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

NCT06175104 | Recruiting DMC

• 1 other identifier: SPR201912
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (3)

• 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, 36 weeks gestation (approximate), infant corrected-age 28 to 56 days, 4 months postpartum (approximate), and infant age 12 months (approximate)

• 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, 36 weeks gestation (approximate), infant corrected-age 28 to 56 days, 4 months postpartum (approximate), and infant age 12 months (approximate)

• 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, 36 weeks gestation (approximate), infant corrected-age 28 to 56 days, 4 months postpartum (approximate), and infant age 12 months (approximate)

Secondary Outcomes (3)

• Infant neurobehavior

  Infant corrected-age 28 to 56 days

• Infant neurodevelopment

  Infant corrected-age 12 months (approximate)

• Mother-infant dyadic synchrony

  Infant corrected-age 12 months (approximate)

Other Outcomes (3)

• Variation of prenatal cortisol levels in maternal saliva

  Baseline, 32 weeks gestation (approximate)

• Variation of cortisol levels in maternal and infant saliva

  Infant corrected-age 12 months (approximate)

• Structural and functional brain development

  Approximately 36 weeks gestation and infant corrected-age 28 to 56 days

Study Arms (2)

HeartGPS (Treatment Arm)

EXPERIMENTAL

Participants will receive usual fetal cardiac care plus the HeartGPS intervention. This is a novel psychological intervention leveraging virtual technology and user-centered design to reduce maternal psychological stress and anxiety after prenatal cardiac diagnosis and improve neurodevelopmental outcomes for infants with single ventricle CHD. GPS stands for: Guiding through emotions, Providing information and support, and Strengthening connections. The intervention includes sessions with a trained psychologist, coupled with tailored educational resources, and a personalized care plan to support longer-term parent, child, and family wellbeing.

Behavioral: HeartGPS

Usual Fetal Cardiac Care (Control Arm)

NO INTERVENTION

In the usual care arm, participants will receive the information, support, and resources currently offered by their fetal heart care team. This can include support from their doctor or nurse, a social worker, psychologist, or support group, as well as information booklets, websites, and other resources to help parents learn more about their baby's heart condition.

Interventions

HeartGPS BEHAVIORAL

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.

HeartGPS (Treatment Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Children's Hospital Los Angeles: collaborator
• Sydney Children's Hospitals Network: collaborator

Study Sites (4)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

NOT YET RECRUITING

Children's Hospital Medical Center, Cincinnati

Cincinnati, Ohio, 45229, United States

RECRUITING

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

NOT YET RECRUITING

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

NOT YET RECRUITING

Related Links

• Kasparian Lab

MeSH Terms

Conditions

Heart Defects, Congenital; Depression, Postpartum; Psychological Trauma; Neurodevelopmental Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Personal Satisfaction; Behavior

Study Officials

• Nadine A. Kasparian, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadine A. Kasparian, PhD

CONTACT

513-636-5575; nadine.kasparian@cchmc.org

James F. Cnota, MD

CONTACT

513-636-3868; james.cnota@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: December 18, 2023
• Study Start: July 14, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 12 months and ending 24 months following publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

US (2); AU (2)