Attention-Deficit-Disordered ChildrenNCT05428085
Digital Media Usage With Impulsivity and Attention Deficit in Children
An observational study of Attention-Deficit-Disordered Children, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
To explore the relationship between children's digital media usage and attention, activity, parenting pressure; to explore the relationship between family basic data factors and screen usage. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Attention-Deficit-Disordered Children
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jun 2022to 30 Nov 2022
- 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 20 to 75 years
- All sexes
- Adult, Older adult
Study population: Children who spent screen time more than two hours a day had more significant implicit and explicit behavioral problems, namely withdrawal, nervousness, anxiety, irritability and attention deficit, and restless behavior.
Who may be able to join
- Caregivers whose children are currently receiving early treatment and who can cooperate with the questionnaire;
- The child's family has the habit of using digital media devices;
- The child's main complaints include inattention and impulsivity;
- The child's age is 3 to 6 years old.
Who cannot join
- The child has other specific diagnosed diseases, such as autism group, sensory disorder, known genetic and genetic diseases, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between the Digital Media Usage With Impulsivity and Attention Deficit in Children With Early Intervention
To explore the relationship between children's digital media usage and attention, activity, parenting pressure; to explore the relationship between family basic data factors and screen usage.
Read the detailed description
Background: Digital products are inseparable from life. Parents may feel that teaching materials are educational because of their high availability.Meaning, busy work, helping to share care or short respite, etc., and providing digital products for children, it is very important to understand children's behavior, usage habits, and the relationship between parents.According to the American Academy of Pediatrics, parents should limit their exposure to most types of screen time until the child is 2 years old , and children 2-5 years old should be less than one hour per day, and it is recommended to watch high Quality program content, accompanied by adults. The standards for screen time in various countries generally follow this policy.However, many studies have found that most children spend far more screen time than recommended guidelines. Research in Canada and the United States indicates that children aged three to five spend more than two hours a day on average. According to a tracking study, children aged three to five were surveyed on their In terms of screen use, it was found that compared with children who watched less than half an hour, children who used more than two hours a day had more significant implicit and explicit behavioral problems, namely withdrawal, nervousness, anxiety, irritability and attention deficit, and restless behavior.
Objective: To explore the relationship between children's digital media usage and attention, activity, parenting pressure; to explore the relationship between family basic data factors and screen usage.
Methods: Individual caregivers were interviewed through paper or electronic questionnaires to assess children's and families' digital media usage habits, children's activity levels, and parental stress. The following assessment tools were used. Including digital media use survey at home (refer to Surveillance of digital-Media habits in earLy childhood Questionnaire, SMALLQ™), Chinese version of parental child activity scale (Werry-Weiss Peters Activity Scale Chinese version, WWPAS), parental stress scale brief Form (Parenting Stress Index: Short form, PSI/SF)
- Conditions
- Attention-Deficit-Disordered Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers whose children are currently receiving early treatment | Individual caregivers were interviewed through paper questionnaires to assess children's and families' digital media usage habits, children's activity levels, and parental stress. Pearson's Chi-Square test and liner regression was used for analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surveillance of digital-Media habits in earLy childhood Questionnaire, SMALLQ™
An survey used to estimate the weekday \& weekend parent-reported on-screen \& off-screen media habits of preschoolers, among other things. The information including three segments: (i) digital media use, parent concern, knowledge and practice of guidelines, outside of school on weekday and weekend; (ii) non-digital media habits: indoor and outdoor play, day time naps, non-screen reading, and drawing; (iii) parent educational attainment and household income, additional child information: height, weight, wearing spectacles or not, and night-time sleep.
Measured: Baseline at first evaluate time
Secondary outcomes (2)
Werry-Weiss Peters Activity Scale Chinese version, WWPAS
It is a 27 items inventory completed by parents, aimed at evaluating the child's activity level in a family context, in various situations of daily life (e.g., during meals, watching television, while playing, in activities abroad). The total result is obtained by adding directly the scores of all the items and represents a general measure of the child's activity level. Parents rated the frequency of their child's behaviors as occurring "none," "some," or "much of the time" . However, interparent interrater reliability was reported to be good (Barkley, 1988). No information regarding the test-retest reliability or internal consistency was located (Barkley, 1988).
