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

Congenital Heart Disease Clinical Trial

— HEARTPrep  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05129631
• Other study ID #: 1813613
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: August 2023
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Nemours Children's Health	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HEARTPrep Evaluation Questionnaire - Session 3	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)	6 weeks (Session 3)
Primary	HEARTPrep Evaluation Questionnaire - Session 6	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)	12 weeks (Session 6)
Primary	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
Primary	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
Primary	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	Change in Hope - PROMIS Short-Form	Assesses change from baseline in feelings of hope (item responses range from 1-5 with lower scores reflecting lower hope; minimum score = 4; maximum score = 20)	Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12