Parent Navigator Program (PNP) to Improve Outcomes in Latino/x Children and Parents

Обзор

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

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Total number of Visits to the High Risk Infant Follow Up clinic and Early Intervention between Parent Navigator Program and Standard of Care [Срок оценки: Baseline to 6 months]
• Group comparison of neurodevelopmental outcomes measured by the Bayley Scales of Infant and Toddler Development [Срок оценки: Baseline to 6 months]
• Average parental stress score over 6 months measured by the Parental Stress Scale [Срок оценки: Baseline to 6 months]

Критерии участия

Latino/x Infants:

Критерии включения

• Infants born with CHD requiring medical/surgical intervention at less than 30 days of age
• Identify as Latino/x

Критерии исключения

• Presence of a major genetic syndrome
• Intraventricular hemorrhage or other major structural brain lesion
• Undergoing end of life care

Parents of Latino/x Infants:

Критерии включения

• Identify as Latino/x

Критерии исключения

• Not fluent in English or Spanish

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Children's Hospital Los Angeles — Los Angeles

Идентификаторы

NCT: NCT07023367 · CHLA-25-00190

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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