ChildNCT02485314
Reliability and Validity of Turkish Version of PEM-CY
An observational study of Child, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The Participation and Environment Measure for Children and Youth (PEM-CY) is the first instrument that combines parental assessment of children's participation in home, school, and community activities with qualities of each environment that are perceived to support or hinder participation. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Child
- What is being tested?
- Participation
- How many people
- 470 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2016to Mar 2019
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Caregivers of children with and without disabilities
Who may be able to join
- they will identify themselves as a parent or legal guardian of the child who is the focus of the study
- they are able to read Turkish
- their child is between 5 and 17 years old at the time of enrolment.
Who cannot join
- who don't want to attend the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Validity of Turkish Version of the Participation and Environment Measure for Children and Youth
The Participation and Environment Measure for Children and Youth (PEM-CY) is the first instrument that combines parental assessment of children's participation in home, school, and community activities with qualities of each environment that are perceived to support or hinder participation. This combined format may help to clarify the relative impact of environmental factors (including the natural and built environment), compared to personal factors, on children's participation in specific settings. The aim of this study was to examine reliability and validity of Turkish version of the Participation and Environment Measure for Children and Youth (PEM-CY).
Read the detailed description
The International Classification of Functioning, Disability and Health-Child and Youth Version (ICF-CY; WHO 2007) is designed to guide assessment and intervention efforts to minimize disparities in children's participation. Participation is defined in the ICF-CY as ''involvement in life situations'' and is further conceptualized as a multidimensional construct with both objective (e.g., frequency) and subjective (e.g., satisfaction) dimensions. Participation is linked to contextual factors, including: 1) personal factors (child personal factors such as child's age, gender, and functional abilities; family demographic factors); and 2) features of environments (physical (natural and built), social, attitudinal, and institutional factors, and availability and adequacy of resources). Since its adoption in the ICF-CY, an increasing number of participation measures have been developed. Among these measures, the Participation and Environment Measure for Children and Youth (PEM-CY) is the first instrument that combines parental assessment of children's participation in home, school, and community activities with qualities of each environment that are perceived to support or hinder participation. This combined format may help to clarify the relative impact of environmental factors (including the natural and built environment), compared to personal factors, on children's participation in specific settings.
- Conditions
- Child
- Being tested
- Participation
- Keywords
- children, disability, family, participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParticipationOther
Also called PEM-CY
The PEM-CY will be field-tested with a sample of 650 caregivers of children with and without disabilities residing in the Turkey.
| Study group | Role | What they receive |
|---|---|---|
| Participation | Parents will complete the PEM-CY (Participation and Environment Measure for Children and Youth). Receives: Other: Participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation and Environment Measure for Children and Youth with and without disability as a measure of participation
The PEM-CY will be applied for once for 500 participants. • A comparison will be made between results of children with disabilities and healthy children to test the validity of the Turkish version of PEM-CY.
Measured: 1 year
Secondary outcomes (2)
Variation in participation and environment measure for children and youth with and without disability
Investigate the intraclass correlation coefficient of Turkish version of PEM-CY was used to calculate test retest reliability. PEM-CY was administered twice within a period of 1 week to participants in order to test the test-retest reliability of the scale.
Measured: 1 year
Correlation between different items of Participation and Environment Measure for Children and Youth with and without disability
Investigate the internal consistency reliability of Turkish version of PEM-CY by using Cronbach's alpha coefficient.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startMar 2016
- Primary completionSep 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ChildStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgun Kaya Kara, Hacettepe University
- Investigators
- Ozgun Kaya Kara, PhD, Study director, Akdeniz UniversityDuygu Turker, PhD, Principal investigator, Saglik Bilimleri Universitesi Gulhane Tip FakultesiKoray Kara, Assist. Prof, Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485314
- Sponsor's protocol ID
- GO14/553
- Status last verified
- Mar 2019
- First submitted
- 10 Jun 2015
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Khetani MA, Cliff AB, Schelly C, Daunhauer L, Anaby D. Decisional Support Algorithm for Collaborative Care Planning using the Participation and Environment Measure for Children and Youth (PEM-CY): A Mixed Methods Study. Phys Occup Ther Pediatr. 2014 Mar 26. doi: 10.3109/01942638.2014.899288. Online ahead of print.
PubMed 24670061Coster W, Bedell G, Law M, Khetani MA, Teplicky R, Liljenquist K, Gleason K, Kao YC. Psychometric evaluation of the Participation and Environment Measure for Children and Youth. Dev Med Child Neurol. 2011 Nov;53(11):1030-7. doi: 10.1111/j.1469-8749.2011.04094.x.
PubMed 22014322Coster W, Law M, Bedell G, Liljenquist K, Kao YC, Khetani M, Teplicky R. School participation, supports and barriers of students with and without disabilities. Child Care Health Dev. 2013 Jul;39(4):535-43. doi: 10.1111/cch.12046.
