Advancing Adolescent Bedtime by MI and Text Reminders

November 28, 2021 updated by: CHAN NGAN YIN, Chinese University of Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sha Tin, Hong Kong
        • Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
refer to the arm description
Other Names:
  • Motivational interviewing
NO_INTERVENTION: Control group
Control group will no receive any intervention

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
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
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
Baseline, 1 week, 3 month and 6 month after treatment

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
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
Change of Daytime Sleepiness
Time Frame: 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.
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

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
Change of Sleep Hygiene
Time Frame: 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).
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
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
Change of Academic performance
Time Frame: 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.
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
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
Change of objective cognitive performance (working memory by digit span)
Time Frame: 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.
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
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
Change of risk-taking & decision making
Time Frame: 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.
Baseline, 3 month and 6 month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ACTUAL)

October 31, 2021

Study Completion (ACTUAL)

October 31, 2021

Study Registration Dates

First Submitted

July 21, 2018

First Submitted That Met QC Criteria

July 30, 2018

First Posted (ACTUAL)

August 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 28, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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