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

2. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

160

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Švýcarsko
    • Canton of Zurich
      • Zurich, Canton of Zurich, Švýcarsko, 8008

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ano

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Jiný: 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.
Žádný zásah: 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.
Žádný zásah: Healthy Control Group
Children in this group will fill in daily activity logs during the 12 week period.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in executive functions in everyday life from pre-intervention to post-intervention
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Persisting effects of the E-Fit intervention on executive functions in everyday life, 3 months after the post-intervention visit.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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))
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: Baseline, 3 months, 6 months
A self-report questionnaire for adults that assesses depression.
Baseline, 3 months, 6 months
Social Responsiveness Scale (SRS)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Bea Latal

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

1. prosince 2030

Dokončení studie (Odhadovaný)

1. prosince 2030

Termíny zápisu do studia

První předloženo

11. června 2026

První předloženo, které splnilo kritéria kontroly kvality

2. července 2026

První zveřejněno (Aktuální)

9. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2026-INV-001
  • 10003319 (Jiné číslo grantu/financování: Swiss National Science Foundation)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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