Executive Function Intervention for Children With Complex Congenital Heart Disease

Official title

Executive Function Intervention for Children With Complex Congenital Heart Disease: A Randomised Control Study

Overview

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.

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 impro

Primary outcome measures

• Changes in executive functions in everyday life from pre-intervention to post-intervention [Time frame: Screening, 3 months]

Secondary outcome measures (12)

• Persisting effects of the E-Fit intervention on executive functions in everyday life, 3 months after the post-intervention visit. [Time frame: Screening, 3 months, 6 months]
• Resting-state functional connectivity [Time frame: Baseline, 3 months, 6 months]
• Task-based fMRI activation during executive function tasks [Time frame: Baseline]
• Training-related changes in task-based fMRI activation [Time frame: Baseline, 3 months, 6 months]
• Multi-shell diffusion-tensor imaging [Time frame: 3 months]
• Myelin Mapping with multiparametric MRI [Time frame: 6 months]
• Color Word Interference Test (D-KEFS) [Time frame: Baseline, 3 months, and 6 months]
• Alertness (TAP) [Time frame: Baseline, 3 months, and 6 months]
• Go/No-Go (TAP) [Time frame: Baseline, 3 months, and 6 months]
• Tower Test (D-KEFS) [Time frame: Baseline, 3 months, and 6 months]
• Trail Making Test (D-KEFS) [Time frame: Baseline, 3 months, and 6 months]
• Regensburger Word Fluency Test (RWT) [Time frame: Baseline, 3 months, and 6 months]

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 (<36 weeks of gestation); diagnosed with a neurological or substantial developmental disorder (e.g., learning disorder, attention deficit hyperactivity disorder or autism spectrum disorder); Insufficient German language skills of the child and parent(s); Attending a separative special educational school (Separative Sonderschulung)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Switzerland · 1 center

• University Children's Hosptial Zurich — Zurich

Identifiers

NCT: NCT07692958 · 2026-INV-001 · 10003319

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