NCT02551913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,841

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

6 months

First QC Date

September 11, 2015

Last Update Submit

February 8, 2018

Conditions

Sleep

Keywords

Psychological Theoryadolescents

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Changes in psychological predictors of sleep hygiene behavior (attitude, subjective norms intention, perceived behavioral control , Self-monitoring, action planning and coping planning)

    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

    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

  • +2 more secondary outcomes

Study Arms (2)

control

ACTIVE COMPARATOR

The adolescents will not receive any specific information

Behavioral: Control

Intervention

EXPERIMENTAL

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

Interventions

ControlBEHAVIORAL

the adolescents will not receive any specific intervention

control
InterventionBEHAVIORAL

A theory based sleep hygiene intervention based on the theory planned behavior will be conduced on the adolescent

Intervention

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • They are not involved in any sleep education program
  • study at secondary schools in Qazvin city
  • Ability to understand Persian language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Organization for Education

Qazvin, Iran

Location

Related Publications (1)

  • 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.

    PMID: 30423178DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Director

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 16, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2017

Last Updated

February 9, 2018

Record last verified: 2018-02

Locations

IR(1)