- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05905523
Testing of Online Version of QAPS
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Virginia Chu, PhD, OTR/L
- Phone Number: 804-828-1564
- Email: vchu@vcu.edu
Study Locations
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Virginia
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Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonweath University
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Contact:
- Virginia Chu
- Phone Number: 804-828-1564
- Email: vchu@vcu.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children between 3 to 7 years old
Exclusion Criteria:
- Children unable to follow directions to attempt copying shapes.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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3 year old participants
In this study, your child will be asked to do the following things:
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In this study, your child will be asked to do the following things:
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4 year old participants
In this study, your child will be asked to do the following things:
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In this study, your child will be asked to do the following things:
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5 year old participants
In this study, your child will be asked to do the following things:
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In this study, your child will be asked to do the following things:
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6 year old participants
In this study, your child will be asked to do the following things:
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In this study, your child will be asked to do the following things:
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7 year old participants
In this study, your child will be asked to do the following things:
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In this study, your child will be asked to do the following things:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Online QAPS
Time Frame: 5-10 minutes
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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.
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5-10 minutes
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Beery VMI
Time Frame: 5-10 minutes
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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.
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5-10 minutes
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Functional hand tasks
Time Frame: 5-10 minutes
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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.
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5-10 minutes
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Demographics survey
Time Frame: 5 minutes
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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.
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5 minutes
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Emotionality Assessment
Time Frame: 5 minutes
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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.
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5 minutes
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Strengths & difficulties Questionnaire Inattention/Hyperactivity subscale
Time Frame: 5 minutes
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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.
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5 minutes
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Ego Resiliency Scale
Time Frame: 5 minutes
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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.
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5 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Virginia Chu, PhD, OTR/L, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HM20026549
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.