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NCT Number: NCT07582861

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.

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Key information

Conditions

Congenital Heart Disease (CHD) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phoenix Children's Hospital, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

HeartGPS

Other

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.

Primary outcomes

  1. STAI - State total score at 4 months. Range is 20-80, with higher scores indicating higher levels of anxiety.

    Time frame: 4 months

    State-Trait Anxiety Inventory (STAI) - State total score at 4 months

Secondary outcomes

  1. STAI-State total score at 36 weeks gestation

    Time frame: 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.

  2. STAI-State total score at 1-2 months postpartum

    Time frame: 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.

  3. STAI-State total score at 12 months postpartum

    Time frame: 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.

  4. PCL-5 total score at 4 months

    Time frame: 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.

  5. PCL-5 total score at 36 weeks gestation

    Time frame: 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.

  6. PCL-5 total score at 1-2 months postpartum

    Time frame: 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.

  7. PCL-5 total score at 12 months postpartum

    Time frame: 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.

  8. BSID-4 at age 12 months

    Time frame: 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.

  9. EDS total score at 4 months

    Time frame: 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.

  10. EDS total score at 36 weeks gestation, 1-2 months postpartum, and 12 months

    Time frame: 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.

  11. CARE-Index at age 12 months

    Time frame: 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. PedsQL Infant Scales at age 12 months

    Time frame: 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

  13. gestational age at birth infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months

    Time frame: birth

    gestational age at birth in weeks

  14. birthweight infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months

    Time frame: birth

    weight at birth in kg

  15. length of hospital stay through 12 months infant clinical outcomes through 12 months. Infant clinical outcomes through 12 months

    Time frame: birth through 12 months

    length of hospital stay through 12 months in days

  16. PTGI-SF at 12 months

    Time frame: 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.

  17. Diurnal cortisol pattern at 32 weeks gestation

    Time frame: 32 weeks gestation

    Adaptive diurnal cortisol pattern as measured by Cortisol Area Under the Curve (AUCg) at 32 weeks gestation

Study contacts

Contact information is provided by the study sponsor or research team.

Julie E Miller

CONTACT

[email protected]

7812274645

Susan Price

CONTACT

[email protected]

859-940-1223

Sponsors and collaborators

Lead sponsor

Carelon Research

Other

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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