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

Recruiting

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)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Both mothers and infants are study participants.

Inclusion Criteria:

1. Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.
2. Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.
3. CHD diagnosis received between 16.0 and 30.0 weeks gestation.
4. Singleton pregnancy.
5. Pregnant mother is planning to continue the pregnancy and pursue surgical or transcatheter intervention for the infant.

5\. Pregnant mother is able to participate and complete study assessments in English or Spanish.

Exclusion Criteria:

1. Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.
2. 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.
3. Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.
4. Postnatal diagnosis of CHD.
5. Fetus with a comorbid condition with a predictable and major impact on neurodevelopment (e.g., Trisomy 21, DiGeorge syndrome).
6. Pregnant individual is aged \<18 years.
7. Pregnant individual is carrying a surrogate pregnancy.
8. Consented mother completes \<70% of survey questions at first (baseline) assessment.

About the study

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.

What is being tested

Sponsor: Carelon Research · Participants: 210 · Started: Jul 22, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07582861

Locations in the U.S.

ArizonaPhoenix Children's Hospital, Phoenix (Not yet recruiting)
CaliforniaChildren's Hospital of Los Angeles, Los Angeles (Not yet recruiting)
ColoradoChildren's Hospital Colorado, Aurora (Not yet recruiting)
GeorgiaChildren's Healthcare of Atlanta, Atlanta
IllinoisLurie Children's Hospital, Chicago (Not yet recruiting)
KentuckyGolisano Children's at UK, Lexington (Not yet recruiting)
MassachusettsBoston Children's Hospital, Boston (Not yet recruiting)
MichiganUniversity of Michigan Health System, Ann Arbor, Ann Arbor
MissouriChildren's Mercy Hospital, Kansas City (Not yet recruiting)
Washington University School of Medicine, St Louis (Not yet recruiting)
New YorkChildren's Hospital of New York, New York (Not yet recruiting)
Icahn School of Medicine at Mount Sinai, New York (Not yet recruiting)
OhioCincinnati Children's Hospital Medical Center, Cincinnati
PennsylvaniaUniversity of Pittsburgh School of Medicine, Pittsburgh (Not yet recruiting)
South CarolinaMedical University of South Carolina, Charleston
TennesseeLe Bonheur Children's Hospital, Memphis
UtahPrimary Children's Medical Center, Salt Lake City (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.