Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Children

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

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.

Study Overview

• Status: Completed
• Conditions: Difficulty Writing
• Intervention / Treatment: Other: OTHIG

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kedah
    • Jitra, Kedah, Malaysia, 06000
      • Kiddie Care Centre
  • PU
    • Putrajaya, PU, Malaysia, 62150
      • Ryan Special Needs Rehabilitation Centre
  • Selangor
    • Bangi, Selangor, Malaysia
      • Excel Qhalif Playgroup Centre
    • Shah Alam, Selangor, Malaysia
      • Kizzu Kids Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OTHIG; 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; Occupational Therapy Handwriting Intervention Guideline
No Intervention: NOTi; 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?

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

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Collaborators: Ministry of Education, Malaysia
• Investigators: Study Director: Masne Kadar, Faculty of Health Sciences, UKM

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: January 9, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: children; effectiveness; intervention; handwriting; study protocol; clustered randomized controlled trial
• Other Study ID Numbers: FRGS/1/2020/SSI0/UKM/03/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All data collected will be shared among researchers
• IPD Sharing Time Frame: October 2021 until September 2022
• IPD Sharing Access Criteria: Study protocol will be shared with all researchers
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No