Heart Defects, CongenitalHeartGPSNCT06175104
HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis
A study testing HeartGPS in people with Heart Defects, Congenital and Anxiety in Pregnancy, run by Children's Hospital Medical Center, Cincinnati at 4 sites in 2 countries.
Trial summary
Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Defects, Congenital, Anxiety in Pregnancy, Depression, Postpartum
- What is being tested?
- HeartGPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 14 Jul 2025to Dec 2027
- 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 person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).
- Single ventricle CHD diagnosis between 16 and 30 weeks gestation.
- Singleton pregnancy.
- Pregnant person is planning to continue with the pregnancy.
- Pregnant person is able to participate and complete study assessments in English.
Who cannot join
- Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).
- Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.
- Parent with an untreated major psychiatric condition, substance use disorder, or other circumstances that would interfere with study engagement or safe participation in the trial.
- Parent with a moderate to severe intellectual disability.
- Parent age <18 years.
- Surrogate for pregnancy.
- Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Children's Hospital Medical Center, Cincinnati
Cincinnati, Ohio, 45229
Nadine A Kasparian, PhD, 513-636-5575, nadine.kasparian@cchmc.org
Nadine A Kasparian, PhD
- Not yet recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Jodie Votava-Smith, MD, jvotavasmith@chla.usc.edu
Jodie Votava-Smith, MD
Australia2 sites, 2 recruiting
- Not yet recruiting
Sydney Children's Hospital
Randwick, New South Wales, 2031
Gary Sholler, MBBS, gary.sholler@health.nsw.gov.au
Rebecca Henderson, MBA, rebecca.henderson@health.nsw.gov.au
- Not yet recruiting
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
Gary Sholler, MBBS (Hons), gary.sholler@health.nsw.gov.au
Rebecca Henderson, MBA, rebecca.henderson@health.nsw.gov.au
About this study
Official title: HeartGPS: A Longitudinal Randomized Controlled Trial Examining the Effects of a Prenatally-Delivered Psychological Intervention for Parents and Their Babies With Single Ventricle Congenital Heart Disease
Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.
Read the detailed description
Maternal prenatal stress and anxiety can affect brain development in fetuses with and without congenital heart disease (CHD), influencing neurodevelopmental trajectories and establishing a neural basis for phenotypes associated with adverse mental health outcomes later in life. The prenatal period offers a critical window of opportunity, when ameliorating maternal psychological stress is likely to have enormous benefits for parents and their babies. Yet, there is a remarkable lack of prenatal interventions to support parent mental health and optimize child development during this period. This longitudinal randomized controlled trial compares a novel, 8-week, prenatally-delivered psychological intervention (called HeartGPS) to usual fetal cardiac care. In comparison with usual care, the study aims are to examine the effects of HeartGPS on: (1) maternal psychological distress (anxiety, depression, and traumatic stress) across the perinatal period; (2) fetal and infant brain development; (3) infant neurodevelopment; and (4) parent-infant behavioral synchrony. The study will also explore how neurobiological, psychological, behavioral, and social factors may explain intervention effects.
Across multiple sites, the investigators will enroll 104 mothers and their babies with single ventricle congenital heart disease to receive usual fetal cardiac care or usual fetal cardiac care plus the HeartGPS intervention. HeartGPS includes psychology sessions during pregnancy and the early postpartum period, coupled with tailored educational resources, and a personalized care plan to support longer-term parent, child, and family mental health and wellbeing. Maternal prenatal assessments will be performed at baseline (pre-randomization) and approximately 36-weeks gestation followed by maternal and infant assessments at approximately infant age 28-days, 6-months, and 12-months. Fetal neuroimaging will occur at approximately 36-weeks gestation and infant neuroimaging will take place at approximately infant age 28-days, using structural and functional magnetic resonance imaging (MRI). Placental tissue, maternal, paternal and infant blood, and maternal and infant saliva samples will also be collected. The primary outcomes for the trial are changes in maternal anxiety, depression, and traumatic stress scores from baseline to 6-months postpartum. Secondary outcomes include neonatal neurobehavior (NeoNatal Neurobehavioral Scale), infant neurodevelopment at 12 months (Bayley Scales of Infant Development), and mother-infant behavioral synchrony at 12 months (CARE-Index). In addition to rigorously testing a promising new therapy, this study will generate knowledge to accelerate treatments for maternal prenatal psychological stress and define mechanisms underlying the fetal origins of brain development and neurodevelopmental outcomes in CHD.
