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NOT YET RECRUITING
NCT07582861
NA

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

Sponsor: Carelon Research

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2026-04

Completion Date

2030-06

Last Updated

2026-05-13

Healthy Volunteers

No

Interventions

OTHER

HeartGPS

GPS stands for Guiding parents through emotions, Providing information and support, and Strengthening connections. Participants randomized to the treatment group will participate in HeartGPS, which includes three key components tailored to the CHD population: 1. Eight virtually administered counseling sessions, 2. Tailored educational resource, 3. Mental health care plan.

Locations (17)

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