HeartGPS: A Longitudinal Randomized Controlled Trial Examining the Effects of a Prenatally-Delivered Psychological Intervention for Parents and Their Babies With Single Ventricle Congenital Heart Disease
Children's Hospital Medical Center, Cincinnati
Summary
Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.
Description
Maternal prenatal stress and anxiety can affect brain development in fetuses with and without congenital heart disease (CHD), influencing neurodevelopmental trajectories and establishing a neural basis for phenotypes associated with adverse mental health outcomes later in life. The prenatal period offers a critical window of opportunity, when ameliorating maternal psychological stress is likely to have enormous benefits for parents and their babies. Yet, there is a remarkable lack of prenatal interventions to support parent mental health and optimize child development during this period. This…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD). 2. Single ventricle CHD diagnosis between 16 and 30 weeks gestation. 3. Singleton pregnancy. 4. Pregnant person is planning to continue with the pregnancy. 5. Pregnant person is able to participate and complete study assessments in English. Exclusion Criteria 1. Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome). 2. Fetal or maternal medical condition determined by treating physician to be contraindicative to study…
Interventions
- BehavioralHeartGPS
HeartGPS includes three key components: 1. Sessions with a psychologist trained to deliver the intervention using attachment-based and trauma-informed therapy techniques, coupled with mind-body skills. The intervention can be delivered in-person or via telehealth, in accordance with participants' preferences. 2. Educational resources, including a series of modules to complement the sessions and evidence-based tools to support psychological adjustment and coping, parent-infant bonding and attachment, and parent-clinician communication. 3. A personalized care plan, charting mental health care needs, goals, and preferences, with evidence-based strategies to support longer-term wellbeing.
Locations (4)
- Children's Hospital Los AngelesLos Angeles, California
- Children's Hospital Medical Center, CincinnatiCincinnati, Ohio
- Sydney Children's HospitalRandwick, New South Wales
- The Children's Hospital at WestmeadWestmead, New South Wales