A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study

Part of paid clinical trials in Stanford, California.

Sponsor
Carelon Research
Study ID
NCT07525843
Status
Recruiting
Apply to this trial

Conditions

  • Adolescent Congenital Heart Disease
  • Patient-Reported Outcome Measures (PROMs)
  • Pragmatic Trial
  • Resilience, Psychological
  • Resiliency-building Intervention
  • Telemedicine-Based Education

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Telemedicine-based resiliency-building intervention — BEHAVIORAL
    Improving Access and Increasing Resilience through the WE BEAT Well-Being Education Program. The WE BEAT Well-Being Education Program was developed for pediatric patients with heart disease. The evidence-based components of the 5-module WE BEAT intervention are derived from cognitive behavioral theory, stress management and resiliency research, and behavioral intervention science across pediatric populations and adult heart disease. The five WE BEAT modules include: Well-being Education--Introduction, Breathe--Mindfulness and Relaxation-Based Skills, Energize--Positive Psychology Skills, Adjust--Cognitive Skills Training, and Thanks--Gratitude Practice. The objective is to foster positive psychological well-being and resilient outcomes in adolescents with CHD through a mental health promotion and prevention while providing access to safe, peer-to-peer community building. Through its group-based telemedicine delivery, the program aims to increase access to mental health care.

Study Details

The goal of this pragmatic clinical trial is to learn if the WE BEAT program, a 5-week group-based online wellbeing and skill-building program, can help teens with congenital heart disease (CHD) improve their ability to handle stress. The main question it aims to answer is if participants who receive the WE BEAT program become more resilient (the ability to bounce back from from tough times or recover from something difficult) and have better quality of life compared to participants who receive usual care. The study also aims to learn if there are connections between participant-reported psychosocial data (such as resilience, feelings about one's life and one's physical, mental, and social wellbeing) and clinical outcomes. Eligible participants who are 12-17-year-old will be in the study for about 6 months and be randomized to receive either the WE BEAT program or usual care. Following completion of the primary WE BEAT intervention at Week 5, intervention arm participants will be randomized to a single-session booster session (occurring at Week 18) vs no booster session. The booster session will be provided in a similar format to the WE BEAT program. A review of all modules/skills introduced in the program will be provided. All participants will complete 4 sets of online surveys and give 3 hair/saliva samples at different timepoints. Some participants may volunteer to give optional blood and urine samples.

Key Dates

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

Study Design

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

Arms

  • No Intervention: Usual Care
    Usual Care arm used as a control
  • Experimental: Intervention arm
    WE BEAT telemedicine intervention

Primary Outcome Measure

Connor-Davidson Resilience Scale (CD-RISC) [ Time Frame: from baseline to week 5 (immediately post-intervention). ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Stanford School of MedicineStanfordCalifornia94305
Lauren M Schneider, PsyD
[email protected]
650-723-5511
Children's Hospital ColoradoAuroraColorado80045
Sarah L Kelly, PsyD
[email protected]
720-777-4599
Emory University School of MedicineAtlantaGeorgia30322
Lazaros Kochilas, MD, MSCR
[email protected]
University of Kentucky College of MedicineLexingtonKentucky40506
Louis I Bezold, MD
[email protected]
859-323-6754
Boston Children's HospitalBostonMassachusetts02114
Sarah de Ferranti, MD, MPH
[email protected]
University of Michigan Health SystemAnn ArborMichigan48109
Kurt R Schumacher, MD, MS
[email protected]
732-615-2369
Washington University School of MedicineSt LouisMissouri63110
Aecha M Ybarra, MD, MS
[email protected]
Columbia University Irving Medical CenterNew YorkNew York10032
Michael P DiLorenzo, MD, MSCE
[email protected]
212-342-1562
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Brett R Anderson, MD, MBA, MS
[email protected]
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Paul J Critser, MD, PhD
[email protected]
513-517-1523
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Andrea L Jones, MD, MSCE
[email protected]
Children's Hospital of PittsburghPittsburghPennsylvania15224
Bryan Goldstein, MD
[email protected]
Medical University of South CarolinaCharlestonSouth Carolina29425
Eric Graham, MD
[email protected]
Primary Children's Hospital, University of UtahSalt Lake CityUtah84108
Laura Wood, PhD
[email protected]
713-557-4868

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