Promoting Teenage Sleep for Improved Mental Health and School Performance

NCT ID: NCT06306092

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-17
• Study Completion Date: 2030-06-30

Brief Summary

The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms. The programs will be offered to students aged 13-19 at Swedish high schools and upper secondary schools at the classroom level. The students will be compared to teaching as usual (control group).

Detailed Description

Sleep problems are common among young people and there are connections between sleep problems and mental health, concentration problems, and lower grades. Over time (historically since the 80's), teenagers sleep less and less and too little, which affects mental health and school performance in the short term. Long-term lack of sleep increases the risk of leaving school with failed grades and of having long-term health problems. It is therefore important to break this trend.

A challenge in existing preventive sleep programs is to motivate young people to change their sleep habits. Just like adults, teenagers have many activities that demand their time. It can therefore be difficult to balance sleep with schoolwork, exercise, etc. Young people need knowledge about sleep to gain an understanding of how it can affect their mood and ability to cope with school. The reasons for the lack of sleep among young people are multifold: the 24-hour society and easily accessible entertainment/society via technology use, puberty-related changes in the circadian rhythm, and stress about the future. The school has a clear responsibility for the students' knowledge and understanding of the importance of lifestyle for health as well as for supporting the students in orienting themselves in society. The school is therefore a natural arena to reach out to teenagers because most young people are there, and the school health department can offer health-promotion initiatives.

The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms. The programs will be offered to students aged 13-19 at Swedish high schools and upper secondary schools at the classroom level. The students will be compared to teaching as usual (control group).

Sleep on schedule is a program (5 lessons over 5 weeks) that integrates sleep knowledge and skill training to promote good sleep routines. Technology restriction is a program (2 lessons over 2 weeks) that targets mobile phone use at bedtime. Both programs have shown good results (up to 20 minutes more sleep on school days). The current goal was to test the effects of the programs on young people in a Swedish context to investigate if they can affect teenagers' sleep and mental health.

The study design is a cluster-randomized study where schools are randomized to either 1) Sleep on schedule, 2) Technology restriction, or 3) Control group (no intervention). All schools will be informed of the results and receive training in the program that proves to be most effective at the end of the project, if desired. The intervention is aimed at students aged 13-19. We want to involve large parts of the school's staff and avoid that knowledge and responsibility resting on a few members of staff. The program will be delivered by teachers or school health professionals (e.g., school counsellor, school nurse).

The interventions will directly benefit young people because sleep problems are a risk factor for mental illness and worse school performance. Sleep on schedule and restricting use of technology are important life skills and strategies that can help young people manage their everyday lives both now and in the future. The study offers benefits to the students in the intervention group in that they can learn strategies for preventive purposes regarding sleep before clinical problems arise. The participants will also have their voices heard on the subject.

Conditions

Mental Health Issue; Insomnia; Depression; Anxiety; Daytime Sleepiness; Wellness, Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

"Sleep on Schedule" - sleep education at school

The sleep training includes five lessons during school hours, and will be held by school staff (teachers, school nurses and school counsellors). The teaching consists of sleep education (sleep knowledge and good sleep routines), time management (e.g., planning homework without distraction, planning other activities, quiet time before bedtime), information to guardians, and discussions with peers in the classroom (e.g., rules regarding evening interaction via electronic media). Homework/exercises and behavioral experiments are also included. Data collection takes place in connection with the first and last lesson of Sleep on Schedule.

Group Type: EXPERIMENTAL

Sleep on Schedule

Intervention Type: BEHAVIORAL

Sleep education at school

"TechRest" - reduction of electronic media use before bedtime

This intervention has been tested in Australia with a small sample of teenagers, and it was associated with promising effects. The data collection consists of a digital questionnaire regarding sleep habits, insomnia, motivation, physical and mental health, and electronic media use; a selection of students will use the actigraph for a week. After the first week, the participants will be instructed to stop using screens 1 hour before their usual bedtime. After one week has passed, participants in the Technology restriction intervention will be asked to complete the previously mentioned questionnaires as well as questions about the intervention itself: its applicability, compliance, and whether or not they will continue to limit their screen time before bedtime. One year after the intervention, they will be asked to complete the same questionnaire as at baseline. A selection of students will also wear a wrist actigraph.

Group Type: EXPERIMENTAL

Technology restriction

Intervention Type: BEHAVIORAL

Reduction of electronic media use before bedtime

Control

School as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sleep on Schedule

Sleep education at school

Intervention Type: BEHAVIORAL

Technology restriction

Reduction of electronic media use before bedtime

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Students in Swedish high schools and upper secondary schools.

Exclusion Criteria

-

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Örebro University, Sweden

OTHER

Sponsor Role: collaborator

Academic Primary Health Care Centre, Region Stockholm

UNKNOWN

Sponsor Role: collaborator

Kristianstad University

OTHER

Sponsor Role: lead

Responsible Party

Pernilla Garmy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annika Norell, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Christina Sandlund, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Pernilla Garmy, PhD

Role: PRINCIPAL_INVESTIGATOR

Kristianstad University

Serena Bauducco, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

Kristianstad University

Kristianstad, Skåne County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Pernilla Garmy, PhD

Role: CONTACT

pernilla.garmy@hkr.se

+46739791316

Serena Bauducco, PhD

Role: CONTACT

Serena.Bauducco@oru.se

Facility Contacts

Pernilla Garmy, PhD

Role: primary

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2023-02885-01

Identifier Type: -

Identifier Source: org_study_id