Congenital Heart Disease (CHD)
Conditions
Keywords
HeartGPS, CHD, intervention, Parent mental health, Neurodevelopment
Brief summary
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.
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.
Interventions
OTHERHeartGPS
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.
Sponsors
Carelon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Investigator)
Intervention model description
Participants will be randomized 1:1 to the HeartGPS mental health intervention or standard of care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| STAI - State total score at 4 months. Range is 20-80, with higher scores indicating higher levels of anxiety. | 4 months | State-Trait Anxiety Inventory (STAI) - State total score at 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gestational age at birth infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months | birth | gestational age at birth in weeks |
| birthweight infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months | birth | weight at birth in kg |
| length of hospital stay through 12 months infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months | birth through 12 months | length of hospital stay through 12 months in days |
| PTGI-SF at 12 months | 12 months postpartum | 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. |
| Diurnal cortisol pattern at 32 weeks gestation | 32 weeks gestation | Adaptive diurnal cortisol pattern as measured by Cortisol Area Under the Curve (AUCg) at 32 weeks gestation |
| STAI-State total score at 36 weeks gestation | 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. |
| STAI-State total score at 1-2 months postpartum | 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. |
| STAI-State total score at 12 months postpartum | 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. |
| PCL-5 total score at 4 months | 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. |
| PCL-5 total score at 36 weeks gestation | 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. |
| PCL-5 total score at 1-2 months postpartum | 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. |
| PCL-5 total score at 12 months postpartum | 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. |
| BSID-4 at age 12 months | 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. |
| EDS total score at 4 months | 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. |
| EDS total score at 36 weeks gestation, 1-2 months postpartum, and 12 months | 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. |
| PedsQL Infant Scales at age 12 months | 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 |
| CARE-Index at age 12 months | 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. |
Countries
United States
Contacts
CONTACTStephanie Lynch, MPH
CONTACTJulie E Miller, MPH
STUDY_CHAIRNadine Kasparian, PhD, PMH-C, FAHA
Cincinatti Children's Hospital
Outcome results
None listed