search
Back to results

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

Primary Purpose

Congenital Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HEARTPrep
Sponsored by
Nemours Children's Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Congenital Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nemours Children's HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HEARTPrep

Arm Description

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.

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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)

Secondary Outcome Measures

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)

Full Information

First Posted
October 31, 2021
Last Updated
August 9, 2023
Sponsor
Nemours Children's Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT05129631
Brief Title
HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease
Acronym
HEARTPrep
Official Title
HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HEARTPrep
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HEARTPrep
Intervention Description
HEARTPrep is a virtually-delivered psychosocial intervention for mothers expecting a baby with CHD.
Primary Outcome Measure Information:
Title
HEARTPrep Evaluation Questionnaire - Session 3
Description
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)
Time Frame
6 weeks (Session 3)
Title
HEARTPrep Evaluation Questionnaire - Session 6
Description
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)
Time Frame
12 weeks (Session 6)
Title
Change in Emotional Distress - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Description
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)
Time Frame
Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Title
Change in Social Isolation - PROMIS Short-Form
Description
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)
Time Frame
Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Title
Change in Parenting Self-Efficacy - PROMIS Short-Form
Description
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)
Time Frame
Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Secondary Outcome Measure Information:
Title
Change in Hope - PROMIS Short-Form
Description
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)
Time Frame
Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Nemours Children's Health
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Sood, PhD
Phone
302-651-4000
Email
erica.sood@nemours.org

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs