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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• STAI - State total score at 4 months. Range is 20-80, with higher scores indicating higher levels of anxiety. [Срок оценки: 4 months]

Вторичные конечные точки (12)

• STAI-State total score at 36 weeks gestation [Срок оценки: 36 weeks gestation]
• STAI-State total score at 1-2 months postpartum [Срок оценки: 1-2 months postpartum]
• STAI-State total score at 12 months postpartum [Срок оценки: 12 months postpartum]
• PCL-5 total score at 4 months [Срок оценки: 4 months]
• PCL-5 total score at 36 weeks gestation [Срок оценки: 36 weeks gestation]
• PCL-5 total score at 1-2 months postpartum [Срок оценки: 1-2 months postpartum]
• PCL-5 total score at 12 months postpartum [Срок оценки: 12 months postpartum]
• BSID-4 at age 12 months [Срок оценки: 12 months]
• EDS total score at 4 months [Срок оценки: 4 months]
• EDS total score at 36 weeks gestation, 1-2 months postpartum, and 12 months [Срок оценки: 36 weeks gestation, 1-2 months postpartum, and 12 months]
• CARE-Index at age 12 months [Срок оценки: 12 months]
• PedsQL Infant Scales at age 12 months [Срок оценки: 12 months]

Критерии участия

Both mothers and infants are study participants.

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 17 центров

• 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
• … и ещё 9 центров

Идентификаторы

NCT: NCT07582861 · 20858 BOND HeartGPS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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