WE BEAT CHD

(Recruiting)

About This Study

Living with heart disease can be stressful. Adolescents with moderate and severe congenital heart disease (CHD) have a higher chance of facing mental health issues. Taking care of one’s mental health is important because it can affect cardiovascular health and overall well-being. Access to mental health care, however, is limited, and there have been few psychological interventions specific to adolescent CHD. This study will evaluate the effectiveness of a resilience and well-being-focused telemedicine intervention in adolescents with CHD and study associations between self-reported psychosocial health, cardiac health, and biomarkers.  

Study Locations

Click on a pin to see study site location details

The WE BEAT Wellbeing Education Program is a 5-week, group-based online program focused on resilience and coping skills training for 12-17 year olds with CHD. “Resilience” is someone’s ability to bounce back from tough times or recover from something difficult or challenging. The group sessions, which will be led by a trained psychologist, are a safe space for participants to share as much or little as they want with other teens born with heart conditions.

The main reason for the WE BEAT CHD Study is to learn if the WE BEAT program helps teens with CHD improve their ability to handle stress. We will compare teens who complete the WE BEAT program to teens who receive usual care over 6 months. We will also look at how the program may help improve mood and reduce stress and anxiety. We hope to enroll approximately 390 participants from 14 hospitals across the United States.

12-17 year olds with congenital heart disease of moderate or severe complexity (Class II/III per 2018 AHA/ACC guidelines)

The study will be explained to you and your parent/guardian(s) in detail by one of the study investigators. Once your questions have been answered, you will be asked to provide e-Consent/Assent to enter the study.

These are the things that will happen during the study if you choose to participate:

    • At the beginning of the study, your parents will be asked to complete questionnaires about family demographics, social factors, and mental health history, which will take about 20 minutes to complete. You will be asked to complete one questionnaire, which will take about 10 minutes to complete.
    • You will be assigned randomly (by chance, like flipping a coin) to receive the WE BEAT telemedicine 5-week program or continue with your usual care (see note). About half of the participants who complete the WE BEAT program will be assigned randomly to one extra online session.
    • You will be asked to complete a set of online questionnaires called participant-reported outcome measures (PROMs) 4 times during the study. Each set of questionnaires/PROMs will ask you about your physical, mental, and social health, and will take about one hour to complete. Your parents will have the option to complete parent-reported versions of the same questionnaires at the same 4 study timepoints.
    • You will be asked to provide hair and saliva samples 3 times during the study. You may also choose to provide optional blood and urine samples.

Note: Any participants in the usual care group who want to complete the WE BEAT program will have the chance to join a program group after they complete the study.

You will be in the study for about 6-7 months.

We can’t promise that you or others will benefit from being part of this research. However, there might be some good things, like feeling less stressed or learning more about mental health. By joining this study, you might become more aware of how important good mental health is for people born with heart conditions and feel more open to getting help in the future. You and your family might feel proud knowing that you have helped researchers understand more about helping others born with heart conditions.

There is no known direct benefit to giving samples for this study. However, your samples might help scientists learn more about how certain cells in your body behave and how they might predict future health outcomes for people with CHD.

You may experience risks or discomforts from the procedures that are required as part of the study:

  • Minor discomfort or distress while completing questionnaires or participating in group sessions
  • Minor discomfort while providing optional blood samples. There is a very small chance of pain, bruising, and bleeding where the needle goes into the skin.

There will be no extra costs to you if your child participates in the study, and your insurance will not be billed for any research-only activities. You will be responsible for your child’s normal medical care.