Evaluating the Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Handwriting Skills for Children: A Protocol for Clustered-Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- The Print Tool
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between five and nine years
- •engaged in OTs intervention either in an individual or group session.
排除标准
- •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
结局指标
主要结局
The Print Tool
时间窗: 2 weeks
Handwriting assessment
次要结局
- Test of Visual Perceptual Skills-4(2 weeks)