Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)

BOND HeartGPS: A Longitudinal Randomized Controlled Trial Examining the Maternal and Infant Effects of a Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)

This is a two-arm, prospective, longitudinal, randomized controlled trial (RCT) that will compare usual care to usual care plus a prenatally initiated, virtually administered psychological intervention, called HeartGPS.

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Heart Disease (CHD)
• Intervention / Treatment: Other: HeartGPS

Detailed Description

This is a domain of the Building Optimal Strategies to Enhance Parent and Infant Wellbeing in CHD (BOND) platform trail. BOND is a randomized, multifactorial, adaptive platform trial that seeks to optimize parent wellbeing and infant development following prenatal or neonatal diagnosis of congenital heart disease (CHD). The primary objective of this domain is to determine the effects of a prenatally initiated, virtually administered mental health intervention, called HeartGPS, on maternal mental health and infant development following prenatal CHD diagnosis.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Price; Phone Number: 859-940-1223; Email: susan.price@carelon.com
• Study Contact Backup: Name: Julie E Miller; Phone Number: 7812274645; Email: julie.miller2@carelon.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
      • Contact: Principal Investigator
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital of Los Angeles
      • Contact: Principal Investigator
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
      • Contact: Principal Investigator
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta
      • Contact: Principal Investigator
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Lurie Children's Hospital
      • Contact: Principal Investigator
  • Kentucky
    • Lexington, Kentucky, United States, 40502
      • Golisano Children's at UK
      • Contact: Principal Investigator
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
      • Contact: Principal Investigator
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System, Ann Arbor
      • Contact: Principal Investigator
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital
      • Contact: Principal Investigator
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
      • Contact: Principal Investigator
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
      • Contact: Principal Investigator
    • New York, New York, United States, 10032
      • Children's Hospital of New York
      • Contact: Principal Investigator
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
      • Contact: Principal Investigator
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh School of Medicine
      • Contact: Principal Investigator
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
      • Contact: Principal Investigator
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Le Bonheur Children's Hospital
      • Contact: Principal Investigator
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Medical Center
      • Contact: Principal Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Both mothers and infants are study participants.

Inclusion Criteria:

1. Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.
2. Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.
3. CHD diagnosis received between 16.0 and 30.0 weeks gestation.
4. Singleton pregnancy.
5. Pregnant mother is planning to continue the pregnancy and pursue surgical or transcatheter intervention for the infant.

5. Pregnant mother is able to participate and complete study assessments in English or Spanish.

Exclusion Criteria:

1. Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.
2. Mother with a severe, untreated psychiatric condition, substance use disorder, or other circumstances that, in the opinion of the investigator, would interfere with engagement with study tasks or safe participation in the trial.
3. Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.
4. Postnatal diagnosis of CHD.
5. Fetus with a comorbid condition with a predictable and major impact on neurodevelopment (e.g., Trisomy 21, DiGeorge syndrome).
6. Pregnant individual is aged <18 years.
7. Pregnant individual is carrying a surrogate pregnancy.
8. Consented mother completes <70% of survey questions at first (baseline) assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Fetal Cardiac Care; This is standard of care.
Experimental: HeartGPS; Usual Fetal Cardiac Care + HeartGPS intervention. GPS stands for Guiding parents through emotions, Providing information and support, and Strengthening connections. The HeartGPS intervention includes three key components tailored to the CHD population: 1. Eight virtually administered counseling sessions, 2. Tailored educational resource, 3. Mental health care plan.	Other: HeartGPS; GPS stands for Guiding parents through emotions, Providing information and support, and Strengthening connections. Participants randomized to the treatment group will participate in HeartGPS, which includes three key components tailored to the CHD population: 1. Eight virtually administered counseling sessions, 2. Tailored educational resource, 3. Mental health care plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STAI - State total score at 4 months. Range is 20-80, with higher scores indicating higher levels of anxiety.	State-Trait Anxiety Inventory (STAI) - State total score at 4 months	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STAI-State total score at 36 weeks gestation	State-Trait Anxiety Inventory (STAI) - State total score at 36 weeks gestation. Range is 20-80, with higher scores indicating higher levels of anxiety.	36 weeks gestation
STAI-State total score at 1-2 months postpartum	State-Trait Anxiety Inventory (STAI)-State total score at 1-2 months postpartum. Range is 20-80, with higher scores indicating higher levels of anxiety.	1-2 months postpartum
STAI-State total score at 12 months postpartum	State-Trait Anxiety Inventory (STAI)-State total score at 12 months postpartum. Range is 20-80, with higher scores indicating higher levels of anxiety.	12 months postpartum
PCL-5 total score at 4 months	PTSD Checklist for DSM-5 (PCL-5) total score at 4 months. Range is 0-80, with higher scores indicating greater symptom severity.	4 months
PCL-5 total score at 36 weeks gestation	PTSD Checklist for DSM-5 (PCL-5) total score at 36 weeks gestation. Range is 0-80, with higher scores indicating greater symptom severity.	36 weeks gestation
PCL-5 total score at 1-2 months postpartum	PTSD Checklist for DSM-5 (PCL-5) total score at 1-2 months postpartum. Range is 0-80, with higher scores indicating greater symptom severity.	1-2 months postpartum
PCL-5 total score at 12 months postpartum	PTSD Checklist for DSM-5 (PCL-5) total score at 12 months postpartum. Range is 0-80, with higher scores indicating greater symptom severity.	12 months postpartum
BSID-4 at age 12 months	Infant neurodevelopmental outcomes at age 12 months measured by Bayley Scales of Infant and Toddler Development, Fourth Edition (BSID-4). Scores are scaled (0-100) and interpreted as percentile ranks, with higher scores indicating better development. There are five composite domain scores - Cognitive, Language, Motor, Social-Emotional, and Adaptive Behavior - normed to mean 100 and SD 15, with higher scores indicating better development.	12 months
EDS total score at 4 months	Maternal depressive symptoms at 4 months postpartum measured by the Edinburgh Depression Scale (EDS) total score. Range is 0-30, with higher scores indicating greater symptom severity.	4 months
EDS total score at 36 weeks gestation, 1-2 months postpartum, and 12 months	Maternal depressive symptoms measured by the Edinburgh Depression Scale (EDS) total score. Range is 0-30, with higher scores indicating greater symptom severity.	36 weeks gestation, 1-2 months postpartum, and 12 months
CARE-Index at age 12 months	Mother-infant interaction (dyadic synchrony) at 12 months measured by the Child-Adult Relationship Experimental Index (CARE-Index) at 12 months. The scores on these scales range from 0-14, with zero being dangerously insensitive, 7 being normally sensitive, and 14 being outstandingly sensitive.	12 months
PedsQL Infant Scales at age 12 months	Pediatric Quality of Life (PedsQL) Infant Scales at 12 months. The scores range from 0 to 100, with higher scores indicating better quality of life	12 months
gestational age at birth infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months	gestational age at birth in weeks	birth
birthweight infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months	weight at birth in kg	birth
length of hospital stay through 12 months infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months	length of hospital stay through 12 months in days	birth through 12 months
PTGI-SF at 12 months	Post-traumatic Growth Inventory Short Form (PTGI-SF) at 12 months postpartum. T-scores are normed to mean 50 and SD 10, with higher scores indicating more posttraumatic growth.	12 months postpartum
Diurnal cortisol pattern at 32 weeks gestation	Adaptive diurnal cortisol pattern as measured by Cortisol Area Under the Curve (AUCg) at 32 weeks gestation	32 weeks gestation

Collaborators and Investigators

• Sponsor: Carelon Research
• Investigators: Study Chair: Nadine Kasparian, PhD, PMH-C, FAHA, Cincinatti Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: intervention; CHD; Neurodevelopment; Parent mental health; HeartGPS
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: 20858 BOND HeartGPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified public use datasets with all study data will be created in accordance with NIH policy
• IPD Sharing Time Frame: Data will be shared as soon as possible, but no later than the time of an associated publication or the end of the grant period, whichever comes first. Data will be available for as long as it is deemed useful for the larger research community, as directed by the PHN NHLBI project officers.
• IPD Sharing Access Criteria: Creation of (free) login on PHN public website
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No