Clinical trial NCT05129631: HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease
Official title: HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: HEARTPrep Evaluation Questionnaire
timeFrame: Post-intervention
measure: Change in Emotional Distress - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
timeFrame: Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Change in Social Isolation - PROMIS Short-Form
timeFrame: Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Change in Parenting Self-Efficacy - PROMIS Short-Form
timeFrame: Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Secondary outcomes:
measure: Change in Hope - PROMIS Short-Form
timeFrame: Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Children's Health
state: Delaware
Study officials:
References: