NCT05553171

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

September 21, 2022

Last Update Submit

September 21, 2022

Conditions

Keywords

insomniavalidityQuestionnaire

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Protective factors index

    baseline

  • Subscale scores for each protective factors

    baseline

Eligibility Criteria

Age3 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Having chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 23, 2022

Study Start

October 1, 2022

Primary Completion

June 1, 2023

Study Completion

September 1, 2023

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

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.