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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04097587
Other study ID # (TMU-JIRB N201803013)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 13, 2018
Est. completion date December 28, 2018

Study information

Verified date September 2019
Source Taipei Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 129
Est. completion date December 28, 2018
Est. primary completion date December 28, 2018
Accepts healthy volunteers No
Gender All
Age group 48 Months to 72 Months
Eligibility Inclusion Criteria:

- children aged 4~6 years with screen time of = 2 h/day.

Exclusion Criteria:

- cerebral palsy,

- mental retardation

- psychosis

- Down's syndrome

- chronic disease

- hearing impairment.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
experimental group
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.
Other:
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.

Locations

Country Name City State
Taiwan Su-Ru Chen Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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