NCT07582861 · Carelon Research
Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)
What this study is about
This is a two-treatment group$1, forward-looking, longitudinal, randomly assigned controlled trial (RCT) that will compare usual care to usual care plus a prenatally initiated, virtually administered psychological intervention, called HeartGPS.
View original scientific description
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.
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.
Primary outcome measures
STAI - State total score at 4 months. Range is 20-80, with higher scores indicating higher levels of anxiety.
Time frame: 4 months
State-Trait Anxiety Inventory (STAI) - State total score at 4 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. 5\. Pregnant mother is able to participate and complete study assessments in English or Spanish.
Exclusion criteria
- 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
- Phoenix, Arizona
- Los Angeles, California
- Aurora, Colorado
- Atlanta, Georgia
- Chicago, Illinois
- Lexington, Kentucky
- Boston, Massachusetts
- Ann Arbor, Michigan
- Kansas City, Missouri
- St Louis, Missouri
- New York, New York
- Cincinnati, Ohio
And 4 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 10, 2026 · Source of record for eligibility and locations