Promoting Teenage Sleep for Improved Mental Health and School Performance

Depression Clinical Trial

— TeenSleep  

Official title:

Promoting Teenage Sleep - for Better Mental Health and School Performance

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06306092
• Other study ID #: 2023-02885-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: June 2030

Study information

• Verified date: March 2024
• Source: Kristianstad University
• Contact: Pernilla Garmy, PhD
• Phone: +46739791316
• Email: pernilla.garmy[@]hkr.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: June 2030
• Est. primary completion date: June 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

Inclusion Criteria:

Students in Swedish high schools and upper secondary schools.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Anxiety
• Daytime Sleepiness
• Depression
• Disorders of Excessive Somnolence
• Insomnia
• Mental Health Issue
• Sleepiness

Intervention

Behavioral:
• Sleep on Schedule
Sleep education at school
• Technology restriction
Reduction of electronic media use before bedtime

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Kristianstad University	Academic Primary Health Care Centre, Region Stockholm, Karolinska Institutet, Örebro University, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sleep duration, hours and minutes	Self reported average time for sleep onset, time awake during the night and time for wakening in the morning, school days and weekends	Baseline, 3 month, 1 year
Secondary	Change in Hospital Anxiety and Depression Scale scores	Hospital Anxiety and Depression Scale measures anxiety and depression with 7 items for anxiety (range 0-21, higher scores mean worse outcome) and 7 items measure depression (range 0-21, higher scores mean worse outcome).	Baseline, 3 month, 1 year
Secondary	Change in Adolescent Sleep Hygiene Scale scores	Adolescent Sleep Hygiene Scale measures sleep habits, range 10-60, higher scores mean worse outcome.	Baseline, 3 month, 1 year
Secondary	Change in Insomnia Severity Index score	The Insomnia Severity Index (ISI) is a 7-item scale that asesses the severity of sleep disturbance, how much sleep disturbance interferes with daily life and functioning, the noticeability of these impairments to others, worry and distress resulting from sleep disturbance, and general sleep satisfaction/dissatisfaction. Responses are provided on a Likert-scale (0-4). The total score ranges from 0 to 28, and higher scores indicate more severe problems	Baseline, 3 month, 1 year
Secondary	Change in EuroQol Visual Analog Scale (EQ VAS) score	The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.	Baseline, 3 month, 1 year
Secondary	Change in CHU9D Child Health Utility 9D (CHU9D) scores	The CHU9D is a paediatric generic preference-based measure of health-related quality of life suitable for 7 to 17 year olds. It consists of a short questionnaire and a set of preference weights using general population values. The questionnaire has 9 questions with 5 response levels per question and is self-completed by the child. Range 9-45, higher scores mean worse outcome.	Baseline, 3 month, 1 year
Secondary	Change in Sleep knowledge	Sleep knowledge is measured with 9 questions, range 0-9, higher scores mean better sleep knowledge.	Baseline, 3 month, 1 year
Secondary	Change in electronic media use	Electronic media use is measured with 3 questions, range 3-12, higher scores mean more bedtime elecronic media use.	Baseline, 3 month, 1 year
Secondary	Change in sleep habits	Sleep habits regarding school days and weekends are measured with 10 questions.	Baseline, 3 month, 1 year
Secondary	Change in meta-cognitions	The Meta-Cognitions Questionnaire for Adolescents (MCQ-A) measures beliefs about worry and intrusive thoughts in adolescents aged between 13 and 17 year. Range 30-120, higher scores mean worse outcome.	Baseline, 3 month, 1 year
Secondary	Change in motivation	The Academic Self-Regulation Questionnaire (SRQ-A) - Intrinsic motivation subscale Why I do things measuer motivation. Range 7-28, higher scores mean worse outcome.	Baseline, 3 month, 1 year