Screen TimeNCT04097587
Parental Education and Children's Screen Time
A study testing experimental group in people with Screen Time, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The study was to investigate the efficacy of a parental educational program on reducing screen use, and improving sleep quality and psychosocial adaptations in children aged 4-6 years. Read more about this study
- Who is it for?
- Ages 48 to 72 months
- Conditions the study is for
- Screen Time
- What is being tested?
- experimental group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Mar 2018to 28 Dec 2018
- Phase
- Interventional
- 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 48 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 4~6 years with screen time of ≥ 2 h/day.
Who cannot join
- cerebral palsy,
- mental retardation
- psychosis
- Down's syndrome
- chronic disease
- hearing impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parental Educational Intervention Reduces Screen Time and Improves Sleep Disturbances and Attention Problems in Preschool Children: a Clustered Randomized Controlled Study
The study was to investigate the efficacy of a parental educational program on reducing screen use, and improving sleep quality and psychosocial adaptations in children aged 4-6 years.
Read the detailed description
A total of 129 parent-child dyads were randomly allocated to two groups: experimental group (receiving parental education, n=63), and control group (daily activities, n=66). Data were collected before and after intervention. Instruments included screen time, Children's Sleep Habits Questionnaire, and Pediatric Symptom Checklist-17. A linear mixed model analysis was used to examine the efficacy of education intervention.
- Conditions
- Screen Time
- Being tested
- experimental group, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupBehavioural
Also called parental educational program
This program was carried out for 50 min/week over 8 weeks to empower parents with knowledge and self-efficacy about children's screen use, and motivate them to monitor and change their children's screen behaviors. Teaching strategies included lectures, group discussions, reflection, role playing, and peer sharing (Table 1). Topics included 1) parents' and children's screen use, 2) the relationship between network equipment and children's internet use, 3) the positive and negative effects of excessive screen use on children's physical and psychological development, 4) limiting screen use at mealtimes and bedtime, 5) strategies for screen-related devices, 6) alternative activities to screen use, such as board games and outdoor activities, 7) setting a target of appropriate screen times, and 8) encouraging the signing of a contract between parents and children to limit screen time. We also provided parents with a handbook of the course content.
control groupOther
Also called usual activity
received standard school classes and usual activities offered at the kindergarten. Briefly, kindergarten activities included daily learning activities, outdoor activities, breakfast, lunch, snacks, and nap time.
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | received standard school classes and usual activities offered at the kindergarten. Briefly, kindergarten activities included daily learning activities, outdoor activities, breakfast, lunch, snacks, and nap time. Receives: Behavioral: experimental group; Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
screen time
children's screen time, was measured by parents as the time children spent watching TV/DVD/videos, playing TV games, and using a computer on weekdays and weekends.
Measured: one week assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start13 Mar 2018
- Primary completion28 Dec 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Screen TimeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A clustered randomized controlled study with a parallel-group design.
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su-Ru Chen, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097587
- Sponsor's protocol ID
- (TMU-JIRB N201803013)
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao J, Zhang Y, Jiang F, Ip P, Ho FKW, Zhang Y, Huang H. Excessive Screen Time and Psychosocial Well-Being: The Mediating Role of Body Mass Index, Sleep Duration, and Parent-Child Interaction. J Pediatr. 2018 Nov;202:157-162.e1. doi: 10.1016/j.jpeds.2018.06.029. Epub 2018 Aug 9.
PubMed 30100232
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Educational Intervention Reduces Screen Time and Improves Sleep Disturbances and Attention Problems in Preschool Children: a Clustered Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04097587
- Acronym / sponsor ID
- (TMU-JIRB N201803013)
- Conditions
- Screen Time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 20 Sep 2019 (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.
The study was to investigate the efficacy of a parental educational program on reducing screen use, and improving sleep quality and psychosocial adaptations in children aged 4-6 years.
Detailed description
A total of 129 parent-child dyads were randomly allocated to two groups: experimental group (receiving parental education, n=63), and control group (daily activities, n=66). Data were collected before and after intervention. Instruments included screen time, Children's Sleep Habits Questionnaire, and Pediatric Symptom Checklist-17. A linear mixed model analysis was used to examine the efficacy of education intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A clustered randomized controlled study with a parallel-group design.
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Behavioral: experimental group, Other: control groupreceived standard school classes and usual activities offered at the kindergarten. Briefly, kindergarten activities included daily learning activities, outdoor activities, breakfast, lunch, snacks, and nap time. |
Who may qualify
- Ages
- 48 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children aged 4~6 years with screen time of ≥ 2 h/day.
Key exclusion criteria (6 listed)
- cerebral palsy,
- mental retardation
- psychosis
- Down's syndrome
- chronic disease
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 |
|---|---|---|
| experimental groupAlso: parental educational programThis program was carried out for 50 min/week over 8 weeks to empower parents with knowledge and self-efficacy about children's screen use, and motivate them to monitor and change their children's screen behaviors. Teaching strategies included lectures, group discussions, reflection, role playing, and peer sharing (Table 1). Topics included 1) parents' and children's screen use, 2) the relationship between network equipment and children's internet use, 3) the positive and negative effects of excessive screen use on children's physical and psychological development, 4) limiting screen use at mealtimes and bedtime, 5) strategies for screen-related devices, 6) alternative activities to screen use, such as board games and outdoor activities, 7) setting a target of appropriate screen times, and 8) encouraging the signing of a contract between parents and children to limit screen time. We also provided parents with a handbook of the course content. | Behavioural | control group |
| control groupAlso: usual activityreceived standard school classes and usual activities offered at the kindergarten. Briefly, kindergarten activities included daily learning activities, outdoor activities, breakfast, lunch, snacks, and nap time. | Other | control group |
Primary outcome
screen time
Time frame: one week assessment
children's screen time, was measured by parents as the time children spent watching TV/DVD/videos, playing TV games, and using a computer on weekdays and weekends.
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 20 Sep 2019.
- Background: PubMed 30100232Zhao J, Zhang Y, Jiang F, Ip P, Ho FKW, Zhang Y, Huang H. Excessive Screen Time and Psychosocial Well-Being: The Mediating Role of Body Mass Index, Sleep Duration, and Parent-Child Interaction. J Pediatr. 2018 Nov;202:157-162.e1. doi: 10.1016/j.jpeds.2018.06.029. Epub 2018 Aug 9.
- reference linkLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group in people with Screen Time, run by Taipei Medical University 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 1 inclusion and 6 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 20 Sep 2019. 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?
screen time (time frame: one week assessment). 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 NCT04097587, which also lists 1 linked publication.
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 20 Sep 2019.