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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05905523
Other study ID # HM20026549
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 3, 2023
Est. completion date August 1, 2025

Study information

Verified date November 2023
Source Virginia Commonwealth University
Contact Virginia Chu, PhD, OTR/L
Phone 804-828-1564
Email vchu@vcu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Early evaluation of prewriting skills is important, as prewriting skills set the stage for later learning of the fine motor and visual motor skills needed for writing. Evaluation of prewriting skills allows for the identification of those children who struggle with these tasks so that early intervention might address these foundational skills before academic demands become more challenging. However, current prewriting skill assessments are limited to pencil-and-paper assessments that require an evaluator to score the drawn shapes. Manual scoring is time consuming, can be subjective, and limit the ability to capture subtle changes in performance. We have developed an assessment on a tablet to assess prewriting skills in children. The preliminary testing of the assessment is published in a paper (https://pubmed.ncbi.nlm.nih.gov/35417278/). We are now working on developing an online version of the assessment that will allow offsite data collection and will automate the analysis on the website so that the results can be automatically generated for the clinician or educator who wants to use this with the children they work with.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 3 Years to 7 Years
Eligibility Inclusion Criteria: - Children between 3 to 7 years old Exclusion Criteria: - Children unable to follow directions to attempt copying shapes.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assessing prewriting skills in children
In this study, your child will be asked to do the following things: Play a drawing game on a tablet Copy shapes using a pencil in a paper booklet Write some letters and cut paper with scissors You will complete surveys and answer questions about your child's development

Locations

Country Name City State
United States Virginia Commonweath University Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Online QAPS Children will be asked to draw shapes on a touch-screen tablet, where the top half of the screen will show the shapes that they needed to draw, and the bottom of half of the screen will show a space for them to copy the shape. There are 10 shapes for the children to copy. This assessment takes 5-10 minutes to complete. 5-10 minutes
Primary Beery VMI This is a pencil-paper visual motor assessment where children are asked to copy the shapes of increasing difficulty. There are 24 shapes in this assessment and the assessment is continued until the child cannot copy 3 consecutive shapes. This assessment takes 5-10 minutes to complete. 5-10 minutes
Primary Functional hand tasks We will have the children demonstrate their handwriting and scissors skills. The tasks that the children as asked to complete is listed in the attached documents. This assessment takes 5-10 minutes to complete. 5-10 minutes
Primary Demographics survey This is a 12 question survey that ask about the child's age, grade level, sex, race, caregiver education level, household income, state of residency, etc. This survey should take about 5 minutes to complete. 5 minutes
Primary Emotionality Assessment This is a 5 question survey that asks the caregiver to rate the child's ability to regulate emotions. This survey should take about 5 minutes to complete. 5 minutes
Primary Strengths & difficulties Questionnaire Inattention/Hyperactivity subscale This is a 5 question survey that asks the caregiver to rate the child's attentional behavior. This survey should take about 5 minutes to complete. 5 minutes
Primary Ego Resiliency Scale This is a 11 question survey that asks the caregiver to rate the child's ability to adapt to change. This survey should take about 5 minutes to complete. 5 minutes
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