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NCT Number: NCT07692958

Executive Function Intervention for Children With Complex Congenital Heart Disease

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.

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Key information

Conditions

Heart Defect, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Executive Dysfunction Heart Defects, Congenital Heart Diseases

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Screening, 3 months

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

Secondary outcomes

  1. 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

    The outcome measure will be assessed at each timepoint throughout the study with the Behavior Rating Inventory for Executive Function (BRIEF)

  2. Resting-state functional connectivity

    Time frame: Baseline, 3 months, 6 months

    Functional connectivity measures using resting state fMRI

  3. Task-based fMRI activation during executive function tasks

    Time frame: Baseline

    Brain activity during executive function tasks assessing working memory, inhibition, and cognitive flexibility. Group differences between children with cCHD and healthy controls will be assessed.

  4. Training-related changes in task-based fMRI activation

    Time frame: Baseline, 3 months, 6 months

    Change in task-related brain activity from baseline (T0) to post-intervention (T1) and follow-up (T2) following the E-Fit intervention.

  5. Multi-shell diffusion-tensor imaging

    Time frame: 3 months

    White matter microstructural integrity, neurite orientation dispersion and density imaging assessed using multi-shell diffusion MRI metrics

  6. Myelin Mapping with multiparametric MRI

    Time frame: 6 months

    Quantitative MRI-derived measures of brain myelination and tissue composition using a relaxometry MRI sequence

  7. Color Word Interference Test (D-KEFS)

    Time frame: Baseline, 3 months, and 6 months

    The Color-Word Interference Test from the Delis-Kaplan Executive Function System (D-KEFS) assesses executive functions including processing speed, inhibitory control, and cognitive flexibility. Participants complete color naming, word reading, inhibition, and inhibition/switching tasks. Outcome measures include completion times and errors across conditions.

  8. Alertness (TAP)

    Time frame: Baseline, 3 months, and 6 months

    The Alertness subtest of the Test Battery for Attention Performance (TAP) assesses basic attention and alertness. Participants respond as quickly as possible to visual stimuli. Outcome measures include reaction times and reaction time variability.

  9. Go/No-Go (TAP)

    Time frame: Baseline, 3 months, and 6 months

    The TAP Go/No-Go subtest assesses inhibitory control and selective attention. Participants respond to target stimuli while withholding responses to predefined non-target stimuli. Outcome measures include reaction times, omission errors, and commission errors.

  10. Tower Test (D-KEFS)

    Time frame: Baseline, 3 months, and 6 months

    The D-KEFS Tower Test assesses planning, problem solving, rule learning, and goal-directed behavior. Participants move discs across pegs to reproduce predefined tower configurations while following specific rules. Outcome measures include achievement scores, completion time, and rule violations.

  11. Trail Making Test (D-KEFS)

    Time frame: Baseline, 3 months, and 6 months

    The Trail Making Test from the D-KEFS assesses cognitive flexibility, visual scanning, sequencing, and set-shifting abilities. Participants connect numbers and letters according to task-specific rules. Outcome measures include completion time and errors.

  12. Regensburger Word Fluency Test (RWT)

    Time frame: Baseline, 3 months, and 6 months

    The Regensburger Word Fluency Test (RWT) assesses verbal fluency and cognitive flexibility. The test includes phonemic fluency, semantic fluency, and category-switching conditions. Participants generate words according to phonemic or semantic criteria and alternate between semantic categories under time constraints. Outcome measures include the number of correct responses and switching performance.

  13. Digit Span Backward (WISC-V)

    Time frame: Baseline, 3 months, and 6 months

    The Digit Span Backward subtest of the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) assesses verbal working memory. Participants repeat sequences of numbers in reverse order. Outcome measures are based on the number of correctly recalled sequences.

  14. Number-Letter Sequencing (WISC-V)

    Time frame: Baseline, 3 months, and 6 months

    The WISC-V Number-Letter Sequencing subtest assesses working memory and mental manipulation of information. Participants reorder mixed sequences of numbers and letters according to predefined rules. Outcome measures are based on the number of correctly recalled sequences.

