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Online well-being program to build resilience in teens with congenital heart disease

Tests an online resilience program in teens with congenital heart disease.

Key facts

Who runs it
Carelon Research
Where
Ann Arbor, Atlanta, Aurora, Boston, Charleston, Cincinnati, Lexington, New York, Philadelphia, Pittsburgh, Salt Lake City, St Louis, and Stanford, United StatesSee the 14 sites
Trial code
Registry title
A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study
Status
Recruiting
People taking part
390 people, planned
Started
20 Apr 2026
Expected to end
Jun 2029
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Telemedicine-based resiliency-building intervention
Record updated
16 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for teens aged 12-17 with moderate or severe congenital heart disease (a heart problem present from birth). It tests a 5-week online group program meant to help them handle stress.

Age
12 to 17 years
Sex
All sexes
Disease stage
Congenital heart disease of moderate or severe complexity (Class II/III, 2018 AHA/ACC ACHD, Table 4). Heart care must be at a PHN or PHN auxiliary site.
Earlier treatment
People who had a heart transplant to treat their congenital heart disease cannot join.

Main reasons for not taking part

  • Mild or simple congenital heart disease (Class I)
  • Heart disease that is not a structural birth defect, such as genetic cardiomyopathy or acquired heart disease
  • Thinking or developmental conditions that limit taking part or filling in surveys
  • Suicidal or homicidal thoughts, or psychosis, in the past 12 months
  • Medically unable to take part, for example on a breathing tube or in active delirium

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • CHD of mild or simple complexity (Class I, 2018 AHA/ACC ACHD, Table 4)
  • 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)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 12 and 17 years old?

Where in United States

  • University of Michigan Health SystemAnn Arbor, United StatesContact: Adriana BatazziTaking people
  • Emory University School of MedicineAtlanta, United StatesContact: Lead Study CoordinatorTaking people
  • Children's Hospital ColoradoAurora, United StatesContact: Lead Study CoordinatorTaking people
  • Boston Children's HospitalBoston, United StatesContact: Zoe WernsingTaking people
  • Medical University of South CarolinaCharleston, United StatesContact: Lead Study CoordinatorTaking people
  • Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: Lead Study CoordinatorTaking people
  • University of Kentucky College of MedicineLexington, United StatesContact: Heather CollinsTaking people
  • Columbia University Irving Medical CenterNew York, United StatesContact: Lead Study CoordinatorTaking people
  • Icahn School of Medicine at Mount SinaiNew York, United StatesContact: Lead Study CoordinatorTaking people
  • Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Lead Study CoordinatorTaking people
  • Children's Hospital of PittsburghPittsburgh, United StatesContact: Lead Study CoordinatorTaking people
  • Primary Children's Hospital/University of UtahSalt Lake City, United StatesContact: Laura Wood, PhDTaking people
  • Washington University School of MedicineSt Louis, United StatesContact: Lead Study CoordinatorTaking people
  • Stanford School of MedicineStanford, United StatesContact: Lead Study CoordinatorTaking people

About the trial

What the trial wants 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 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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Usual CareNo study treatment, for comparison

    Usual Care arm used as a control

  • Intervention armTreatment being tested

    WE BEAT telemedicine intervention

    Treatment: Telemedicine-based resiliency-building intervention

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study
Plain-language title
Online well-being program to build resilience in teens with congenital heart diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07525843, who can take part
Record updated
16 October 2026