RecruitingNot ApplicableNCT06175104

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

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

Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

50 participants

Start Date

Jul 14, 2025

Study Type

INTERVENTIONAL

Conditions

Neurodevelopmental Disorders Heart Defects, Congenital Depression, Postpartum Trauma, Psychological Anxiety in Pregnancy

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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.
Pregnant person is able to participate and complete study assessments in English.

Exclusion Criteria7

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.
Parent age \<18 years.
Surrogate for pregnancy.
Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.

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.