Recruiting

HeartGPS

Sponsor:

Carelon Research

Code:

NCT07582861

Conditions

Congenital Heart Disease (CHD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HeartGPS

Study Details

Brief 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.

Conditions

Congenital Heart Disease (CHD)

Study ID

NCT07582861

Start date

Jul 22, 2026

Status verified date

Sep, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Usual Fetal Cardiac Care

This is standard of care.

experimental: HeartGPS

Usual Fetal Cardiac Care + HeartGPS intervention. GPS stands for Guiding parents through emotions, Providing information and support, and Strengthening connections. The HeartGPS intervention includes three key components tailored to the CHD population: 1. Eight virtually administered counseling sessions, 2. Tailored educational resource, 3. Mental health care plan.

Interventions

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.

Primary outcome measure

  • STAI - State total score at 4 months. Range is 20-80, with higher scores indicating higher levels of anxiety. [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Locations

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

University of Michigan Health System, Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48109

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Le Bonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38103

More Information

Sponsor

Carelon Research

Last update posted

Sep 10, 2026

Last verified

Sep, 2026

Keywords

  • HeartGPS
  • CHD
  • intervention
  • Parent mental health
  • Neurodevelopment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Carelon Research on 2026-09-10.