Child DevelopmentNCT05905523
Testing of Online Version of QAPS
An observational study of Child Development, run by Virginia Commonwealth University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Child Development
- What is being tested?
- Assessing prewriting skills in children
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Children between 3 to 7 years old
Who may be able to join
- Children between 3 to 7 years old
Who cannot join
- Children unable to follow directions to attempt copying shapes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonweath University
Richmond, Virginia, 23298
Virginia Chu, 804-828-1564, vchu@vcu.edu
About this study
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.
- Conditions
- Child Development
- Being tested
- Assessing prewriting skills in children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessing prewriting skills in childrenOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Assessing prewriting skills in children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start3 Oct 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginia Chu, PhD, OTR/L, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905523
- Sponsor's protocol ID
- HM20026549
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of Online Version of QAPS
- ClinicalTrials.gov ID
- NCT05905523
- Acronym / sponsor ID
- HM20026549
- Conditions
- Child Development
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 3 year old participants | – | Other: Assessing prewriting skills in childrenIn 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 |
| 4 year old participants | – | Other: Assessing prewriting skills in childrenIn 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 |
| 5 year old participants | – | Other: Assessing prewriting skills in childrenIn 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 |
| 6 year old participants | – | Other: Assessing prewriting skills in childrenIn 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 |
| 7 year old participants | – | Other: Assessing prewriting skills in childrenIn 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 |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children between 3 to 7 years old
Key inclusion criteria (1 listed)
- Children between 3 to 7 years old
Key exclusion criteria (1 listed)
- Children unable to follow directions to attempt copying shapes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessing prewriting skills in childrenIn 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 | 3 year old participants, 4 year old participants, 5 year old participants, 6 year old participants, 7 year old participants |
Primary outcome
Online QAPS
Time frame: 5-10 minutes
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.
Beery VMI
Time frame: 5-10 minutes
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.
Functional hand tasks
Time frame: 5-10 minutes
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.
Demographics survey
Time frame: 5 minutes
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.
Emotionality Assessment
Time frame: 5 minutes
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.
Strengths & difficulties Questionnaire Inattention/Hyperactivity subscale
Time frame: 5 minutes
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.
Ego Resiliency Scale
Time frame: 5 minutes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Virginia Chu, PhD, OTR/L principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Virginia Chu, PhD, OTR/L (804-828-1564, vchu@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Online QAPS (time frame: 5-10 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.