NCT05905523

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 3, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

October 30, 2025

Status Verified

October 1, 2025

Enrollment Period

2.6 years

First QC Date

June 7, 2023

Last Update Submit

October 29, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (5)

3 year old participants

In this study, your child will be asked to do the following things: 1. Play a drawing game on a tablet 2. Copy shapes using a pencil in a paper booklet 3. Write some letters and cut paper with scissors You will complete surveys and answer questions about your child's development

Other: Assessing prewriting skills in children

4 year old participants

In this study, your child will be asked to do the following things: 1. Play a drawing game on a tablet 2. Copy shapes using a pencil in a paper booklet 3. Write some letters and cut paper with scissors You will complete surveys and answer questions about your child's development

Other: Assessing prewriting skills in children

5 year old participants

In this study, your child will be asked to do the following things: 1. Play a drawing game on a tablet 2. Copy shapes using a pencil in a paper booklet 3. Write some letters and cut paper with scissors You will complete surveys and answer questions about your child's development

Other: Assessing prewriting skills in children

6 year old participants

In this study, your child will be asked to do the following things: 1. Play a drawing game on a tablet 2. Copy shapes using a pencil in a paper booklet 3. Write some letters and cut paper with scissors You will complete surveys and answer questions about your child's development

Other: Assessing prewriting skills in children

7 year old participants

In this study, your child will be asked to do the following things: 1. Play a drawing game on a tablet 2. Copy shapes using a pencil in a paper booklet 3. Write some letters and cut paper with scissors You will complete surveys and answer questions about your child's development

Other: Assessing prewriting skills in children

Interventions

In this study, your child will be asked to do the following things: 1. Play a drawing game on a tablet 2. Copy shapes using a pencil in a paper booklet 3. Write some letters and cut paper with scissors You will complete surveys and answer questions about your child's development

3 year old participants4 year old participants5 year old participants6 year old participants7 year old participants

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children between 3 to 7 years old

You may qualify if:

  • Children between 3 to 7 years old

You may not qualify if:

  • Children unable to follow directions to attempt copying shapes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonweath University

Richmond, Virginia, 23298, United States

RECRUITING

Study Officials

  • Virginia Chu, PhD, OTR/L

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginia Chu, PhD, OTR/L

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 15, 2023

Study Start

October 3, 2023

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

October 30, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations