A Theory-based Sleep Intervention in Improving Sleep Quality in Adolescents

Study Overview
=================
Brief Summary
-----------------
Sleep education has been used as a method of primary and secondary prevention of sleep problems in all age groups. An especially vulnerable age group are adolescents who frequently have poor sleep habits and suffer from sleep deprivation. In adolescents, insufficient sleep, inadequate sleep quality, and irregular sleep patterns are associated with daytime sleepiness, negative moods, increased likelihood of stimulant use, higher levels of risk-taking behavior, poor school performance, and increased risk of unintentional injuries. As an US study has shown, sleepiness was the major causal factor in many traffic accidents and more than 50% of sleep-related crashes involved drivers aged 25 or younger. The study was aimed to evaluate the effectiveness of a theory-based sleep hygiene intervention in improving sleep quality in adolescents.

Official Title
-----------------
Effectiveness of Theory-based Sleep Hygiene Intervention in Improving Sleep Quality in Adolescents: a Cluster Randomized Controlled Trial

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Behavioral: Control
* Behavioral: Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: They are not involved in any sleep education program study at secondary schools in Qazvin city Ability to understand Persian language Exclusion Criteria: Does not meet inclusion criteria

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>The adolescents will not receive any specific information | Behavioral: Control<br>* the adolescents will not receive any specific intervention<br>|
| Experimental: Intervention<br>The adolescents will receive relevant information on the importance of adequate sleep, the consequences of sleep deprivation, Provide information about others' approval,Provide normative information about others' behaviour,Goal setting ,action planning, coping planning, Set graded tasks,Prompt self-monitoring of sleep behaviour | Behavioral: Intervention<br>* A theory based sleep hygiene intervention based on the theory planned behavior will be conduced on the adolescent<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in self-reported Sleep hygiene behavior | Sleep behavior will be assessed through self-report employing 24-h recall of the previous night's sleep | changes from baseline , 1 month and 6 Months follow-up | 
| Changes in Sleep duration | Sleep duration will be measured using the Pittsburgh Sleep Quality Index (PSIQ). The PSQI is a self-administered questionnaire to assess subjective sleep quality during the previous month (Buysse et al., 1989). The self-rated items of the PSQI generate seven component scores (range of subscale scores, 0-3): sleep quality; sleep latency; sleep duration; habitual sleep efficiency; sleep disturbance; use of sleeping medication; and daytime dysfunction. | changes from baseline , 1 month and 6 Months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in psychological predictors of sleep hygiene behavior (attitude, subjective norms intention, perceived behavioral control , Self-monitoring, action planning and coping planning) | psychological predictors of sleep hygiene behavior were assessed using a using a self-reported measure. All items are rated on a Likert-type scale, ranging from 1 to 5. | changes from baseline , 1 month and 6 Months follow-up | 
| Adolescent Sleep Hygiene Scale |  | changes from baseline , 1 month and 6 Months follow-up | 
| General Health Questionnaire | A self-administered questionnaire will be given to each participant, in which the PSQI-I, the Iranian version of the General Health Questionnaire 12 (GHQ12-I) | changes from baseline , 1 month and 6 Months follow-up | 
| Pediatric Daytime Sleepiness Scale |  | changes from baseline , 1 month and 6 Months follow-up | 
| Sleep Disturbances Scale for Children |  | changes from baseline , 1 month and 6 Months follow-up | 
| Changes in health-related quality of life | health-related quality of life will be measured using the Pediatric Quality of Life Inventory™ Short Form 15 Generic Core Scales. | changes from baseline , 1 month and 6 Months follow-up | 
| Sleep knowledge questionnaire |  | changes from baseline , 1 month and 6 Months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychological Theory, adolescents