Actively Recruiting
A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescents with Congenital Heart Disease
Led by Carelon Research · Updated on 2026-04-23
390
Participants Needed
14
Research Sites
8 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
Researchers are studying the WE BEAT program, a 5-week online group-based wellbeing and skill-building program designed for adolescents aged 12 to 17 with moderate to severe congenital heart disease (CHD). The trial aims to see if this program helps participants become more resilient and improves their quality of life compared to usual care. It also examines potential links between participant-reported psychosocial data and clinical outcomes related to CHD. Participants will be randomly assigned to either the WE BEAT program or usual care. After completing the 5-week program, those in the intervention group will be further randomized to receive either a single booster session at week 18 or no booster session. The booster session reviews all skills introduced in the original program. The usual care group will continue their standard treatment without the WE BEAT program. Throughout the approximately 6-month study, all participants will complete four online surveys and provide hair and saliva samples at multiple timepoints. Some may also volunteer for optional blood and urine samples. Researchers will measure resilience using the Connor-Davidson Resilience Scale and assess various psychosocial and biological markers of stress and wellbeing. The study includes ongoing data collection at baseline, week 5, week 18, and week 30 to track outcomes and safety.
CONDITIONS
Brief 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 complexity congenital heart disease
- Proficient in English or Spanish
- Receiving cardiology care at a PHN or PHN auxiliary site
- Parent or guardian and participant willing to comply with study protocol and provide consent and assent
You will not qualify if you...
- Mild or simple complexity congenital heart disease
- Prior heart transplant for CHD
- Heart disease not classified as structural CHD
- Cognitive or developmental conditions limiting participation or survey completion
- Suicidality, homicidality, or psychosis within the past 12 months
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 5 weeks
Participants receive the WE BEAT telemedicine-based resiliency-building intervention consisting of five group modules delivered remotely to promote well-being and resilience.
Weekly telemedicine sessions for 5 weeks
Duration - Up to 25 weeks post-intervention
Participants are monitored with assessments of psychological resilience, quality of life, and biological markers of stress and inflammation to evaluate lasting effects of the intervention.
Assessments at Week 18 and Week 30 (remote or in-person)
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
A
Alliison Crosby-Thompson, MS
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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