Parent Navigator Program for Congenital Heart Disease

Overseen By Emma Salmon, BS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Major genetic syndrome, Brain lesion, End of life care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Parent Navigator Program helps Latino/x parents of babies with congenital heart disease (CHD) access essential follow-up services. Researchers seek to assess whether this program improves children's development and reduces parental stress compared to usual care. Participants will either join the Parent Navigator group or receive standard care, completing surveys and assessments at birth and six months later. The trial seeks Latino/x families with newborns diagnosed with CHD who require early medical intervention.

As an unphased trial, this study offers families the opportunity to contribute to research that could enhance support systems for parents and children facing CHD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing support through a Parent Navigator Program rather than changing medical treatments.

What prior data suggests that the Parent Navigator Program is safe for families?

Research has shown that families generally have a positive experience with the Parent Navigator Program (PNP). No reports have indicated negative effects from participating in this program. The PNP supports parents through regular phone calls and interviews, which are safe and simple activities. This trial does not follow the usual clinical trial phases, indicating very low health risks. The program helps parents find the services their children need for development, minimizing safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parent Navigator Program for congenital heart disease because it aims to provide personalized support to parents navigating their child's complex medical journey. Unlike standard care, which primarily focuses on direct medical interventions for the child, this program emphasizes emotional and informational support for parents, helping them manage stress and make informed decisions. By empowering parents, the program has the potential to improve overall family well-being and possibly enhance outcomes for the child as well.

What evidence suggests that the Parent Navigator Program is effective for connecting Latino/x parents of babies with congenital heart disease to developmental follow-up services?

This trial will compare the Parent Navigator Program (PNP) with the standard of care. Studies have shown that programs like the PNP effectively help parents access important follow-up services. Research indicates that these programs improve access to services for infants at high risk and early intervention services. Initial findings suggest that when parents connect more with these services, their children often experience better brain development. Evidence also shows that similar support programs can reduce parental stress by providing guidance and resources during challenging times. Overall, these programs aim to enhance both family support and child health outcomes. ^{1 2 3 5 6}

Who Is on the Research Team?

Nhu Tran, PhD, RN

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for Latino/x infants with congenital heart disease needing medical or surgical intervention before they are 30 days old. It aims to help their parents connect with developmental services and reduce stress.

Inclusion Criteria

I identify as Latino/x.

My infant needed heart surgery or treatment within the first 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo developmental assessments and surveys at the newborn stage

1 week

1 visit (in-person)

Intervention

Participants in the Parent Navigator group receive weekly phone calls with the parent navigator

24 weeks

Weekly phone calls

Follow-up Assessment

Participants complete developmental assessments and surveys at 6 months

1 week

1 visit (in-person)

Follow-up

Participants are monitored for connection to High-Risk Infant Follow-Up and Early Intervention services

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Parent Navigator Program

Trial Overview The study tests if a Parent Navigator Program (PNP) can better connect families to follow-up services, improve children's neurodevelopmental outcomes, and decrease parental stress compared to standard care.

How Is the Trial Designed?

Group I: Parent Navigator Program Experimental Treatment 1 Intervention

Group II: Standard of Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07023367

Parent Navigator Program (PNP) to Improve Outcomes in ... 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 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/ee1515469561d76e/nct07023367-parent-navigator-program-latino-children-parents

Parent Navigator Program (PNP) to Improve Outcomes in ... 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 ...

3. trialx.com trialx.com/clinical-trials/listings/307681/parent-navigator-program-pnp-to-improve-outcomes-in-latinox-children-and-parents/

Parent Navigator Program (PNP) to Improve Outcomes in ... 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 ...

4. withpower.com withpower.com/trial/phase-heart-defects-congenital-6-2025-0edf0

Parent Navigator Program for Congenital Heart Disease 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) ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10732467/

Nurse-guided Mobile Health Care Program to Reduce ... Findings suggest that a nurse-guided mHealth approach is feasible and may contribute to a clinically important reduction in parents' emotional distress.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6507180/

Public Health Approach to Improve Outcomes for ... The CHD framework is a public health model for addressing disease at the population level, which emphasizes monitoring, interventions, and optimizing outcomes.