InsomniaNCT05553171
The Validity and Reliability of Brief Infant Sleep Questionnaire Revised (BISQ-R)
An observational study of Insomnia and Behavioral Insomnia of Childhood, run by Marmara University.
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. Read more about this study
- Who is it for?
- Ages 3 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Behavioral Insomnia of Childhood
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Typically developing, term born, healthy children between 3 to 36 months of age and their parents
Who may be able to join
- Term born, typically developing children aged between 3 to 36 months and their parents
Who cannot join
- Having chronic diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Insomnia, Behavioral Insomnia of Childhood
- Keywords
- insomnia, validity, Questionnaire
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
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.
Measured: Baseline
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.
Measured: at 3 weeks
Secondary outcomes (2)
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.
Measured: baseline
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perran Boran, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553171
- Sponsor's protocol ID
- 02.09.2022.1127
- Status last verified
- Sep 2022
- First submitted
- 21 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of the Turkish Version of Brief Infant Sleep Questionnaire Revised (BISQ-R)
- ClinicalTrials.gov ID
- NCT05553171
- Acronym / sponsor ID
- 02.09.2022.1127
- Conditions
- Insomnia, Behavioral Insomnia of Childhood
- Keywords
- insomnia, validity, Questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Typically developing, term born, healthy children between 3 to 36 months of age and their parents
Key inclusion criteria (1 listed)
- Term born, typically developing children aged between 3 to 36 months and their parents
Key exclusion criteria (1 listed)
- Having chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
2 secondary outcomes
Protective factors index
Time frame: baseline
Subscale scores for each protective factors
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia and Behavioral Insomnia of Childhood, run by Marmara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Perran Boran (+905417127756, drperran@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turkish Validation of the Brief Infant Sleep Questionnaire Revised (BISQ-R) Survey (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.