Congenital Heart DiseaseNCT07023367
Parent Navigator Program (PNP) to Improve Outcomes in Latino/x Children and Parents
A study testing Parent Navigator Program in people with Congenital Heart Disease, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Parent Navigator Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants born with CHD requiring medical/surgical intervention at less than 30 days of age
- Identify as Latino/x
- Identify as Latino/x
Who cannot join
- Presence of a major genetic syndrome
- Intraventricular hemorrhage or other major structural brain lesion
- Undergoing end of life care
- Parents of Latino/x Infants:
- Not fluent in English or Spanish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Emma Salmon, BS, 323-361-5103, esalmon@chla.usc.edu
Nhu Tran, PhD, RN
About this study
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?
Read more
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
- Conditions
- Congenital Heart Disease
- Being tested
- Parent Navigator Program, Standard of Care
- Keywords
- Congenital Heart Disease, Parent Navigator Program, Latino/x Children, High-Risk Infant Follow-up (HRIF), Early Intervention (EI), Neurodevelopmental Outcomes
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Navigator ProgramBehavioural
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.
Standard of CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parent Navigator Program | Experimental | Not described Receives: Behavioral: Parent Navigator Program |
| Standard of Care | Active comparator | Not described Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of Visits to the High Risk Infant Follow Up clinic and Early Intervention between Parent Navigator Program and Standard of Care
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.
Measured: Baseline to 6 months
Group comparison of neurodevelopmental outcomes measured by the Bayley Scales of Infant and Toddler Development
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.
Measured: Baseline to 6 months
Average parental stress score over 6 months measured by the Parental Stress Scale
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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nhu Tran, Children's Hospital Los Angeles
- Investigators
- Nhu Tran, PhD, RN, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023367
- Sponsor's protocol ID
- CHLA-25-00190
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Navigator Program (PNP) to Improve Outcomes in Latino/x Children and Parents
- ClinicalTrials.gov ID
- NCT07023367
- Acronym / sponsor ID
- CHLA-25-00190
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Navigator Program | Experimental | Behavioral: Parent Navigator Program |
| Standard of Care | Active comparator | Behavioral: Standard of Care |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Infants born with CHD requiring medical/surgical intervention at less than 30 days of age
- Identify as Latino/x
- Identify as Latino/x
Key exclusion criteria (5 listed)
- Presence of a major genetic syndrome
- Intraventricular hemorrhage or other major structural brain lesion
- Undergoing end of life care
- Not fluent in English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent Navigator ProgramParticipants in this group will be connected with a parent with lived experience to help get them obtain developmental follow up services and early intervention. | Behavioural | Parent Navigator Program |
| Standard of CareThe 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. | Behavioural | Standard of Care |
Primary outcome
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
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 Development
Time frame: Baseline 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 Scale
Time frame: Baseline 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nhu Tran, PhD, RN principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Navigator Program in people with Congenital Heart Disease, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Salmon, BS (323-361-5103, esalmon@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.