2 Clinical Trials for Various Conditions
A randomized clinical trial (RCT) design will be used to compare an 8-week Mindfulness for African Americans Postpartum (MAAP) intervention to an 8-week Educational Program (active comparison group). The primary objective is to evaluate the effectiveness of MAAP to decrease maternal psycho-behavioral symptoms and to improve mother/infant bonding. To better meet the needs of new mothers, MAAP will use a online form of delivery (i.e., group synchronous virtual Zoom). A secondary objective is to explore proinflammatory cytokines and oxytocin as possible biological mechanisms by which the MAAP intervention might decrease psycho-behavioral symptoms and improve mother/infant bonding. The MAAP intervention includes best approach and is culturally adapted based on prior evidence and expert opinion, and it addresses weaknesses in rigor of prior studies.
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.