About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.
Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.
CHD diagnosis received between 16.0 and 30.0 weeks gestation.
Singleton pregnancy.
Disqualifiers
Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.
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.
Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.
Postnatal diagnosis of CHD.
Trial design
Parallel
Treatments tested in this trial
HeartGPS
Other interventionGPS 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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