- Conditions
- Heart Defects, Congenital, Anxiety in Pregnancy, Depression, Postpartum, Trauma, Psychological, Neurodevelopmental Disorders
- Being tested
- HeartGPS
- Keywords
- Congenital Heart Disease, Prenatal, Mental Health, Neurodevelopment, Neurobehavior, Fetal Cardiology, Psychological Intervention, Mother-Infant Attachment, Mother-Infant Bonding, Medical Traumatic Stress, Neuroimaging, Brain Development, Fetal Neuroimaging, Perinatal Mental Health, Medical Psychology
- Medical subject headings
- Heart Defects, Congenital, Depression, Postpartum, Psychological Trauma, Neurodevelopmental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartGPSBehavioural
HeartGPS includes three key components:
- Sessions with a psychologist trained to deliver the intervention using attachment-based and trauma-informed therapy techniques, coupled with mind-body skills. The intervention can be delivered in-person or via telehealth, in accordance with participants' preferences.
- Educational resources, including a series of modules to complement the sessions and evidence-based tools to support psychological adjustment and coping, parent-infant bonding and attachment, and parent-clinician communication.
- A personalized care plan, charting mental health care needs, goals, and preferences, with evidence-based strategies to support longer-term wellbeing.
| Study group | Role | What they receive |
|---|---|---|
| HeartGPS (Treatment Arm) | Experimental | Participants will receive usual fetal cardiac care plus the HeartGPS intervention. This is a novel psychological intervention leveraging virtual technology and user-centered design to reduce maternal psychological stress and anxiety after prenatal cardiac diagnosis and improve neurodevelopmental outcomes for infants with single ventricle CHD.
GPS stands for: Guiding through emotions, Providing information and support, and Strengthening connections.
The intervention includes sessions with a trained psychologist, coupled with tailored educational resources, and a personalized care plan to support longer-term parent, child, and family wellbeing. Receives: Behavioral: HeartGPS |
| Usual Fetal Cardiac Care (Control Arm) | No intervention | In the usual care arm, participants will receive the information, support, and resources currently offered by their fetal heart care team. This can include support from their doctor or nurse, a social worker, psychologist, or support group, as well as information booklets, websites, and other resources to help parents learn more about their baby's heart condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal anxiety symptoms
Maternal anxiety symptoms will be measured using the validated, 20-item, self-report State-Trait Anxiety Inventory State subscale. Response options for each item range from 1 ('Not at all') to 4 ('Very much so'), yielding a total possible score ranging from 20 to 80, with higher scores indicating greater anxiety symptoms.
Measured: Baseline, 36 weeks gestation (approximate), infant corrected-age 28 to 56 days, 4 months postpartum (approximate), and infant age 12 months (approximate)
Maternal depressive symptoms
Maternal depressive symptoms will be measured using the validated, 10-item, self-report Edinburgh Depression Scale. Response options for each item range from 0 to 3, yielding a total possible score ranging from 0 to 30, with higher scores indicating greater depressive symptoms.
Measured: Baseline, 36 weeks gestation (approximate), infant corrected-age 28 to 56 days, 4 months postpartum (approximate), and infant age 12 months (approximate)
Maternal traumatic stress symptoms
Maternal traumatic stress symptoms will be measured using the validated, 20-item, self-report Posttraumatic Stress Disorder Checklist for Diagnostic Statistical Manual of Mental Disorders, 5th edition (DSM-5). Response options for each item range from 0 ('Not at all') to 4 ('Extremely'), yielding a total possible score ranging from 0 to 80, with higher scores indicating greater traumatic stress symptoms.
Measured: Baseline, 36 weeks gestation (approximate), infant corrected-age 28 to 56 days, 4 months postpartum (approximate), and infant age 12 months (approximate)
Secondary outcomes (3)
Infant neurobehavior
Infant neurobehavior will be assessed using the NeoNatal Neurobehavioral Scale (NNNS-II). The NNNS-II examines infant neurobehavioral organization, neurological reflexes, motor development (active and passive tone), and signs of stress. Analysis of the NNNS-II is based on summary scores for attention (possible scores: 1-9), handling (0-1), self-regulation (1-9), arousal (1-9), excitability (0-15), lethargy (0-15), hypotonicity (0-10), hypertonicity (0-10), non-optimal reflexes (0-15), asymmetric reflexes (0-16), habituation (1-9), quality of movement (1-9), and stress-abstinence (0-1). Some items may not be administered due to infant sternal precautions. Each infant is assigned to a mutually exclusive profile (category) based on their pattern of scores across the summary scores.
