EC Brain Program for Children With Special Education Needs

NCT05428657 | Active Not Recruiting DMC

• 1 other identifier: 2020.501-T
• Study Type: interventional
• Target: 328
• Locations: 2 countries
• Sites: 3

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.

Conditions

Neurodevelopmental Disorders

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• Conners' Continuous Performance Test

  Attention Test

  15 minutes

• Shape Trail Test

  Attention Test and flexibility

  10 minutes

• Tinkertoy Test

  Frontal functioning test

  5 minutes

• Interview and Questionnaires for Parents and Teachers

  structured interview to collect information about students' behaviors at home and in class

  20 minutes

• 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

Study Arms (2)

Eye-tracking Training Group

EXPERIMENTAL

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

Other: EC Brain After-school Program

Conventional Training Group

ACTIVE COMPARATOR

Conventional intervention program for special educational needs

Other: conventional intervention

Interventions

EC Brain After-school Program OTHER

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

Eye-tracking Training Group

conventional intervention OTHER

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

Conventional Training Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (3)

The Chinese University of Hong Kong

Hong Kong, China

Location

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

Hong Kong, Hong Kong

Location

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (32)

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  RESULT

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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.

  PMID: 37780065 DERIVED

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Agnes SY Chan, Professor

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: One group will be experimental and one group will active control

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 23, 2022
• Study Start: October 19, 2020
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); HK (2)