Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HeartGPS.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease (CHD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
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]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Both mothers and infants are study participants.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 17 centers
- Phoenix Children's Hospital — Phoenix
- Children's Hospital of Los Angeles — Los Angeles
- Children's Hospital Colorado — Aurora
- Children's Healthcare of Atlanta — Atlanta
- Lurie Children's Hospital — Chicago
- Golisano Children's at UK — Lexington
- Boston Children's Hospital — Boston
- University of Michigan Health System, Ann Arbor — Ann Arbor
- … and 9 more centers
Identifiers
NCT: NCT07582861 · 20858 BOND HeartGPS