Reducing Children's Screen Use for Better Sleep, Mental, and Brain Health: a Personalised Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in sustained attention assessed with the Psychomotor Vigilance Task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
研究概览
简要总结
In Singapore, 64.4% of school-age children sleep less than the minimum recommended duration of 9 hours on school nights, thus risking poor mental, cognitive, and brain health. These short-sleeping children, however, spend on average 2.5 hours per school day on non-academic media use, revealing the potential of reducing their screen time for more sleep. Previous interventions targeted at reducing media use and/or improving sleep among school-age children, though effective in increasing sleep, required cooperation from schools, extensive personnel training, and high commitment of participants, rendering them difficult to implement in Singapore. Existing interventions also focused on evening or pre-bedtime screen use, and took a one-size-fits-all approach, ignoring individual differences in the duration, type, and purpose of media use throughout the day. Here, we propose a scalable approach to curtail media use based on individual need throughout the day. We will conduct a randomised controlled trial during term time, recruiting 150 children, aged 6-12 years, who on school days, sleep less than 8 hours and spend more than 2 hours on media use. At baseline, all participants will record their time use patterns. The research staff will then help the intervention group to repurpose at least 60 minutes of media use per school day for sleep. Importantly, participants can decide the type, timing and duration of media use to curtail, thus giving them a sense of agency and mastery, while boosting their self-efficacy, a vital ingredient in behavioural change. The intervention group will follow this personalised schedule for 2 weeks, while the control group will be in a free-living condition. Two weeks after the intervention has ended, the intervention group will undergo follow-up assessments. Throughout the study, sleep, time use, cognitive functions, and psychological well-being will be assessed daily. Other cognitive tasks and questionnaires will be conducted during 2-3 lab/school-classroom visits, with one-third of the participants also undergoing high-density electroencephalography to measure brain activity.
详细描述
Design:
This study will be a randomised controlled trial that assesses the effectiveness of a personalised media use intervention on improving sleep, mood and cognitive functioning in school-aged children. The study will be conducted during term time. A total of 150 children aged from 6 to 12 years old will be recruited in Singapore. Participants will be randomly assigned to either an intervention or a control group.
Recruitment and screening:
Participants will be recruited via primary schools in Singapore, email lists, social media platforms (e.g. Facebook parent groups), flyers in the community and word-of-mouth.
In order to screen for eligibility, parents of interested participants will be invited to complete a screening questionnaire. This questionnaire will take approximately 5-10 minutes to complete. If at screening, they fulfill all the criteria for inclusion in the study, they will be invited to participate in the study. Inclusion in the study will be based on whether (1) The parent is between 25 and 60 years old, (2) The child is between 6 and 12 years old, (3) Both parent and child must be English speaking, (4) Child should be healthy (no sleep disorder, chronic illness, developmental condition, and should not be on any long-term medication), (5) both parent and child should either be a Singaporean Citizen or Permanent Residents, (6) child habitually sleeps < 8 h on school nights and should spend > 2 h on media use (i.e. social media, gaming, and TV / videos) on school days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is a Singaporean or Permanent Resident
- •Speaks English
- •Aged between 6-12 years old
- •Habitually sleeps less than 8 hours during school nights
- •Habitually spends more than 2 hours on media use (i.e. social media, gaming, and TV / videos) on school days
- •Is not on any long-term medications
- •Has no known medical or developmental conditions that could affect sleep (e.g. asthma, arthritis, cancer, congenital heart disease, diabetes, epilepsy, eczema, inflammation)
- •Has no history of psychiatric or neurological disorders
排除标准
- 未提供
研究组 & 干预措施
Screen-use reduction + Sleep extension
For the intervention group, participants are required to follow an agreed schedule where one hour of their daily screen-use time during school days will be repurposed for additional sleep during the two-week manipulation period.
干预措施: Screen-use reduction + Sleep extension (Behavioral)
Free-living control
For the control group, participants will remain under free-living conditions (no restrictions on their screen-use time or sleep time) during the two weeks.
结局指标
主要结局
Change in sustained attention assessed with the Psychomotor Vigilance Task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: PVT will be assessed once daily (up to 3 weeks for the control group and up to 4 weeks for the intervention group) using EMA, and again at the end of the baseline, manipulation and follow-up period through a laptop-based test battery.
Number of attention lapses. More lapses indicate worse performance.
Change in speed of processing assessed with a Symbol Search Task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Assessed once daily using EMA in both the control (up to 3 weeks) and intervention (up to 4 weeks) groups. The specific time at which the EMA is attempted daily (within a one hour time frame) is decided based on the participant's choice.
Number of correct responses in the task. More correct responses indicate better performance.
Change in subjective sleepiness ratings by parents and teachers from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once one the last day of the baseline, manipulation and follow-up period through an online questionnaire sent to parents and teachers. Up to twice in the control group participants and up to thrice in intervention group participants.
Subjective sleepiness will be assessed through the Pediatric Daytime Sleepiness Scale (PDSS) done by the child's parent and teacher. Score will range between 0 and 32 where higher scores indicate more sleepiness.
Change in number of incorrect mismatches assessed with the 2-back task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Number of incorrect mismatches in the 2-back task. Fewer incorrect mismatches indicate better performance.
