Neurodevelopmental DisordersNCT05898906
Turkish Version of the Activity Scales for Kids
An observational study of Neurodevelopmental Disorders, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Children's participation in age-appropriate activities is critical to their overall well-being. Neurodevelopmental disorders cause motor, cognitive, communication, and behavioural problems. Children have restrictions in their ability to participate and engage in activities because of these problems. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2023to 30 Sep 2023
- 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 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children who have diagnosed neurodevelopment disorders
Who may be able to join
- Age between 5 years and 15 years;
- Diagnosed with neurodevelopmental disorders.
- To have the cognitive ability to answer questions for assessment.
- Completing the test-retest assessment.
- To be able to read and speak Turkish
Who cannot join
- Patients with unmanageable psychological disorders (schizophrenia, bipolar disorder, major depressive disorder) would be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Ozgun Kaya Kara, Assoc. Prof. contact
About this study
Official title: Turkish Adaptation, Validity and Reliability Study of Activities Scales for Kids
Children's participation in age-appropriate activities is critical to their overall well-being. Neurodevelopmental disorders cause motor, cognitive, communication, and behavioural problems. Children have restrictions in their ability to participate and engage in activities because of these problems. Children with neurodevelopmental disorders require more parental care and are less likely to participate in activities at home, school, and in the community than their healthy peers. This highlights the significance of evaluating activity restrictions and participation limitations. Our study aims to demonstrate the reliability and validity of the Turkish version of the Activity Scales for Kids (ASK), which assesses children's participation and activity in their daily lives at home, school, and play, as well as cultural sensitivity.
Read the detailed description
Participation in activities is an essential component of maintaining health. The International Classification of Functioning- Child and Youth (ICF-CY) framework includes several components that can be used to determine activity and participation. These components are defined by two terms: capacity and performance. Both capacity and performance are basically measures of capability, even if the performance qualifier is intended as a measure of participation. Performance describes what a person does in their current setting. The current environment brings with it a social context. As a result, performance determines how involved an individual is in his or her living environment and life experience. The ability to do a task or action is known as capacity, which denotes the highest functional level that may be achieved at any moment and in every setting. Capacity is measured in a consistent or standard setting. Therefore, it reflects the individually adjusted ability of the individual. The child's physical and social environment has an impact on their capacity. For instance, while the child can stand up on his own in a standardized clinical setting, he might not be able to do the same after falling during physical exercise in a school context or in public.
According to the ICF-CY, disability is not only related to body structure and function but also to activity constraints and participation restrictions in various situations. An objective assessment demonstrates how performance has changed over time and encourages children to enhance their own abilities. These examinations need to meet psychometric standards before being used with children. In addition, the results of research studies provide useful information about the natural developmental steps expected, especially in childhood disability subgroups. There isn't a valid and reliable scale in Turkish literature that assesses children's capacity and performance in activities at home, school, and in play environments. The goals of our research are to demonstrate the reliability and validity of the ASK, a tool that assesses children's participation and activity levels at play, school, and at home. Families and medical professionals will be guided by this scale.
- Conditions
- Neurodevelopmental Disorders
- Keywords
- Activities, Participation, Children
- Medical subject headings
- Neurodevelopmental Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with special needs Group | Children who have diagnosed neurodevelopment disorders including cerebral palsy, autism spectrum disorder, | |
| Control Group | Typically developing children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities Scales for Kids
The Activities Scales for Kids scale measures pediatric functionality from the perspective of the children. These are ASK-Performance (ASKp) and ASK-Capacity (ASKc). ach version consists of 30 items, including personal care (3 items), dressing (4 items), other skills (4 items), locomotion (7 items), play (2 items), standing (5 items), and transfers (5 items). ASKc evaluates what the child "can do", and ASKp evaluates what the child "usually does". A percentage score (with a range of 0-100) is calculated by dividing this average by 4. On this scale, 100% indicates full physical function.
Measured: Baseline
Secondary outcomes (1)
Participation and Environment- Children and Youth
The participation sections included 10 activities in the home setting, five activities in the school setting, and 10 in the community setting. For each activity, the range of participation is daily to never, with scores between 0 and 8; higher scores indicate greater participation. The range of involvement is from very involved to minimally involved, with scores between 1 and 5; higher scores indicate greater involvement. The range of whether change is desired in the child's participation in this kind of activity is no or yes, with scores between 0 and 1. Environmental features supports and barriers (e.g., do the features of the environment help or make it harder?) for the child to participate in activities at home, school, or in a community setting with scores between 1 and 4; increased scores indicate environmental help.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start20 Jul 2023 (estimated)
- Primary completion20 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgun Kaya Kara, Akdeniz University
- Investigators
- Ozgun Kaya Kara, Assoc. Prof., Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898906
- Sponsor's protocol ID
- 2022-189
- Status last verified
- Jul 2023
- First submitted
- 2 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Young NL, Williams JI, Yoshida KK, Wright JG. Measurement properties of the activities scale for kids. J Clin Epidemiol. 2000 Feb;53(2):125-37. doi: 10.1016/s0895-4356(99)00113-4.
