RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-07-14
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06175104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Nadine A. Kasparian, PhD
CONTACT
513-636-5575
nadine.kasparian@cchmc.org
James F. Cnota, MD
CONTACT
513-636-3868
james.cnota@cchmc.org

Principal Investigator

Nadine A. Kasparian, PhD
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Children's Hospital Medical Center, Cincinnati
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Nadine A. Kasparian, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-14
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-07-14
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

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