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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06175104
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 14, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HeartGPS (Treatment Arm)
    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.
  • No Intervention: Usual Fetal Cardiac Care (Control Arm)
    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.

Primary Outcome Measure

Maternal anxiety symptoms [ Time Frame: Baseline, 36 weeks gestation (approximate), infant corrected-age 28 to 56 days, 4 months postpartum (approximate), and infant age 12 months (approximate) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Jodie Votava-Smith, MD
[email protected]
Jodie Votava-Smith, MD (PRINCIPAL_INVESTIGATOR)
Jay Pruetz, MD (SUB_INVESTIGATOR)
Children's Hospital Medical Center, CincinnatiCincinnatiOhio45229
Nadine A Kasparian, PhD
[email protected]
513-636-5575
Nadine A Kasparian, PhD (PRINCIPAL_INVESTIGATOR)
James F Cnota, MD (PRINCIPAL_INVESTIGATOR)

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Children's Hospital Los Angeles· Los Angeles, CAChildren's Hospital Medical Center, Cincinnati· Cincinnati, OH

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