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

8 de septiembre de 2026 actualizado por: Carelon Research

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)

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

210

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85016
        • Aún no reclutando
        • Phoenix Children's Hospital
        • Contacto:
          • Principal Investigator
    • California
      • Los Angeles, California, Estados Unidos, 90027
        • Aún no reclutando
        • Children's Hospital of Los Angeles
        • Contacto:
          • Principal Investigator
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Aún no reclutando
        • Children's Hospital Colorado
        • Contacto:
          • Principal Investigator
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Reclutamiento
        • Children's Healthcare of Atlanta
        • Contacto:
          • Principal Investigator
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Aún no reclutando
        • Lurie Children's Hospital
        • Contacto:
          • Principal Investigator
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40502
        • Aún no reclutando
        • Golisano Children's at UK
        • Contacto:
          • Principal Investigator
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Aún no reclutando
        • Boston Children's Hospital
        • Contacto:
          • Principal Investigator
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • Reclutamiento
        • University of Michigan Health System, Ann Arbor
        • Contacto:
          • Principal Investigator
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64108
        • Aún no reclutando
        • Children's Mercy Hospital
        • Contacto:
          • Principal Investigator
      • St Louis, Missouri, Estados Unidos, 63110
        • Aún no reclutando
        • Washington University School of Medicine
        • Contacto:
          • Principal Investigator
    • New York
      • New York, New York, Estados Unidos, 10029
        • Aún no reclutando
        • Icahn School of Medicine at Mount Sinai
        • Contacto:
          • Principal Investigator
      • New York, New York, Estados Unidos, 10032
        • Aún no reclutando
        • Children's Hospital of New York
        • Contacto:
          • Principal Investigator
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45229
        • Reclutamiento
        • Cincinnati Children's Hospital Medical Center
        • Contacto:
          • Principal Investigator
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Aún no reclutando
        • University of Pittsburgh School of Medicine
        • Contacto:
          • Principal Investigator
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Reclutamiento
        • Medical University of South Carolina
        • Contacto:
          • Principal Investigator
    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 38103
        • Reclutamiento
        • Le Bonheur Children's Hospital
        • Contacto:
          • Principal Investigator
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84113
        • Aún no reclutando
        • Primary Children's Medical Center
        • Contacto:
          • Principal Investigator

