A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study (PHN WBC)

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.

Study Overview

• Status: Recruiting
• Conditions: Resilience, Psychological; Pragmatic Trial; Patient-Reported Outcome Measures (PROMs); Telemedicine-Based Education; Adolescent Congenital Heart Disease; Resiliency-building Intervention
• Intervention / Treatment: Behavioral: Telemedicine-based resiliency-building intervention

• Study Type: Interventional
• Enrollment (Estimated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica E Teng, MPH; Phone Number: 6179723047; Email: jessica.teng@carelon.com
• Study Contact Backup: Name: Alliison Crosby-Thompson, MS; Phone Number: 6179723285; Email: allison.crosby-thompson@carelon.com

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Not yet recruiting
      • Stanford School of Medicine
      • Contact: Lauren M Schneider, PsyD; Phone Number: 650-723-5511; Email: lmikula@stanford.edu
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Sarah L Kelly, PsyD; Phone Number: 720-777-4599; Email: sarah.kelly@childrenscolorado.org
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Not yet recruiting
      • Emory University School of Medicine
      • Contact: Lazaros Kochilas, MD, MSCR; Email: kochilasl@kidsheart.com
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Not yet recruiting
      • University of Kentucky College of Medicine
      • Contact: Louis I Bezold, MD; Phone Number: 859-323-6754; Email: louis.bezold@uky.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Not yet recruiting
      • Boston Children's Hospital
      • Contact: Sarah de Ferranti, MD, MPH; Email: sarah.deferranti@cardio.chboston.org
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Health System
      • Contact: Kurt R Schumacher, MD, MS; Phone Number: 732-615-2369; Email: kurts@med.umich.edu
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Not yet recruiting
      • Washington University School of Medicine
      • Contact: Aecha M Ybarra, MD, MS; Email: amybarra@wustl.edu
  • New York
    • New York, New York, United States, 10029
      • Not yet recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Brett R Anderson, MD, MBA, MS; Email: Brett.Anderson@mssm.edu
    • New York, New York, United States, 10032
      • Not yet recruiting
      • Columbia University Irving Medical Center
      • Contact: Michael P DiLorenzo, MD, MSCE; Phone Number: 212-342-1562; Email: mpd2001@cumc.columbia.edu
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Not yet recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Paul J Critser, MD, PhD; Phone Number: 513-517-1523; Email: Paul.Critser@cchmc.org
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Not yet recruiting
      • Children's Hospital of Philadelphia
      • Contact: Andrea L Jones, MD, MSCE; Email: jonesa21@chop.edu
    • Pittsburgh, Pennsylvania, United States, 15224
      • Not yet recruiting
      • Children's Hospital of Pittsburgh
      • Contact: Bryan Goldstein, MD; Email: bryan.goldstein@chp.edu
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Not yet recruiting
      • Medical University of South Carolina
      • Contact: Eric Graham, MD; Email: grahamem@musc.edu
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Not yet recruiting
      • Primary Children's Hospital, University of Utah
      • Contact: Laura Wood, PhD; Phone Number: 713-557-4868; Email: laura.k.wood@hsc.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Usual Care arm used as a control
Experimental: Intervention arm; WE BEAT telemedicine intervention	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Connor-Davidson Resilience Scale (CD-RISC)	Connor-Davidson Resilience Scale© (CD-RISC©) is a self-reported, unidimensional 5-point Likert scale measuring resilience. Total scores range from 0-40 with higher scores indicating greater resilience. It has been validated for use in children and adolescents across various countries.	from baseline to week 5 (immediately post-intervention).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Connor-Davidson Resilience Scale (CD-RISC)	Connor-Davidson Resilience Scale© (CD-RISC©) is a self-reported, unidimensional 5-point Likert scale measuring resilience. Total scores range from 0-40 with higher scores indicating greater resilience. It has been validated for use in children and adolescents across various countries.	from baseline to Week 18, from baseline to week 30, from baseline to week 5 (for the subpopulation of participants with moderate to low baseline CD-RISC)
NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Scales	NIH Patient-Reported Outcomes Measurement Information System® (PROMIS®) Scales is a self-reported, 5-point Likert scales measuring depressive symptoms (8 items); anxiety (8 items); meaning and purpose in life (4 items); life satisfaction (4 items).The NIH PROMIS® Scales have been validated for use in children with chronic health conditions ages 8-17 years old.	from baseline to week 5, baseline to week 18, baseline to week 30
Kessler-6 (K6)	Kessler-6 (K6) is a self-reported, 5-point Likert scale measuring general distress. Total scores range from 0-24 with higher scores indicating more psychological distress.	from baseline to week 5, baseline to week 18, baseline to week 30
PedsQL, Generic Core and Cardiac Module	PedsQL, Generic Core and Cardiac Module is a self-reported; 5-point Likert scale measuring health-related quality of life (HRQOL). Scores will be transformed to a 0-100 scale with higher scores indicating more positive HRQOL. The PedsQL™ Generic Core is widely used and includes four domains: Physical, Emotional, Social, and School functioning. The PedsQL™ Cardiac Module is administered in addition to the PedsQL™ Generic Core to gather cardiac-specific constructs important to QOL. Subscales include: Heart Problems and Treatment (e.g., symptoms, medical interventions), Treatment Barriers (e.g., difficulty accessing care, adherence with treatment), Perceived Physical Appearance (e.g., concerns related to scars, body image), Treatment Anxiety (e.g., worries about medical procedures and hospital visits), Cognitive Problems (e.g., difficulties in concentrating, memory issues), and Communication (e.g., ability to discuss condition and treatment with others).	from baseline to week 5, baseline to week 18, baseline to week 30
Life's Essential 8	Life's Essential 8 is a self-reported scoring tool measuring lifestyle behaviors. Items include assessment of diet, sleep, physical activity, and nicotine use/exposure.	from baseline to week 5, baseline to week 18, baseline to week 30
Multidimensional Scale of Perceived Social Support	Multidimensional Scale of Perceived Social Support is a self-reported; 7-point Likert scale measuring perceived social support. Total score ranges from 1-7 with higher scores indicating more perceived social support. Subscales include: family subscale, friends subscale, and significant other subscale.	from baseline to week 5, baseline to week 18, baseline to week 30
Self-Perceived Health Status	Self-Perceived Health Status is a self-reported; linear analog scale. Subjectively perceived health status will be measured with a linear analogue scale ranging from the ''worst imaginable health state'' (score of 0) to the ''best imaginable health state'' (score of 100).	from baseline to week 5, baseline to week 18, baseline to week 30
WE BEAT Survey	WE BEAT Survey is a self-reported. An investigator-designed survey used to gather WE BEAT session and overall program ratings and acceptability, as well as feedback and ideas for program improvement.	Intervention Participant Report at Week 5
Concentration of cortisone (biomarker of stress)	Hair cortisone levels will be assayed from hair samples	baseline, week 5, and week 30
Concentration of C-reactive protein (CRP) (biomarker of inflammation)	Concentration of C-reactive protein will be assayed from saliva samples	baseline, week 5, and week 30
Concentration of TNF-alpha (biomarker of inflammation)	Concentration of TNF-alpha will be assayed from saliva samples	baseline, week 5, and week 30
Concentration of IL-6 (biomarker of inflammation)	Concentration of IL-6 will be assayed from saliva samples	baseline, week 5, and week 30
Concentration of IL-8 (biomarker of inflammation)	Concentration of IL-8 will be assayed from saliva samples	baseline, week 5, and week 30
Biomarkers of aging	epigenetic markers of aging (from genome-wide epigenetic profiling) will be assayed from whole blood samples from all participants who opted to provide blood for the study	baseline, week 5, and week 30

Collaborators and Investigators

• Sponsor: Carelon Research
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Melissa Cousino, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Telemedicine; Pragmatic Clinical Trial; WE BEAT; Well-Being Education Program; Adolescent CHD
• Other Study ID Numbers: 20858 PHN WBC; U24HL172722 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: PUD (Public Use Datasets) are planned to be created at the end of the study
• IPD Sharing Time Frame: Public Use Datasets will be created and posted within the time-limits required by NHLBI
• IPD Sharing Access Criteria: Will be posted on the Web and available to general public
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No