HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis

Neurodevelopmental Disorders Clinical Trial

— HeartGPS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06175104
• Other study ID #: SPR201912
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Nadine A. Kasparian, PhD
• Phone: 513-636-5575
• Email: nadine.kasparian[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Depression, Postpartum
• Heart Defects, Congenital
• Neurodevelopmental Disorders
• Psychological Trauma
• Trauma, Psychological

Intervention

Behavioral:
• HeartGPS
HeartGPS includes three key components: 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. 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. A personalized care plan, charting mental health care needs, goals, and preferences, with evidence-based strategies to support longer-term wellbeing.

Locations

Country	Name	City	State
Australia	Sydney Children's Hospital	Randwick	New South Wales
Australia	The Children's Hospital at Westmead	Westmead	New South Wales
United States	Children's Hospital Medical Center, Cincinnati	Cincinnati	Ohio
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee

Sponsors (5)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Children's Hospital Los Angeles, Sydney Children's Hospitals Network, University of Pittsburgh, Vanderbilt University Medical Center

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline, 32 weeks gestation (approximate)
Other	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.	Infant corrected-age 12 months (approximate)
Other	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.	Approximately 36 weeks gestation and infant corrected-age 28 days
Primary	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.	Baseline, approx. 36 weeks gestation, infant age 28 days, infant age 6 months, infant age 12 months
Primary	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.	Baseline, approx. 36 weeks gestation, infant age 28 days, infant age 6 months, infant age 12 months
Primary	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.	Baseline, approx. 36 weeks gestation, infant age 28 days, infant age 6 months, infant age 12 months
Secondary	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 corrected-age 28 to 56 days
Secondary	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.	Infant corrected-age 12 months (approximate)
Secondary	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.	Infant corrected-age 12 months (approximate)

External Links

•   Kasparian Lab