Change in number of correct mismatches assessed with the 1-back task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Number of correct mismatches in the 1-back task. More correct mismatches indicate better performance.
Change in number of correct matches assessed with the 1-back task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Number of correct matches in the 1-back task. More correct matches indicate better performance.
Change in number of incorrect matches assessed with the 1-back task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Number of incorrect matches in the 1-back task. Fewer incorrect matches indicate better performance.
Change in discriminability measure (A') assessed with the 1-back task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Discriminability measure (A')
Change in bias measure (B"D) assessed with the 1-back task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: On the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Bias measure (B"D)
Change in number of incorrect mismatches assessed with the 1-back task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Number of incorrect mismatches in the 1-back task. Fewer incorrect mismatches indicate better performance.
Change in number of correct matches assessed with the 2-back task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Number of correct matches in the 2-back task. More correct matches indicate better performance.
Change in negative mood from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: PANAS-C will be assessed once daily (up to 3 weeks for the control group and up to 4 weeks for the intervention group) using EMA, and again on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery.
Total score on the negative subscale of the Positive and Negative Affect Schedule for Children(PANAS-C) ranges between 5 and 25. A higher score indicates more negative mood and is considered to be worse.
Change in sleep duration from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Assessed daily using an actiwatch, fitbit and time-use app/sleep diary. Up to a total of 3 weeks in control participants and up to a total of 4 weeks of daily monitoring in intervention participants.
Time spent sleeping will be assessed through an Actiwatch and the Fitbit worn by the children during the entire course of the study. The time-use app and the sleep diary filled in by parents daily during participation in the study will also help us gain a complete understanding of changes in sleep duration patterns throughout study participation.
Change in discriminability measure (A') assessed with the 2-back task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Discriminability measure (A')
Change in internalising and externalising behaviours from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Assessed using the Child Behavioural Checklist done by both parents and teachers.
Change in parent-reported sleep behaviours and sleep-related factors from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Assessed using the Singapore Children Sleep Survey done by parents.
Change in number of incorrect matches assessed with the 2-back task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Number of incorrect matches in the 2-back task. Fewer incorrect matches indicate better performance.
Change in number of correct mismatches assessed with the 2-back task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Number of correct mismatches in the 2-back task. More correct mismatches indicate better performance.
Change in bias measure (B"D) assessed with the 2-back task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Bias measure (B"D)
Change in positive mood from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: PANAS-C will be assessed once daily (up to 3 weeks for the control group and up to 4 weeks for the intervention group) using EMA, and again on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery.
Total score on the positive subscale of the Positive and Negative Affect Schedule for Children(PANAS-C) ranges between 5 and 25. A higher score indicates more positive mood and is considered to be better.
Change in processing speed assessed with the Symbol Digit Modalities Test from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Number of correct responses in the task
Change in digital device use assessed by the Digital Addiction Scale for Children from baseline to manipulation (for both groups), baseline to follow-up (for intervention group only), and manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
The Digital Addiction Scale for Children consists of 25 items rated on a five-point Likert scale ranging from 1 (Never) to 5 (Always). A total score is obtained by summing all 25 items (ranging from 25 to 125), with higher scores indicating a higher level of digital addiction.
Change in daily screen-use time assessed with time-use diary from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Assessed once daily using EMA in both the control (up to 3 weeks) and intervention (up to 4 weeks) groups. The specific time at which the EMA is attempted daily (within a one hour time frame) is decided based on the participant's choice.
Time spent on electronic devices daily
Change in subjective sleepiness assessed with the Karolinska Sleepiness Scale from baseline to manipulation (for both groups), baseline to follow-up (for intervention group only), and manipulation to follow-up period (for intervention group only)
时间窗: KSS will be assessed once daily (up to 3 weeks for the control group and up to 4 weeks for the intervention group) using EMA, and again on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery.
Score on the Karolinska Sleepiness Scale (1-9 points). Higher score indicate more sleepiness.
Change in spatial working memory performance assessed by a Dot Memory Task from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Assessed once daily using EMA in both the control (up to 3 weeks) and intervention (up to 4 weeks) groups. The specific time at which the EMA is attempted daily (within a one hour time frame) is decided based on the participant's choice.
Number of correct responses in the task. More correct responses indicate better performance.
Change in sleep efficiency from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Assessed daily using an actiwatch. Up to a total of 3 weeks in control participants and up to a total of 4 weeks of daily monitoring in intervention participants.
Sleep efficiency will be assessed through an actiwatch worn throughout participation in the study.
Change in internet addiction symptoms from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Assessed using the Parent-child Internet Addiction Test (PC-IAT) which will indicate the level of problematic behaviour associated with compulsive use of electronic devices
Change in EEG power and coherence of the prefrontal cortex from baseline to manipulation (for both groups), from baseline to follow-up (for intervention group only), and from manipulation to follow-up period (for intervention group only)
时间窗: Once on the last day of the baseline, manipulation and follow-up period through a laptop-based test battery. Up to twice in the control group and up to thrice in intervention group participants.
Assessed using high-density EEG. he natural-logged ratio of theta/beta power for frontal leads will be used in the analyses.
次要结局
未报告次要终点
研究者
June Chi Yan Lo
Assistant Professor
National University of Singapore