NCT04097587

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 13, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

September 18, 2019

Last Update Submit

September 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    one week assessment

Study Arms (1)

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.

Behavioral: experimental groupOther: control group

Interventions

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.

Also known as: parental educational program
control group

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.

Also known as: usual activity
control group

Eligibility Criteria

Age48 Months - 72 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children aged 4\~6 years with screen time of ≥ 2 h/day.

You may not qualify if:

  • cerebral palsy,
  • mental retardation
  • psychosis
  • Down's syndrome
  • chronic disease
  • hearing impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Su-Ru Chen

Taipei, 110, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 30100232BACKGROUND

Related Links

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: A clustered randomized controlled study with a parallel-group design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 20, 2019

Study Start

March 13, 2018

Primary Completion

December 28, 2018

Study Completion

December 28, 2018

Last Updated

September 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations