Psychological Intervention for Parents of Babies with Congenital Heart Defects
(HeartGPS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a program called HeartGPS, designed to support parents expecting a baby with single ventricle congenital heart disease (SVCHD), a serious heart condition detected before birth. The program includes sessions with a psychologist and special resources to help parents manage stress and bond with their baby. Researchers aim to determine if HeartGPS can improve parents' mental health and their baby's brain development. Pregnant individuals expecting a baby diagnosed with SVCHD between 16 and 30 weeks of pregnancy might be suitable for this study. As an unphased trial, this study offers a unique opportunity for parents to access specialized support and contribute to research that could benefit future families facing similar challenges.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions that prenatal administration of corticosteroids for fetal lung maturation will be recorded but is not a reason for exclusion.
What prior data suggests that the HeartGPS intervention is safe for parents?
Research has shown that programs like HeartGPS are generally safe for parents expecting babies with heart defects. Similar programs, such as HEARTPrep, have proven safe and well-received by mothers in similar situations. This suggests that HeartGPS is likely to be well-tolerated as well. HeartGPS aims to help parents manage stress and connect with their babies through support from psychologists and personalized resources. While the study examines HeartGPS's effectiveness, existing evidence suggests it is a safe option to consider.12345
Why are researchers excited about this trial?
HeartGPS is unique because it combines psychological support with virtual technology to help parents of babies with congenital heart defects. Unlike standard care, which mainly offers general information and support, HeartGPS provides personalized sessions with a psychologist and a tailored care plan. This approach not only aims to reduce maternal stress and anxiety but also focuses on improving the child's neurodevelopmental outcomes, making it a comprehensive support system for the whole family. Researchers are excited about HeartGPS because it leverages user-centered design to create a more interactive and supportive experience for families facing these challenging diagnoses.
What evidence suggests that the HeartGPS intervention is effective for parents of babies with congenital heart defects?
Research shows that parents of babies with a congenital heart defect often experience significant stress and anxiety. Studies have found that psychological support can help reduce these feelings. In this trial, participants in the HeartGPS treatment arm will receive a novel psychological intervention designed to help parents manage their emotions, provide information, and facilitate connections with others. The goal is to improve parents' mental health and support their bonding with their baby. Although specific data on HeartGPS remains limited, early results from similar programs suggest that such interventions can positively affect both parents and their babies, enhancing the overall wellbeing of the family.24567
Who Is on the Research Team?
Nadine A Kasparian, PhD
Principal Investigator
Children's Hospital Medical Center, Cincinnati
Are You a Good Fit for This Trial?
This trial is for parents expecting a baby diagnosed with single ventricle congenital heart disease (SVCHD) during pregnancy. They are looking to support these parents by providing psychological help and education, aiming to improve their wellbeing and ability to bond with their baby.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Prenatal Intervention
Participants receive the HeartGPS psychological intervention during pregnancy, including 8 sessions with a psychologist and tailored educational resources
Postpartum Assessment
Maternal and infant assessments are conducted at approximately infant age 28 days, 6 months, and 12 months, including neuroimaging and saliva sampling
Follow-up
Participants are monitored for maternal psychological distress and infant neurodevelopmental outcomes
What Are the Treatments Tested in This Trial?
Interventions
- HeartGPS
Trial Overview
The HeartGPS intervention includes 8 sessions with a psychologist, educational materials, and a personalized care plan. It's being tested to see if it helps reduce parental stress, anxiety, depression; improves parent-infant bonding; and benefits the baby's brain development and neurodevelopmental outcomes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
Sydney Children's Hospitals Network
Collaborator
University of Pittsburgh
Collaborator
Vanderbilt University Medical Center
Collaborator
Children's Hospital Los Angeles
Collaborator
Citations
HeartGPS: A Study Exploring the Effects of a Psychological ...
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 ...
HeartGPS: A Study Exploring the Effects of a Psychological ...
The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant ...
3.
withpower.com
withpower.com/trial/psychological-intervention-for-parents-of-babies-with-congenital-heart-defects-b6474Psychological Intervention for Parents of Babies with ...
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 ...
Parental Psychological Response to Prenatal Congenital ...
Psychological stress, Parents of prenatally diagnosed infants with CHD had lower anxiety and stress than those diagnosed postnatally after adjusting for ...
Parental Stress and Resilience in Congenital Heart Disease
This paper provides a thorough synthesis of the current literature on parental stress addressing disparities in parents of children with CHD.
Psychological Outcomes and Interventions for Individuals ...
This American Heart Association scientific statement summarizes the psychological outcomes of patients with congenital heart disease across the life span
Impact of Prenatal and Postnatal Diagnosis on Parents
Parents experience a variety of psychological problems. This article summarizes the influence of CHD in the psychological and economic areas.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.