  15. Balloon Analogue Risk Task (BART)

    Time frame: Baseline, 3 months, and 6 months

    The Balloon Analogue Risk Task (BART) assesses risk-taking behavior and decision-making under uncertainty. Participants inflate a virtual balloon to earn points while balancing potential rewards against the risk of losing accumulated points if the balloon explodes. Outcome measures include average adjusted pumps and total points earned.

  16. Design Fluency Test (D-KEFS)

    Time frame: Baseline, 3 months, and 6 months

    The Design Fluency Test from the D-KEFS assesses nonverbal fluency, cognitive flexibility, and visual creativity. Participants generate as many unique designs as possible while following specific task rules. Outcome measures include the number of correct designs and errors.

  17. Coding (WISC-V)

    Time frame: Baseline, 3 months, and 6 months

    The WISC-V Coding subtest assesses processing speed. Participants rapidly match symbols to numbers according to a predefined key within a limited time period. Outcome measures are based on the number of correctly completed items.

  18. Symbol Search (WISC-V)

    Time frame: Baseline, 3 months, and 6 months

    The WISC-V Symbol Search subtest assesses processing speed and visual discrimination. Participants determine whether target symbols are present among a set of search symbols within a limited time period. Outcome measures are based on the number of correct responses.

  19. Digit Span Forward (WISC-V)

    Time frame: Baseline, 3 months, and 6 months

    The WISC-V Digit Span Forward subtest assesses auditory attention and immediate verbal recall. Participants repeat sequences of numbers in the same order as presented. Outcome measures are based on the number of correctly recalled sequences.

  20. Pegboard & Beads Task (Zürcher Neuromotorik II)

    Time frame: Baseline, 3 months, and 6 months

    The Pegboard & Beads Task from Zürcher Neuromotorik II assesses fine motor skills. Participants complete tasks requiring precise hand and finger movements. Outcome measures are based on task performance and completion time.

  21. Stress assess by hair cortisol concentrations

    Time frame: Baseline, 6 months

    Physiological stress assessed by cortisol concentration measured in 3 cm hair samples

  22. Stress measures using heart rate variability during MRI acquisition

    Time frame: Baseline, 3 months, 6 months

    Stress assessed by heart rate variability derived from pulse oximetry recordings acquired during MRI data collection

  23. Behavior Rating Inventory for Executive Function (BRIEF)

    Time frame: 3 months, 6 months (follow-up)

    Assesses executive functions in the home environment. This questionnaire assesses 8 dimensions of behaviour: Inhibitory control, shift, emotional control, initiate, working memory (WM), planning, organization of materials and monitor.

  24. Family Relationship Index (FRI)

    Time frame: Baseline, 3 months, 6 months

    The FRI is a self-report measure for parents that provides an overall index of the quality of the family environment, as well as subscores that reflect family cohesion, expressiveness, and conflict.

  25. Short Form-12 (SF-12)

    Time frame: Baseline, 3 months, 6 months

    The SF-12 is a self-report measure for parents that assesses quality of life (QoL) and provides two summary scores, with higher scores indicating higher QoL.

  26. Kidscreen-27

    Time frame: Baseline, 3 months, 6 months

    Assesses the subjective health and well-being of the child from the perspective of a parent.

  27. Kidscreen-10

    Time frame: Baseline, 3 months, 6 months

    Assesses the subjective health and well-being of the child from his/her own perspective.

  28. Brief Symptom Inventory (BSI-18)

    Time frame: Baseline, 3 months, 6 months

    A self-report measure for adults to assess mental health.

  29. Parenting Stress Index (PSI-4)

    Time frame: Baseline, 3 months, 6 months

    The German version of the Parenting Stress Index (PSI-4). A self-report measure for adults to assess stress.

  30. Questionnaire for assessing stress and stress coping abilities of children and adolescents (SSKJ 3-8R)

    Time frame: Baseline, 3 months, 6 months

    A self-report questionnaire that assesses stress and stress coping abilities of children and adolescents. Assessment of subscales stress vulnerability and the stress symptoms and well-being will be done, with higher scores indicating higher stress vulnerability and stress symptoms and well-being.

  31. Resilience Scale (RS-13)

    Time frame: Baseline, 3 months, 6 months

    A self-report for adults that measures a global score for resilience, with a higher score indicating higher resilience.

  32. Resilience scale for children aged 7-10 years (RS-GS)

    Time frame: Baseline, 3 months, 6 months

    A self-report questionnaire that assesses resilience of children aged 7-10 years. Higher scores indicate higher resilience.

  33. Resilience scale for adolescents (RS-J)

    Time frame: Baseline, 3 months, 6 months

    A self-report questionnaire that assesses resilience of adolescents aged 10-18 years. Higher scores indicate higher resilience.

  34. Questionnaire assessing personal and social resources of children and adolescents (FRKJ 8-16)

    Time frame: Baseline, 3 months, 6 months

    A self-report questionnaire that assesses personal and social resources of children and adolescents. Subscales assessed being self-efficacy and self-esteem. Higher scores indicate better resources.

  35. Conners-3 Parent Short form (Conners 3-P(S))

    Time frame: Baseline, 3 months, 6 months

    A proxy-questionnaire for children, filled in by their parents that assesses their child's behavior.

  36. State Trait Anxiety Inventory (STAI)

    Time frame: Baseline, 3 months, 6 months

    A self-report questionnaire for adults to assess anxiety and depression, mainly anxiety.

  37. Child Behavior Checklist (CBCL 6-18R)

    Time frame: Baseline, 3 months, 6 months

    A proxy-questionnaire completed by the parents for their child. The anxious/depressed subscale (CBCL-A/D) will be used to assess symptoms of anxiety and depression. Higher scores indicate higher anxiety and depression

  38. Youth Self Report (YSR 11-18R)

    Time frame: Baseline, 3 months, 6 months

    A self-report questionnaire completed by the child to assess symptoms of anxiety and depression with the anxious/depressed subscale (YSR-A/D). Higher scores indicate higher anxiety and depression.

  39. Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline, 3 months, 6 months

    A self-report questionnaire for adults that assesses depression.

  40. Social Responsiveness Scale (SRS)

    Time frame: Baseline, 3 months, 6 months

    A proxy-questionnaire filled in by parents for their child. The SRS assesses social impairment in children.

  41. Children's Sleep Habits Questionnaire (CSHQ)

    Time frame: Baseline, 3 months, 6 months

    A proxy-questionnaire completed by the parents for their child. The CSHQ assesses sleep quality with 8 subscales regarding sleep habits, sleep problems and fatigue.

  42. Pediatric Daytime Sleepiness Scale (PDSS)

    Time frame: Baseline, 3 months, 6 months

    A self-report questionnaire for children and assesses sleepiness and fatigue. Higher scores indicate more acute daytime sleepiness.

  43. International Trauma Questionnaire for children and adolescents (ITQ-CA)

    Time frame: Baseline, 3 months, 6 months

    Available as a self-report questionnaire for children and adolescents and a proxy-report questionnaire for caregivers. Caregivers will be completing the questionnaire for their children. The ITQ-CA assesses trauma and trauma related problems. A higher total score indicates higher trauma related load.

  44. Pubertal Development Scale (PDS)

    Time frame: Baseline, 3 months, 6 months

    A self-report questionnaire for children to assess puberty status. Calculation of an overall gender specific pubertal development score will be done.

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Dr. Ruth O'Gorman Tuura

CONTACT

[email protected]

Prof. Dr. med. Bea Latal

CONTACT

[email protected]

+41 44 249 63 95

Sponsors and collaborators

Lead sponsor

Bea Latal

Other

Registry information

Official study title

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

Acronym: E-Fit Heart

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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