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EC Brain Program for Children With Special Education Needs

Primary Purpose

Neurodevelopmental Disorders

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
EC Brain After-school Program
conventional intervention
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurodevelopmental Disorders

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Chinese University of Hong KongRecruiting
  • Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong KongRecruiting
  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Eye-tracking Training Group

Conventional Training Group

Arm Description

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

Conventional intervention program for special educational needs

Outcomes

Primary Outcome Measures

Wechsler Intelligence Scale for Children, 4th edition (Hong Kong)
It is an intellectual functioning test. The short-form comprising four subtests will adopted to estimate full scale IQ. The scaled scores of each subtest will be computed, ranging from 1 to 19, where higher scores indicate better performance.
Hong Kong List Learning Test
It is a memory test which composes of three learning trials of 16 Chinese words, and two delayed recall trials. The score ranges from 0 to 16 in each trial, where higher scores indicate better performance.
Conners' Continuous Performance Test
Attention Test
Shape Trail Test
Attention Test and flexibility
Tinkertoy Test
Frontal functioning test
Interview and Questionnaires for Parents and Teachers
structured interview to collect information about students' behaviors at home and in class
saccadic testing
Saccadic eye movements will be measured during the tests included but not limited to pro-saccade and anti-saccade tasks, the rapid digit and letter naming tasks, the Chinese and English passage reading, and the Corsi task

Secondary Outcome Measures

Full Information

First Posted
June 17, 2022
Last Updated
October 4, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05428657
Brief Title
EC Brain Program for Children With Special Education Needs
Official Title
EC (Emotion and Cognition) Brain Program for Children With Special Education Needs in Primary School
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodevelopmental Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group will be experimental and one group will active control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eye-tracking Training Group
Arm Type
Experimental
Arm Description
EC Brain After-school Program- computerised eye-tracking training program
Arm Title
Conventional Training Group
Arm Type
Active Comparator
Arm Description
Conventional intervention program for special educational needs
Intervention Type
Other
Intervention Name(s)
EC Brain After-school Program
Intervention Description
Computerized Eye-tracking Attention and Impulse Control Training Computerized Temporal Processing Training Education on Relaxation, Stress Management and Healthy Balanced Diet
Intervention Type
Other
Intervention Name(s)
conventional intervention
Intervention Description
Conventional cognitive training on their language and learning capacities (e.g., learning adjectives, logical reasoning, composition, reading words and story) and attention ability
Primary Outcome Measure Information:
Title
Wechsler Intelligence Scale for Children, 4th edition (Hong Kong)
Description
It is an intellectual functioning test. The short-form comprising four subtests will adopted to estimate full scale IQ. The scaled scores of each subtest will be computed, ranging from 1 to 19, where higher scores indicate better performance.
Time Frame
10 minutes
Title
Hong Kong List Learning Test
Description
It is a memory test which composes of three learning trials of 16 Chinese words, and two delayed recall trials. The score ranges from 0 to 16 in each trial, where higher scores indicate better performance.
Time Frame
10 minutes
Title
Conners' Continuous Performance Test
Description
Attention Test
Time Frame
15 minutes
Title
Shape Trail Test
Description
Attention Test and flexibility
Time Frame
10 minutes
Title
Tinkertoy Test
Description
Frontal functioning test
Time Frame
5 minutes
Title
Interview and Questionnaires for Parents and Teachers
Description
structured interview to collect information about students' behaviors at home and in class
Time Frame
20 minutes
Title
saccadic testing
Description
Saccadic eye movements will be measured during the tests included but not limited to pro-saccade and anti-saccade tasks, the rapid digit and letter naming tasks, the Chinese and English passage reading, and the Corsi task
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnes SY Chan, Professor
Phone
+85239436648
Email
aschan@psy.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Sophia LM Sze, PhD
Phone
+85239434166
Email
lmsze@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes SY Chan, Professor
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnes SY Chan, Professor
Phone
+85239436648
Email
aschan@psy.cuhk.edu.hk
Facility Name
Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sui-yin Agnes Chan, PhD
Phone
+85239434166
Email
aschan@cuhk.edu.hk
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnes SY Chan, Professor
Phone
+85239436648
Email
aschan@psy.cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigator do not plan to share Individual Participant Data. It is because this study is funded by a private funding source, the data are belonged to that source. So, sharing IPD is not available.
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EC Brain Program for Children With Special Education Needs

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