Executive Function Intervention for Children With Complex Congenital Heart Disease: A Randomised Control Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Changes in executive functions in everyday life from pre-intervention to post-intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Changes in executive functions in everyday life from pre-intervention to post-intervention
时间窗: 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)
次要结局
- Persisting effects of the E-Fit intervention on executive functions in everyday life, 3 months after the post-intervention visit.(Screening, 3 months, 6 months)
- Resting-state functional connectivity(Baseline, 3 months, 6 months)
- Task-based fMRI activation during executive function tasks(Baseline)
- Training-related changes in task-based fMRI activation(Baseline, 3 months, 6 months)
- Multi-shell diffusion-tensor imaging(3 months)
- Myelin Mapping with multiparametric MRI(6 months)
- Color Word Interference Test (D-KEFS)(Baseline, 3 months, and 6 months)
- Alertness (TAP)(Baseline, 3 months, and 6 months)
- Go/No-Go (TAP)(Baseline, 3 months, and 6 months)
- Tower Test (D-KEFS)(Baseline, 3 months, and 6 months)
- Trail Making Test (D-KEFS)(Baseline, 3 months, and 6 months)
- Regensburger Word Fluency Test (RWT)(Baseline, 3 months, and 6 months)
- Digit Span Backward (WISC-V)(Baseline, 3 months, and 6 months)
- Number-Letter Sequencing (WISC-V)(Baseline, 3 months, and 6 months)
- Balloon Analogue Risk Task (BART)(Baseline, 3 months, and 6 months)
- Design Fluency Test (D-KEFS)(Baseline, 3 months, and 6 months)
- Coding (WISC-V)(Baseline, 3 months, and 6 months)
- Symbol Search (WISC-V)(Baseline, 3 months, and 6 months)
- Digit Span Forward (WISC-V)(Baseline, 3 months, and 6 months)
- Pegboard & Beads Task (Zürcher Neuromotorik II)(Baseline, 3 months, and 6 months)
- Stress assess by hair cortisol concentrations(Baseline, 6 months)
- Stress measures using heart rate variability during MRI acquisition(Baseline, 3 months, 6 months)
- Behavior Rating Inventory for Executive Function (BRIEF)(3 months, 6 months (follow-up))
- Family Relationship Index (FRI)(Baseline, 3 months, 6 months)
- Short Form-12 (SF-12)(Baseline, 3 months, 6 months)
- Kidscreen-27(Baseline, 3 months, 6 months)
- Kidscreen-10(Baseline, 3 months, 6 months)
- Brief Symptom Inventory (BSI-18)(Baseline, 3 months, 6 months)
- Parenting Stress Index (PSI-4)(Baseline, 3 months, 6 months)
- Questionnaire for assessing stress and stress coping abilities of children and adolescents (SSKJ 3-8R)(Baseline, 3 months, 6 months)
- Resilience Scale (RS-13)(Baseline, 3 months, 6 months)
- Resilience scale for children aged 7-10 years (RS-GS)(Baseline, 3 months, 6 months)
- Resilience scale for adolescents (RS-J)(Baseline, 3 months, 6 months)
- Questionnaire assessing personal and social resources of children and adolescents (FRKJ 8-16)(Baseline, 3 months, 6 months)
- Conners-3 Parent Short form (Conners 3-P(S))(Baseline, 3 months, 6 months)
- State Trait Anxiety Inventory (STAI)(Baseline, 3 months, 6 months)
- Child Behavior Checklist (CBCL 6-18R)(Baseline, 3 months, 6 months)
- Youth Self Report (YSR 11-18R)(Baseline, 3 months, 6 months)
- Patient Health Questionnaire (PHQ-9)(Baseline, 3 months, 6 months)
- Social Responsiveness Scale (SRS)(Baseline, 3 months, 6 months)
- Children's Sleep Habits Questionnaire (CSHQ)(Baseline, 3 months, 6 months)
- Pediatric Daytime Sleepiness Scale (PDSS)(Baseline, 3 months, 6 months)
- International Trauma Questionnaire for children and adolescents (ITQ-CA)(Baseline, 3 months, 6 months)
- Pubertal Development Scale (PDS)(Baseline, 3 months, 6 months)
研究者
Bea Latal
Prof. Dr. med Beatrix Latal
University Children's Hospital, Zurich