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

A vizsgálat adatai

Ki végzi

Carelon Research

Azonosító

NCT07582861

A regiszteradat frissítve

2026. szeptember 10.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

BOND HeartGPS: A Longitudinal Randomized Controlled Trial Examining the Maternal and Infant Effects of a Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)

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.

Bevonási feltételek: 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; Pregnant mother is able to participate and complete study assessments in English or Spanish.

Kizáró feltételek: 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; Fetus with a comorbid condition with a predictable and major impact on neurodevelopment (e.g., Trisomy 21, DiGeorge syndrome); Pregnant individual is aged <18 years; Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent; Postnatal diagnosis of CHD; Pregnant individual is carrying a surrogate pregnancy; Consented mother completes <70% of survey questions at first (baseline) assessment.

Both mothers and infants are study participants.

ClinicalTrials.gov NCT07582861