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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Carelon Research
Study ID
NCT07582861
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Congenital Heart Disease (CHD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Apr 30, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Usual Fetal Cardiac Care
    This is standard of care.
  • 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.

Primary Outcome Measure

STAI - State total score at 4 months. Range is 20-80, with higher scores indicating higher levels of anxiety. [ Time Frame: 4 months ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016
Principal Investigator
Children's Hospital of Los AngelesLos AngelesCalifornia90027
Principal Investigator
Children's Hospital ColoradoAuroraColorado80045
Principal Investigator
Children's Healthcare of AtlantaAtlantaGeorgia30322
Principal Investigator
Lurie Children's HospitalChicagoIllinois60611
Principal Investigator
Golisano Children's at UKLexingtonKentucky40502
Principal Investigator
Boston Children's HospitalBostonMassachusetts02115
Principal Investigator
University of Michigan Health System, Ann ArborAnn ArborMichigan48109
Principal Investigator
Children's Mercy HospitalKansas CityMissouri64108
Principal Investigator
Washington University School of MedicineSt LouisMissouri63110
Principal Investigator
Children's Hospital of New YorkNew YorkNew York10032
Principal Investigator
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Principal Investigator
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Principal Investigator
University of Pittsburgh School of MedicinePittsburghPennsylvania15213
Principal Investigator
Medical University of South CarolinaCharlestonSouth Carolina29425
Principal Investigator
Le Bonheur Children's HospitalMemphisTennessee38103
Principal Investigator
Primary Children's Medical CenterSalt Lake CityUtah84113
Principal Investigator

Find similar trials in Phoenix, AZ

By research site
Phoenix Children's Hospital· Phoenix, AZChildren's Hospital of Los Angeles· Los Angeles, CAChildren's Hospital Colorado· Aurora, COChildren's Healthcare of Atlanta· Atlanta, GALurie Children's Hospital· Chicago, ILGolisano Children's at UK· Lexington, KY

Related Studies