EC Brain Program for Children With Special Education Needs

Neurodevelopmental Disorders Clinical Trial

Official title:

EC (Emotion and Cognition) Brain Program for Children With Special Education Needs in Primary School

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05428657
• Other study ID #: 2020.501-T
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 328
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurodevelopmental Disorders

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
China	The Chinese University of Hong Kong	Hong Kong
Hong Kong	Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong Kong	Hong Kong
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Countries where clinical trial is conducted

China,  Hong Kong, 

References & Publications (30)

Biederman J, Monuteaux MC, Doyle AE, Seidman LJ, Wilens TE, Ferrero F, Morgan CL, Faraone SV. Impact of executive function deficits and attention-deficit/hyperactivity disorder (ADHD) on academic outcomes in children. J Consult Clin Psychol. 2004 Oct;72(5 — View Citation

Breier JI, Fletcher JM, Foorman BR, Klaas P, Gray LC. Auditory temporal processing in children with specific reading disability with and without attention deficit/hyperactivity disorder. J Speech Lang Hear Res. 2003 Feb;46(1):31-42. doi: 10.1044/1092-4388 — View Citation

Chan AS, Cheung MC, Sze SL, Leung WW, Shi D. Shaolin dan tian breathing fosters relaxed and attentive mind: a randomized controlled neuro-electrophysiological study. Evid Based Complement Alternat Med. 2011;2011:180704. doi: 10.1155/2011/180704. Epub 2010 — View Citation

Chan AS, Han YM, Sze SL, Lau EM. Neuroenhancement of Memory for Children with Autism by a Mind-Body Exercise. Front Psychol. 2015 Dec 11;6:1893. doi: 10.3389/fpsyg.2015.01893. eCollection 2015. — View Citation

Chan AS, Sze SL, Han YM, Cheung MC. A chan dietary intervention enhances executive functions and anterior cingulate activity in autism spectrum disorders: a randomized controlled trial. Evid Based Complement Alternat Med. 2012;2012:262136. doi: 10.1155/20 — View Citation

Chan AS, Sze SL, Siu NY, Lau EM, Cheung MC. A chinese mind-body exercise improves self-control of children with autism: a randomized controlled trial. PLoS One. 2013 Jul 10;8(7):e68184. doi: 10.1371/journal.pone.0068184. Print 2013. — View Citation

Chan AS, Wong QY, Sze SL, Kwong PP, Han YM, Cheung MC. A Chinese Chan-based mind-body intervention for patients with depression. J Affect Disord. 2012 Dec 15;142(1-3):283-9. doi: 10.1016/j.jad.2012.05.018. Epub 2012 Jul 25. — View Citation

Chan AS, Wong QY, Sze SL, Kwong PP, Han YM, Cheung MC. A Chinese chan-based mind-body intervention improves sleep on patients with depression: a randomized controlled trial. ScientificWorldJournal. 2012;2012:235206. doi: 10.1100/2012/235206. Epub 2012 Apr — View Citation

Chan, A.S., Sze, S.L., & Shi, D. (2008). Traditional Chinese mind-body exercises improve self control ability of an adolescent with Asperger's disorder. Journal of Psychology in Chinese Societies, 9, 225-239.

Craig F, Margari F, Legrottaglie AR, Palumbi R, de Giambattista C, Margari L. A review of executive function deficits in autism spectrum disorder and attention-deficit/hyperactivity disorder. Neuropsychiatr Dis Treat. 2016 May 12;12:1191-202. doi: 10.2147 — View Citation

Harrington DL, Haaland KY. Neural underpinnings of temporal processing: a review of focal lesion, pharmacological, and functional imaging research. Rev Neurosci. 1999;10(2):91-116. doi: 10.1515/revneuro.1999.10.2.91. — View Citation

Johnson MH. Functional brain development in humans. Nat Rev Neurosci. 2001 Jul;2(7):475-83. doi: 10.1038/35081509. No abstract available. — View Citation

Kwakye LD, Foss-Feig JH, Cascio CJ, Stone WL, Wallace MT. Altered auditory and multisensory temporal processing in autism spectrum disorders. Front Integr Neurosci. 2011 Jan 5;4:129. doi: 10.3389/fnint.2010.00129. eCollection 2011. — View Citation

Lee TL, Yeung MK, Sze SL, Chan AS. Computerized Eye-Tracking Training Improves the Saccadic Eye Movements of Children with Attention-Deficit/Hyperactivity Disorder. Brain Sci. 2020 Dec 21;10(12):1016. doi: 10.3390/brainsci10121016. — View Citation

Lee TL, Yeung MK, Sze SL, Chan AS. Eye-Tracking Training Improves Inhibitory Control in Children with Attention-Deficit/Hyperactivity Disorder. Brain Sci. 2021 Mar 2;11(3):314. doi: 10.3390/brainsci11030314. — View Citation

Loo JH, Bamiou DE, Campbell N, Luxon LM. Computer-based auditory training (CBAT): benefits for children with language- and reading-related learning difficulties. Dev Med Child Neurol. 2010 Aug;52(8):708-17. doi: 10.1111/j.1469-8749.2010.03654.x. Epub 2010 — View Citation

Mauk MD, Buonomano DV. The neural basis of temporal processing. Annu Rev Neurosci. 2004;27:307-40. doi: 10.1146/annurev.neuro.27.070203.144247. — View Citation

Merzenich M, Wright B, Jenkins W, Xerri C, Byl N, Miller S, Tallal P. Cortical plasticity underlying perceptual, motor, and cognitive skill development: implications for neurorehabilitation. Cold Spring Harb Symp Quant Biol. 1996;61:1-8. No abstract avail — View Citation

Powell G, Wass SV, Erichsen JT, Leekam SR. First evidence of the feasibility of gaze-contingent attention training for school children with autism. Autism. 2016 Nov;20(8):927-937. doi: 10.1177/1362361315617880. Epub 2016 Feb 9. — View Citation

Riggs NR, Blair CB, Greenberg MT. Concurrent and 2-year longitudinal relations between executive function and the behavior of 1st and 2nd grade children. Child Neuropsychol. 2003 Dec;9(4):267-76. doi: 10.1076/chin.9.4.267.23513. — View Citation

Rommelse NN, Van der Stigchel S, Sergeant JA. A review on eye movement studies in childhood and adolescent psychiatry. Brain Cogn. 2008 Dec;68(3):391-414. doi: 10.1016/j.bandc.2008.08.025. Epub 2008 Oct 2. — View Citation

Schulte-Korne G, Deimel W, Bartling J, Remschmidt H. Role of auditory temporal processing for reading and spelling disability. Percept Mot Skills. 1998 Jun;86(3 Pt 1):1043-7. doi: 10.2466/pms.1998.86.3.1043. — View Citation

Steinmayr, R., Ziegler, M., & Träuble, B. (2010). Do intelligence and sustained attention interact in predicting academic achievement?. Learning and Individual Differences, 20(1), 14-18.

Tallal P. Improving language and literacy is a matter of time. Nat Rev Neurosci. 2004 Sep;5(9):721-8. doi: 10.1038/nrn1499. — View Citation

Tarver S. G., & Hallahan, D. P. (1974). Attention deficits in children with learning disabilities: a review. Journal of Learning Disabilities, 7, 560-569.

Temple E, Deutsch GK, Poldrack RA, Miller SL, Tallal P, Merzenich MM, Gabrieli JD. Neural deficits in children with dyslexia ameliorated by behavioral remediation: evidence from functional MRI. Proc Natl Acad Sci U S A. 2003 Mar 4;100(5):2860-5. doi: 10.1 — View Citation

Toplak ME, Dockstader C, Tannock R. Temporal information processing in ADHD: findings to date and new methods. J Neurosci Methods. 2006 Feb 15;151(1):15-29. doi: 10.1016/j.jneumeth.2005.09.018. Epub 2005 Dec 27. — View Citation

Tuso PJ, Ismail MH, Ha BP, Bartolotto C. Nutritional update for physicians: plant-based diets. Perm J. 2013 Spring;17(2):61-6. doi: 10.7812/TPP/12-085. — View Citation

Wang LC, Liu D, Xu Z. Distinct effects of visual and auditory temporal processing training on reading and reading-related abilities in Chinese children with dyslexia. Ann Dyslexia. 2019 Jul;69(2):166-185. doi: 10.1007/s11881-019-00176-8. Epub 2019 Jan 22. — View Citation

Zhao Q, Guo Q, Li F, Zhou Y, Wang B, Hong Z. The Shape Trail Test: application of a new variant of the Trail making test. PLoS One. 2013;8(2):e57333. doi: 10.1371/journal.pone.0057333. Epub 2013 Feb 20. — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes
Primary	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.	10 minutes
Primary	Conners' Continuous Performance Test	Attention Test	15 minutes
Primary	Shape Trail Test	Attention Test and flexibility	10 minutes
Primary	Tinkertoy Test	Frontal functioning test	5 minutes
Primary	Interview and Questionnaires for Parents and Teachers	structured interview to collect information about students' behaviors at home and in class	20 minutes
Primary	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	30 minutes