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Purpose

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

Eligibility

Eligible Ages
Between 12 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Eligible participants will be randomly assigned to one of two treatment arms: intervention or usual care. Participants will be randomized in an approximately 3:1 ratio (3 in the intervention arm to 1 in the usual care arm) and in the order they are enrolled into the study. 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. Intervention arm participants who missed more than 2 program sessions will not be eligible for the booster.
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Children's Hospital Colorado
Aurora, Colorado 80045
Contact:
Sarah L Kelly, PsyD
720-777-4599
sarah.kelly@childrenscolorado.org

University of Michigan Health System
Ann Arbor, Michigan 48109
Contact:
Kurt R Schumacher, MD, MS
732-615-2369
kurts@med.umich.edu

More Details

Status
Recruiting
Sponsor
Carelon Research

Study Contact

Jessica E Teng, MPH
6179723047
jessica.teng@carelon.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.