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NCT05129631 · ClinicalTrials.gov registry record · NA
HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease
A NA study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT05129631: Completed NA study, sponsored by Nemours Children's Clinic.
NCT05129631 is a NA study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05129631, a NA study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Congenital heart disease (CHD) is the most common birth defect and is increasingly diagnosed prenatally. Mothers describe their prenatal experiences as highly stressful and traumatic after a diagnosis of CHD. Maternal stress during pregnancy exerts a powerful influence on birth outcomes and developmental trajectories, particularly for children in underserved populations. In partnership with diverse parent and clinician stakeholders, our team designed HEARTPrep, an innovative, virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. This project will pilot HEARTPrep with mothers expecting a baby with CHD to obtain preliminary data for a larger future trial. This intervention has the potential to improve emotional wellbeing in mothers expecting a baby with CHD, thereby altering developmental trajectories for this large population of children.
Primary Outcome
Assesses depression over six weeks of HEARTPrep. Item responses range from 1-5 with higher scores reflecting greater depression. Raw scores are converted to T-scores, which have a population mean of 50 with a standard deviation of 10. Higher scores represent a worse outcome. A T-score of 60-69 is indicative of a moderate level of depression and a T-score of 70 and above is indicative of a severe level of depression.
Interventions
- BEHAVIORAL HEARTPrep
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-07-14 |
| Est. Completion | 2025-05-31 |
| Phase | NA |
What the finished NCT05129631 record still lists
NCT05129631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which HEARTPrep is the first listed.
NCT05129631 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05129631 about?
NCT05129631 is a clinical study titled "HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease". Congenital heart disease (CHD) is the most common birth defect and is increasingly diagnosed prenatally. Mothers describe their prenatal experiences as highly stressful and traumatic after a diagnosis of CHD. Maternal stress during pregnancy exerts a powerful influence on birth outcomes and developm...
What is the current status of trial NCT05129631?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2023-07-14. Estimated completion is 2025-05-31.
What interventions are being tested in trial NCT05129631?
The interventions under investigation include: HEARTPrep (BEHAVIORAL).
Who is sponsoring clinical trial NCT05129631?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05129631's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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