Recruiting

WE BEAT

Sponsor:

Carelon Research

Code:

NCT07525843

Conditions

Patient-Reported Outcome Measures (PROMs)

Pragmatic Trial

Adolescent Congenital Heart Disease

Resiliency-building Intervention

Resilience, Psychological

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Telemedicine-based resiliency-building intervention

Study Details

Brief summary:

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

Patient-Reported Outcome Measures (PROMs)

Pragmatic Trial

Adolescent Congenital Heart Disease

Resiliency-building Intervention

Resilience, Psychological

Study ID

NCT07525843

Start date

Apr 20, 2026

Status verified date

Apr, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

390 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Usual Care

Usual Care arm used as a control

experimental: Intervention arm

WE BEAT telemedicine intervention

Interventions

Telemedicine-based resiliency-building intervention

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jessica E Teng, MPH

6179723047jessica.teng@carelon.com

Alliison Crosby-Thompson, MS

6179723285allison.crosby-thompson@carelon.com

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Sarah L Kelly, PsyD

720-777-4599sarah.kelly@childrenscolorado.org

Principal Investigator:

Sarah Kelly, PsyD

Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Kolby Sanders-Lewis

Kolby.sanders-lewis@choa.org

Principal Investigator:

Lazaros Kochilas, MD, MSCR

University of Kentucky College of Medicine

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Heather Collins

859-562-1103heather.collins1@uky.edu

Principal Investigator:

Louis I Bezold, MD

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Zoe Wernsing

617-355-4266Zoe.wernsing@childrens.harvard.edu

Thomas Giorgio

617-355-4201Thomas.giorgio@cardio.chboston.org

Principal Investigator:

Sarah de Ferranti, MD, MPH

University of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Adriana Batazzi

732-615-2369batazzia@med.umich.edu

Principal Investigator:

Kurt Schumacher, MD, MS

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Xuery Mu

347-335-7148xueru.mu@mssm.edu

Principal Investigator:

Brett Anderson, MD, MBA, MS

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Michael P DiLorenzo, MD, MSCE

212-342-1562mpd2001@cumc.columbia.edu

Principal Investigator:

Michael DiLorenzo, MD, MSCE

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Paul J Critser, MD, PhD

513-517-1523Paul.Critser@cchmc.org

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Andrea L Jones, MD, MSCE

jonesa21@chop.edu

Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Bryan Goldstein, MD

bryan.goldstein@chp.edu

Principal Investigator:

Bryan Goldstein, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Eric Graham, MD

grahamem@musc.edu

Principal Investigator:

Eric Graham, MD

Primary Children's Hospital, University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Laura Wood, PhD

713-557-4868laura.k.wood@hsc.utah.edu

More Information

Sponsor

Carelon Research

Last update posted

Jul 17, 2026

Last verified

Apr, 2026

Keywords

  • WE BEAT
  • Well-Being Education Program
  • Adolescent CHD
  • Pragmatic Clinical Trial
  • Telemedicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Carelon Research on 2026-07-17.