Back to resultsAdvancing Adolescent Bedtime by MI and Text Reminders
Primary Purpose
Sleep Deprivation
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Group MI
Sponsored by
About this trial
This is an interventional other trial for Sleep Deprivation focused on measuring Sleep deprivation, Motivational Interviewing, Text reminders
Eligibility Criteria
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
Sites / Locations
- Department of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group MI
Control group
Arm Description
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.
Control group will no receive any intervention
Outcomes
Primary Outcome Measures
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
Change of Sleep duration by actigraphy
Sleep parameter estimated by actigraphy: total sleep time (TST) in hours
Secondary Outcome Measures
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
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.
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.
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).
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.
Change of Academic performance
Academic performance is evaluated by the difference in average grade point between baseline, 3 month and 6 month.
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.
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.
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.
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.
Full Information
NCT ID
NCT03614572
First Posted
July 21, 2018
Last Updated
November 28, 2021
Sponsor
Chinese University of Hong Kong
Collaborators
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03614572
Brief Title
Advancing Adolescent Bedtime by MI and Text Reminders
Official Title
Advancing Adolescent Bedtime by Using Motivational Interviewing and Text Reminders - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
Sleep deprivation, Motivational Interviewing, Text reminders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessor will be blinded to the condition of the subjects
Allocation
Randomized
Enrollment
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group MI
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will no receive any intervention
Intervention Type
Behavioral
Intervention Name(s)
Group MI
Other Intervention Name(s)
Motivational interviewing
Intervention Description
refer to the arm description
Primary Outcome Measure Information:
Title
Change of Sleep duration by sleep diary
Description
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours
Time Frame
Baseline, 1 week, 3 month and 6 month after treatment
Title
Change of Sleep duration by actigraphy
Description
Sleep parameter estimated by actigraphy: total sleep time (TST) in hours
Time Frame
Baseline, 1 week, 3 month and 6 month after treatment
Secondary Outcome Measure Information:
Title
Change of Sleep knowledge
Description
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
Time Frame
Baseline, 1 week, 3 month and 6 month after treatment
Title
Change of Daytime Sleepiness
Description
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.
Time Frame
Baseline, 1 week, 3 month and 6 month after treatment
Title
Change of Quality of Life
Description
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.
Time Frame
Baseline, 1 week, 3 month and 6 month after treatment
Title
Change of Sleep Hygiene
Description
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).
Time Frame
Baseline, 1 week, 3 month and 6 month after treatment
Title
Change of Anxiety and depressive symptoms
Description
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.
Time Frame
Baseline, 1 week, 3 month and 6 month after treatment
Title
Change of Academic performance
Description
Academic performance is evaluated by the difference in average grade point between baseline, 3 month and 6 month.
Time Frame
Baseline, 3 month and 6 month after treatment
Title
Change of objective cognitive performance (inhibitory ability)
Description
Go/No-go Task for assessing inhibitory ability. In Go/No-go Task, a higher error rate indicates lower inhibition control.
Time Frame
Baseline, 3 month and 6 month after treatment
Title
Change of objective cognitive performance (working memory by digit span)
Description
Digit Span Task for assessing working memory capacity. In Digit Span Task, a higher number of recalled digits indicates better working memory.
Time Frame
Baseline, 3 month and 6 month after treatment
Title
Change of objective cognitive performance (working memory by N-Back)
Description
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.
Time Frame
Baseline, 3 month and 6 month after treatment
Title
Change of risk-taking & decision making
Description
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.
Time Frame
Baseline, 3 month and 6 month after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ngan Yin Chan, Mphi
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry
City
Sha Tin
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
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Advancing Adolescent Bedtime by MI and Text Reminders
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