Child DevelopmentNCT04524923
Touch Screen Usage Time In Relation To Visual Motor Integration and Quality of Life In Preschoolers
An observational study of Child Development, run by Cairo University at 1 site in Egypt.
Trial summary
Recent literatures are associating digital technology extensive and addictive use with physical, psychosocial and cognitive inverse consequences. This research focuses more on number of touch screen devices; age started using devices and usage time in relation to cognitive function in preschoolers. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Child Development
- What is being tested?
- visual motor integration, Quality of life assessment and Cognitive Functioning
- How many people
- 97 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 10 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 years
- All sexes
- Child
Study population: This study will be delimited to typically developing preschool children, from both genders, with age ranging from three to five years.
Who may be able to join
- Children were enrolled in this study according to the following criteria:
- Age ranges from three to five years.
- Both genders were included.
Who cannot join
- Children were excluded from the study if they had any of the following criteria:
- Diagnosed with attention deficit/hyperactivity disorder (ADD/ADHD) or developmental co-ordination disorder (DCD).
- Preterm children; children with major physical disabilities, genetic disorders; prenatal exposure to alcohol; children with a history of head trauma and infections.
- Diagnosed with psychiatric conditions such as autism and depression.
- Diagnosed with significant behavioral disorders
- Diagnosed with fine motor problems.
- Significant auditory or visual deficits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Touch Screen Usage Time In Relation To Visual Motor Integration and Quality of Life In Preschoolers: A Cross Sectional Study
Recent literatures are associating digital technology extensive and addictive use with physical, psychosocial and cognitive inverse consequences. This research focuses more on number of touch screen devices; age started using devices and usage time in relation to cognitive function in preschoolers.
Read the detailed description
A hundred typically developing preschool children of both genders with age ranges from three to five years will be included in this study. Visual motor integration, quality of life and cognitive function were assessed by the Peabody Developmental Motor Scale, the Pediatric Quality of Life Inventory™ and the Pediatric Quality of Life Inventory™ cognitive functioning scale respectively
Sample size To avoid type II error, sample size calculation was based on data from a pilot study on correlation between touch screen usage time and visual motor integration. Using G*POWER statistica software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) [Correlational study, α=0.05, β=0.2, and medium effect size = 0.3] revealed that the appropriate sample size for this study was N=84 Therefore, one-hundred children were recruited for possible dropouts during assessment.
- Conditions
- Child Development
- Being tested
- visual motor integration, Quality of life assessment, Cognitive Functioning
- Keywords
- Cognitive development, Digital devices, Quality of Life Inventory, Visual motor integration, touch screen usage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual motor integrationOther
investigate the relation between touch screen usage and visual motor integration in preschoolers
Quality of life assessmentOther
investigate the relation between touch screen usage and Quality of life assessment in preschoolers
Cognitive FunctioningOther
investigate the relation between touch screen usage and Cognitive Functioning assessment in preschoolers
| Study group | Role | What they receive |
|---|---|---|
| cohort group | Ninety-seven typically developing preschool children of both genders with age ranges from three to five years will be included in this study. Visual motor integration, quality of life and cognitive function were assessed by the Peabody Developmental Motor Scale, the Pediatric Quality of Life Inventory™ and the Pediatric Quality of Life Inventory™ cognitive functioning scale respectively Receives: Other: visual motor integration; Other: Quality of life assessment; Other: Cognitive Functioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual motor integration
The Peabody Developmental Motor Scale will be used to assess visual motor integration. It is a standardized, norm-referenced test used for the assessment of upper limb functions. It is an early childhood motor development program that provides (in one package) both in depth assessment and training of gross and fine motor skills. It can be used by occupational therapists, physical therapists, psychologists, and others who are interested in examining the motor abilities of young children. It is composed of six subtests:-Reflexes (8 items), stationary (30 items), locomotion (89 items), object manipulation (24 items), grasping (25 items) and visual motor integration (72 items). The results of the subtests may be used to generate 3 global indexes of motor performance called (composites). These composites are gross motor quotient, fine motor quotient and total motor quotient with higher scores represent better performance
Measured: 1 September 2020 to 31 March 2021
Physical and Psychosocial Health
The Pediatric quality of life inventory™ generic Arabic parent proxy-report for children from two to five years was used to assess quality of life. It was developed to quantify health- related quality of life (HRQoL) of children and adolescents aged 2-18 years. It consists of 23 questions and evaluate how frequently of a trouble the child has had over the past month. Interpretation of the scale reveals the mean performance as total scale score, physical functioning score (eight questions), emotional functioning score (five questions), social functioning score (five questions) and school function scores (five items). the scores are from 0 to 100 with higher results reflecting better performance.
Measured: 1 September 2020 to 31 March 2021
cognitive function
Pediatric Quality of Life Inventory™ Cognitive Functioning Scale will be used to assess cognitive function. It was developed as a brief generic symptom-specific instrument to measure cognitive functioning. The 6-item scale was designed as a brief and easy-to-administer patient self-reported and parent proxy-reported generic symptom specific instrument to measure cognitive functioning across pediatric populations, originally developed in a pediatric cancer population. The PedsQLTM Cognitive Functioning Scale includes format, instructions, Likert scale from 0 to 100 with higher scores indicating better cognitive function.
Measured: 1 September 2020 to 31 March 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Sep 2020
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
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 Cairo 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira M Abd-elmonem, PHD, Cairo University
- Investigators
- Amira M El-tohamy, Phd, Study chair, Cairo UniversityAmira M Mahmoud, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524923
- Sponsor's protocol ID
- child development
- Status last verified
- Jun 2021
- First submitted
- 21 Aug 2020
- Last updated
- 30 Jun 2021
- Results posted
- 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 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Touch Screen Usage Time In Relation To Visual Motor Integration and Quality of Life In Preschoolers: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04524923
- Acronym / sponsor ID
- child development
- Conditions
- Child Development
- Keywords
- Cognitive development, Digital devices, Quality of Life Inventory, Visual motor integration, touch screen usage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 24 Aug 2020 (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.
Recent literatures are associating digital technology extensive and addictive use with physical, psychosocial and cognitive inverse consequences. This research focuses more on number of touch screen devices; age started using devices and usage time in relation to cognitive function in preschoolers.
Detailed description
A hundred typically developing preschool children of both genders with age ranges from three to five years will be included in this study. Visual motor integration, quality of life and cognitive function were assessed by the Peabody Developmental Motor Scale, the Pediatric Quality of Life Inventory™ and the Pediatric Quality of Life Inventory™ cognitive functioning scale respectively
Sample size To avoid type II error, sample size calculation was based on data from a pilot study on correlation between touch screen usage time and visual motor integration. Using G*POWER statistica software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) [Correlational study, α=0.05, β=0.2, and medium effect size = 0.3] revealed that the appropriate sample size for this study was N=84 Therefore, one-hundred children were recruited for possible dropouts during assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort group | – | Other: visual motor integration, Other: Quality of life assessment, Other: Cognitive FunctioningNinety-seven typically developing preschool children of both genders with age ranges from three to five years will be included in this study. Visual motor integration, quality of life and cognitive function were assessed by the Peabody Developmental Motor Scale, the Pediatric Quality of Life Inventory™ and the Pediatric Quality of Life Inventory™ cognitive functioning scale respectively |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Age groups
- Child
- Study population
- This study will be delimited to typically developing preschool children, from both genders, with age ranging from three to five years.
Key inclusion criteria (3 listed)
- Age ranges from three to five years.
- Both genders were included.
Key exclusion criteria (7 listed)
- Diagnosed with attention deficit/hyperactivity disorder (ADD/ADHD) or developmental co-ordination disorder (DCD).
- Preterm children; children with major physical disabilities, genetic disorders; prenatal exposure to alcohol; children with a history of head trauma and infections.
- Diagnosed with psychiatric conditions such as autism and depression.
- Diagnosed with significant behavioral disorders
- Diagnosed with fine motor problems.
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 |
|---|---|---|
| visual motor integrationinvestigate the relation between touch screen usage and visual motor integration in preschoolers | Other | cohort group |
| Quality of life assessmentinvestigate the relation between touch screen usage and Quality of life assessment in preschoolers | Other | cohort group |
| Cognitive Functioninginvestigate the relation between touch screen usage and Cognitive Functioning assessment in preschoolers | Other | cohort group |
Primary outcome
visual motor integration
Time frame: 1 September 2020 to 31 March 2021
The Peabody Developmental Motor Scale will be used to assess visual motor integration. It is a standardized, norm-referenced test used for the assessment of upper limb functions. It is an early childhood motor development program that provides (in one package) both in depth assessment and training of gross and fine motor skills. It can be used by occupational therapists, physical therapists, psychologists, and others who are interested in examining the motor abilities of young children. It is composed of six subtests:-Reflexes (8 items), stationary (30 items), locomotion (89 items), object manipulation (24 items), grasping (25 items) and visual motor integration (72 items). The results of the subtests may be used to generate 3 global indexes of motor performance called (composites). These composites are gross motor quotient, fine motor quotient and total motor quotient with higher scores represent better performance
Physical and Psychosocial Health
Time frame: 1 September 2020 to 31 March 2021
The Pediatric quality of life inventory™ generic Arabic parent proxy-report for children from two to five years was used to assess quality of life. It was developed to quantify health- related quality of life (HRQoL) of children and adolescents aged 2-18 years. It consists of 23 questions and evaluate how frequently of a trouble the child has had over the past month. Interpretation of the scale reveals the mean performance as total scale score, physical functioning score (eight questions), emotional functioning score (five questions), social functioning score (five questions) and school function scores (five items). the scores are from 0 to 100 with higher results reflecting better performance.
cognitive function
Time frame: 1 September 2020 to 31 March 2021
Pediatric Quality of Life Inventory™ Cognitive Functioning Scale will be used to assess cognitive function. It was developed as a brief generic symptom-specific instrument to measure cognitive functioning. The 6-item scale was designed as a brief and easy-to-administer patient self-reported and parent proxy-reported generic symptom specific instrument to measure cognitive functioning across pediatric populations, originally developed in a pediatric cancer population. The PedsQLTM Cognitive Functioning Scale includes format, instructions, Likert scale from 0 to 100 with higher scores indicating better cognitive function.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- 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. This study is not recruiting at the moment.
Amira M El-tohamy, Phd study chair
Cairo University
Amira M Mahmoud study director
Cairo 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 Cairo University at 1 site in Egypt.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 30 Jun 2021. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual motor integration (time frame: 1 September 2020 to 31 March 2021). The study lists 3 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 30 Jun 2021.