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

NCT05129631 | Completed

• 1 other identifier: 1813613
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (4)

• HEARTPrep Evaluation Questionnaire

  Assesses perceived acceptability and feasibility of HEARTPrep (item responses range from 0-4 with higher scores reflecting greater acceptability and feasibility; minimum score = 0; maximum score = 64)

  Post-intervention

• Change in Emotional Distress - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form

  Assesses change from baseline in feelings of anxiety and depression (item responses range from 1-5 with higher scores reflecting greater emotional distress; minimum score = 4; maximum score = 20)

  Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Change in Social Isolation - PROMIS Short-Form

  Assesses change from baseline in feelings of social isolation (item responses range from 1-5 with higher scores reflecting greater social isolation; minimum score = 4; maximum score = 20)

  Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Change in Parenting Self-Efficacy - PROMIS Short-Form

  Assesses change from baseline in feelings of parenting self-efficacy (item responses range from 1-5 with lower scores reflecting lower parenting self-efficacy; minimum score = 4; maximum score = 20)

  Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Secondary Outcomes (1)

• Change in Hope - PROMIS Short-Form

  Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Study Arms (1)

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.

Behavioral: HEARTPrep

Interventions

HEARTPrep BEHAVIORAL

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

HEARTPrep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Health

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Psychologist

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: November 22, 2021
• Study Start: July 14, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

US (1)