Measured: Baseline at first evaluate time
Parental stress scale brief Form
The scale assessing parents' feelings about their parenting role, exploring both positive aspects (e.g. emotional benefits, personal development) and negative aspects of parenthood (e.g. demands on resources, feelings of stress). It contains various measures of stress, emotion and role satisfaction, including perceived stress, work/family stress, loneliness, anxiety, guilt, marital satisfaction/commitment, job satisfaction, and social support. The PSI has 36 items with a 5-point Likert scale, with response options ranging from "strongly agree" to "strongly disagree." Responses on the measure are summed to create a total stress (TS) composite, which provides an indication of the amount of stress adults are experiencing due to their role as a parent (Abidin 1995). Internal consistency reliability was high for TS (α = .90).
Measured: Baseline at first evaluate time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start22 Jun 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit-Disordered ChildrenStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsinchieh Lee, Taipei Medical University Shuang Ho Hospital
- Investigators
- Hsinchieh Lee, master, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428085
- Sponsor's protocol ID
- N202204077
- Status last verified
- Apr 2023
- First submitted
- 16 Jun 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chia, M., Tay, L. Y., & Chua, T. B. K. (2019). The development of an online surveillance of digital media use in early childhood questionnaire-SMALLQ™-for Singapore.
Huang Y, Yan Q, Tong L. Reliability and validity of an observation-based parent-child interaction rating scale for Chinese children aged 0-6 years. Psychol Assess. 2022 May;34(5):e45-e54. doi: 10.1037/pas0001121. Epub 2022 Mar 24.
PubMed 35324253Werry-Weiss-Peters Activity Scale, W. W. P. Center for Research in Neuropsychology and Cognitive Behavioral Intervention.
Abidin, R. R. (1995). Parenting Stress Index (PSI) manual . Odessa, FL: Psychological Assessment Resources.
Tamana SK, Ezeugwu V, Chikuma J, Lefebvre DL, Azad MB, Moraes TJ, Subbarao P, Becker AB, Turvey SE, Sears MR, Dick BD, Carson V, Rasmussen C; CHILD study Investigators; Pei J, Mandhane PJ. Screen-time is associated with inattention problems in preschoolers: Results from the CHILD birth cohort study. PLoS One. 2019 Apr 17;14(4):e0213995. doi: 10.1371/journal.pone.0213995. eCollection 2019.
PubMed 30995220Poitras VJ, Gray CE, Janssen X, Aubert S, Carson V, Faulkner G, Goldfield GS, Reilly JJ, Sampson M, Tremblay MS. Systematic review of the relationships between sedentary behaviour and health indicators in the early years (0-4 years). BMC Public Health. 2017 Nov 20;17(Suppl 5):868. doi: 10.1186/s12889-017-4849-8.
PubMed 29219092Beal JA. Screen Time and Toddlers: New Evidence on Potentially Negative Effects. MCN Am J Matern Child Nurs. 2020 Jul/Aug;45(4):241. doi: 10.1097/NMC.0000000000000632. No abstract available.
PubMed 32604184Radesky JS, Christakis DA. Increased Screen Time: Implications for Early Childhood Development and Behavior. Pediatr Clin North Am. 2016 Oct;63(5):827-39. doi: 10.1016/j.pcl.2016.06.006.
PubMed 27565361Madigan S, Browne D, Racine N, Mori C, Tough S. Association Between Screen Time and Children's Performance on a Developmental Screening Test. JAMA Pediatr. 2019 Mar 1;173(3):244-250. doi: 10.1001/jamapediatrics.2018.5056.
PubMed 30688984Kids & Tech: Tips for Parents in the Digital Age. HealthyChildren.org. (n.d.). https://www.healthychildren.org/English/family-life/Media/Pages/Tips-for-Parents-Digital-Age.aspx.
American Academy of Pediatrics Healthy Children. Org. (2016). How to develop a family media plan [Website]. https://www.healthychildren.org/English/family-life/Media/Pages/How-to-Make-a-Family-Media-Use-Plan.aspx
Australian Government Department of Health and Ageing (DoHA) (2011). Get Up and Grow: Healthy Eating and Physical Activity for Early Childhood-Family Book. Retrieved 20 February 2022, from www.health.gov.au/internet/publications/publishing.nsf/Content/gug-family-toc.
Xie G, Deng Q, Cao J, Chang Q. Digital screen time and its effect on preschoolers' behavior in China: results from a cross-sectional study. Ital J Pediatr. 2020 Jan 23;46(1):9. doi: 10.1186/s13052-020-0776-x.
PubMed 31973770Reid Chassiakos YL, Radesky J, Christakis D, Moreno MA, Cross C; COUNCIL ON COMMUNICATIONS AND MEDIA. Children and Adolescents and Digital Media. Pediatrics. 2016 Nov;138(5):e20162593. doi: 10.1542/peds.2016-2593.
PubMed 27940795Vandewater EA, Rideout VJ, Wartella EA, Huang X, Lee JH, Shim MS. Digital childhood: electronic media and technology use among infants, toddlers, and preschoolers. Pediatrics. 2007 May;119(5):e1006-15. doi: 10.1542/peds.2006-1804.
PubMed 17473074
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Digital Media Usage With Impulsivity and Attention Deficit in Children With Early Intervention
- ClinicalTrials.gov ID
- NCT05428085
- Acronym / sponsor ID
- N202204077
- Conditions
- Attention-Deficit-Disordered Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 22 Jun 2022 (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.
To explore the relationship between children's digital media usage and attention, activity, parenting pressure; to explore the relationship between family basic data factors and screen usage.
Detailed description
Background: Digital products are inseparable from life. Parents may feel that teaching materials are educational because of their high availability.Meaning, busy work, helping to share care or short respite, etc., and providing digital products for children, it is very important to understand children's behavior, usage habits, and the relationship between parents.According to the American Academy of Pediatrics, parents should limit their exposure to most types of screen time until the child is 2 years old , and children 2-5 years old should be less than one hour per day, and it is recommended to watch high Quality program content, accompanied by adults. The standards for screen time in various countries generally follow this policy.However, many studies have found that most children spend far more screen time than recommended guidelines. Research in Canada and the United States indicates that children aged three to five spend more than two hours a day on average. According to a tracking study, children aged three to five were surveyed on their In terms of screen use, it was found that compared with children who watched less than half an hour, children who used more than two hours a day had more significant implicit and explicit behavioral problems, namely withdrawal, nervousness, anxiety, irritability and attention deficit, and restless behavior.
Objective: To explore the relationship between children's digital media usage and attention, activity, parenting pressure; to explore the relationship between family basic data factors and screen usage.
Methods: Individual caregivers were interviewed through paper or electronic questionnaires to assess children's and families' digital media usage habits, children's activity levels, and parental stress. The following assessment tools were used. Including digital media use survey at home (refer to Surveillance of digital-Media habits in earLy childhood Questionnaire, SMALLQ™), Chinese version of parental child activity scale (Werry-Weiss Peters Activity Scale Chinese version, WWPAS), parental stress scale brief Form (Parenting Stress Index: Short form, PSI/SF)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers whose children are currently receiving early treatment | – | –Individual caregivers were interviewed through paper questionnaires to assess children's and families' digital media usage habits, children's activity levels, and parental stress. Pearson's Chi-Square test and liner regression was used for analysis. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Children who spent screen time more than two hours a day had more significant implicit and explicit behavioral problems, namely withdrawal, nervousness, anxiety, irritability and attention deficit, and restless behavior.
Key inclusion criteria (4 listed)
- Caregivers whose children are currently receiving early treatment and who can cooperate with the questionnaire;
- The child's family has the habit of using digital media devices;
- The child's main complaints include inattention and impulsivity;
- The child's age is 3 to 6 years old.
Key exclusion criteria (1 listed)
- The child has other specific diagnosed diseases, such as autism group, sensory disorder, known genetic and genetic diseases, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surveillance of digital-Media habits in earLy childhood Questionnaire, SMALLQ™
Time frame: Baseline at first evaluate time
An survey used to estimate the weekday \& weekend parent-reported on-screen \& off-screen media habits of preschoolers, among other things. The information including three segments: (i) digital media use, parent concern, knowledge and practice of guidelines, outside of school on weekday and weekend; (ii) non-digital media habits: indoor and outdoor play, day time naps, non-screen reading, and drawing; (iii) parent educational attainment and household income, additional child information: height, weight, wearing spectacles or not, and night-time sleep.
2 secondary outcomes
Werry-Weiss Peters Activity Scale Chinese version, WWPAS
Time frame: Baseline at first evaluate time
Parental stress scale brief Form
Time frame: Baseline at first evaluate time
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 28 Apr 2023.
- BackgroundChia, M., Tay, L. Y., & Chua, T. B. K. (2019). The development of an online surveillance of digital media use in early childhood questionnaire-SMALLQ™-for Singapore.
- Background: PubMed 35324253Huang Y, Yan Q, Tong L. Reliability and validity of an observation-based parent-child interaction rating scale for Chinese children aged 0-6 years. Psychol Assess. 2022 May;34(5):e45-e54. doi: 10.1037/pas0001121. Epub 2022 Mar 24.
- BackgroundWerry-Weiss-Peters Activity Scale, W. W. P. Center for Research in Neuropsychology and Cognitive Behavioral Intervention.
- BackgroundAbidin, R. R. (1995). Parenting Stress Index (PSI) manual . Odessa, FL: Psychological Assessment Resources.
- Background: PubMed 30995220Tamana SK, Ezeugwu V, Chikuma J, Lefebvre DL, Azad MB, Moraes TJ, Subbarao P, Becker AB, Turvey SE, Sears MR, Dick BD, Carson V, Rasmussen C; CHILD study Investigators; Pei J, Mandhane PJ. Screen-time is associated with inattention problems in preschoolers: Results from the CHILD birth cohort study. PLoS One. 2019 Apr 17;14(4):e0213995. doi: 10.1371/journal.pone.0213995. eCollection 2019.
- Background: PubMed 29219092Poitras VJ, Gray CE, Janssen X, Aubert S, Carson V, Faulkner G, Goldfield GS, Reilly JJ, Sampson M, Tremblay MS. Systematic review of the relationships between sedentary behaviour and health indicators in the early years (0-4 years). BMC Public Health. 2017 Nov 20;17(Suppl 5):868. doi: 10.1186/s12889-017-4849-8.
- Background: PubMed 32604184Beal JA. Screen Time and Toddlers: New Evidence on Potentially Negative Effects. MCN Am J Matern Child Nurs. 2020 Jul/Aug;45(4):241. doi: 10.1097/NMC.0000000000000632. No abstract available.
- Background: PubMed 27565361Radesky JS, Christakis DA. Increased Screen Time: Implications for Early Childhood Development and Behavior. Pediatr Clin North Am. 2016 Oct;63(5):827-39. doi: 10.1016/j.pcl.2016.06.006.
- Background: PubMed 30688984Madigan S, Browne D, Racine N, Mori C, Tough S. Association Between Screen Time and Children's Performance on a Developmental Screening Test. JAMA Pediatr. 2019 Mar 1;173(3):244-250. doi: 10.1001/jamapediatrics.2018.5056.
- BackgroundKids & Tech: Tips for Parents in the Digital Age. HealthyChildren.org. (n.d.). https://www.healthychildren.org/English/family-life/Media/Pages/Tips-for-Parents-Digital-Age.aspx.
- BackgroundAmerican Academy of Pediatrics Healthy Children. Org. (2016). How to develop a family media plan [Website]. https://www.healthychildren.org/English/family-life/Media/Pages/How-to-Make-a-Family-Media-Use-Plan.aspx
- BackgroundAustralian Government Department of Health and Ageing (DoHA) (2011). Get Up and Grow: Healthy Eating and Physical Activity for Early Childhood-Family Book. Retrieved 20 February 2022, from www.health.gov.au/internet/publications/publishing.nsf/Content/gug-family-toc.
- Individual participant dataSharing planned: No
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.
Hsinchieh Lee, master principal investigator
Taipei Medical University Shuang Ho Hospital
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 Attention-Deficit-Disordered Children, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 4 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: finished, as of the sponsor's last update on 28 Apr 2023. 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 Taiwan. 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?
Surveillance of digital-Media habits in earLy childhood Questionnaire, SMALLQ™ (time frame: Baseline at first evaluate time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05428085, which also lists 16 linked publications.
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 28 Apr 2023.