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

8 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

210

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Arizona
      • Phoenix, Arizona, États-Unis, 85016
        • Pas encore de recrutement
        • Phoenix Children's Hospital
        • Contact:
          • Principal Investigator
    • California
      • Los Angeles, California, États-Unis, 90027
        • Pas encore de recrutement
        • Children's Hospital of Los Angeles
        • Contact:
          • Principal Investigator
    • Colorado
      • Aurora, Colorado, États-Unis, 80045
        • Pas encore de recrutement
        • Children's Hospital Colorado
        • Contact:
          • Principal Investigator
    • Georgia
      • Atlanta, Georgia, États-Unis, 30322
        • Recrutement
        • Children's Healthcare of Atlanta
        • Contact:
          • Principal Investigator
    • Illinois
      • Chicago, Illinois, États-Unis, 60611
        • Pas encore de recrutement
        • Lurie Children's Hospital
        • Contact:
          • Principal Investigator
    • Kentucky
      • Lexington, Kentucky, États-Unis, 40502
        • Pas encore de recrutement
        • Golisano Children's at UK
        • Contact:
          • Principal Investigator
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02115
        • Pas encore de recrutement
        • Boston Children's Hospital
        • Contact:
          • Principal Investigator
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48109
        • Recrutement
        • University of Michigan Health System, Ann Arbor
        • Contact:
          • Principal Investigator
    • Missouri
      • Kansas City, Missouri, États-Unis, 64108
        • Pas encore de recrutement
        • Children's Mercy Hospital
        • Contact:
          • Principal Investigator
      • St Louis, Missouri, États-Unis, 63110
        • Pas encore de recrutement
        • Washington University School of Medicine
        • Contact:
          • Principal Investigator
    • New York
      • New York, New York, États-Unis, 10029
        • Pas encore de recrutement
        • Icahn School of Medicine at Mount Sinai
        • Contact:
          • Principal Investigator
      • New York, New York, États-Unis, 10032
        • Pas encore de recrutement
        • Children's Hospital of New York
        • Contact:
          • Principal Investigator
    • Ohio
      • Cincinnati, Ohio, États-Unis, 45229
        • Recrutement
        • Cincinnati Children's Hospital Medical Center
        • Contact:
          • Principal Investigator
    • Pennsylvania
      • Pittsburgh, Pennsylvania, États-Unis, 15213
        • Pas encore de recrutement
        • University of Pittsburgh School of Medicine
        • Contact:
          • Principal Investigator
    • South Carolina
      • Charleston, South Carolina, États-Unis, 29425
        • Recrutement
        • Medical University of South Carolina
        • Contact:
          • Principal Investigator
    • Tennessee
      • Memphis, Tennessee, États-Unis, 38103
        • Recrutement
        • Le Bonheur Children's Hospital
        • Contact:
          • Principal Investigator
    • Utah
      • Salt Lake City, Utah, États-Unis, 84113
        • Pas encore de recrutement
        • Primary Children's Medical Center
        • Contact:
          • Principal Investigator

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Usual Fetal Cardiac Care
This is standard of care.
Expérimental: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
STAI - State total score at 4 months. Range is 20-80, with higher scores indicating higher levels of anxiety.
Délai: 4 months
State-Trait Anxiety Inventory (STAI) - State total score at 4 months
4 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
STAI-State total score at 36 weeks gestation
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: birth
gestational age at birth in weeks
birth
birthweight infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months
Délai: 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
Délai: birth through 12 months
length of hospital stay through 12 months in days
birth through 12 months
PTGI-SF at 12 months
Délai: 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
Délai: 32 weeks gestation
Adaptive diurnal cortisol pattern as measured by Cortisol Area Under the Curve (AUCg) at 32 weeks gestation
32 weeks gestation

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Carelon Research

Les enquêteurs

  • Chaise d'étude: Nadine Kasparian, PhD, PMH-C, FAHA, Cincinatti Children's Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 juillet 2026

Achèvement primaire (Estimé)

1 juillet 2029

Achèvement de l'étude (Estimé)

1 août 2030

Dates d'inscription aux études

Première soumission

29 avril 2026

Première soumission répondant aux critères de contrôle qualité

6 mai 2026

Première publication (Réel)

13 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 20858 BOND HeartGPS

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage 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.

Critères d'accès au partage IPD

Creation of (free) login on PHN public website

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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