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

2026년 9월 8일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

210

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Usual Fetal Cardiac Care
This is standard of care.
실험적: 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.
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
STAI - State total score at 4 months. Range is 20-80, with higher scores indicating higher levels of anxiety.
기간: 4 months
State-Trait Anxiety Inventory (STAI) - State total score at 4 months
4 months

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Carelon Research

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 22일

기본 완료 (추정된)

2029년 7월 1일

연구 완료 (추정된)

2030년 8월 1일

연구 등록 날짜

최초 제출

2026년 4월 29일

QC 기준을 충족하는 최초 제출

2026년 5월 6일

처음 게시됨 (실제)

2026년 5월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 8일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 20858 BOND HeartGPS

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

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 공유 액세스 기준

Creation of (free) login on PHN public website

IPD 공유 지원 정보 유형

  • 연구_프로토콜

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다