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

Starting soon · Not applicable

Conditions studied: Congenital Heart Disease (CHD)

In brief

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.

Key facts

Study ID

NCT07582861

Run by

Carelon Research

People needed

210

Starts

2026-04-01

Expected to finish

2030-06-01

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.
• Pregnant individual is carrying a surrogate pregnancy.
• Consented mother completes <70% of survey questions at first (baseline) assessment.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Lurie Children's Hospital — Chicago, Illinois, United States
• Golisano Children's at UK — Lexington, Kentucky, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan Health System, Ann Arbor — Ann Arbor, Michigan, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Children's Hospital of New York — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Le Bonheur Children's Hospital — Memphis, Tennessee, United States
• Primary Children's Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.