Autism Spectrum DisorderNCT05841511
Effectiveness of Chinese Handwriting Intervention Program for Children With ASD
A study testing Chinese handwriting intervention program for children with ASD, named "Go Go Handwriting - ASD version" in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This research aims to investigate the effectiveness and acceptability of the newly developed Chinese handwriting performance intervention program Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Chinese handwriting intervention program for children with ASD, named "Go Go Handwriting - ASD version"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Apr 2023to 4 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- first or second grader
- reported problems with poor handwriting legibility or performed less readable handwriting as claimed by their school teachers or caregivers
- score at most 33 scores in overall legibility dimension or at-least 45 incorrect strokes in Chinese Handwriting Legibility Assessment for Children (CHLAC)
- previously diagnosed with ASD
- and score at least seven scores in Autism Behavior Checklist Taiwan Version (ABC-T) will be included in this study.
Who cannot join
- any physical disability affecting the upper limb
- any hearing or visual impairment
- intelligence quotient below 70 or previously diagnosed with intellectual disability
- unable to follow the evaluation instruction.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University, Department of Occupational Therapy
Taipei, 100
About this study
Official title: Effectiveness of Chinese Handwriting Intervention Program for Children With ASD: A Randomized Crossover Trail
This research aims to investigate the effectiveness and acceptability of the newly developed Chinese handwriting performance intervention program
- Conditions
- Autism Spectrum Disorder
- Being tested
- Chinese handwriting intervention program for children with ASD, named "Go Go Handwriting - ASD version"
- Keywords
- handwriting performance, neurodevelopmental disorder, visual perceptual skills, fine motor skills, visual motor integration skills
- Medical subject headings
- Autism Spectrum Disorder, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese handwriting intervention program for children with ASD, named "Go Go Handwriting - ASD version"Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment group | Experimental | The immediate treatment group will receive the intervention in the first time period, while the wait-list control group will receive the intervention program during the second time period. Baseline and outcome evaluation will be accessed at three-time points: baseline assessment (1st week), assessment 1-midway (5th week), and assessment 2-final (10th week) in this study.
To establish and develop an efficient program, several theories were implemented into the intervention design to address handwriting problems in children with ASD, including psycho-geometric theory, motor learning theory, and cognitive training theories. The intervention will be delivered in thirty-six activities for visual perceptual, fine motor, and visual motor integration skill training integrated with the unique properties of the Chinese writing system. A total of 12 hours of intervention program will be conducted in eight sessions within four weeks. Receives: Behavioral: Chinese handwriting intervention program for children with ASD, named "Go Go Handwriting - ASD version" |
| Wait-list control group | Experimental | The immediate treatment group will receive the intervention in the first time period, while the wait-list control group will receive the intervention program during the second time period. Baseline and outcome evaluation will be accessed at three-time points: baseline assessment (1st week), assessment 1-midway (5th week), and assessment 2-final (10th week) in this study.
To establish and develop an efficient program, several theories were implemented into the intervention design to address handwriting problems in children with ASD, including psycho-geometric theory, motor learning theory, and cognitive training theories. The intervention will be delivered in thirty-six activities for visual perceptual, fine motor, and visual motor integration skill training integrated with the unique properties of the Chinese writing system. A total of 12 hours of intervention program will be conducted in eight sessions within four weeks. Receives: Behavioral: Chinese handwriting intervention program for children with ASD, named "Go Go Handwriting - ASD version" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
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.
Measured: baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
Secondary outcomes (5)
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.
Measured: baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
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.
Measured: baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
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.
Measured: baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
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.
Measured: baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
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.
Measured: baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start7 Apr 2023
- Primary completion4 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841511
- Sponsor's protocol ID
- 202302086RINB
- Status last verified
- Mar 2024
- First submitted
- 21 Apr 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Chinese Handwriting Intervention Program for Children With ASD: A Randomized Crossover Trail
- ClinicalTrials.gov ID
- NCT05841511
- Acronym / sponsor ID
- 202302086RINB
- Conditions
- Autism Spectrum Disorder
- Keywords
- handwriting performance, neurodevelopmental disorder, visual perceptual skills, fine motor skills, visual motor integration skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research aims to investigate the effectiveness and acceptability of the newly developed Chinese handwriting performance intervention program
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment group | Experimental | Behavioral: Chinese handwriting intervention program for children with ASD, named "Go Go Handwriting - ASD version"The immediate treatment group will receive the intervention in the first time period, while the wait-list control group will receive the intervention program during the second time period. Baseline and outcome evaluation will be accessed at three-time points: baseline assessment (1st week), assessment 1-midway (5th week), and assessment 2-final (10th week) in this study. To establish and develop an efficient program, several theories were implemented into the intervention design to address handwriting problems in children with ASD, including psycho-geometric theory, motor learning theory, and cognitive training theories. The intervention will be delivered in thirty-six activities for visual perceptual, fine motor, and visual motor integration skill training integrated with the unique properties of the Chinese writing system. A total of 12 hours of intervention program will be conducted in eight sessions within four weeks. |
| Wait-list control group | Experimental | Behavioral: Chinese handwriting intervention program for children with ASD, named "Go Go Handwriting - ASD version"The immediate treatment group will receive the intervention in the first time period, while the wait-list control group will receive the intervention program during the second time period. Baseline and outcome evaluation will be accessed at three-time points: baseline assessment (1st week), assessment 1-midway (5th week), and assessment 2-final (10th week) in this study. To establish and develop an efficient program, several theories were implemented into the intervention design to address handwriting problems in children with ASD, including psycho-geometric theory, motor learning theory, and cognitive training theories. The intervention will be delivered in thirty-six activities for visual perceptual, fine motor, and visual motor integration skill training integrated with the unique properties of the Chinese writing system. A total of 12 hours of intervention program will be conducted in eight sessions within four weeks. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- first or second grader
- reported problems with poor handwriting legibility or performed less readable handwriting as claimed by their school teachers or caregivers
- score at most 33 scores in overall legibility dimension or at-least 45 incorrect strokes in Chinese Handwriting Legibility Assessment for Children (CHLAC)
- previously diagnosed with ASD
- and score at least seven scores in Autism Behavior Checklist Taiwan Version (ABC-T) will be included in this study.
Key exclusion criteria (4 listed)
- any physical disability affecting the upper limb
- any hearing or visual impairment
- intelligence quotient below 70 or previously diagnosed with intellectual disability
- unable to follow the evaluation instruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Immediate treatment group, Wait-list control group |
Primary outcome
Changes of Chinese Handwriting Legibility Assessment for Children (CHLAC)
Time frame: baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
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.
Changes of The Battery of Chinese Basic Literacy (BCBL)
Time frame: baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
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.
5 secondary outcomes
Changes of Beery-Buktenica Developmental Test of Visual-Motor Integration - Sixth Edition (VMI-6)
Time frame: baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
Changes of Developmental Test of Visual Perception - Third Edition (DTVP-3)
Time frame: baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
Changes of Test of Visual Perceptual Skills - Fourth Edition (TVPS-4)
Time frame: baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
Changes of Bruininks-Oseretsky Test of Motor Proficiency - Second Edition (BOT-2)
Time frame: baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
Changes of Pediatric Motivation Questionnaire (PMQ) and Satisfaction Questionnaire for the caregiver (SQ)
Time frame: baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese handwriting intervention program for children with ASD, named "Go Go Handwriting - ASD version" in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Chinese Handwriting Legibility Assessment for Children (CHLAC) (time frame: baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.