Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Dise… (NCT07582861) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)
United States210 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
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Inclusion criteria
. 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.
. Pregnant mother is planning to continue the pregnancy and pursue surgical or transcatheter intervention for the infant.
Exclusion criteria
. 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.
What they're measuring
1
STAI - State total score at 4 months. Range is 20-80, with higher scores indicating higher levels of anxiety.