Condition category
Nervous System Diseases
Date applied
02/07/2013
Date assigned
17/07/2013
Last edited
17/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Evidence indicates that 61% of teenagers do not get enough sleep. Late bedtime is the main cause of lack of sleep. Therefore, we are carrying out this study to find out how teenagers can be motivated to go to bed earlier.

Who can participate?
We aim to enrol 30 teenagers (age 12-18 years old) from a high school in Montreal, Canada.

What does the study involve?
The study involves four 1-hour sessions and the completion of several online questionnaires. The sessions will be one-on-one and will happen during four consecutive weeks. Participants will also complete online questionnaires, which assess sleep-related variables like bedtime.

What are the possible benefits and risks of participating?
Participation in this study can help the teenager go to bed earlier, which can have a positive impact on many aspects of his/her daily life (e.g. attention, mood). Also, they may better understand the importance of a good night’s sleep, as well as ways to improve their sleep habits. It is expected that the findings of the study will help in understanding effective ways to encourage teenagers to go to bed earlier. It can potentially improve the overall health and well-being of teenagers. There are no anticipated risks of participation in this study.

Where is the study run from?
This study is run from McGill University, Canada.

When is the study starting and how long is it expected to run for?
Recruitment of participants started in November 2012. Participants will be enrolled in the study for four consecutive weeks. The study will end after collecting information from following the participants for 6 months.

Who is funding the study?
This study is funded by the Doctoral Research Allowance and Doctoral Research Award of the Canadian Institute for Health Research (CIHR), Canada.

Who is the main contact?
Ms Jamie Cassoff
jamie.cassoff@mail.mcgill.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Reut Gruber

ORCID ID

Contact details

Attention
Behaviour and Sleep Lab
Douglas Mental Health University Institute
6875 LaSalle Boulevard
Verdun
H4H 1R3
Canada
514-761-6131 ext. 2050
reut.gruber@douglas.mcgill.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluating the effectiveness of the Motivating Teens to Sleep More program in advancing bedtime in adolescents: a randomized controlled trial

Acronym

MTSM

Study hypothesis

It is hypothesized that adolescents participating in the Motivating Teens to Sleep More program will go into bed earlier, fall asleep earlier and obtain longer sleep duration than the participants in the control group (sleep education only).

The null hypothesis is that there will be no differences in bedtime, sleep onset and sleep duration between the experimental and the control group.

Ethics approval

The study has obtained approval by the McGill Research Ethics Board in November 2012 (REB# 115-0912)

Study design

One-month single-blinded randomized parallel group controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Sleep restriction in adolescents

Intervention

Participants in the study will be randomly assigned to either the experimental arm (“Motivating Teens to Sleep More” program), or the active control group (sleep education only). Participants in both groups will undergo four one-on-one (the interventionist and the participant) 1-hour sessions during four consecutive weeks. Both arms of this sleep promotion program aim at improving adolescents’ sleep habits and will be delivered by doctoral students in Psychology trained in the necessary clinical techniques.

Participants in the active control group will receive sleep education only (i.e. presentations about why we need sleep, sleep in adolescence, sleep disorders etc.).

Adolescents in the experimental group will not only receive information about sleep but will also be encouraged to change their bedtime. The goal of the experimental session is to increase participants’ intrinsic motivation to go to bed earlier by using the principles of Motivational Interviewing, tailoring the session activities to personal characteristics and conducting session activities that are congruent with the participant’s current levels of readiness to go to bed earlier. Before the first session in both the experimental and control condition, each participant will fill out a computerized questionnaire to assess background characteristics and information related to their sleep behaviours and personal attitudes. In both conditions, participants will be asked to wear an actiwatch for a period of one week before and after completing the program in order to assess their sleep. An actiwatch is a small “sleep-watch” that records body movement during the night. Three months and six months after completing the sessions, all participants will be asked to complete a few questionnaires about their sleep habits.

Joint/Scientific contact details
Drs. Bärbel Knäuper and Reut Gruber are Co-PIs on this study.

Bärbel Knäuper, Dr. phil.
Department of Psychology, McGill University
Stewart Biology Building, 1205 Dr. Penfield Avenue
Montreal, QC H3A 1B1, Canada
Email: barbel.knauper@mcgill.ca
Tel: 514-398-8186
Fax: 514-398-4896

Reut Gruber, PhD
Attention, Behaviour and Sleep Lab
Douglas Mental Health University Institute,
6875 LaSalle Boulevard, Verdun, QC H4H 1R3, Canada
Email: reut.gruber@douglas.mcgill.ca
Tel: 514-761-6131 ext. 2050
Fax: 514-762-3858

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Bedtime, self-reported and assessed with an actiwatch (a small “sleep-watch” that records body movement during night) at baseline, mid-study, end of the study, three months and six months.
2. Sleep onset, assessed with an actiwatch at baseline and at the end of the study.
3. Sleep duration, assessed with an actiwatch at baseline, mid-study, end of the study, three months and six months.

Secondary outcome measures

1. Sleep-related self-efficacy, assessed with the Sleep Specific Self-Efficacy questionnaire (Watts, East & Coyle, 1995; Schwarzer & Renner, 2009) at baseline, after each session, at three months and six months.
2. Attitudes toward sleep, assessed with a Decisional Balance questionnaire (developed by the authors for this study) at baseline, after the study, at three months and six months.

Overall trial start date

01/11/2012

Overall trial end date

01/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. The participants in this trial can be male or female between the ages of 12-18 years old
2. The participants in this trial obtain 8 or less hours of sleep during a weeknight
2. The participants in this trial are open to changing their sleep habits within the next year

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

30

Participant exclusion criteria

The participants in this trial cannot not suffer from a medical, mental or sleep disorder.

Recruitment start date

01/11/2012

Recruitment end date

01/01/2015

Locations

Countries of recruitment

Canada

Trial participating centre

Attention, Behaviour and Sleep Lab
Verdun
H4H 1R3
Canada

Sponsor information

Organisation

McGill University (Canada)

Sponsor details

c/o Lynda McNeil
Research Ethics Officer
REB-I,II,III
Office of the Vice-Principal (Research&International Relations)
Research Ethics & Compliance
James Administration Building
Room 429
845 Sherbrooke Street West
Montreal
H3A 0G4
Canada
514-398-6831
lynda.mcneil@mcgill.ca

Sponsor type

University/education

Website

http://www.mcgill.ca/research/researchers/compliance/human/

Funders

Funder type

Government

Funder name

This study is funded by the Doctoral Research Allowance and Doctoral research award (Priority Announcement: Patient-Oriented Research) of the Canadian Institute for Health Research (CIHR) to Jamie Cassoff, PhD Candidate at McGill University (application number 291062).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes