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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06175104




Registration number
NCT06175104
Ethics application status
Date submitted
3/11/2023
Date registered
18/12/2023

Titles & IDs
Public title
HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis
Scientific 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
Secondary ID [1] 0 0
SPR201912
Universal Trial Number (UTN)
Trial acronym
HeartGPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Defects, Congenital 0 0
Anxiety in Pregnancy 0 0
Depression, Postpartum 0 0
Trauma, Psychological 0 0
Neurodevelopmental Disorders 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - HeartGPS

Experimental: HeartGPS (Treatment Arm) - 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.

No intervention: Usual Fetal Cardiac Care (Control Arm) - 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.


BEHAVIORAL: HeartGPS
HeartGPS 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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maternal anxiety symptoms
Timepoint [1] 0 0
Baseline, approx. 36 weeks gestation, infant age 28 days, infant age 6 months, infant age 12 months
Primary outcome [2] 0 0
Maternal depressive symptoms
Timepoint [2] 0 0
Baseline, approx. 36 weeks gestation, infant age 28 days, infant age 6 months, infant age 12 months
Primary outcome [3] 0 0
Maternal traumatic stress symptoms
Timepoint [3] 0 0
Baseline, approx. 36 weeks gestation, infant age 28 days, infant age 6 months, infant age 12 months
Secondary outcome [1] 0 0
Infant neurobehavior
Timepoint [1] 0 0
Infant corrected-age 28 to 56 days
Secondary outcome [2] 0 0
Infant neurodevelopment
Timepoint [2] 0 0
Infant corrected-age 12 months (approximate)
Secondary outcome [3] 0 0
Mother-infant dyadic synchrony
Timepoint [3] 0 0
Infant corrected-age 12 months (approximate)

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).
2. Single ventricle CHD diagnosis between 16 and 30 weeks gestation.
3. Singleton pregnancy.
4. Pregnant person is planning to continue with the pregnancy.
5. Pregnant person is able to participate and complete study assessments in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).
2. Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.
3. 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.
4. Parent with a moderate to severe intellectual disability.
5. Parent age <18 years.
6. Surrogate for pregnancy.

Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Hospital Medical Center, Cincinnati
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Children's Hospital Los Angeles
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Vanderbilt University Medical Center
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Sydney Children's Hospitals Network
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Pittsburgh
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nadine A. Kasparian, PhD
Address 0 0
Children's Hospital Medical Center, Cincinnati
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nadine A. Kasparian, PhD
Address 0 0
Country 0 0
Phone 0 0
513-636-5575
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participant data that underlie the results reported in the published paper, after deidentification (text, tables, figures, and appendices).

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
Beginning 12 months and ending 24 months following publication.
Available to whom?
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.cincinnatichildrens.org/research/divisions/b/psychology/labs/kasparian


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06175104