No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
12 – 17
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
390 (estimated)
Sponsor
Carelon Research · Other
Who this trial is looking for
This trial is looking for teens aged 12-17 with congenital heart disease. Participants will take part in a 5-week online program that aims to help them improve their ability to handle stress and live better lives.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 12 and 17 years old
I have moderate or severe congenital heart disease
I can speak and understand English or Spanish
I receive heart care at a specific clinic
I and my parent or guardian agree to participate
You may not be able to join if
I have mild or simple congenital heart disease
I have had a heart transplant for my heart disease
I have heart disease that is not structural congenital heart disease
I have a condition that makes it hard for me to take part in the program
I have had thoughts of hurting myself or others in the past year
I am unable to participate for medical reasons
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 tough times or recover …
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 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 urine and second saliva samples.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 12-17 years old
* CHD of moderate or severe complexity (Class II/III, 2018 AHA/ACC ACHD, Table 4)
* English or Spanish language proficiency
* Receives cardiology care at a PHN or PHN auxiliary site
* Parent or guardian and participant willing to comply with protocol and pr…
Inclusion Criteria:
* Age 12-17 years old
* CHD of moderate or severe complexity (Class II/III, 2018 AHA/ACC ACHD, Table 4)
* English or Spanish language proficiency
* Receives cardiology care at a PHN or PHN auxiliary site
* Parent or guardian and participant willing to comply with protocol and provide written/electronic informed consent and assent
Exclusion Criteria:
* CHD of mild or simple complexity (Class I, 2018 AHA/ACC ACHD, Table 4)
* Prior heart transplant to treat CHD
* Heart disease that is not classified as structural CHD (e.g., connective tissue disease, genetic cardiomyopathy, or acquired heart disease)
* Cognitive or developmental conditions that limit program participation and/or ability to complete self-reported measures as determined by a primary cardiology clinician
* Suicidality, homicidality, or psychosis in the past 12 months as per medical chart review, clinician report, or eligibility screening
* Medically unable to participate (e.g., intubated, unable to respond verbally, active delirium)
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