Executive Function Intervention for Children With Complex Congenital Heart Disease (E-Fit Heart)
2026年7月2日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
160
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Prof. Dr. med. Bea Latal
- 電話番号：+41 44 249 63 95
- メール：bea.latal@kispi.uzh.ch
研究連絡先のバックアップ
- 名前：Prof. Dr. Ruth O'Gorman Tuura
- メール：ruth.tuura@kispi.uzh.ch
研究場所
-
-
Canton of Zurich
-
Zurich、Canton of Zurich、スイス、8008
- University Children's Hosptial Zurich
-
コンタクト：
- Prof. Dr. Ruth O'Gorman Tuura
- メール：ruth.tuura@kispi.uzh.ch
-
コンタクト：
- Prof. Dr. med Bea Latal
- 電話番号：+41 44 249 63 95
- メール：bea.latal@kispi.uzh.ch
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
はい
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
介入なし：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.
|
|
|
介入なし：Healthy Control Group
Children in this group will fill in daily activity logs during the 12 week period.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in executive functions in everyday life from pre-intervention to post-intervention
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Persisting effects of the E-Fit intervention on executive functions in everyday life, 3 months after the post-intervention visit.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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))
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：Baseline, 3 months, 6 months
|
A self-report questionnaire for adults that assesses depression.
|
Baseline, 3 months, 6 months
|
|
Social Responsiveness Scale (SRS)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2030年12月1日
研究の完了 (推定)
2030年12月1日
試験登録日
最初に提出
2026年6月11日
QC基準を満たした最初の提出物
2026年7月2日
最初の投稿 (実際)
2026年7月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月9日
QC基準を満たした最後の更新が送信されました
2026年7月2日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。