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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04936269
Other study ID # GO 21/430 2021/07-44
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date April 1, 2023

Study information

Verified date June 2021
Source Hacettepe University
Contact Kübra S Biyik
Phone +903123051576
Email kubra.seyhan@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Young Children's Participation and Environment Measure (YC-PEM) is a parent/caregiver reported outcome measure that evaluates the participation status and environmental factors of children under five years old. The aim of this study is to translate the Young Children's Participation and Environment Measure (YC-PEM) into the Turkish language and to investigate the psychometric properties of the Turkish version of YC-PEM in children with typical development and neurodevelopmental disabilities under five years old.


Description:

Cross-cultural adaptation Rest-retest reliability Discriminant validity Concurrent validity


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date April 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 60 Months
Eligibility Inclusion Criteria: - children under five years - children with neurodevelopmental disabilities Exclusion Criteria: - parents who refused to participate in the study

Study Design


Locations

Country Name City State
Turkey Hacettepe University Ankara Sihhiye

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Young children's participation and environment measure (YC- PEM) Young children's participation and environment measure (YC- PEM) is developed for assessing the activity and participation levels and effects of environmental factors on functional abilities in children with neurodevelopmental disabilities or typically development under five years. two years
Secondary Pediatric Evaluation of Disability Inventory (PEDI) Pediatric Evaluation of Disability Inventory (PEDI) for assessing the activity and participation levels and effects of environmental factors on functional abilities in children with neurodevelopmental disabilities or typically development under seven years. two years
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