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

September 21, 2022 updated by: Perran Boran, Marmara University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Typically developing, term born, healthy children between 3 to 36 months of age and their parents

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Having chronic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Turkish Validation of the Brief Infant Sleep Questionnaire Revised (BISQ-R) Survey
Time Frame: Baseline
Brief Infant Sleep Questionnaire-Revised (BISQ-R) Survey will be validated using exploratory and confirmatory factor analytical techniques
Baseline
Turkish Reliability of the Brief Infant Sleep Questionnaire Revised (BISQ-R) Survey
Time Frame: Baseline
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
Turkish Reliability of the Brief Infant Sleep Questionnaire Revised (BISQ-R) Survey
Time Frame: at 3 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protective factors index
Time Frame: baseline
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
Subscale scores for each protective factors
Time Frame: baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

September 21, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02.09.2022.1127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Requests for wider sharing of data (for example in response to publications about the study and willingness to share), will be addressed on a case-by-case basis. Any data sharing request will be made to investigators through a pre-defined data requisition form. This form will contain information about the applicant, institution, purpose of data request, study objectives, ethical clearance of the study, etc. Once a request has been made the data governance body will discuss if that request was appropriate; data will be released following signing of the data sharing agreement. The data will be stored on the Marmara University servers and not be deposited in any 'community' database.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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