Measured: Infant corrected-age 28 to 56 days
Infant neurodevelopment
Infant neurodevelopment will be assessed using the Bayley Scales of Infant Development - Fourth Edition (BSID-4). Cognitive, language, and motor domains will be assessed, as well as infant social-emotional and adaptive behavior development. For each subtest or subdomain the highest possible score is 19, and the lowest possible score is 1. Scores from 8 to 12 are considered average.
Measured: Infant corrected-age 12 months (approximate)
Mother-infant dyadic synchrony
Mother-infant dyadic synchrony will be assessed using a standardized, 3-minute, free-play observational procedure, called the Child-Adult Relationship Experimental (CARE) Index. Four aspects of affective attunement (facial expression, vocal expressions, position and body contact, expressions of affection), and three aspects of behavioral attunement (pacing of turns, control, choice of activity) will each be rated and combined to generate an overall dyadic synchrony score ranging from 0-14, with higher scores indicating greater synchrony.
Measured: Infant corrected-age 12 months (approximate)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start14 Jul 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles, Sydney Children's Hospitals Network
- Responsible party
- Sponsor
- Investigators
- Nadine A. Kasparian, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175104
- Sponsor's protocol ID
- SPR201912
- Acronym
- HeartGPS
- Status last verified
- Jul 2025
- First submitted
- 3 Nov 2023
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data that underlie the results reported in the published paper, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartGPS: A Longitudinal Randomized Controlled Trial Examining the Effects of a Prenatally-Delivered Psychological Intervention for Parents and Their Babies With Single Ventricle Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06175104
- Acronym / sponsor ID
- HeartGPS / SPR201912
- Conditions
- Heart Defects, Congenital, Anxiety in Pregnancy, Depression, Postpartum, Trauma, Psychological, Neurodevelopmental Disorders
- Keywords
- Congenital Heart Disease, Prenatal, Mental Health, Neurodevelopment, Neurobehavior, Fetal Cardiology, Psychological Intervention, Mother-Infant Attachment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles, Sydney Children's Hospitals Network
- Study start
- 14 Jul 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Dec 2023 (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.
Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.
Detailed description
Maternal prenatal stress and anxiety can affect brain development in fetuses with and without congenital heart disease (CHD), influencing neurodevelopmental trajectories and establishing a neural basis for phenotypes associated with adverse mental health outcomes later in life. The prenatal period offers a critical window of opportunity, when ameliorating maternal psychological stress is likely to have enormous benefits for parents and their babies. Yet, there is a remarkable lack of prenatal interventions to support parent mental health and optimize child development during this period. This longitudinal randomized controlled trial compares a novel, 8-week, prenatally-delivered psychological intervention (called HeartGPS) to usual fetal cardiac care. In comparison with usual care, the study aims are to examine the effects of HeartGPS on: (1) maternal psychological distress (anxiety, depression, and traumatic stress) across the perinatal period; (2) fetal and infant brain development; (3) infant neurodevelopment; and (4) parent-infant behavioral synchrony. The study will also explore how neurobiological, psychological, behavioral, and social factors may explain intervention effects.
Across multiple sites, the investigators will enroll 104 mothers and their babies with single ventricle congenital heart disease to receive usual fetal cardiac care or usual fetal cardiac care plus the HeartGPS intervention. HeartGPS includes psychology sessions during pregnancy and the early postpartum period, coupled with tailored educational resources, and a personalized care plan to support longer-term parent, child, and family mental health and wellbeing. Maternal prenatal assessments will be performed at baseline (pre-randomization) and approximately 36-weeks gestation followed by maternal and infant assessments at approximately infant age 28-days, 6-months, and 12-months. Fetal neuroimaging will occur at approximately 36-weeks gestation and infant neuroimaging will take place at approximately infant age 28-days, using structural and functional magnetic resonance imaging (MRI). Placental tissue, maternal, paternal and infant blood, and maternal and infant saliva samples will also be collected. The primary outcomes for the trial are changes in maternal anxiety, depression, and traumatic stress scores from baseline to 6-months postpartum. Secondary outcomes include neonatal neurobehavior (NeoNatal Neurobehavioral Scale), infant neurodevelopment at 12 months (Bayley Scales of Infant Development), and mother-infant behavioral synchrony at 12 months (CARE-Index). In addition to rigorously testing a promising new therapy, this study will generate knowledge to accelerate treatments for maternal prenatal psychological stress and define mechanisms underlying the fetal origins of brain development and neurodevelopmental outcomes in CHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HeartGPS (Treatment Arm) | Experimental | Behavioral: HeartGPSParticipants will receive usual fetal cardiac care plus the HeartGPS intervention. This is a novel psychological intervention leveraging virtual technology and user-centered design to reduce maternal psychological stress and anxiety after prenatal cardiac diagnosis and improve neurodevelopmental outcomes for infants with single ventricle CHD. GPS stands for: Guiding through emotions, Providing information and support, and Strengthening connections. The intervention includes sessions with a trained psychologist, coupled with tailored educational resources, and a personalized care plan to support longer-term parent, child, and family wellbeing. |
| Usual Fetal Cardiac Care (Control Arm) | No intervention | –In the usual care arm, participants will receive the information, support, and resources currently offered by their fetal heart care team. This can include support from their doctor or nurse, a social worker, psychologist, or support group, as well as information booklets, websites, and other resources to help parents learn more about their baby's heart condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).
- Single ventricle CHD diagnosis between 16 and 30 weeks gestation.
- Singleton pregnancy.
- Pregnant person is planning to continue with the pregnancy.
- Pregnant person is able to participate and complete study assessments in English.
Key exclusion criteria (7 listed)
- Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).
- Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.
- Parent with an untreated major psychiatric condition, substance use disorder, or other circumstances that would interfere with study engagement or safe participation in the trial.
- Parent with a moderate to severe intellectual disability.
- Parent age <18 years.
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 |
|---|---|---|
| HeartGPSHeartGPS includes three key components: 1. Sessions with a psychologist trained to deliver the intervention using attachment-based and trauma-informed therapy techniques, coupled with mind-body skills. The intervention can be delivered in-person or via telehealth, in accordance with participants' preferences. 2. Educational resources, including a series of modules to complement the sessions and evidence-based tools to support psychological adjustment and coping, parent-infant bonding and attachment, and parent-clinician communication. 3. A personalized care plan, charting mental health care needs, goals, and preferences, with evidence-based strategies to support longer-term wellbeing. | Behavioural | HeartGPS (Treatment Arm) |
Primary outcome
Maternal anxiety symptoms
Time frame: Baseline, 36 weeks gestation (approximate), infant corrected-age 28 to 56 days, 4 months postpartum (approximate), and infant age 12 months (approximate)
Maternal anxiety symptoms will be measured using the validated, 20-item, self-report State-Trait Anxiety Inventory State subscale. Response options for each item range from 1 ('Not at all') to 4 ('Very much so'), yielding a total possible score ranging from 20 to 80, with higher scores indicating greater anxiety symptoms.
Maternal depressive symptoms
Time frame: Baseline, 36 weeks gestation (approximate), infant corrected-age 28 to 56 days, 4 months postpartum (approximate), and infant age 12 months (approximate)
Maternal depressive symptoms will be measured using the validated, 10-item, self-report Edinburgh Depression Scale. Response options for each item range from 0 to 3, yielding a total possible score ranging from 0 to 30, with higher scores indicating greater depressive symptoms.
Maternal traumatic stress symptoms
Time frame: Baseline, 36 weeks gestation (approximate), infant corrected-age 28 to 56 days, 4 months postpartum (approximate), and infant age 12 months (approximate)
Maternal traumatic stress symptoms will be measured using the validated, 20-item, self-report Posttraumatic Stress Disorder Checklist for Diagnostic Statistical Manual of Mental Disorders, 5th edition (DSM-5). Response options for each item range from 0 ('Not at all') to 4 ('Extremely'), yielding a total possible score ranging from 0 to 80, with higher scores indicating greater traumatic stress symptoms.
3 secondary outcomes
Infant neurobehavior
Time frame: Infant corrected-age 28 to 56 days
Infant neurodevelopment
Time frame: Infant corrected-age 12 months (approximate)
Mother-infant dyadic synchrony
Time frame: Infant corrected-age 12 months (approximate)
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 20 Jul 2025.
- Kasparian LabLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participant data that underlie the results reported in the published paper, after deidentification (text, tables, figures, and appendices).
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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 A. Kasparian, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartGPS in people with Heart Defects, Congenital and Anxiety in Pregnancy, run by Children's Hospital Medical Center, Cincinnati at 4 sites in 2 countries.
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 5 inclusion and 7 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 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. 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 Nadine A. Kasparian, PhD (513-636-5575, nadine.kasparian@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal anxiety symptoms (time frame: Baseline, 36 weeks gestation (approximate), infant corrected-age 28 to 56 days, 4 months postpartum (approximate), and infant age 12 months (approximate)). The study lists 3 primary outcomes in all. 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 20 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.