Clinical trial NCT06175104: HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Defects, Congenital
Anxiety in Pregnancy
Depression, Postpartum
Trauma, Psychological
Neurodevelopmental Disorders
Keywords: Congenital Heart Disease
Prenatal
Mental Health
Neurodevelopment
Neurobehavior
Fetal Cardiology
Psychological Intervention
Mother-Infant Attachment
Mother-Infant Bonding
Medical Traumatic Stress
Neuroimaging
Brain Development
Fetal Neuroimaging
Perinatal Mental Health
Medical Psychology
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
name: Vanderbilt University Medical Center
name: Sydney Children's Hospitals Network
name: University of Pittsburgh
First posted: 2023-12-18
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 longitudinal randomized controlled trial compares a novel, 8-week, prenatally-delivered psychological intervention (called HeartGPS) to usual fetal cardiac care. In comparison with usual care, the study aims are to examine the effects of HeartGPS on: (1) maternal psychological distress (anxiety, depression, and traumatic stress) across the perinatal period; (2) fetal and infant brain development; (3) infant neurodevelopment; and (4) parent-infant behavioral synchrony. The study will also explore how neurobiological, psychological, behavioral, and social factors may explain intervention effects.

Across multiple sites, the investigators will enroll 104 mothers and their babies with single ventricle congenital heart disease to receive usual fetal cardiac care or usual fetal cardiac care plus the HeartGPS intervention. HeartGPS includes psychology sessions during pregnancy and the early postpartum period, coupled with tailored educational resources, and a personalized care plan to support longer-term parent, child, and family mental health and wellbeing. Maternal prenatal assessments will be performed at baseline (pre-randomization) and approximately 36-weeks gestation followed by maternal and infant assessments at approximately infant age 28-days, 6-months, and 12-months. Fetal neuroimaging will occur at approximately 36-weeks gestation and infant neuroimaging will take place at approximately infant age 28-days, using structural and functional magnetic resonance imaging (MRI). Placental tissue, maternal, paternal and infant blood, and maternal and infant saliva samples will also be collected. The primary outcomes for the trial are changes in maternal anxiety, depression, and traumatic stress scores from baseline to 6-months postpartum. Secondary outcomes include neonatal neurobehavior (NeoNatal Neurobehavioral Scale), infant neurodevelopment at 12 months (Bayley Scales of Infant Development), and mother-infant behavioral synchrony at 12 months (CARE-Index). In addition to rigorously testing a promising new therapy, this study will generate knowledge to accelerate treatments for maternal prenatal psychological stress and define mechanisms underlying the fetal origins of brain development and neurodevelopmental outcomes in CHD.

Eligibility criteria: 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 participation.
3. 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.
4. Parent with a moderate to severe intellectual disability.
5. Parent age \<18 years.
6. Surrogate for pregnancy.

Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.

Primary outcomes:
measure: Maternal anxiety symptoms
timeFrame: Baseline, approx. 36 weeks gestation, infant age 28 days, infant age 6 months, infant age 12 months
measure: Maternal depressive symptoms
timeFrame: Baseline, approx. 36 weeks gestation, infant age 28 days, infant age 6 months, infant age 12 months
measure: Maternal traumatic stress symptoms
timeFrame: Baseline, approx. 36 weeks gestation, infant age 28 days, infant age 6 months, infant age 12 months
Secondary outcomes:
measure: Infant neurobehavior
timeFrame: Infant corrected-age 28 to 56 days
measure: Infant neurodevelopment
timeFrame: Infant corrected-age 12 months (approximate)
measure: Mother-infant dyadic synchrony
timeFrame: Infant corrected-age 12 months (approximate)
Other outcomes:
measure: Variation of prenatal cortisol levels in maternal saliva
timeFrame: Baseline, 32 weeks gestation (approximate)
measure: Variation of cortisol levels in maternal and infant saliva
timeFrame: Infant corrected-age 12 months (approximate)
measure: Structural and functional brain development
timeFrame: Approximately 36 weeks gestation and infant corrected-age 28 days
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center, Cincinnati
state: Ohio
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
city: Randwick
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
city: Westmead
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Nadine A. Kasparian, PhD
role: PRINCIPAL_INVESTIGATOR
References: