Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Children

NCT ID: NCT05217394

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-02-28

Brief Summary

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

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.

Conditions

Difficulty Writing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

OTHIG

Intervention Type: OTHER

Occupational Therapy Handwriting Intervention Guideline

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

OTHIG

Occupational Therapy Handwriting Intervention Guideline

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Education, Malaysia

OTHER_GOV

Sponsor Role: collaborator

National University of Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Masne Kadar

Role: STUDY_DIRECTOR

Faculty of Health Sciences, UKM

Locations

Kiddie Care Centre

Jitra, Kedah, Malaysia

Ryan Special Needs Rehabilitation Centre

Putrajaya, PU, Malaysia

Excel Qhalif Playgroup Centre

Bangi, Selangor, Malaysia

Kizzu Kids Centre

Shah Alam, Selangor, Malaysia

Countries

Malaysia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

FRGS/1/2020/SSI0/UKM/03/2

Identifier Type: -

Identifier Source: org_study_id