Effectiveness of Chinese Handwriting Intervention Program for Children With ASD

Autism Spectrum Disorder Clinical Trial

Official title:

Effectiveness of Chinese Handwriting Intervention Program for Children With ASD: A Randomized Crossover Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05841511
• Other study ID #: 202302086RINB
• Status: Completed
• Phase: N/A
• Start date: April 7, 2023
• Est. completion date: May 4, 2023

Study information

• Verified date: March 2024
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research aims to investigate the effectiveness and acceptability of the newly developed Chinese handwriting performance intervention program

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 4, 2023
• Est. primary completion date: May 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

Inclusion Criteria:

1. first or second grader

2. reported problems with poor handwriting legibility or performed less readable handwriting as claimed by their school teachers or caregivers

3. score at most 33 scores in overall legibility dimension or at-least 45 incorrect strokes in Chinese Handwriting Legibility Assessment for Children (CHLAC)

4. previously diagnosed with ASD

5. and score at least seven scores in Autism Behavior Checklist Taiwan Version (ABC-T) will be included in this study.

Exclusion Criteria:

1. any physical disability affecting the upper limb

2. any hearing or visual impairment

3. intelligence quotient below 70 or previously diagnosed with intellectual disability

4. unable to follow the evaluation instruction.

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• Chinese handwriting intervention program for children with ASD, named "Go Go Handwriting - ASD version"
The intervention program was developed and finalized by a group of occupational therapist specialists in the pediatric field. Thirty-six 20-minute activities with twelve activities for each handwriting fundamental skill were designed in this program. All intervention activities were designed based on the characteristic of Chinese characters and included different types of characters. The activities designed will also be graded according to the following principle: (1) the similarities between the character given, (2) the complexity of the figure or character in the activities, and (3) the frequency and level of therapist assistance. Furthermore, a playful and interesting intervention context will also be integratedinto the program with the design of the adventure journey of an astronaut to further facilitate the motivation and participation of the participants in our program.

Locations

Country	Name	City	State
Taiwan	National Taiwan University, Department of Occupational Therapy	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Chinese Handwriting Legibility Assessment for Children (CHLAC)	CHLAC is a self-developed assessment tool to measure handwriting legibility. The participants will be requested to copy the printed 10 Chinese characters to 2*2cm squares on the exam sheet. These Chinese characters were selected from three versions of current mandarin textbooks, and those with high-frequency and around-the-average stroke counts were chosen. These chosen characters were then selected to ensure a similar ratio of each character type in the test. A trained examiner will score the character legibility according to handwriting legibility and amounts of incorrect strokes. The handwriting legibility dimensions include size, position, orientation, proportion, and space. The total score for handwriting legibility will be 50, and a higher score indicates more legible handwriting. The incorrect strokes will also be counted; a higher score indicates less legible handwriting.	baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
Primary	Changes of The Battery of Chinese Basic Literacy (BCBL)	The BCBL is a standardized assessment to evaluate Chinese reading and writing skills. It consists of reading and writing tests. Only the copying subtest will be administered in this study to measure the handwriting speed of participants. In this test, the participant is requested to correctly and accurately copy 25 Chinese characters printed on the exam sheet (near copy subtest and 25 Chinese characters displayed on a cloth strip (far copy subtest). The number of correct characters written within the prescribed time will be calculated and converted into character copy per minute to represent their handwriting speed.	baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
Secondary	Changes of Beery-Buktenica Developmental Test of Visual-Motor Integration - Sixth Edition (VMI-6)	Beery-Buktenica Developmental Test of Visual-Motor Integration - Sixth Edition (VMI-6) is a standardized, norm-referenced assessment to measure the integration level between visual and motor systems of an individual using geometric figure copying tasks. Only the full-form test will be administered in our study. The participants were requested to copy the geometric figure printed, and a trained examiner will score the results according to the criteria given in the scoring sheet. A higher score on this test will represent a better visual-motor integration skill.	baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
Secondary	Changes of Developmental Test of Visual Perception - Third Edition (DTVP-3)	The DTVP-3 is a standardized, norm-reference test used to evaluate the visual perception skills of children between 4 and 12 years old . The test consists of 5 subscales. Only the eye-hand coordination subtest will be assessed in this study to measure the ability of children to integrate the functioning of visual and fine motor control.	baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
Secondary	Changes of Test of Visual Perceptual Skills - Fourth Edition (TVPS-4)	TVPS-4 is a motor-free visual perception test for individuals between 4 and 18 years of age. There are seven subtests in TVPS-4, including visual discrimination, visual memory, spatial relationships, form constancy, sequential memory, figure-ground and visual closure. The child is requested to choose the correct answer among 4-5 other plausible options based on the instruction, which is different in every subtest. The test was completed when there were five incorrect answers among seven consecutive questions. The raw score can be converted into a scaled score for each subtest, and the sum of the scaled score can be converted into standard scores with a mean of 100 and a standard deviation of 15 to represent the overall test performance. A higher scaled or standard score obtained represents a better visual perception skill.	baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
Secondary	Changes of Bruininks-Oseretsky Test of Motor Proficiency - Second Edition (BOT-2)	The BOT-2 is a standardized instrument to measure fine motor function in children from 4 to 21 years old. The BOT-2 consists of eight tasks; only two for fine motor control and two for manual coordination will be measured in this study: a fine motor precision task, a fine motor integration task, a manual dexterity, and an upper-limb coordination task. The raw score can be converted into item scaled score and subtest standard score to represent the fine motor performance of the children.	baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
Secondary	Changes of Pediatric Motivation Questionnaire (PMQ) and Satisfaction Questionnaire for the caregiver (SQ)	Pediatric Motivation Questionnaire (PMQ, Appendix 1) and Satisfaction Questionnaire for the caregiver (SQ, Appendix 2) is our self-developed questionnaire that aims to understand the acceptance of both participants and their caregiver to our program. PMQ and SQ are both five point-Likert scale questionnaires with 12 and 10 questions, respectively. The questions were designed based on three major domains, which include the degree of internal regulation and extrinsic motivation (value or usefulness, effort or importance), basic psychosocial need (relatedness, competence, autonomy), and degree of intrinsic motivation (interest, enjoyment). A higher average score out of 5 indicates the more acceptance and satisfaction with our program.	baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)