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โ† Trials
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Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)

RecruitingNAAges 18 Years - anyAllCarelon Research
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Both mothers and infants are study participants. Inclusion Criteria: 1. Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period. 2. Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life. 3. CHD diagnosis received between 16.0 and 30.0 weeks gestation. 4. Singleton pregnancy. 5. 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: 1. Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation. 2. 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. 3. Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent. 4. Postnatal diagnosis of CHD. 5. Fetus with a comorbid condition with a predictable and major impact on neurodevelopment (e.g., Trisomy 21, DiGeorge syndrome). 6. Pregnant individual is aged \<18 years. 7. Pregnant individual is carrying a surrogate pregnancy. 8. Consented mother completes \<70% of survey questions at first (baseline) assessment.
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What it tests

  • HeartGPS
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Where

17 sites
Phoenix Children's Hospital
Phoenix, United States
Children's Hospital of Los Angeles
Los Angeles, United States
Children's Hospital Colorado
Aurora, United States
Children's Healthcare of Atlanta
Atlanta, United States
Lurie Children's Hospital
Chicago, United States
Golisano Children's at UK
Lexington, United States
Boston Children's Hospital
Boston, United States
University of Michigan Health System, Ann Arbor
Ann Arbor, United States

โ€ฆand 9 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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