risk Infant Follow Up clinic and Early Intervention between Parent Navigator Program and Standard of CareBaseline to 6 months
Each group's number of visits to the High Risk Infant Follow Up clinic will be counted using electronic medical record chart abstraction. Each group's number of Early Intervention visits will be counted using the Medical Abstraction Form, a self-report survey developed by the principal investigator that will be completed by parents. Parents will be asked how frequently they see the early interventionist and when the visits started, allowing for a calculation of the total number of visits.
- Group comparison of neurodevelopmental outcomes measured by the Bayley Scales of Infant and Toddler DevelopmentBaseline to 6 months
Each infant in both arms of the study will be evaluated using the Bayley Scales of Infant and Toddler Development - 4th Edition at 6 months of age. Scores in cognitive, language, and motor domains will be obtained. Separate multiple linear regression analyses to examine group association with standard scores in each of the three domains (cognitive, language, and motor). Standard scores on the Bayley Scales of Infant and Toddler Development - 4th Edition are scaled to a metric with a mean of 100 and a standard deviation of 15. Standard scores range from 45 to 155, with 45 corresponding to a score below the 0.1st percentile and 155 corresponding to a score above the 99.9th percentile.
- Average parental stress score over 6 months measured by the Parental Stress ScaleBaseline to 6 months
Each parent in both arms of the study will complete the Parental Stress Scale at the two visits. Repeated measures analysis of variance or mixed model for repeated measures will be used to compare average parental stress between the groups over time. Scores on the Parental Stress Scale range from 18 to 90, with 18 indicating low stress and 90 indicating high stress.