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

8. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

210

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Usual Fetal Cardiac Care
This is standard of care.
Eksperimentel: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
STAI - State total score at 4 months. Range is 20-80, with higher scores indicating higher levels of anxiety.
Tidsramme: 4 months
State-Trait Anxiety Inventory (STAI) - State total score at 4 months
4 months

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Carelon Research

Efterforskere

  • Studiestol: Nadine Kasparian, PhD, PMH-C, FAHA, Cincinatti Children's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2029

Studieafslutning (Anslået)

1. august 2030

Datoer for studieregistrering

Først indsendt

29. april 2026

Først indsendt, der opfyldte QC-kriterier

6. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20858 BOND HeartGPS

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

Creation of (free) login on PHN public website

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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