Congenital Heart DiseaseHEARTPrepNCT05129631

HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease

A study testing HEARTPrep in people with Congenital Heart Disease, run by Nemours Children's Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Congenital Heart Disease
What is being tested?: HEARTPrep
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 14 Jul 2023to 31 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Expectant mothers carrying a fetus with congenital heart disease expected to require cardiac surgery in the first year of life
Partners of participating expectant mothers can also participate together with the mother
Receiving fetal cardiac care at Nemours Children's Health
Speaks English or Spanish fluently
Age 18 or older
Access to a computer, tablet or mobile device with internet access

Who cannot join

-Fetus has a genetic syndrome or other comorbid condition associated with a life expectancy of less than one year

Trial locations and contacts

1 site in 1 country.

United States1 site

Nemours Children's Health
Wilmington, Delaware, 19803

Other trials in United States

About this study

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.

Read the detailed description

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. Targeted efforts to mitigate impacts of maternal stress for this highly vulnerable population are lacking. In partnership with diverse parent and clinician stakeholders, the investigators designed HEARTPrep, an innovative, virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. HEARTPrep will be delivered through the Nemours App, an accessible tool for telehealth and patient education. The investigators aim to determine whether HEARTPrep modules produce clinically significant improvements on outcomes in mothers expecting a baby with CHD (Proof-of-Concept). This program of research has the potential to improve emotional wellbeing in mothers expecting a baby with CHD, thereby altering developmental trajectories for this large population of children.

Conditions: Congenital Heart Disease
Being tested: HEARTPrep
Medical subject headings: Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HEARTPrepBehavioural
HEARTPrep is a virtually-delivered psychosocial intervention for mothers expecting a baby with CHD.

Study groups in NCT05129631
Study group	Role	What they receive
HEARTPrep	Experimental	HEARTPrep is a virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. HEARTPrep consists of three distinct modules: Adjusting, Connecting, and Preparing. Each module targets one distinct primary outcome (emotional distress, social isolation, parenting self-efficacy) and a common secondary outcome (hope) through a suite of evidence-based intervention elements (e.g., psychoeducation, cognitive restructuring, mindfulness) for addressing emotional problems in other populations, including pregnant women. HEARTPrep elements include: a) telehealth with a psychosocial provider, b) recorded videos, c) educational tools, and d) links to resources. Receives: Behavioral: HEARTPrep

What is being measured

The primary outcome is the main question the study is designed to answer.

Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
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.
Measured: Weeks 1, 2, 3, 4, 6
Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Assesses anxiety over six weeks of HEARTPrep. Item responses range from 1-5 with higher scores reflecting greater anxiety. 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 anxiety and a T-score of 70 and above is indicative of a severe level of anxiety.
Measured: Weeks 1, 2, 3, 4, 6
Social Isolation - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Assesses social isolation over six weeks of HEARTPrep. Item responses range from 1-5 with higher scores reflecting greater social isolation. 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 social isolation and a T-score of 70 and above is indicative of a severe level of social isolation.
Measured: Weeks 1, 2, 3, 4, 6

Secondary outcomes (2)

Self-Efficacy Short-Form
Assesses feelings of self-efficacy over six weeks of HEARTPrep (item responses range from 1-5 with higher scores reflecting greater self-efficacy; minimum score = 4; maximum score = 20)
Measured: Weeks 1, 2, 3, 4, 6
Hope Short-Form
Assesses feelings of hope over six weeks of HEARTPrep (item responses range from 1-5 with higher scores reflecting greater hope; minimum score = 4; maximum score = 20)
Measured: Weeks 1, 2, 3, 4, 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jul 202331 May 2025

First posted22 Nov 2021
Study start14 Jul 2023
Primary completion31 May 2025
Study completion31 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05129631
Sponsor's protocol ID: 1813613
Acronym: HEARTPrep
Status last verified: Jul 2026
First submitted: 31 Oct 2021
Last updated: 31 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep

All Congenital Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease
ClinicalTrials.gov ID: NCT05129631
Acronym / sponsor ID: HEARTPrep / 1813613
Conditions: Congenital Heart Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Nemours Children's ClinicUniversity, hospital or other
Study start: 14 Jul 2023 (actual)
Primary completion: 31 May 2025 (actual)
Study completion: 31 May 2025 (actual)
First posted: 22 Nov 2021 (actual)
Results: Posted 31 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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. Targeted efforts to mitigate impacts of maternal stress for this highly vulnerable population are lacking. In partnership with diverse parent and clinician stakeholders, the investigators designed HEARTPrep, an innovative, virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. HEARTPrep will be delivered through the Nemours App, an accessible tool for telehealth and patient education. The investigators aim to determine whether HEARTPrep modules produce clinically significant improvements on outcomes in mothers expecting a baby with CHD (Proof-of-Concept). This program of research has the potential to improve emotional wellbeing in mothers expecting a baby with CHD, thereby altering developmental trajectories for this large population of children.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
HEARTPrep	Experimental	Behavioral: HEARTPrepHEARTPrep is a virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. HEARTPrep consists of three distinct modules: Adjusting, Connecting, and Preparing. Each module targets one distinct primary outcome (emotional distress, social isolation, parenting self-efficacy) and a common secondary outcome (hope) through a suite of evidence-based intervention elements (e.g., psychoeducation, cognitive restructuring, mindfulness) for addressing emotional problems in other populations, including pregnant women. HEARTPrep elements include: a) telehealth with a psychosocial provider, b) recorded videos, c) educational tools, and d) links to resources.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Expectant mothers carrying a fetus with congenital heart disease expected to require cardiac surgery in the first year of life
Partners of participating expectant mothers can also participate together with the mother
Receiving fetal cardiac care at Nemours Children's Health
Speaks English or Spanish fluently
Age 18 or older

Key exclusion criteria (1 listed)

-Fetus has a genetic syndrome or other comorbid condition associated with a life expectancy of less than one year

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HEARTPrepHEARTPrep is a virtually-delivered psychosocial intervention for mothers expecting a baby with CHD.	Behavioural	HEARTPrep

Primary outcome

Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Time frame: Weeks 1, 2, 3, 4, 6
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.
Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Time frame: Weeks 1, 2, 3, 4, 6
Assesses anxiety over six weeks of HEARTPrep. Item responses range from 1-5 with higher scores reflecting greater anxiety. 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 anxiety and a T-score of 70 and above is indicative of a severe level of anxiety.
Social Isolation - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Time frame: Weeks 1, 2, 3, 4, 6
Assesses social isolation over six weeks of HEARTPrep. Item responses range from 1-5 with higher scores reflecting greater social isolation. 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 social isolation and a T-score of 70 and above is indicative of a severe level of social isolation.

2 secondary outcomes

Self-Efficacy Short-Form
Time frame: Weeks 1, 2, 3, 4, 6
Hope Short-Form
Time frame: Weeks 1, 2, 3, 4, 6

Results and safety

Results posted to the registry on 31 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HEARTPrep Intervention	30	23

Primary outcome: Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form

Time frame: Weeks 1, 2, 3, 4, 6. Mean (Standard Deviation). Unit: T-score

Measure	HEARTPrep Intervention n = 24
Week 1	53.64 (11.75)
Week 2	54.47 (10.58)
Week 3	53.55 (10.54)
Week 4	54.97 (10.93)
Week 6	51.31 (7.62)

Population analysed: Participating mothers were asked to complete brief measures on a weekly basis throughout participation in HEARTPrep. Due to variability in timing of measure completion, weeks were defined as 1 (8-14 days after starting HEARTPrep), 2 (15-21 days), 3 (22-28 days), 4 (29-35 days), and 6 (36-49 days).

Primary outcome: Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form

Time frame: Weeks 1, 2, 3, 4, 6. Mean (Standard Deviation). Unit: T-score

Measure	HEARTPrep Intervention n = 24
Week 1	57.53 (9.60)
Week 2	58.29 (8.44)
Week 3	56.03 (10.17)
Week 4	58.9 (11.36)
Week 6	55.12 (8.95)

Primary outcome: Social Isolation - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form

Time frame: Weeks 1, 2, 3, 4, 6. Mean (Standard Deviation). Unit: T-score

Measure	HEARTPrep Intervention n = 24
Week 1	47.48 (10.32)
Week 2	48.53 (11.89)
Week 3	45.87 (11.82)
Week 4	47.85 (10.19)
Week 6	43.21 (8.26)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment through study completion, an average of 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HEARTPrep Intervention	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Limitations and caveats (from the sponsor): There was variability in the timing of participant questionnaire completion, resulting in missing data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Congenital Heart Disease

RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
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Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
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UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
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Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
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Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HEARTPrep in people with Congenital Heart Disease, run by Nemours Children's Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form (time frame: Weeks 1, 2, 3, 4, 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05129631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.