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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Behavioral: Control; Behavioral: Intervention

• Study Type: Interventional
• Enrollment (Actual): 2841
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Qazvin, Iran, Islamic Republic of
    • The Organization for Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: control; The adolescents will not receive any specific information	Behavioral: Control; the adolescents will not receive any specific intervention
EXPERIMENTAL: Intervention; 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; A theory based sleep hygiene intervention based on the theory planned behavior will be conduced on the adolescent

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

Collaborators and Investigators

• Sponsor: Qazvin University Of Medical Sciences

Publications and helpful links

General Publications

• Lin CY, Strong C, Scott AJ, Brostrom A, Pakpour AH, Webb TL. A cluster randomized controlled trial of a theory-based sleep hygiene intervention for adolescents. Sleep. 2018 Nov 1;41(11). doi: 10.1093/sleep/zsy170.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): April 1, 2017

Study Registration Dates

• First Submitted: September 11, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (ESTIMATE): September 16, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: adolescents; Psychological Theory
• Other Study ID Numbers: QUMS398