EC Brain Program for Children With Special Education Needs

NCT ID: NCT05428657

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2025-08-31

Brief Summary

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Children with special education needs (SEN) (e.g., autism, attention-deficit/hyperactivity disorder, dyslexia) who are studying in the mainstream primary schools are commonly found to have difficulties in learning school materials, and controlling their emotion and behaviors in class. Such schooling problems are likely related to their deficient attention, self-control ability and language abilities. As a result, they will easily be stressful, losing confidence, or even be the target of bullying or discrimination. This project aims to evaluate a neuroscience based after-school training program, namely EC Brain Program, to improve academic performance, cognition (attention, self-control and language ability), behaviors and psychological health of primary school students with SEN. The EC Brain Program is composed of computerized training programs that were developed to enhance abilities of attention, self-control and temporal processing (i.e., a fundamental cognitive ability in mastering reading and language skills), and education on basic neuroscience knowledge and ways to enhance brain functions and psychological wellness, e.g., relaxation, stress management and balanced healthy diet. A total of 100 - 250 students with SEN from 10 ordinary primary schools will be recruited in 3-year period. They will be randomly assigned into two groups. Both groups will undergo pre- and post-assessments evaluating their academic performance, cognitive functions, saccadic eye movements, physical and mental health conditions before and after the training. Students in the group A will have to participate in the EC Brain after-school program, whereas students in the group B will join conventional intervention. It is an eight-month weekly program, 90 minutes per session. It is hypothesized that students who have joined the EC Brain Program will show greater extent of improvement in academic performance, behavioral problems, cognitive functions (e.g., attention, learning, self-control, language), saccadic eye movements and psychological wellness than those in the other group. The findings of present study will shed some light on the effectiveness and applicability of the EC Brain Program as a potential after-school neuropsychological intervention for students with SEN.

Detailed Description

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Children with neurodevelopmental disorders are repeatedly found to have impairment in attention and self-control ability, which are part of executive functions and are largely mediated by the network among frontal, parietal and anterior cingulate brain regions. A recent review (Craig et al., 2016) suggested that ASD and ADHD share impairment in attention, response inhibition, working memory, flexibility, monitoring, fluency, and concept formation. In the review of Tarver and Hallahan (1974), children with SpLD were found to exhibit more distractibility on tasks, more impulsive and more hyperactive in a structured situation than typically developed children. Deficits in attention and self-control are highly associated with poorer school performance and more problem behaviors at school (Biederman et al., 2004; Riggs, Blair, Greenberg, 2010; Steinmayr, Ziegler, Träuble, 2010).

Eye gaze processing and temporal processing are two fundamental building blocks for higher cortical functions such as attention, memory, inhibitory control, language. Empirical research suggests that abnormal neurodevelopment of visual tracking correlates with the delayed maturation of functions in the frontal brain region, such as attention, inhibition and social communication (Johnson, 2001). In addition, children with SEN demonstrating abnormal cognitive functions or behaviours are found to have abnormal control of eye movement. For instance, atypical eye gazing at early stage of development is found to be related to attention deficit, joint attention and social functioning in ASD (Johnson, 2001). Abnormal eye movement is also evident in children with ADHD and reading disorder (Rommelse, Van der Stigchel \& Sergeant, 2008). Increasing empirical research have been conducted to study the effectiveness of eye-tracking training in children with SEN. Powell et al. (2016) have conducted a computerized attention training to a group of ASD children using an eye-tracking system. After a training of 120 minutes within an average of 12 weeks, there was an improvement in visual sustained attention in a group of ASD children. Based on the similar concept, our research team has developed a gaze-contingent sustained attention and self-control training using the eye-tracking system. Our recent pilot study (Lee, Yeung, Sze, \& Chan, 2021) revealed that 240-minute eye-tracking training for children with and without ADHD demonstrated significantly improved inhibitory control and mental flexibility after training, whereas children in the control group did not show significant changes.

Temporal processing underpinning all sensory and motor processing refers to how the nervous system processes time in the range of tens to hundreds of milliseconds. Temporal processing is a prerequisite condition for linguistic abilities (Schulte-Körne, Deimel, Bartling \& Remschmidt, 1998) and highly associated with attention, memory and behavioural inhibition (Harrington \& Haaland, 1999; Toplak, Dockstader, Tannock, 2006). Brain regions including basal ganglia, cerebellum, right parietal and dorsolateral prefrontal cortex play an important role in temporal processing (Mauk \& Buonomano, 2004). Temporal processing deficits in visual or auditory modalities are repeatedly found among individuals with ASD, ADHD and SpLD. Kwakye et al., (2011) found that children with ASD demonstrated impaired auditory temporal processing as reflected by their higher threshold in the auditory temporal order judgment task comparing to typically developed children. Breier et al. (2003) found that children with ADHD or ADHD comorbid with reading disability showed a more pervasive deficit in perception of auditory temporal cues in nonspeech stimuli. Tallal (2004) and Merzenich et al. (2008) proposed that temporal processing deficit is basic deficit underlying the phonological and language difficulties of children with SpLD.

