NCT05841511

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2023

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

27 days

First QC Date

April 21, 2023

Last Update Submit

March 8, 2024

Conditions

Keywords

handwriting performanceneurodevelopmental disordervisual perceptual skillsfine motor skillsvisual motor integration skills

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (5)

  • Changes of Beery-Buktenica Developmental Test of Visual-Motor Integration - Sixth Edition (VMI-6)

    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)

    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)

    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)

    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)

    baseline assessment (1st week), assessment 1- midway (5th week), and assessment 2-final (10th week)

Study Arms (2)

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.

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.

Behavioral: Chinese handwriting intervention program for children with ASD, named "Go Go Handwriting - ASD version"

Interventions

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.

Immediate treatment groupWait-list control group

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University, Department of Occupational Therapy

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Autism Spectrum DisorderNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 3, 2023

Study Start

April 7, 2023

Primary Completion

May 4, 2023

Study Completion

May 4, 2023

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations