Actively Recruiting
A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study
Led by Carelon Research · Updated on 2026-04-23
390
Participants Needed
14
Research Sites
165 weeks
Total Duration
On this page
Sponsors
C
Carelon Research
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12-17 years old
- Moderate or severe congenital heart disease (Class II/III, 2018 AHA/ACC ACHD, Table 4)
- Proficiency in English or Spanish
- Receives cardiology care at a PHN or PHN auxiliary site
- Parent or guardian and participant willing to comply with study protocol and provide written or electronic consent and assent
You will not qualify if you...
- Mild or simple congenital heart disease (Class I, 2018 AHA/ACC ACHD, Table 4)
- Prior heart transplant to treat congenital heart disease
- Heart disease not classified as structural congenital heart disease (e.g., connective tissue disease, genetic cardiomyopathy, acquired heart disease)
- Cognitive or developmental conditions limiting program participation or ability to complete self-reported measures as determined by a cardiology clinician
- Suicidality, homicidality, or psychosis in the past 12 months based on medical records, clinician report, or screening
- Medically unable to participate (e.g., intubated, unable to respond verbally, active delirium)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Stanford School of Medicine
Stanford, California, United States, 94305
Not Yet Recruiting
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
4
University of Kentucky College of Medicine
Lexington, Kentucky, United States, 40506
Not Yet Recruiting
5
Boston Children's Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
6
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Not Yet Recruiting
8
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Not Yet Recruiting
9
Columbia University Irving Medical Center
New York, New York, United States, 10032
Not Yet Recruiting
10
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
11
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
12
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Not Yet Recruiting
13
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
14
Primary Children's Hospital, University of Utah
Salt Lake City, Utah, United States, 84108
Not Yet Recruiting
Research Team
J
Jessica E Teng, MPH
CONTACT
A
Alliison Crosby-Thompson, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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