Clinical trial NCT05217394: Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Children
Official title: Evaluating the Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Handwriting Skills for Children: A Protocol for Clustered-Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficulty Writing
Keywords: handwriting
intervention
effectiveness
children
study protocol
clustered randomized controlled trial
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Malaysia
First posted: 2022-02-01
Enrollment: 42
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: The Print Tool
timeFrame: 2 weeks
Secondary outcomes:
measure: Test of Visual Perceptual Skills-4
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Jitra
country: Malaysia
facility: Kiddie Care Centre
state: Kedah
city: Putrajaya
country: Malaysia
facility: Ryan Special Needs Rehabilitation Centre
state: PU
city: Bangi
country: Malaysia
facility: Excel Qhalif Playgroup Centre
state: Selangor
city: Shah Alam
country: Malaysia
facility: Kizzu Kids Centre
state: Selangor
Study officials:
affiliation: Faculty of Health Sciences, UKM
name: Masne Kadar
role: STUDY_DIRECTOR
References: