Executive Function Intervention for Children With Complex Congenital Heart Disease

NCT07692958 | Not Yet Recruiting

• 2 other identifiers: 2026-INV-00110003319
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Executive Dysfunction; Heart Defect, Congenital

Outcome Measures

Primary Outcomes (1)

• Changes in executive functions in everyday life from pre-intervention to post-intervention

  The primary outcome measure will be assessed at the pre-intervention and post-intervention visit with the Behavior Rating Inventory for Executive Function (BRIEF)

  Screening, 3 months

Secondary Outcomes (44)

• Persisting effects of the E-Fit intervention on executive functions in everyday life, 3 months after the post-intervention visit.

  Screening, 3 months, 6 months

• Resting-state functional connectivity

  Baseline, 3 months, 6 months

• Task-based fMRI activation during executive function tasks

  Baseline

• Training-related changes in task-based fMRI activation

  Baseline, 3 months, 6 months

• Multi-shell diffusion-tensor imaging

  3 months

Study Arms (3)

Congenital Heart Disease Children Intervention Group

EXPERIMENTAL

The children in the intervention group will participate in the 12-week long E-Fit intervention to enhance their executive functions.

Other: E-Fit Intervention

Congenital Heart Disease Children Control Group

NO INTERVENTION

Children in this group will fill in daily activity logs during the 12 week period. After data collection they will get access to a delayed E-Fit Intervention.

Healthy Control Group

NO INTERVENTION

Children in this group will fill in daily activity logs during the 12 week period.

Interventions

E-Fit Intervention OTHER

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.

Congenital Heart Disease Children Intervention Group

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bea Latal: lead

Study Sites (1)

University Children's Hosptial Zurich

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Prof. Dr. med. Bea Latal

CONTACT

+41 44 249 63 95; bea.latal@kispi.uzh.ch

Prof. Dr. Ruth O'Gorman Tuura

CONTACT

ruth.tuura@kispi.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med Beatrix Latal

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: July 9, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

CH (1)