Completed

NCT Number: NCT05217394

Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Children

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.

Completed

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Key information

Conditions

Difficulty Writing

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kiddie Care Centre, Jitra, Kedah, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OTHIG

Other

Occupational Therapy Handwriting Intervention Guideline

Primary outcomes

The Print Tool

Time frame: 2 weeks

Handwriting assessment

Secondary outcomes

Test of Visual Perceptual Skills-4

Time frame: 2 weeks

Visual perceptual skills assessment

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Collaborators

Ministry of Education, Malaysia

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2022
First posted: Feb 1, 2022
Registry last updated: Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.