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

8. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

210

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Usual Fetal Cardiac Care
This is standard of care.
Eksperimentell: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Carelon Research

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. juli 2026

Primær fullføring (Antatt)

1. juli 2029

Studiet fullført (Antatt)

1. august 2030

Datoer for studieregistrering

Først innsendt

29. april 2026

Først innsendt som oppfylte QC-kriteriene

6. mai 2026

Først lagt ut (Faktiske)

13. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20858 BOND HeartGPS

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

Creation of (free) login on PHN public website

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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