Advancing Adolescent Bedtime by MI and Text Reminders

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT03614572
Collaborator
The University of Hong Kong (Other)
212
1
2
38
5.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Group MI
N/A

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

Study Type:
Interventional
Actual Enrollment :
212 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The assessor will be blinded to the condition of the subjects
Primary Purpose:
Other
Official Title:
Advancing Adolescent Bedtime by Using Motivational Interviewing and Text Reminders - A Randomized Controlled Trial
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Oct 31, 2021
Actual Study Completion Date :
Oct 31, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Behavioral: Group MI
refer to the arm description
Other Names:
  • Motivational interviewing
  • No Intervention: Control group

    Control group will no receive any intervention

    Outcome Measures

    Primary Outcome Measures

    1. Change of Sleep duration by sleep diary [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

    2. Change of Sleep duration by actigraphy [Baseline, 1 week, 3 month and 6 month after treatment]

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

    Secondary Outcome Measures

    1. Change of Sleep knowledge [Baseline, 1 week, 3 month and 6 month after treatment]

      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

    2. Change of Daytime Sleepiness [Baseline, 1 week, 3 month and 6 month after treatment]

      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.

    3. Change of Quality of Life [Baseline, 1 week, 3 month and 6 month after treatment]

      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.

    4. Change of Sleep Hygiene [Baseline, 1 week, 3 month and 6 month after treatment]

      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).

    5. Change of Anxiety and depressive symptoms [Baseline, 1 week, 3 month and 6 month after treatment]

      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.

    6. Change of Academic performance [Baseline, 3 month and 6 month after treatment]

      Academic performance is evaluated by the difference in average grade point between baseline, 3 month and 6 month.

    7. Change of objective cognitive performance (inhibitory ability) [Baseline, 3 month and 6 month after treatment]

      Go/No-go Task for assessing inhibitory ability. In Go/No-go Task, a higher error rate indicates lower inhibition control.

    8. Change of objective cognitive performance (working memory by digit span) [Baseline, 3 month and 6 month after treatment]

      Digit Span Task for assessing working memory capacity. In Digit Span Task, a higher number of recalled digits indicates better working memory.

    9. Change of objective cognitive performance (working memory by N-Back) [Baseline, 3 month and 6 month after treatment]

      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.

    10. Change of risk-taking & decision making [Baseline, 3 month and 6 month after treatment]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Psychiatry Sha Tin Hong Kong

    Sponsors and Collaborators

    • Chinese University of Hong Kong
    • The University of Hong Kong

    Investigators

    • Principal Investigator: Ngan Yin Chan, Mphi, Chinese University of Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CHAN NGAN YIN, Research Associate, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT03614572
    Other Study ID Numbers:
    • 15163071
    First Posted:
    Aug 3, 2018
    Last Update Posted:
    Nov 30, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by CHAN NGAN YIN, Research Associate, Chinese University of Hong Kong
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 30, 2021