Clinical trial NCT05553171: The Validity and Reliability of Brief Infant Sleep Questionnaire Revised (BISQ-R)
Official title: The Validity and Reliability of the Turkish Version of Brief Infant Sleep Questionnaire Revised (BISQ-R)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Insomnia
Behavioral Insomnia of Childhood
Keywords: insomnia
validity
Questionnaire
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Typically developing, term born, healthy children between 3 to 36 months of age and their parents

Brief summary: Brief Infant Sleep Questionnaire is a frequently used validated tool originally developed by Sadeh for evaluation of behavioral sleep problems in young children. It has been translated into Turkish and found reliable. The questionnaire has been revised and a norm referenced scoring system for the Brief Infant Sleep Questionnaire Revised (BISQ-R) was developed by Mindell and her team (Mindell JA, Gould RA, Tikotzy L, Leichman ES, Walters RM. Norm-referenced scoring system for the Brief Infant Sleep Questionnaire - Revised (BISQ-R). Sleep Med 2019; 63:106-114). We aimed to validate BISQ-R using exploratory and confirmatory factor analytical techniques, to provide evidence for its factor validity and reliability in a Turkish population.

Detailed description: Brief Infant Sleep Questionnaire is a frequently used validated tool originally developed by Sadeh for evaluation of behavioral sleep problems in young children. It has been translated into Turkish and found reliable. The questionnaire has been revised and a norm referenced scoring system for the Brief Infant Sleep Questionnaire Revised (BISQ-R) was developed by Mindell and her team (Mindell JA, Gould RA, Tikotzy L, Leichman ES, Walters RM. Norm-referenced scoring system for the Brief Infant Sleep Questionnaire - Revised (BISQ-R). Sleep Med 2019; 63:106-114). We aimed to validate BISQ-R using exploratory and confirmatory factor analytical techniques, to provide evidence for its factor validity and reliability in a Turkish population.

The BISQ-R consists of 33 questions with 19 questions for scoring. There are 3 subscales including infant sleep, parent perception and parent behavior. The total and each subscale score ranges from 0 to 100. Total score is the average of the 3 subscale scores. Higher scores indicate better sleep quality, more positive perception of infant sleep, and parental behaviors that promote healthy and independent sleep.

Independent Turkish to English, and back translations were completed, and reviewed by BISQ-R team for consistency, and identified problems were resolved. The study is designed as a prospective observational study with an anticipated sample size of 300 children. An online google survey will be developed on the google platform securing data collection by a confidential log in system which can be filled out from smartphones, tablet or computer. For a test-retest reliability evaluation, a retest will be conducted in 100 participants with a 3 weeks interval between the administrations using Cronbach's alpha internal consistency coefficients, item analysis and test-retest method. The project has received Institutional Review Board (IRB) from Marmara University School of Medicine (02.09.2022.1127). After the data collection is completed, an application and an agreement form will be filled out and sent to BISQ-R team for scoring.

Eligibility criteria: Inclusion Criteria:

* Term born, typically developing children aged between 3 to 36 months and their parents

Exclusion Criteria:

* Having chronic diseases

Primary outcomes:
measure: Turkish Validation of the Brief Infant Sleep Questionnaire Revised (BISQ-R) Survey
timeFrame: Baseline
measure: Turkish Reliability of the Brief Infant Sleep Questionnaire Revised (BISQ-R) Survey
timeFrame: Baseline
measure: Turkish Reliability of the Brief Infant Sleep Questionnaire Revised (BISQ-R) Survey
timeFrame: at 3 weeks
Secondary outcomes:
measure: Protective factors index
timeFrame: baseline
measure: Subscale scores for each protective factors
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References: