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Not Yet Recruiting NCT07692958

Executive Function Intervention for Children With Complex Congenital Heart Disease

Conditions: Heart Defect, Congenital, Executive Dysfunction

Sex: All
Ages: 9 Years – 13 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 160
Sponsor: Bea Latal

Location: University Children's Hosptial Zurich Zurich Canton of Zurich

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.

Eligibility Criteria

Inclusion Criteria: * Children with CHD: Born with CHD; Underwent cardiopulmonary bypass surgery before the age of one; Children with a genetic disorder or syndromal disorder will be included, if standardized IQ testing with WISC-V can be conducted, and self-rated questionnaires can be filled in; Aged 9 years 0 months to 13 years 11 months (at time of recruitment); Oral informed consent by potential participants (all ages) and parents, as well as written informed consent of parents; EF deficits showing in screening (BRIEF-score ≥ 60) * Healthy Controls: Aged 9 years 0 months to 13 years 11 months (at time of recruitment); Oral informed consent by potential participants (all ages) and parents, as well as written informed consent of parents Exclusion Criteria: * Children with CHD: Heart surgery without cardiopulmonary bypass; Children with known large cerebral lesions or injuries, including stroke and severe hypoxic-ischemic encephalopathy with significant neurological sequelae; Insufficient German language skills of the child and parent(s); Attending a separative special educational school (Separative Sonderschulung) * Healthy Controls: preterm birth (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07692958). StuddyBuddy aggregates publicly available trial information.