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Usual Fetal Cardiac Care
This is standard of care.
Experimental: HeartGPS
Usual Fetal Cardiac Care + HeartGPS intervention. GPS stands for Guiding parents through emotions, Providing information and support, and Strengthening connections. The HeartGPS intervention includes three key components tailored to the CHD population: 1. Eight virtually administered counseling sessions, 2. Tailored educational resource, 3. Mental health care plan.
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
STAI - State total score at 4 months. Range is 20-80, with higher scores indicating higher levels of anxiety.
Periodo de tiempo: 4 months
State-Trait Anxiety Inventory (STAI) - State total score at 4 months
4 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
STAI-State total score at 36 weeks gestation
Periodo de tiempo: 36 weeks gestation
State-Trait Anxiety Inventory (STAI) - State total score at 36 weeks gestation. Range is 20-80, with higher scores indicating higher levels of anxiety.
36 weeks gestation
STAI-State total score at 1-2 months postpartum
Periodo de tiempo: 1-2 months postpartum
State-Trait Anxiety Inventory (STAI)-State total score at 1-2 months postpartum. Range is 20-80, with higher scores indicating higher levels of anxiety.
1-2 months postpartum
STAI-State total score at 12 months postpartum
Periodo de tiempo: 12 months postpartum
State-Trait Anxiety Inventory (STAI)-State total score at 12 months postpartum. Range is 20-80, with higher scores indicating higher levels of anxiety.
12 months postpartum
PCL-5 total score at 4 months
Periodo de tiempo: 4 months
PTSD Checklist for DSM-5 (PCL-5) total score at 4 months. Range is 0-80, with higher scores indicating greater symptom severity.
4 months
PCL-5 total score at 36 weeks gestation
Periodo de tiempo: 36 weeks gestation
PTSD Checklist for DSM-5 (PCL-5) total score at 36 weeks gestation. Range is 0-80, with higher scores indicating greater symptom severity.
36 weeks gestation
PCL-5 total score at 1-2 months postpartum
Periodo de tiempo: 1-2 months postpartum
PTSD Checklist for DSM-5 (PCL-5) total score at 1-2 months postpartum. Range is 0-80, with higher scores indicating greater symptom severity.
1-2 months postpartum
PCL-5 total score at 12 months postpartum
Periodo de tiempo: 12 months postpartum
PTSD Checklist for DSM-5 (PCL-5) total score at 12 months postpartum. Range is 0-80, with higher scores indicating greater symptom severity.
12 months postpartum
BSID-4 at age 12 months
Periodo de tiempo: 12 months
Infant neurodevelopmental outcomes at age 12 months measured by Bayley Scales of Infant and Toddler Development, Fourth Edition (BSID-4). Scores are scaled (0-100) and interpreted as percentile ranks, with higher scores indicating better development. There are five composite domain scores - Cognitive, Language, Motor, Social-Emotional, and Adaptive Behavior - normed to mean 100 and SD 15, with higher scores indicating better development.
12 months
EDS total score at 4 months
Periodo de tiempo: 4 months
Maternal depressive symptoms at 4 months postpartum measured by the Edinburgh Depression Scale (EDS) total score. Range is 0-30, with higher scores indicating greater symptom severity.
4 months
EDS total score at 36 weeks gestation, 1-2 months postpartum, and 12 months
Periodo de tiempo: 36 weeks gestation, 1-2 months postpartum, and 12 months
Maternal depressive symptoms measured by the Edinburgh Depression Scale (EDS) total score. Range is 0-30, with higher scores indicating greater symptom severity.
36 weeks gestation, 1-2 months postpartum, and 12 months
CARE-Index at age 12 months
Periodo de tiempo: 12 months
Mother-infant interaction (dyadic synchrony) at 12 months measured by the Child-Adult Relationship Experimental Index (CARE-Index) at 12 months. The scores on these scales range from 0-14, with zero being dangerously insensitive, 7 being normally sensitive, and 14 being outstandingly sensitive.
12 months
PedsQL Infant Scales at age 12 months
Periodo de tiempo: 12 months
Pediatric Quality of Life (PedsQL) Infant Scales at 12 months. The scores range from 0 to 100, with higher scores indicating better quality of life
12 months
gestational age at birth infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months
Periodo de tiempo: birth
gestational age at birth in weeks
birth
birthweight infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months
Periodo de tiempo: birth
weight at birth in kg
birth
length of hospital stay through 12 months infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months
Periodo de tiempo: birth through 12 months
length of hospital stay through 12 months in days
birth through 12 months
PTGI-SF at 12 months
Periodo de tiempo: 12 months postpartum
Post-traumatic Growth Inventory Short Form (PTGI-SF) at 12 months postpartum. T-scores are normed to mean 50 and SD 10, with higher scores indicating more posttraumatic growth.
12 months postpartum
Diurnal cortisol pattern at 32 weeks gestation
Periodo de tiempo: 32 weeks gestation
Adaptive diurnal cortisol pattern as measured by Cortisol Area Under the Curve (AUCg) at 32 weeks gestation
32 weeks gestation

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Carelon Research

Investigadores

  • Silla de estudio: Nadine Kasparian, PhD, PMH-C, FAHA, Cincinatti Children's Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de julio de 2026

Finalización primaria (Estimado)

1 de julio de 2029

Finalización del estudio (Estimado)

1 de agosto de 2030

Fechas de registro del estudio

Enviado por primera vez

29 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de mayo de 2026

Publicado por primera vez (Actual)

13 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 20858 BOND HeartGPS

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified public use datasets with all study data will be created in accordance with NIH policy

Marco de tiempo para compartir IPD

Data will be shared as soon as possible, but no later than the time of an associated publication or the end of the grant period, whichever comes first. Data will be available for as long as it is deemed useful for the larger research community, as directed by the PHN NHLBI project officers.

Criterios de acceso compartido de IPD

Creation of (free) login on PHN public website

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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