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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Fetal Cardiac Care | No Intervention | This is standard of care. | |
| HeartGPS | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartGPS | Other | 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. |
| 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 |
| 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 |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susan Price | Contact | 859-940-1223 | susan.price@carelon.com | |
| Julie E Miller | Contact | 7812274645 | julie.miller2@carelon.com |
| Name | Affiliation | Role |
|---|---|---|
| Nadine Kasparian, PhD, PMH-C, FAHA | Cincinatti Children's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States |
De-identified public use datasets with all study data will be created in accordance with NIH policy
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.
Creation of (free) login on PHN public website
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Participants will be randomized 1:1 to the HeartGPS mental health intervention or standard of care.
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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 |
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | United States |
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| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
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| Lurie Children's Hospital | Chicago | Illinois | 60611 | United States |
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| Golisano Children's at UK | Lexington | Kentucky | 40502 | United States |
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| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
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| University of Michigan Health System, Ann Arbor | Ann Arbor | Michigan | 48109 | United States |
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| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
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| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| Children's Hospital of New York | New York | New York | 10032 | United States |
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| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| University of Pittsburgh School of Medicine | Pittsburgh | Pennsylvania | 15213 | United States |
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| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| Le Bonheur Children's Hospital | Memphis | Tennessee | 38103 | United States |
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| Primary Children's Medical Center | Salt Lake City | Utah | 84113 | United States |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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