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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06306092
Other study ID # 2023-02885-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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: -

Study Design


Related Conditions & MeSH terms


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
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