PubMed 23763254Chien CW, Rodger S, Copley J, Skorka K. Comparative content review of children's participation measures using the International Classification of Functioning, Disability and Health-Children and Youth. Arch Phys Med Rehabil. 2014 Jan;95(1):141-52. doi: 10.1016/j.apmr.2013.06.027. Epub 2013 Jul 12.
PubMed 23851418
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Turkish Version of the Participation and Environment Measure for Children and Youth
- ClinicalTrials.gov ID
- NCT02485314
- Acronym / sponsor ID
- GO14/553
- Conditions
- Child
- Keywords
- children, disability, family, participation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 30 Jun 2015 (estimated)
- 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.
The Participation and Environment Measure for Children and Youth (PEM-CY) is the first instrument that combines parental assessment of children's participation in home, school, and community activities with qualities of each environment that are perceived to support or hinder participation. This combined format may help to clarify the relative impact of environmental factors (including the natural and built environment), compared to personal factors, on children's participation in specific settings. The aim of this study was to examine reliability and validity of Turkish version of the Participation and Environment Measure for Children and Youth (PEM-CY).
Detailed description
The International Classification of Functioning, Disability and Health-Child and Youth Version (ICF-CY; WHO 2007) is designed to guide assessment and intervention efforts to minimize disparities in children's participation. Participation is defined in the ICF-CY as ''involvement in life situations'' and is further conceptualized as a multidimensional construct with both objective (e.g., frequency) and subjective (e.g., satisfaction) dimensions. Participation is linked to contextual factors, including: 1) personal factors (child personal factors such as child's age, gender, and functional abilities; family demographic factors); and 2) features of environments (physical (natural and built), social, attitudinal, and institutional factors, and availability and adequacy of resources). Since its adoption in the ICF-CY, an increasing number of participation measures have been developed. Among these measures, the Participation and Environment Measure for Children and Youth (PEM-CY) is the first instrument that combines parental assessment of children's participation in home, school, and community activities with qualities of each environment that are perceived to support or hinder participation. This combined format may help to clarify the relative impact of environmental factors (including the natural and built environment), compared to personal factors, on children's participation in specific settings.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participation | – | Other: ParticipationParents will complete the PEM-CY (Participation and Environment Measure for Children and Youth). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Caregivers of children with and without disabilities
Key inclusion criteria (3 listed)
- they will identify themselves as a parent or legal guardian of the child who is the focus of the study
- they are able to read Turkish
- their child is between 5 and 17 years old at the time of enrolment.
Key exclusion criteria (1 listed)
- who don't want to attend the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParticipationAlso: PEM-CYThe PEM-CY will be field-tested with a sample of 650 caregivers of children with and without disabilities residing in the Turkey. | Other | Participation |
Primary outcome
Participation and Environment Measure for Children and Youth with and without disability as a measure of participation
Time frame: 1 year
The PEM-CY will be applied for once for 500 participants. • A comparison will be made between results of children with disabilities and healthy children to test the validity of the Turkish version of PEM-CY.
2 secondary outcomes
Variation in participation and environment measure for children and youth with and without disability
Time frame: 1 year
Correlation between different items of Participation and Environment Measure for Children and Youth with and without disability
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Background: PubMed 24670061Khetani MA, Cliff AB, Schelly C, Daunhauer L, Anaby D. Decisional Support Algorithm for Collaborative Care Planning using the Participation and Environment Measure for Children and Youth (PEM-CY): A Mixed Methods Study. Phys Occup Ther Pediatr. 2014 Mar 26. doi: 10.3109/01942638.2014.899288. Online ahead of print.
- Background: PubMed 22014322Coster W, Bedell G, Law M, Khetani MA, Teplicky R, Liljenquist K, Gleason K, Kao YC. Psychometric evaluation of the Participation and Environment Measure for Children and Youth. Dev Med Child Neurol. 2011 Nov;53(11):1030-7. doi: 10.1111/j.1469-8749.2011.04094.x.
- Background: PubMed 23763254Coster W, Law M, Bedell G, Liljenquist K, Kao YC, Khetani M, Teplicky R. School participation, supports and barriers of students with and without disabilities. Child Care Health Dev. 2013 Jul;39(4):535-43. doi: 10.1111/cch.12046.
- Background: PubMed 23851418Chien CW, Rodger S, Copley J, Skorka K. Comparative content review of children's participation measures using the International Classification of Functioning, Disability and Health-Children and Youth. Arch Phys Med Rehabil. 2014 Jan;95(1):141-52. doi: 10.1016/j.apmr.2013.06.027. Epub 2013 Jul 12.
- websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ozgun Kaya Kara, PhD study director
Akdeniz University
Duygu Turker, PhD principal investigator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Koray Kara, Assist. Prof principal investigator
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation and Environment Measure for Children and Youth with and without disability as a measure of participation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02485314, which also lists 4 linked publications.
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 26 Mar 2019.