Congenital Heart Disease (CHD)NCT07582861
Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)
A study testing HeartGPS in people with Congenital Heart Disease (CHD), run by Carelon Research at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease (CHD)
- What is being tested?
- HeartGPS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 17 sitesUnited States
- Study dates
- 22 Jul 2026to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 17 recruiting
- Recruiting
University of Michigan Health System, Ann Arbor
Ann Arbor, Michigan, 48109
Principal Investigator
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Principal Investigator
- Not yet recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Principal Investigator
- Not yet recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Principal Investigator
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Principal Investigator
- Not yet recruiting
Lurie Children's Hospital
Chicago, Illinois, 60611
Principal Investigator
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Principal Investigator
- Not yet recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Principal Investigator
- Not yet recruiting
Golisano Children's at UK
Lexington, Kentucky, 40502
Principal Investigator
- Not yet recruiting
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Principal Investigator
- Recruiting
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Principal Investigator
- Not yet recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Principal Investigator
- Not yet recruiting
Children's Hospital of New York
New York, New York, 10032
Principal Investigator
- Not yet recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Principal Investigator
- Not yet recruiting
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
Principal Investigator
- Not yet recruiting
Primary Children's Medical Center
Salt Lake City, Utah, 84113
Principal Investigator
- Not yet recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Principal Investigator
About this study
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)
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.
Read the 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.
- Conditions
- Congenital Heart Disease (CHD)
- Being tested
- HeartGPS
- Keywords
- HeartGPS, CHD, intervention, Parent mental health, Neurodevelopment
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartGPSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Fetal Cardiac Care | No intervention | This is standard of care. |
| HeartGPS | Experimental | 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. Receives: Other: HeartGPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Secondary outcomes (17)
STAI-State total score at 36 weeks gestation
State-Trait Anxiety Inventory (STAI) - State total score at 36 weeks gestation. Range is 20-80, with higher scores indicating higher levels of anxiety.
Measured: 36 weeks gestation
STAI-State total score at 1-2 months postpartum
State-Trait Anxiety Inventory (STAI)-State total score at 1-2 months postpartum. Range is 20-80, with higher scores indicating higher levels of anxiety.
Measured: 1-2 months postpartum
STAI-State total score at 12 months postpartum
State-Trait Anxiety Inventory (STAI)-State total score at 12 months postpartum. Range is 20-80, with higher scores indicating higher levels of anxiety.
Measured: 12 months postpartum
PCL-5 total score at 4 months
PTSD Checklist for DSM-5 (PCL-5) total score at 4 months. Range is 0-80, with higher scores indicating greater symptom severity.
Measured: 4 months
PCL-5 total score at 36 weeks gestation
PTSD Checklist for DSM-5 (PCL-5) total score at 36 weeks gestation. Range is 0-80, with higher scores indicating greater symptom severity.
Measured: 36 weeks gestation
PCL-5 total score at 1-2 months postpartum
PTSD Checklist for DSM-5 (PCL-5) total score at 1-2 months postpartum. Range is 0-80, with higher scores indicating greater symptom severity.
Measured: 1-2 months postpartum
PCL-5 total score at 12 months postpartum
PTSD Checklist for DSM-5 (PCL-5) total score at 12 months postpartum. Range is 0-80, with higher scores indicating greater symptom severity.
Measured: 12 months postpartum
BSID-4 at age 12 months
Infant neurodevelopmental outcomes at age 12 months measured by Bayley Scales of Infant and Toddler Development, Fourth Edition (BSID-4). Scores are scaled (0-100) and interpreted as percentile ranks, with higher scores indicating better development. There are five composite domain scores - Cognitive, Language, Motor, Social-Emotional, and Adaptive Behavior - normed to mean 100 and SD 15, with higher scores indicating better development.
Measured: 12 months
EDS total score at 4 months
Maternal depressive symptoms at 4 months postpartum measured by the Edinburgh Depression Scale (EDS) total score. Range is 0-30, with higher scores indicating greater symptom severity.
Measured: 4 months
EDS total score at 36 weeks gestation, 1-2 months postpartum, and 12 months
Maternal depressive symptoms measured by the Edinburgh Depression Scale (EDS) total score. Range is 0-30, with higher scores indicating greater symptom severity.
Measured: 36 weeks gestation, 1-2 months postpartum, and 12 months
CARE-Index at age 12 months
Mother-infant interaction (dyadic synchrony) at 12 months measured by the Child-Adult Relationship Experimental Index (CARE-Index) at 12 months. The scores on these scales range from 0-14, with zero being dangerously insensitive, 7 being normally sensitive, and 14 being outstandingly sensitive.
Measured: 12 months
PedsQL Infant Scales at age 12 months
Pediatric Quality of Life (PedsQL) Infant Scales at 12 months. The scores range from 0 to 100, with higher scores indicating better quality of life
Measured: 12 months
gestational age at birth infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months
gestational age at birth in weeks
Measured: birth
birthweight infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months
weight at birth in kg
Measured: birth
length of hospital stay through 12 months infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months
length of hospital stay through 12 months in days
Measured: birth through 12 months
PTGI-SF at 12 months
Post-traumatic Growth Inventory Short Form (PTGI-SF) at 12 months postpartum. T-scores are normed to mean 50 and SD 10, with higher scores indicating more posttraumatic growth.
Measured: 12 months postpartum
Diurnal cortisol pattern at 32 weeks gestation
Adaptive diurnal cortisol pattern as measured by Cortisol Area Under the Curve (AUCg) at 32 weeks gestation
Measured: 32 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start22 Jul 2026
- Primary completionJul 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to the HeartGPS mental health intervention or standard of care.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadine Kasparian, PhD, PMH-C, FAHA, Study chair, Cincinatti Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582861
- Sponsor's protocol ID
- 20858 BOND HeartGPS
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified public use datasets with all study data will be created in accordance with NIH policy
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07582861
- Acronym / sponsor ID
- 20858 BOND HeartGPS
- Conditions
- Congenital Heart Disease (CHD)
- Keywords
- HeartGPS, CHD, intervention, Parent mental health, Neurodevelopment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to the HeartGPS mental health intervention or standard of care.
| Arm | Type | Receives |
|---|---|---|
| Usual Fetal Cardiac Care | No intervention | –This is standard of care. |
| HeartGPS | Experimental | Other: HeartGPSUsual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartGPSGPS 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. | Other | HeartGPS |
Primary outcome
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
17 secondary outcomes
STAI-State total score at 36 weeks gestation
Time frame: 36 weeks gestation
STAI-State total score at 1-2 months postpartum
Time frame: 1-2 months postpartum
STAI-State total score at 12 months postpartum
Time frame: 12 months postpartum
PCL-5 total score at 4 months
Time frame: 4 months
PCL-5 total score at 36 weeks gestation
Time frame: 36 weeks gestation
PCL-5 total score at 1-2 months postpartum
Time frame: 1-2 months postpartum
PCL-5 total score at 12 months postpartum
Time frame: 12 months postpartum
BSID-4 at age 12 months
Time frame: 12 months
EDS total score at 4 months
Time frame: 4 months
EDS total score at 36 weeks gestation, 1-2 months postpartum, and 12 months
Time frame: 36 weeks gestation, 1-2 months postpartum, and 12 months
CARE-Index at age 12 months
Time frame: 12 months
PedsQL Infant Scales at age 12 months
Time frame: 12 months
gestational age at birth infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months
Time frame: birth
birthweight infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months
Time frame: birth
length of hospital stay through 12 months infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months
Time frame: birth through 12 months
PTGI-SF at 12 months
Time frame: 12 months postpartum
Diurnal cortisol pattern at 32 weeks gestation
Time frame: 32 weeks gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified public use datasets with all study data will be created in accordance with NIH policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadine Kasparian, PhD, PMH-C, FAHA study chair
Cincinatti Children's Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartGPS in people with Congenital Heart Disease (CHD), run by Carelon Research at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Lynch, MPH (339-368-9294, stephanie.lynch@carelon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.