- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04936269
Psychometric Properties of the Turkish Version of Young Children's Participation and Environment Measure
June 15, 2021 updated by: Kübra Seyhan, Hacettepe University
Psychometric Properties of the Turkish Version of Young Children's Participation and Environment Measure (YC-PEM) in Young Children With Typical Development and Neurodevelopmental Disorders
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Cross-cultural adaptation Rest-retest reliability Discriminant validity Concurrent validity
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
- Name: Kübra S Bıyık
- Phone Number: +903123051576
- Email: kubra.seyhan@yahoo.com
Study Locations
-
-
Sıhhıye
-
Ankara, Sıhhıye, Turkey, 06100
- Recruiting
- Hacettepe University
-
Contact:
- Kübra S BIYIK, Dr
- Phone Number: 00903123051576
- Email: kubra.seyhan@yahoo.com
-
Contact:
- Mintaze KEREM GÜNEL, Prof.
- Phone Number: 00903123051576
- Email: mintaze@yahoo.com
-
-
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
1 year to 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children with typical development and children with neurodevelopmental disabilities (Cerebral palsy, obstetric brachial plexus palsy, autism spectrum disorders or developmental coordination disorders etc.)
Description
Inclusion Criteria:
- children under five years
- children with neurodevelopmental disabilities
Exclusion Criteria:
- parents who refused to participate in the study
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
Cohorts and Interventions
Group / Cohort |
---|
Group 1
Children under five years old
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Young children's participation and environment measure (YC- PEM)
Time Frame: two years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric Evaluation of Disability Inventory (PEDI)
Time Frame: two years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kübra S Bıyık, Dr.Pt
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 (Actual)
April 1, 2021
Primary Completion (Anticipated)
April 1, 2023
Study Completion (Anticipated)
April 1, 2023
Study Registration Dates
First Submitted
June 15, 2021
First Submitted That Met QC Criteria
June 15, 2021
First Posted (Actual)
June 23, 2021
Study Record Updates
Last Update Posted (Actual)
June 23, 2021
Last Update Submitted That Met QC Criteria
June 15, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 21/430 2021/07-44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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