Clinical trial NCT06306092: Promoting Teenage Sleep for Improved Mental Health and School Performance
Official title: Promoting Teenage Sleep - for Better Mental Health and School Performance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Insomnia
Depression
Anxiety
Daytime Sleepiness
Wellness, Psychological
Keywords: Sleep
Mental health
Adolescents
School-based intervention
Lead sponsor: Kristianstad University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Örebro University, Sweden
name: Academic Primary Health Care Centre, Region Stockholm
First posted: 2024-03-12
Enrollment: 3000
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

Students in Swedish high schools and upper secondary schools.

Exclusion Criteria:

-

Primary outcomes:
measure: Change in sleep duration, hours and minutes
timeFrame: Baseline, 3 month, 1 year
Secondary outcomes:
measure: Change in Hospital Anxiety and Depression Scale scores
timeFrame: Baseline, 3 month, 1 year
measure: Change in Adolescent Sleep Hygiene Scale scores
timeFrame: Baseline, 3 month, 1 year
measure: Change in Insomnia Severity Index score
timeFrame: Baseline, 3 month, 1 year
measure: Change in EuroQol Visual Analog Scale (EQ VAS) score
timeFrame: Baseline, 3 month, 1 year
measure: Change in CHU9D Child Health Utility 9D (CHU9D) scores
timeFrame: Baseline, 3 month, 1 year
measure: Change in Sleep knowledge
timeFrame: Baseline, 3 month, 1 year
measure: Change in electronic media use
timeFrame: Baseline, 3 month, 1 year
measure: Change in sleep habits
timeFrame: Baseline, 3 month, 1 year
measure: Change in meta-cognitions
timeFrame: Baseline, 3 month, 1 year
measure: Change in motivation
timeFrame: Baseline, 3 month, 1 year
Other outcomes:
Locations:
city: Kristianstad
country: Sweden
facility: Kristianstad University
state: Skåne
Study officials:
affiliation: Örebro University, Sweden
name: Annika Norell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Christina Sandlund, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kristianstad University
name: Pernilla Garmy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Örebro University, Sweden
name: Serena Bauducco, PhD
role: PRINCIPAL_INVESTIGATOR
References: