An interventional study of HeartGPS in Congenital Heart Disease (CHD), sponsored by Carelon Research. Recruiting at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Carelon Research · Not applicable, Interventional, and Supportive care
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.
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.
1,007 studies on the registry are indexed under Heart Defects, Congenital; 257 are open to participants now.
This study's planned enrollment of 210 is above the median of 60 across 524 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Carelon Research is the lead sponsor of 55 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Both mothers and infants are study participants.
Inclusion Criteria:
5. Pregnant mother is able to participate and complete study assessments in English or Spanish.
Exclusion Criteria:
This is standard of care.
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.
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
Time frame: 4 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 12 months
gestational age at birth infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months
gestational age at birth in weeks
Time frame: birth
birthweight infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months
weight at birth in kg
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 32 weeks gestation
Plan to share: Yes — De-identified public use datasets with all study data will be created in accordance with NIH policy
Supporting information: Study protocol
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