Recruiting

HeartGPS

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06175104

Conditions

Heart Defects, Congenital

Anxiety in Pregnancy

Depression, Postpartum

Trauma, Psychological

Neurodevelopmental Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HeartGPS

Study Details

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

Study ID

NCT06175104

Start date

Jul 14, 2025

Status verified date

Jul, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

HeartGPS

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.

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) ]
  • Maternal depressive 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) ]
  • Maternal traumatic stress 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 and Locations

Central contacts

Nadine A. Kasparian, PhD

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

James F. Cnota, MD

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

Locations

Children's Hospital Medical Center, Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Nadine A Kasparian, PhD

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

Principal Investigator:

Nadine A Kasparian, PhD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jul 20, 2025

Last verified

Jul, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-07-20.