NCT04936269

Brief 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.

Trial Health

43
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 Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

June 15, 2021

Last Update Submit

June 15, 2021

Conditions

Keywords

Cerebral palsyActivityParticipaitonEnvironment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pediatric Evaluation of Disability Inventory (PEDI)

    two years

Study Arms (1)

Group 1

Children under five years old

Eligibility Criteria

Age12 Months - 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.)

You may qualify if:

  • children under five years
  • children with neurodevelopmental disabilities

You may not qualify if:

  • parents who refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Sıhhıye, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Developmental DisabilitiesMotor ActivityCerebral Palsy

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersBehaviorBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Kübra S Bıyık

    Dr.Pt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Pt

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 23, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

June 23, 2021

Record last verified: 2021-06

Locations