Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarelon Research

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

Qualifiers

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

Treatments tested in this trial

  • HeartGPS

Treatment groups

210 Participants
are divided into 2 treatment groups

Sponsors and collaborators