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临床试验/NCT03614572
NCT03614572已完成不适用

Advancing Adolescent Bedtime by Using Motivational Interviewing and Text Reminders - A Randomized Controlled Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2018年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
212
试验地点
1
主要终点
Change of Sleep duration by sleep diary

研究概览

简要总结

Chronic sleep deprivation among adolescents is a prevalent health problem across the world and is associated with a series of short and long term consequences. However, effective interventions targeting on this vulnerable adolescent population is very limited. Majority of the previous sleep education programme are conducted in a school context which personal factors and individualized problems were not addressed. In addition, failure to address "knowledge-action gap" may also explain why individual fail to enact health behaviors even holding positive motivation. In regard to this, investigators proposed an active and person-oriented protocol with the aid of advanced technology in order to improve adolescent sleep health.

详细描述

This study will conduct a randomized control trial to evaluate the effectiveness of group-based sleep intervention using motivational interviewing plus text reminders in changing adolescent sleep deprivation problem with both subjective and objective measurements. The intervention will consists of 4 weekly group therapy targeting on adolescent with school day sleep duration less than 7 hours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

The assessor will be blinded to the condition of the subjects

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Chinese aged 12-18 years old
  • •Written informed consent of participation into the study is given by adolescents and his/her parents;
  • •Being able to comply with the study protocol;
  • •Having weekday sleep duration less than 7 hours for past 1 month as reported by questionnaire and average of <7hr weekday sleep as reported by sleep diary as an indication of chronic sleep deprivation status.
  • •Possess a mobile phone

排除标准

  • •A current or past history of neuropsychiatric disorder(s);
  • •A prominent medical condition or taking medication with potential side effects that may influence sleep quantity and quality
  • •Having a clinical sleep disorder that may potentially contribute to the disruption of sleep quantity and quality as ascertained by both Structured Diagnostic Interview for Sleep patterns and Disorders such as insomnia, delayed sleep phase and narcolepsy.
  • •have enrolled in any intervention programme that may affect their sleep patterns in the past three months or are planning to join intervention programme in the next three month

研究组 & 干预措施

Group MI

Experimental

The structure and content of the active intervention programme will be developed and adopted on the basis of previous research on sleep educational programme and motivational interviewing techniques. The whole treatment package consists of 4 sessions of group therapy (n=6-8) followed by 3 week daily text reminders.

干预措施: Group MI (Behavioral)

Control group

No Intervention

Control group will no receive any intervention

结局指标

主要结局

Change of Sleep duration by sleep diary

时间窗: Baseline, 1 week, 3 month and 6 month after treatment

Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours

Change of Sleep duration by actigraphy

时间窗: Baseline, 1 week, 3 month and 6 month after treatment

Sleep parameter estimated by actigraphy: total sleep time (TST) in hours

次要结局

  • Change of objective cognitive performance (inhibitory ability)(Baseline, 3 month and 6 month after treatment)
  • Change of Daytime Sleepiness(Baseline, 1 week, 3 month and 6 month after treatment)
  • Change of Sleep Hygiene(Baseline, 1 week, 3 month and 6 month after treatment)
  • Change of objective cognitive performance (working memory by N-Back)(Baseline, 3 month and 6 month after treatment)
  • Change of Sleep knowledge(Baseline, 1 week, 3 month and 6 month after treatment)
  • Change of Anxiety and depressive symptoms(Baseline, 1 week, 3 month and 6 month after treatment)
  • Change of Quality of Life(Baseline, 1 week, 3 month and 6 month after treatment)
  • Change of Academic performance(Baseline, 3 month and 6 month after treatment)
  • Change of objective cognitive performance (working memory by digit span)(Baseline, 3 month and 6 month after treatment)
  • Change of risk-taking & decision making(Baseline, 3 month and 6 month after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

CHAN NGAN YIN

Research Associate

Chinese University of Hong Kong

研究点 (1)

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