Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)
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)
1 other identifier
interventional
210
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2026
CompletedFirst Submitted
Initial submission to the registry
April 29, 2026
CompletedFirst Posted
Study publicly available on registry
May 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
May 13, 2026
February 1, 2026
3 years
April 29, 2026
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
STAI - State total score at 4 months. Range is 20-80, with higher scores indicating higher levels of anxiety.
State-Trait Anxiety Inventory (STAI) - State total score at 4 months
4 months
Secondary Outcomes (17)
STAI-State total score at 36 weeks gestation
36 weeks gestation
STAI-State total score at 1-2 months postpartum
1-2 months postpartum
STAI-State total score at 12 months postpartum
12 months postpartum
PCL-5 total score at 4 months
4 months
PCL-5 total score at 36 weeks gestation
36 weeks gestation
- +12 more secondary outcomes
Study Arms (2)
Usual Fetal Cardiac Care
NO INTERVENTIONThis is standard of care.
HeartGPS
EXPERIMENTALUsual 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
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.
Eligibility Criteria
You may qualify if:
- 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.
- \. Pregnant mother is able to participate and complete study assessments in English or Spanish.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carelon Researchlead
Study Sites (17)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nadine Kasparian, PhD, PMH-C, FAHA
Cincinatti Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2026
First Posted
May 13, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
June 1, 2030
Last Updated
May 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be shared as soon as possible, but no later than the time of an associated publication or the end of the grant period, whichever comes first. Data will be available for as long as it is deemed useful for the larger research community, as directed by the PHN NHLBI project officers.
- Access Criteria
- Creation of (free) login on PHN public website
De-identified public use datasets with all study data will be created in accordance with NIH policy