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NCT07582861NARecruiting

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

Carelon Research

Start Date

7/22/2026

Completion Date

8/1/2030

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.

Detailed Description

This is a domain of the Building Optimal Strategies to Enhance Parent and Infant Wellbeing in CHD (BOND) platform trail. BOND is a randomized, multifactorial, adaptive platform trial that seeks to optimize parent wellbeing and infant development following prenatal or neonatal diagnosis of congenital heart disease (CHD). The primary objective of this domain is to determine the effects of a prenatally initiated, virtually administered mental health intervention, called HeartGPS, on maternal mental health and infant development following prenatal CHD diagnosis.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

OTHER

HeartGPS

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Conditions

Congenital Heart Disease (CHD)

Locations

Phoenix Children's Hospital

Phoenix, Arizona 85016

United States

Children's Hospital of Los Angeles

Los Angeles, California 90027

United States

Children's Hospital Colorado

Aurora, Colorado 80045

United States

Children's Healthcare of Atlanta

Atlanta, Georgia 30322

United States

Lurie Children's Hospital

Chicago, Illinois 60611

United States

Golisano Children's at UK

Lexington, Kentucky 40502

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

University of Michigan Health System, Ann Arbor

Ann Arbor, Michigan 48109

United States

Children's Mercy Hospital

Kansas City, Missouri 64108

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Children's Hospital of New York

New York, New York 10032

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania 15213

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Le Bonheur Children's Hospital

Memphis, Tennessee 38103

United States

Primary Children's Medical Center

Salt Lake City, Utah 84113

United States