Executive Function Intervention for Children With Complex Congenital Heart Disease
NCT07692958 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2026-07-09
Summary
Children with complex congenital heart disease (cCHD) nowadays survive thanks to medical advances into their teenage years and adulthood. However, many of them have difficulties with so-called executive functions. These include skills such as paying attention, planning, self-control, and flexible thinking, which are very important for school, daily life, and becoming independent. These difficulties are linked to changes in the brain and to a higher level of stress. Previous computer-based training programs on their own have either not been very effective, or the effects were lost soon after.
In this study, the researchers are testing a newly developed, personalized training program called E-Fit. It combines digital cognitive training, individualized online strategy coaching and analog games. The goal is to find out whether this program can improve executive functions in everyday life for 9-to 13-year-old children with complex congenital heart disease.
The study is planed as a randomized controlled trial at the University Children's Hospital Zurich. Children will be assigned either to the training group or to a control group. In addition, the results will be compared with those of a group of healthy children of the same age. The children will visit the University Children's Hospital Zurich three times throughout the whole duration of the study. The first visit will take place before the children start the intervention, the second visit right after the children finished the intervention and the last visit will be 3 months after finishing the intervention. During all these visits neuropsychological assessments, questionnaires, brains scans (MRI) and stress measurements will be collected.
The results are intended to help develop effective support programs for these children, improve their well-being, and better prepare them for transition into adulthood.
Conditions
- Heart Defect, Congenital
- Executive Dysfunction
Interventions
- OTHER
-
E-Fit Intervention
The E-Fit Intervention lasts a total of 12 weeks and consists of three parts: strategy coaching, computerized training, and a analog games. For the strategy coaching, the children meet once a week with a member of the study team. During these sessions, they discuss challenges from their everyday lives and work together to find solutions and develop helpful strategies. In the computerized training, the children train three times per week for 20 minutes each time. The games are designed to improve executive functions including working memory, cognitive flexibility, planning and inhibition. In addition, families receive card or board games. They can decide for themselves whether and how often they play these games at home. There are also three coaching sessions with parents, addressing the discussed strategies, as well as challenges faced by children with cCHD. Optionally, teachers will receive an eLearning course.
Sponsors & Collaborators
-
Bea Latal
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 9 Years
- Max Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2030-12-31
- Completion
- 2030-12-31
Countries
- Switzerland
Study Locations
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