Executive Function Intervention for Children With Complex Congenital Heart Disease (E-Fit Heart)
2 июля 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Оцененный)
160
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Prof. Dr. med. Bea Latal
- Номер телефона: +41 44 249 63 95
- Электронная почта: bea.latal@kispi.uzh.ch
Учебное резервное копирование контактов
- Имя: Prof. Dr. Ruth O'Gorman Tuura
- Электронная почта: ruth.tuura@kispi.uzh.ch
Места учебы
-
-
Canton of Zurich
-
Zurich, Canton of Zurich, Швейцария, 8008
- University Children's Hosptial Zurich
-
Контакт:
- Prof. Dr. Ruth O'Gorman Tuura
- Электронная почта: ruth.tuura@kispi.uzh.ch
-
Контакт:
- Prof. Dr. med Bea Latal
- Номер телефона: +41 44 249 63 95
- Электронная почта: bea.latal@kispi.uzh.ch
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Да
Описание
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)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
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. |
|
Без вмешательства: 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.
|
|
|
Без вмешательства: Healthy Control Group
Children in this group will fill in daily activity logs during the 12 week period.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Changes in executive functions in everyday life from pre-intervention to post-intervention
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Persisting effects of the E-Fit intervention on executive functions in everyday life, 3 months after the post-intervention visit.
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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))
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: Baseline, 3 months, 6 months
|
A self-report questionnaire for adults that assesses depression.
|
Baseline, 3 months, 6 months
|
|
Social Responsiveness Scale (SRS)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 августа 2026 г.
Первичное завершение (Оцененный)
1 декабря 2030 г.
Завершение исследования (Оцененный)
1 декабря 2030 г.
Даты регистрации исследования
Первый отправленный
11 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
2 июля 2026 г.
Первый опубликованный (Действительный)
9 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
9 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
2 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2026-INV-001
- 10003319 (Другой номер гранта/финансирования: Swiss National Science Foundation)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .