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Executive Function Intervention for Children With Complex Congenital Heart Disease (E-Fit Heart)

2 juli 2026 bijgewerkt door: Bea Latal

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

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

160

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Zwitserland
    • Canton of Zurich
      • Zurich, Canton of Zurich, Zwitserland, 8008

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Congenital Heart Disease Children Intervention Group
The children in the intervention group will participate in the 12-week long E-Fit intervention to enhance their executive functions.
Ander: 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.
Geen tussenkomst: Congenital Heart Disease Children Control Group
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.
Geen tussenkomst: Healthy Control Group
Children in this group will fill in daily activity logs during the 12 week period.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in executive functions in everyday life from pre-intervention to post-intervention
Tijdsspanne: 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)
Screening, 3 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Persisting effects of the E-Fit intervention on executive functions in everyday life, 3 months after the post-intervention visit.
Tijdsspanne: 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)
Screening, 3 months, 6 months
Resting-state functional connectivity
Tijdsspanne: Baseline, 3 months, 6 months
Functional connectivity measures using resting state fMRI
Baseline, 3 months, 6 months
Task-based fMRI activation during executive function tasks
Tijdsspanne: 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.
Baseline
Training-related changes in task-based fMRI activation
Tijdsspanne: 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.
Baseline, 3 months, 6 months
Multi-shell diffusion-tensor imaging
Tijdsspanne: 3 months
White matter microstructural integrity, neurite orientation dispersion and density imaging assessed using multi-shell diffusion MRI metrics
3 months
Myelin Mapping with multiparametric MRI
Tijdsspanne: 6 months
Quantitative MRI-derived measures of brain myelination and tissue composition using a relaxometry MRI sequence
6 months
Color Word Interference Test (D-KEFS)
Tijdsspanne: 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.
Baseline, 3 months, and 6 months
Alertness (TAP)
Tijdsspanne: 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.
Baseline, 3 months, and 6 months
Go/No-Go (TAP)
Tijdsspanne: 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.
Baseline, 3 months, and 6 months
Tower Test (D-KEFS)
Tijdsspanne: 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.
Baseline, 3 months, and 6 months
Trail Making Test (D-KEFS)
Tijdsspanne: 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.
Baseline, 3 months, and 6 months
Regensburger Word Fluency Test (RWT)
Tijdsspanne: 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.
Baseline, 3 months, and 6 months
Digit Span Backward (WISC-V)
Tijdsspanne: 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.
Baseline, 3 months, and 6 months
Number-Letter Sequencing (WISC-V)
Tijdsspanne: 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.
Baseline, 3 months, and 6 months
Balloon Analogue Risk Task (BART)
Tijdsspanne: 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.
Baseline, 3 months, and 6 months
Design Fluency Test (D-KEFS)
Tijdsspanne: 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.
Baseline, 3 months, and 6 months
Coding (WISC-V)
Tijdsspanne: 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.
Baseline, 3 months, and 6 months
Symbol Search (WISC-V)
Tijdsspanne: 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.
Baseline, 3 months, and 6 months
Digit Span Forward (WISC-V)
Tijdsspanne: 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.
Baseline, 3 months, and 6 months
Pegboard & Beads Task (Zürcher Neuromotorik II)
Tijdsspanne: 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.
Baseline, 3 months, and 6 months
Stress assess by hair cortisol concentrations
Tijdsspanne: Baseline, 6 months
Physiological stress assessed by cortisol concentration measured in 3 cm hair samples
Baseline, 6 months
Stress measures using heart rate variability during MRI acquisition
Tijdsspanne: Baseline, 3 months, 6 months
Stress assessed by heart rate variability derived from pulse oximetry recordings acquired during MRI data collection
