The Validity and Reliability of Brief Infant Sleep Questionnaire Revised (BISQ-R)

Insomnia Clinical Trial

Official title:

The Validity and Reliability of the Turkish Version of Brief Infant Sleep Questionnaire Revised (BISQ-R)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05553171
• Other study ID #: 02.09.2022.1127
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: September 2023

Study information

• Verified date: September 2022
• Source: Marmara University
• Contact: Perran Boran
• Phone: +905417127756
• Email: drperran[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: September 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 36 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Having chronic diseases

Related Conditions & MeSH terms

• Behavioral Insomnia of Childhood
• Insomnia
• Sleep Initiation and Maintenance Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Turkish Validation of the Brief Infant Sleep Questionnaire Revised (BISQ-R) Survey	Brief Infant Sleep Questionnaire-Revised (BISQ-R) Survey will be validated using exploratory and confirmatory factor analytical techniques	Baseline
Primary	Turkish Reliability of the Brief Infant Sleep Questionnaire Revised (BISQ-R) Survey	Reliability will be examined by re-applying the questionnaire to 100 participants 3 weeks after the application of the questionnaire, using Cronbach's alpha internal consistency coefficients, item analysis and test-retest method.	Baseline
Primary	Turkish Reliability of the Brief Infant Sleep Questionnaire Revised (BISQ-R) Survey	Reliability will be examined by re-applying the questionnaire to 100 participants 3 weeks after the application of the questionnaire, using Cronbach's alpha internal consistency coefficients, item analysis and test-retest method.	at 3 weeks
Secondary	Protective factors index	Brief Infant Sleep Questionnaire-Revised (BISQ-R) Survey total scores will be summed by the average of 3 subscale scores. Scores from each subscale and total score ranges from 0 to 100; higher scores indicate better sleep quality, more positive perception of infant sleep, and parental behaviors that promote healthy and independent sleep.	baseline
Secondary	Subscale scores for each protective factors	Brief Infant Sleep Questionnaire-Revised (BISQ-R) Survey subscale scores [infant sleep (IS) subscale, parental perception (PP), Parental Behavior (PB) subscales] will be computed. Higher scores indicate better sleep quality, more positive perception of infant sleep, and parental behaviors that promote healthy and independent sleep.In the infant sleep (IS) subscale, there are 5 questions about sleep patterns: sleep onset latency, number and duration of waking up at night, longest sleep duration, and total night sleep. In the parental perception (PP) subscale, there are 3 questions regarding the caregiver's perception of difficulty in bedtime, night sleep and general child sleep problems (Question 32,28,14). Eleven questions in the Parental Behavior (PB) subscale about sleep ecology, including routine consistency at bedtime, bedtime, parental behavior at sleep onset, and night awakenings.	baseline