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.
Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).
Single ventricle CHD diagnosis between 16 and 30 weeks gestation.
Singleton pregnancy.
Pregnant person is planning to continue with the pregnancy.
Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).
Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.
Parent with an untreated major psychiatric condition, substance use disorder, or other circumstances that would interfere with study engagement or safe participation in the trial.
Parent with a moderate to severe intellectual disability.
Parallel
HeartGPS
BehavioralHeartGPS 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.
Maternal anxiety symptoms
Maternal anxiety symptoms will be measured using the validated, 20-item, self-report State-Trait Anxiety Inventory State subscale. Response options for each item range from 1 ('Not at all') to 4 ('Very much so'), yielding a total possible score ranging from 20 to 80, with higher scores indicating greater anxiety symptoms.
Maternal depressive symptoms
Maternal depressive symptoms will be measured using the validated, 10-item, self-report Edinburgh Depression Scale. Response options for each item range from 0 to 3, yielding a total possible score ranging from 0 to 30, with higher scores indicating greater depressive symptoms.
Maternal traumatic stress symptoms
Maternal traumatic stress symptoms will be measured using the validated, 20-item, self-report Posttraumatic Stress Disorder Checklist for Diagnostic Statistical Manual of Mental Disorders, 5th edition (DSM-5). Response options for each item range from 0 ('Not at all') to 4 ('Extremely'), yielding a total possible score ranging from 0 to 80, with higher scores indicating greater traumatic stress symptoms.
Infant neurobehavior
Infant neurobehavior will be assessed using the NeoNatal Neurobehavioral Scale (NNNS-II). The NNNS-II examines infant neurobehavioral organization, neurological reflexes, motor development (active and passive tone), and signs of stress. Analysis of the NNNS-II is based on summary scores for attention (possible scores: 1-9), handling (0-1), self-regulation (1-9), arousal (1-9), excitability (0-15), lethargy (0-15), hypotonicity (0-10), hypertonicity (0-10), non-optimal reflexes (0-15), asymmetric reflexes (0-16), habituation (1-9), quality of movement (1-9), and stress-abstinence (0-1). Some items may not be administered due to infant sternal precautions. Each infant is assigned to a mutually exclusive profile (category) based on their pattern of scores across the summary scores.
Infant neurodevelopment
Infant neurodevelopment will be assessed using the Bayley Scales of Infant Development - Fourth Edition (BSID-4). Cognitive, language, and motor domains will be assessed, as well as infant social-emotional and adaptive behavior development. For each subtest or subdomain the highest possible score is 19, and the lowest possible score is 1. Scores from 8 to 12 are considered average.
Mother-infant dyadic synchrony
Mother-infant dyadic synchrony will be assessed using a standardized, 3-minute, free-play observational procedure, called the Child-Adult Relationship Experimental (CARE) Index. Four aspects of affective attunement (facial expression, vocal expressions, position and body contact, expressions of affection), and three aspects of behavioral attunement (pacing of turns, control, choice of activity) will each be rated and combined to generate an overall dyadic synchrony score ranging from 0-14, with higher scores indicating greater synchrony.
Variation of prenatal cortisol levels in maternal saliva
Maternal hypothalamic-pituitary-adrenal (HPA) axis functioning will be assessed using saliva sampling at 3 timepoints daily on two consecutive weekdays.
Variation of cortisol levels in maternal and infant saliva
Maternal and infant hypothalamic-pituitary-adrenal (HPA) axis functioning will be assessed using saliva sampling at 4 timepoints before and after the Child-Adult Relationship Experimental (CARE) Index.
Structural and functional brain development
Functional magnetic resonance imaging (fMRI) indices will be used to compare variations of fetal and infant structural and functional brain development.
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Children's Hospital Medical Center, Cincinnati
Lead sponsor
Children's Hospital Los Angeles
Collaborator
Sydney Children's Hospitals Network
Collaborator
