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.
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
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
Parallel
Telemedicine-based resiliency-building intervention
BehavioralImproving 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.
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.
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.
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.
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.
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).
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Carelon Research
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
