Advancing Adolescent Bedtime by MI and Text Reminders

Sleep Deprivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03614572
• Other study ID #: 15163071
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Behavioral:
• Group MI
refer to the arm description

Locations

Country	Name	City	State
Hong Kong	Department of Psychiatry	Sha Tin

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Sleep duration by sleep diary	Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours	Baseline, 1 week, 3 month and 6 month after treatment
Primary	Change of Sleep duration by actigraphy	Sleep parameter estimated by actigraphy: total sleep time (TST) in hours	Baseline, 1 week, 3 month and 6 month after treatment
Secondary	Change of Sleep knowledge	Sleep knowledge is measured by Sleep Knowledge Questionnaire. It consists of 25 items, ranging from -50 to 50 with higher score indicates better sleep knowledge	Baseline, 1 week, 3 month and 6 month after treatment
Secondary	Change of Daytime Sleepiness	Paediatric Daytime Sleepiness Scale (PDSS) is an 8-item self-rated scale measuring daytime sleepiness, ranging in total scores from 0 to 32 with higher scores indicating more sleepiness.	Baseline, 1 week, 3 month and 6 month after treatment
Secondary	Change of Quality of Life	KIDSCREEN-27 health questionnaire for children and young people for the measurement of quality of life by rating 27 items related to general health on a 5 point Likert scale.; There are five subscales on: physical well-being (possibly scored from 5 to 25), psychological well-being (possibly scored 7 to 35), autonomy & parents (possibly scored 7 to 35), peers & social support (possibly scored 4 to 20), and school environment (possibly scored 4 to 20). A grand total score can be calculated by summing up the five sub scores. In all cases, a higher score represents higher perceived well-being.	Baseline, 1 week, 3 month and 6 month after treatment
Secondary	Change of Sleep Hygiene	Adolescent Sleep Hygiene Scale (ASHS): It is a 28-item instrument used to assess how adolescent apply sleep hygiene practice. total score range from 28 to 168 with higher score indicates better sleep practice. The instrument assessed adolescent sleep practice in nine domains: physiological(5 items, score 5-30), cognitive(6 items, score: 6 to 36), emotional(3 items; score: 3-18), sleep environment(4 items; score: 4-24), daytime sleep(1 items; score 1-6), substance(2 items; score: 2 to 12), bedtime routine(1 items; score:1-6), sleep stability(4 items; score: 4 to 16) and bedroom sharing(2 items; score 2-12).	Baseline, 1 week, 3 month and 6 month after treatment
Secondary	Change of Anxiety and depressive symptoms	Hospital Anxiety and Depression Scale (HADS) is a self-assessed scale for detecting states of depression and anxiety. The depression subscale range in scores from 0 to 21, with higher scores indicating severer states of depression. Similarly, the anxiety subscale range in scores from 0-21 with higher scores indicating severer states of anxiety. No additional computation will be made with the two subscores.	Baseline, 1 week, 3 month and 6 month after treatment
Secondary	Change of Academic performance	Academic performance is evaluated by the difference in average grade point between baseline, 3 month and 6 month.	Baseline, 3 month and 6 month after treatment
Secondary	Change of objective cognitive performance (inhibitory ability)	Go/No-go Task for assessing inhibitory ability. In Go/No-go Task, a higher error rate indicates lower inhibition control.	Baseline, 3 month and 6 month after treatment
Secondary	Change of objective cognitive performance (working memory by digit span)	Digit Span Task for assessing working memory capacity. In Digit Span Task, a higher number of recalled digits indicates better working memory.	Baseline, 3 month and 6 month after treatment
Secondary	Change of objective cognitive performance (working memory by N-Back)	N-back Task for assessing working memory capacity and manipulation. In N-back Task, a d prime score will be calculated based on the signal detection theory, where a higher score indicates better working memory performance.	Baseline, 3 month and 6 month after treatment
Secondary	Change of risk-taking & decision making	Balloon Analogue Risk Task for assessing risk-taking and decision-making. In Balloon Analogue Risk Task, a score will be calculated by averaging the number of pumps on unexploded blue balloons, where a higher score indicates more risk-taking and impulsive propensities.	Baseline, 3 month and 6 month after treatment