Meanwhile, it has been found that early intervention to improve auditory and visual temporal processing can have a significant positive impact on a child's learning. A systematic review (Loo et al., 2010) on the effectiveness of computer-based auditory training on processing non-speech and simple speech sounds has reported that some forms of training can improve children's phonological awareness skills (a fundamental skill for reading and verbal communication), whereas others may be effective in improving children's reading skills. Temple et al. (2003) conducted an empirical study and they found that 20 children with dyslexia demonstrated significantly improved oral language and reading performance after auditory processing training for an average of 27.9 training days, 100 min per day, 5 days per week. After the training, children with dyslexia showed increased activity in the left-sided brain regions, in which they showed hypo-activity compared to typically developed children before training. Wang, Liu, Xu (2019) also reported distinct effects of visual and auditory temporal processing training on reading and reading-related abilities in Chinese children with dyslexia. Children receiving 12 sessions, 3 to 4 times per week, 30-40 minutes per session of (1) auditory temporal processing training or (2) visual temporal processing training exhibited significantly improved reading and rapid naming ability. Yet, the control group with no specific training did not show such changes.

In view of the encouraging findings of eye tracking training and temporal processing training, the EC Brain after-school training program proposed in present study has thus incorporated these two forms of training for students with SEN. In addition to these two trainings, participating students are also educated on scientific lifestyle medicine methods to enhance their learning capacity and resilience against stress. They will be encouraged to develop a healthy life habit by practicing relaxation and stress management techniques and adopting a healthy balanced diet. According to WHO guidelines (2010), children aged 5-17 years old should accumulate at least 60 minutes of moderate-to vigorous-intensity physical activity daily, in order to improve physical and mental health. A traditional Chinese mind-body exercise, namely Neigong, involves gentle and calm movement and emphasizes on training self-awareness and concentration with a relaxed mind (Chan et al., 2008, 2011, 2013, 2015). It can be classified as a moderate intensity cardiovascular exercise and a relaxation exercise that primary school children can easily master. Research shows that one-month practice of the mind-body exercise can enhance self-control ability and memory function, and altered the corresponding brain activity level of children with ASD (Chan et al., 2008, 2013, 2015). Clinical observation also showed better control of temper and impulsive acts, and higher resilience against stressors after regular practice of Neigong in children with SEN. A healthy balanced diet according to MyPlate is the nutrition guide published by the United States Department of Agriculture (USDA). MyPlate suggests intake of healthy food at a specified balanced proportion: Whole grains (30%), Vegetables and Fruits (50%), and Protein (20%). For the Protein category, more emphasis is put on a higher intake of plant-based protein (e.g., seeds, beans, nuts). Children with ASD adopting the balanced healthy diet showed significantly enhanced cognitive flexibility, impulse control and planning ability, reduced social communication problem and repetitive behaviors, and increased EEG brain activity (Chan, et al., 2012a).

The primary objective of the present study is to examine the effectiveness and applicability of a neuroscience-based after-school EC Brain Program in improving academic performance, cognition, saccadic eye movements, behaviors and psychological health of 100-250 Chinese students with SEN from 10 ordinary local primary schools. It is hypothesized that students joining EC Brain Program will demonstrate greater extent of improvement in academic performance, attention, self-control, language ability, and saccadic eye movements, greater reduction in behavioral problems and better psychological well-being after training. In contrast, children in the conventional training group will not have similar extent of improvements as the EC Brain group.

Conditions

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Neurodevelopmental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One group will be experimental and one group will active control
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Eye-tracking Training Group

EC Brain After-school Program- computerised eye-tracking training program

Group Type EXPERIMENTAL

EC Brain After-school Program

Intervention Type OTHER

* Computerized Eye-tracking Attention and Impulse Control Training
* Computerized Temporal Processing Training
* Education on Relaxation, Stress Management and Healthy Balanced Diet

Conventional Training Group

Conventional intervention program for special educational needs

Group Type ACTIVE_COMPARATOR

conventional intervention

Intervention Type OTHER

Conventional cognitive training on their language and learning capacities (e.g., learning adjectives, logical reasoning, composition, reading words and story) and attention ability

Interventions

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EC Brain After-school Program

* Computerized Eye-tracking Attention and Impulse Control Training
* Computerized Temporal Processing Training
* Education on Relaxation, Stress Management and Healthy Balanced Diet

Intervention Type OTHER

conventional intervention

Conventional cognitive training on their language and learning capacities (e.g., learning adjectives, logical reasoning, composition, reading words and story) and attention ability

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* primary school Chinese students with SEN (e.g., Autism Spectrum Disorders, Attention-Deficit/Hyperactivity Disorders, Specific Learning Disorders)
* aged between 6 to 12 years
* with formal diagnosis of neurodevelopmental disorders by psychiatrist or clinical / educational psychologist

Exclusion Criteria

・students with mental disabilities, significant physical disability, or history of other neurological or psychiatric disorder or brain injury
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Professor Chan Sui-yin Agnes

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Agnes SY Chan, Professor

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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The Chinese University of Hong Kong

Hong Kong, , China

Site Status

Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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China Hong Kong

References

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Chan AS, Leung PY, Pang TW, Sze SL. Eye-tracking training improves visuospatial working memory of children with attention-deficit/hyperactivity disorder and autism spectrum disorder. Autism Res. 2024 Nov;17(11):2244-2260. doi: 10.1002/aur.3238. Epub 2024 Oct 4.

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Chan AS, Sze SL, Cheung MC. Temporal processing tele-intervention improves language, attention, and memory in children with neurodevelopmental disorders. Digit Health. 2023 Sep 28;9:20552076231203900. doi: 10.1177/20552076231203900. eCollection 2023 Jan-Dec.

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Other Identifiers

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2020.501-T

Identifier Type: -

Identifier Source: org_study_id

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