Sleep DeprivationNCT03614572
Advancing Adolescent Bedtime by MI and Text Reminders
A study testing Group MI in people with Sleep Deprivation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Group MI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2018to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advancing Adolescent Bedtime by Using Motivational Interviewing and Text Reminders - A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Sleep Deprivation
- Being tested
- Group MI
- Keywords
- Sleep deprivation, Motivational Interviewing, Text reminders
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group MIBehavioural
Also called Motivational interviewing
refer to the arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Group MI |
| Control group | No intervention | Control group will no receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 1 week, 3 month and 6 month after treatment
Change of Sleep duration by actigraphy
Sleep parameter estimated by actigraphy: total sleep time (TST) in hours
Measured: Baseline, 1 week, 3 month and 6 month after treatment
Secondary outcomes (10)
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
Measured: Baseline, 1 week, 3 month and 6 month after treatment
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.
Measured: Baseline, 1 week, 3 month and 6 month after treatment
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.
Measured: Baseline, 1 week, 3 month and 6 month after treatment
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).
Measured: Baseline, 1 week, 3 month and 6 month after treatment
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.
Measured: Baseline, 1 week, 3 month and 6 month after treatment
Change of Academic performance
Academic performance is evaluated by the difference in average grade point between baseline, 3 month and 6 month.
Measured: Baseline, 3 month and 6 month after treatment
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.
Measured: Baseline, 3 month and 6 month after treatment
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.
Measured: Baseline, 3 month and 6 month after treatment
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.
Measured: Baseline, 3 month and 6 month after treatment
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.
Measured: Baseline, 3 month and 6 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Sep 2018
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, CHAN NGAN YIN, Chinese University of Hong Kong
- Investigators
- Ngan Yin Chan, Mphi, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614572
- Sponsor's protocol ID
- 15163071
- Status last verified
- Nov 2021
- First submitted
- 21 Jul 2018
- Last updated
- 30 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan NY, Chen SJ, Ngan CL, Li SX, Zhang J, Lam SP, Chan JWY, Yu MWM, Chan KCC, Li AM, Wing YK. Advancing adolescent bedtime by motivational interviewing and text message: a randomized controlled trial. J Child Psychol Psychiatry. 2025 Jul;66(7):1005-1017. doi: 10.1111/jcpp.14115. Epub 2025 Jan 20.
PubMed 39834005
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Adolescent Bedtime by Using Motivational Interviewing and Text Reminders - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03614572
- Acronym / sponsor ID
- 15163071
- Conditions
- Sleep Deprivation
- Keywords
- Sleep deprivation, Motivational Interviewing, Text reminders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group MI | Experimental | Behavioral: Group MIThe 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 | No intervention | –Control group will no receive any intervention |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group MIAlso: Motivational interviewingrefer to the arm description | Behavioural | Group MI |
Primary outcome
Change of Sleep duration by sleep diary
Time frame: 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
Time frame: Baseline, 1 week, 3 month and 6 month after treatment
Sleep parameter estimated by actigraphy: total sleep time (TST) in hours
10 secondary outcomes
Change of Sleep knowledge
Time frame: Baseline, 1 week, 3 month and 6 month after treatment
Change of Daytime Sleepiness
Time frame: Baseline, 1 week, 3 month and 6 month after treatment
Change of Quality of Life
Time frame: Baseline, 1 week, 3 month and 6 month after treatment
Change of Sleep Hygiene
Time frame: Baseline, 1 week, 3 month and 6 month after treatment
Change of Anxiety and depressive symptoms
Time frame: Baseline, 1 week, 3 month and 6 month after treatment
Change of Academic performance
Time frame: Baseline, 3 month and 6 month after treatment
Change of objective cognitive performance (inhibitory ability)
Time frame: Baseline, 3 month and 6 month after treatment
Change of objective cognitive performance (working memory by digit span)
Time frame: Baseline, 3 month and 6 month after treatment
Change of objective cognitive performance (working memory by N-Back)
Time frame: Baseline, 3 month and 6 month after treatment
Change of risk-taking & decision making
Time frame: Baseline, 3 month and 6 month after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Derived from this study: PubMed 39834005Chan NY, Chen SJ, Ngan CL, Li SX, Zhang J, Lam SP, Chan JWY, Yu MWM, Chan KCC, Li AM, Wing YK. Advancing adolescent bedtime by motivational interviewing and text message: a randomized controlled trial. J Child Psychol Psychiatry. 2025 Jul;66(7):1005-1017. doi: 10.1111/jcpp.14115. Epub 2025 Jan 20.
- Individual participant dataSharing planned: No
Related trials for Sleep Deprivation
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Sleep and Circadian Rhythm Intervention in ICU
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Effect of Sleep Extension in Prevention to Sleep Deprivation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ngan Yin Chan, Mphi principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group MI in people with Sleep Deprivation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Sleep duration by sleep diary (time frame: Baseline, 1 week, 3 month and 6 month after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03614572, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.