Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Children

Study Overview
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Brief Summary
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This study aims to evaluate the effectiveness of the Occupational Therapy Handwriting Interventions Guidelines (OTHIG) in enhancing handwriting performance among children. Method: Forty-two children recruited from private centers with occupational therapy indications and with handwriting issues, aged five to nine years, will be assigned to the experimental and control groups. Participants will receive a total of 10-week sessions, including training, intervention, and outcome measures. The experimental group will receive the developed OTHIG during handwriting skills intervention. Meanwhile, the control group will receive conventional interventions which not exposed to the OTHIG. This study is expected to provide evidence for the effectiveness of using the developed OTHIG to OTs in delivering their services, targeting children struggling with handwriting skills.

Detailed Description
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The study is a Cluster Randomised Controlled Trial (C-RCT) that systematically clusters the centers into the treatment and control groups. A total of 10 centers will be involved in this study. The clustering of all ten centers will allocate randomly into the treatment and control groups based on submitting the consent letter to the researcher and after an assessment of TPT and TVPS-4 are conducted. Ten early interventions have similar characteristics such as (1) hiring graduated occupational therapists from recognized universities in Malaysia, (2) having occupational therapists working daily at the centre, (3) having children aged five to nine years who receive OTs intervention. This randomization will be allocated based on the list of the centers that give an early submission of a signed consent form. The randomization will be carried out with a mechanism that neither the researcher nor children or center owners will know which group of intervention they will be assigned.

Official Title
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Evaluating the Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Handwriting Skills for Children: A Protocol for Clustered-Randomised Control Trial

Conditions
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Difficulty Writing

Intervention / Treatment
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* Other: OTHIG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between five and nine years engaged in OTs intervention either in an individual or group session. Exclusion Criteria: refuse to participate in the study fail to comply with the whole intervention process during the study present severe sensory problems present poor behavior during intervention

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTHIG<br>Occupational Therapy Handwriting Intervention Guideline - this is the experimental guideline to be tested in this study. Section C: Intervention for Handwriting Readiness Skills Handwriting development Pre-writing skills Gross motor skills activities Fine motor skills activities Motor visual skills activities Section D: Intervention for Handwriting Skills Handwriting tools Pencil grasp Posture and position Hand dominance Writing capitals, lowercase, and numbers Handwriting speed Section E: Handwriting Intervention Module Session 1: Development of Handwriting Skills Activities Session 2: Pre-writing Skills Activities Session 3: Gross and Fine Motor Skills Activities Session 4: Writing Capital Letters Session 5: Writing Lowercase Letters Session 6: Writing Numbers | Other: OTHIG<br>* Occupational Therapy Handwriting Intervention Guideline<br>|
| No Intervention: NOTi<br>Natural Occupational Therapy Intervention - this means, the participants in this group are not exposed to the OTHIG. They receive natural OT intervention without exposure to the OTHIG. The natural OT intervention includes: Gross motor skills, fine motor skills, pre-writing skills, basic handwriting tasks such as copying, tracing, imitating and colouring. It will follow the occupational therapist intervention set up by the respected therapist in charge. The OT in charge had qualifications from the local university in Malaysia. The natural OT intervention includes: Gross motor skills, fine motor skills, pre-writing skills, basic handwriting tasks such as copying, tracing, imitating and colouring. It will follow the occupational therapist intervention set up by the respected therapist in charge. The OT in charge had qualifications from the local university in Malaysia. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Print Tool | Handwriting assessment | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test of Visual Perceptual Skills-4 | Visual perceptual skills assessment | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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handwriting, intervention, effectiveness, children, study protocol, clustered randomized controlled trial