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NCT06175104 · ClinicalTrials.gov registry record · NA
HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis
A NA study of Neurodevelopmental Disorders and Depression, Postpartum, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 4
- Study locations
NCT06175104: Recruiting NA study of Neurodevelopmental Disorders and Depression, Postpartum, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT06175104 is a NA study of Neurodevelopmental Disorders and Depression, Postpartum that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 50 participants, below the 579-participant average among 27 other Neurodevelopmental Disorders trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06175104, a NA study of Neurodevelopmental Disorders and Depression, Postpartum, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL HeartGPS
Study Locations (4)
New South Wales
- Sydney Children's Hospital - Randwick
- The Children's Hospital at Westmead - Westmead
California
- Children's Hospital Los Angeles - Los Angeles
Ohio
- Children's Hospital Medical Center, Cincinnati - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-07-14 |
| Est. Completion | 2027-12 |
| Phase | NA |
What NCT06175104 shows while recruiting
NCT06175104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 579-participant average among 27 other Neurodevelopmental Disorders trials with a reported enrollment target (91% lower).
The record links to 5 conditions, with Neurodevelopmental Disorders appearing as the primary indexed condition, and to 1 intervention - of which HeartGPS is the first listed.
NCT06175104 reports a single indexed study location in New South Wales, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT06175104 about?
NCT06175104 is a clinical study titled "HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis". 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 interventio...
What is the current status of trial NCT06175104?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2025-07-14. Estimated completion is 2027-12.
What conditions does trial NCT06175104 study?
This clinical trial studies the following conditions: Neurodevelopmental Disorders, Depression, Postpartum, Trauma, Psychological, Heart Defects, Congenital, Anxiety in Pregnancy.
What interventions are being tested in trial NCT06175104?
The interventions under investigation include: HeartGPS (BEHAVIORAL).
Who is sponsoring clinical trial NCT06175104?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06175104 being conducted?
This trial has 4 study locations across California, Ohio, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06175104's enrollment target sits among peer trials
50 23rd of 27 higher than 5 of 27 other Neurodevelopmental Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurodevelopmental Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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