Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)
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)
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Stephanie Lynch, MPH
- Telefonnummer: 339-368-9294
- E-Mail: stephanie.lynch@carelon.com
Studieren Sie die Kontaktsicherung
- Name: Julie E Miller, MPH
- Telefonnummer: 7812274645
- E-Mail: julie.miller2@carelon.com
Studienorte
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Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85016
- Noch keine Rekrutierung
- Phoenix Children's Hospital
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Kontakt:
- Principal Investigator
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California
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Los Angeles, California, Vereinigte Staaten, 90027
- Noch keine Rekrutierung
- Children's Hospital of Los Angeles
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Kontakt:
- Principal Investigator
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80045
- Noch keine Rekrutierung
- Children's Hospital Colorado
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Kontakt:
- Principal Investigator
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30322
- Rekrutierung
- Children's Healthcare of Atlanta
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Kontakt:
- Principal Investigator
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60611
- Noch keine Rekrutierung
- Lurie Children's Hospital
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Kontakt:
- Principal Investigator
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Kentucky
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Lexington, Kentucky, Vereinigte Staaten, 40502
- Noch keine Rekrutierung
- Golisano Children's at UK
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Kontakt:
- Principal Investigator
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Noch keine Rekrutierung
- Boston Children's Hospital
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Kontakt:
- Principal Investigator
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48109
- Rekrutierung
- University of Michigan Health System, Ann Arbor
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Kontakt:
- Principal Investigator
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Missouri
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Kansas City, Missouri, Vereinigte Staaten, 64108
- Noch keine Rekrutierung
- Children's Mercy Hospital
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Kontakt:
- Principal Investigator
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St Louis, Missouri, Vereinigte Staaten, 63110
- Noch keine Rekrutierung
- Washington University School of Medicine
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Kontakt:
- Principal Investigator
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New York
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New York, New York, Vereinigte Staaten, 10029
- Noch keine Rekrutierung
- Icahn School of Medicine at Mount Sinai
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Kontakt:
- Principal Investigator
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New York, New York, Vereinigte Staaten, 10032
- Noch keine Rekrutierung
- Children's Hospital of New York
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Kontakt:
- Principal Investigator
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45229
- Rekrutierung
- Cincinnati Children's Hospital Medical Center
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Kontakt:
- Principal Investigator
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Pennsylvania
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
- Noch keine Rekrutierung
- University of Pittsburgh School of Medicine
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Kontakt:
- Principal Investigator
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South Carolina
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Charleston, South Carolina, Vereinigte Staaten, 29425
- Rekrutierung
- Medical University of South Carolina
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Kontakt:
- Principal Investigator
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Tennessee
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Memphis, Tennessee, Vereinigte Staaten, 38103
- Rekrutierung
- Le Bonheur Children's Hospital
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Kontakt:
- Principal Investigator
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Utah
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Salt Lake City, Utah, Vereinigte Staaten, 84113
- Noch keine Rekrutierung
- Primary Children's Medical Center
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Kontakt:
- Principal Investigator
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Both mothers and infants are study participants.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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Kein Eingriff: Usual Fetal Cardiac Care
This is standard of care.
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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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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STAI - State total score at 4 months. Range is 20-80, with higher scores indicating higher levels of anxiety.
Zeitfenster: 4 months
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State-Trait Anxiety Inventory (STAI) - State total score at 4 months
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4 months
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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STAI-State total score at 36 weeks gestation
Zeitfenster: 36 weeks gestation
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State-Trait Anxiety Inventory (STAI) - State total score at 36 weeks gestation.
Range is 20-80, with higher scores indicating higher levels of anxiety.
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36 weeks gestation
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STAI-State total score at 1-2 months postpartum
Zeitfenster: 1-2 months postpartum
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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.
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1-2 months postpartum
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STAI-State total score at 12 months postpartum
Zeitfenster: 12 months postpartum
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State-Trait Anxiety Inventory (STAI)-State total score at 12 months postpartum.
Range is 20-80, with higher scores indicating higher levels of anxiety.
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12 months postpartum
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PCL-5 total score at 4 months
Zeitfenster: 4 months
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PTSD Checklist for DSM-5 (PCL-5) total score at 4 months.
Range is 0-80, with higher scores indicating greater symptom severity.
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4 months
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PCL-5 total score at 36 weeks gestation
Zeitfenster: 36 weeks gestation
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PTSD Checklist for DSM-5 (PCL-5) total score at 36 weeks gestation.
Range is 0-80, with higher scores indicating greater symptom severity.
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36 weeks gestation
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PCL-5 total score at 1-2 months postpartum
Zeitfenster: 1-2 months postpartum
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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.
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1-2 months postpartum
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PCL-5 total score at 12 months postpartum
Zeitfenster: 12 months postpartum
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PTSD Checklist for DSM-5 (PCL-5) total score at 12 months postpartum.
Range is 0-80, with higher scores indicating greater symptom severity.
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12 months postpartum
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BSID-4 at age 12 months
Zeitfenster: 12 months
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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.
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12 months
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EDS total score at 4 months
Zeitfenster: 4 months
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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.
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4 months
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EDS total score at 36 weeks gestation, 1-2 months postpartum, and 12 months
Zeitfenster: 36 weeks gestation, 1-2 months postpartum, and 12 months
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Maternal depressive symptoms measured by the Edinburgh Depression Scale (EDS) total score.
Range is 0-30, with higher scores indicating greater symptom severity.
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36 weeks gestation, 1-2 months postpartum, and 12 months
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CARE-Index at age 12 months
Zeitfenster: 12 months
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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.
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12 months
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PedsQL Infant Scales at age 12 months
Zeitfenster: 12 months
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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
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12 months
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gestational age at birth infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months
Zeitfenster: birth
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gestational age at birth in weeks
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birth
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birthweight infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months
Zeitfenster: birth
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weight at birth in kg
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birth
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length of hospital stay through 12 months infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months
Zeitfenster: birth through 12 months
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length of hospital stay through 12 months in days
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birth through 12 months
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PTGI-SF at 12 months
Zeitfenster: 12 months postpartum
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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.
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12 months postpartum
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Diurnal cortisol pattern at 32 weeks gestation
Zeitfenster: 32 weeks gestation
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Adaptive diurnal cortisol pattern as measured by Cortisol Area Under the Curve (AUCg) at 32 weeks gestation
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32 weeks gestation
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Studienstuhl: Nadine Kasparian, PhD, PMH-C, FAHA, Cincinatti Children's Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- 20858 BOND HeartGPS
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Beschreibung des IPD-Plans
IPD-Sharing-Zeitrahmen
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