Baseline, 3 months, 6 months
Behavior Rating Inventory for Executive Function (BRIEF)
Tijdsspanne: 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.
3 months, 6 months (follow-up)
Family Relationship Index (FRI)
Tijdsspanne: 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.
Baseline, 3 months, 6 months
Short Form-12 (SF-12)
Tijdsspanne: 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.
Baseline, 3 months, 6 months
Kidscreen-27
Tijdsspanne: Baseline, 3 months, 6 months
Assesses the subjective health and well-being of the child from the perspective of a parent.
Baseline, 3 months, 6 months
Kidscreen-10
Tijdsspanne: Baseline, 3 months, 6 months
Assesses the subjective health and well-being of the child from his/her own perspective.
Baseline, 3 months, 6 months
Brief Symptom Inventory (BSI-18)
Tijdsspanne: Baseline, 3 months, 6 months
A self-report measure for adults to assess mental health.
Baseline, 3 months, 6 months
Parenting Stress Index (PSI-4)
Tijdsspanne: Baseline, 3 months, 6 months
The German version of the Parenting Stress Index (PSI-4). A self-report measure for adults to assess stress.
Baseline, 3 months, 6 months
Questionnaire for assessing stress and stress coping abilities of children and adolescents (SSKJ 3-8R)
Tijdsspanne: 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.
Baseline, 3 months, 6 months
Resilience Scale (RS-13)
Tijdsspanne: Baseline, 3 months, 6 months
A self-report for adults that measures a global score for resilience, with a higher score indicating higher resilience.
Baseline, 3 months, 6 months
Resilience scale for children aged 7-10 years (RS-GS)
Tijdsspanne: Baseline, 3 months, 6 months
A self-report questionnaire that assesses resilience of children aged 7-10 years. Higher scores indicate higher resilience.
Baseline, 3 months, 6 months
Resilience scale for adolescents (RS-J)
Tijdsspanne: Baseline, 3 months, 6 months
A self-report questionnaire that assesses resilience of adolescents aged 10-18 years. Higher scores indicate higher resilience.
Baseline, 3 months, 6 months
Questionnaire assessing personal and social resources of children and adolescents (FRKJ 8-16)
Tijdsspanne: 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.
Baseline, 3 months, 6 months
Conners-3 Parent Short form (Conners 3-P(S))
Tijdsspanne: Baseline, 3 months, 6 months
A proxy-questionnaire for children, filled in by their parents that assesses their child's behavior.
Baseline, 3 months, 6 months
State Trait Anxiety Inventory (STAI)
Tijdsspanne: Baseline, 3 months, 6 months
A self-report questionnaire for adults to assess anxiety and depression, mainly anxiety.
Baseline, 3 months, 6 months
Child Behavior Checklist (CBCL 6-18R)
Tijdsspanne: 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
Baseline, 3 months, 6 months
Youth Self Report (YSR 11-18R)
Tijdsspanne: 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.
Baseline, 3 months, 6 months
Patient Health Questionnaire (PHQ-9)
Tijdsspanne: Baseline, 3 months, 6 months
A self-report questionnaire for adults that assesses depression.
Baseline, 3 months, 6 months
Social Responsiveness Scale (SRS)
Tijdsspanne: Baseline, 3 months, 6 months
A proxy-questionnaire filled in by parents for their child. The SRS assesses social impairment in children.
Baseline, 3 months, 6 months
Children's Sleep Habits Questionnaire (CSHQ)
Tijdsspanne: 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.
Baseline, 3 months, 6 months
Pediatric Daytime Sleepiness Scale (PDSS)
Tijdsspanne: Baseline, 3 months, 6 months
A self-report questionnaire for children and assesses sleepiness and fatigue. Higher scores indicate more acute daytime sleepiness.
Baseline, 3 months, 6 months
International Trauma Questionnaire for children and adolescents (ITQ-CA)
Tijdsspanne: 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.
Baseline, 3 months, 6 months
Pubertal Development Scale (PDS)
Tijdsspanne: 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.
Baseline, 3 months, 6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Bea Latal

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

1 december 2030

Studie voltooiing (Geschat)

1 december 2030

Studieregistratiedata

Eerst ingediend

11 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juli 2026

Eerst geplaatst (Werkelijk)

9 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-INV-001
  • 10003319 (Ander subsidie-/financieringsnummer: Swiss National Science Foundation)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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