- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03614572
Advancing Adolescent Bedtime by MI and Text Reminders
Advancing Adolescent Bedtime by Using Motivational Interviewing and Text Reminders - A Randomized Controlled Trial
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sha Tin, Hong Kong
- Department of Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Group MI
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.
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refer to the arm description
Other Names:
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NO_INTERVENTION: Control group
Control group will no receive any intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Sleep duration by sleep diary
Time Frame: Baseline, 1 week, 3 month and 6 month after treatment
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Daily sleep diary for consecutive seven days.
Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours
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Baseline, 1 week, 3 month and 6 month after treatment
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Change of Sleep duration by actigraphy
Time Frame: Baseline, 1 week, 3 month and 6 month after treatment
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Sleep parameter estimated by actigraphy: total sleep time (TST) in hours
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Baseline, 1 week, 3 month and 6 month after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Sleep knowledge
Time Frame: Baseline, 1 week, 3 month and 6 month after treatment
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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
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Baseline, 1 week, 3 month and 6 month after treatment
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Change of Daytime Sleepiness
Time Frame: Baseline, 1 week, 3 month and 6 month after treatment
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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.
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Baseline, 1 week, 3 month and 6 month after treatment
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Change of Quality of Life
Time Frame: Baseline, 1 week, 3 month and 6 month after treatment
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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
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Change of Sleep Hygiene
Time Frame: Baseline, 1 week, 3 month and 6 month after treatment
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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).
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Baseline, 1 week, 3 month and 6 month after treatment
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Change of Anxiety and depressive symptoms
Time Frame: Baseline, 1 week, 3 month and 6 month after treatment
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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.
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Baseline, 1 week, 3 month and 6 month after treatment
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Change of Academic performance
Time Frame: Baseline, 3 month and 6 month after treatment
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Academic performance is evaluated by the difference in average grade point between baseline, 3 month and 6 month.
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Baseline, 3 month and 6 month after treatment
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Change of objective cognitive performance (inhibitory ability)
Time Frame: Baseline, 3 month and 6 month after treatment
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Go/No-go Task for assessing inhibitory ability.
In Go/No-go Task, a higher error rate indicates lower inhibition control.
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Baseline, 3 month and 6 month after treatment
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Change of objective cognitive performance (working memory by digit span)
Time Frame: Baseline, 3 month and 6 month after treatment
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Digit Span Task for assessing working memory capacity.
In Digit Span Task, a higher number of recalled digits indicates better working memory.
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Baseline, 3 month and 6 month after treatment
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Change of objective cognitive performance (working memory by N-Back)
Time Frame: Baseline, 3 month and 6 month after treatment
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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.
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Baseline, 3 month and 6 month after treatment
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Change of risk-taking & decision making
Time Frame: Baseline, 3 month and 6 month after treatment
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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.
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Baseline, 3 month and 6 month after treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ngan Yin Chan, Mphi, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15163071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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