Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-30 @ 2:07 PM
Study NCT ID:
NCT07023367
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parent Navigator Program (PNP) to Improve Outcomes in Latino/x Children and Parents
Sponsor:
Children's Hospital Los Angeles
Organization:
Study Overview
Official Title:
Parent Navigator Program (PNP) to Improve Outcomes in Latino/x Children and Parents
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: