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CompletedNCT02551913Updated Feb 9, 2018

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

An interventional study of Control and Intervention in Sleep, sponsored by Qazvin University Of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-09.

Sponsored by Qazvin University Of Medical Sciences · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
2,841
Allocation
Randomized
Ages
Up to 18 Years
Sex
All
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Study 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.

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Conditions studied

  • Sleep

Keywords

  • Psychological Theory
  • adolescents
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In context

Lead sponsor

Qazvin University Of Medical Sciences is the lead sponsor of 32 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Does not meet inclusion criteria
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
2,841 participants (actual)

Study arms

  • Active comparator
    control

    The adolescents will not receive any specific information

    Behavioral: Control

  • 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

Interventions

  • BehavioralControl

    the adolescents will not receive any specific intervention

  • BehavioralIntervention

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: changes from baseline , 1 month and 6 Months follow-up

  2. 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.

    Time frame: changes from baseline , 1 month and 6 Months follow-up

Secondary outcomes

  1. 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.

    Time frame: changes from baseline , 1 month and 6 Months follow-up

  2. Adolescent Sleep Hygiene Scale

    Time frame: changes from baseline , 1 month and 6 Months follow-up

  3. 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)

    Time frame: changes from baseline , 1 month and 6 Months follow-up

  4. Pediatric Daytime Sleepiness Scale

    Time frame: changes from baseline , 1 month and 6 Months follow-up

  5. Sleep Disturbances Scale for Children

    Time frame: changes from baseline , 1 month and 6 Months follow-up

  6. 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.

    Time frame: changes from baseline , 1 month and 6 Months follow-up

  7. Sleep knowledge questionnaire

    Time frame: changes from baseline , 1 month and 6 Months follow-up

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Study locations

1 site
  • The Organization for Education
    Qazvin, Iran, Islamic Republic of
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References and documents

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. PubMed 30423178 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02551913
Lead sponsor
Qazvin University Of Medical Sciences
Responsible party
Amir H Pakpour (Associate Professor and Director, Qazvin University Of Medical Sciences) — Principal investigator
First posted
Sep 16, 2015
Start date
Sep 2015
Primary completion
Mar 2016
Completion
Apr 2017
Last update
Feb 9, 2018

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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