PubMed 10729684Santamaria-Vazquez M, Guijo-Blanco V, Puente-Martinez A, Ubillos-Landa S. Psychometric properties of the Spanish version of the Activities Scale for Kids (ASK): reliability, validity and the Rasch model. BMJ Open. 2023 Apr 27;13(4):e069248. doi: 10.1136/bmjopen-2022-069248.
PubMed 37105695de Oliveira VGC, Balau LC, Arrebola LS, Young NL, Yi LC. Translation, cross-cultural adaptation, validity and reliability of the Brazilian Portuguese version of Activity Scale for Kids questionnaire. Child Care Health Dev. 2023 Jul;49(4):725-731. doi: 10.1111/cch.13085. Epub 2022 Dec 8.
PubMed 36444144Shakya R, Suwal R, Adhikari I, Shrestha J, Gyawali S, Shrestha A. Cross cultural adaptation and validation of Nepali Version of Activity Scale for Kids (ASK). J Patient Rep Outcomes. 2022 Jun 16;6(1):68. doi: 10.1186/s41687-022-00479-2.
PubMed 35708828Fabbri L, Neviani R, Festini F, Costi S. Transcultural validation of Activities Scale for Kids (ASK): translation and pilot test. Acta Biomed. 2016 May 26;87 Suppl 2:70-9.
PubMed 27240035Paixao D, Cavalheiro LM, Goncalves RS, Ferreira PL. Portuguese cultural adaptation and validation of the Activities Scale for Kids (ASK). J Pediatr (Rio J). 2016 Jul-Aug;92(4):367-73. doi: 10.1016/j.jped.2015.09.010. Epub 2016 May 3.
PubMed 27151375Costi S, Mecugni D, Beccani L, Alboresi S, Bressi B, Paltrinieri S, Ferrari A, Pelosin E. Construct Validity of the Activities Scale for Kids Performance in Children with Cerebral Palsy: Brief Report. Dev Neurorehabil. 2020 Oct;23(7):474-477. doi: 10.1080/17518423.2020.1764649. Epub 2020 Jun 7.
PubMed 32508188Kaya Kara O, Turker D, Kara K, Yardimci-Lokmanoglu BN. Psychometric properties of the Turkish version of Participation and Environment Measure for Children and Youth. Child Care Health Dev. 2020 Nov;46(6):711-722. doi: 10.1111/cch.12801. Epub 2020 Aug 19.
PubMed 32776565Costi S, Filippi MC, Braglia L, Beccani L, Corradi I, Bruzzi E, Signorelli C, Pelosin E. Reliability and construct validity of the Activities Scale for Kids in Italian children with cerebral palsy. Disabil Rehabil. 2022 Oct;44(21):6445-6451. doi: 10.1080/09638288.2021.1966519. Epub 2021 Aug 20.
PubMed 34415225
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Adaptation, Validity and Reliability Study of Activities Scales for Kids
- ClinicalTrials.gov ID
- NCT05898906
- Acronym / sponsor ID
- 2022-189
- Conditions
- Neurodevelopmental Disorders
- Keywords
- Activities, Participation, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (estimated)
- Primary completion
- 20 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 12 Jun 2023 (actual)
- 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.
Children's participation in age-appropriate activities is critical to their overall well-being. Neurodevelopmental disorders cause motor, cognitive, communication, and behavioural problems. Children have restrictions in their ability to participate and engage in activities because of these problems. Children with neurodevelopmental disorders require more parental care and are less likely to participate in activities at home, school, and in the community than their healthy peers. This highlights the significance of evaluating activity restrictions and participation limitations. Our study aims to demonstrate the reliability and validity of the Turkish version of the Activity Scales for Kids (ASK), which assesses children's participation and activity in their daily lives at home, school, and play, as well as cultural sensitivity.
Detailed description
Participation in activities is an essential component of maintaining health. The International Classification of Functioning- Child and Youth (ICF-CY) framework includes several components that can be used to determine activity and participation. These components are defined by two terms: capacity and performance. Both capacity and performance are basically measures of capability, even if the performance qualifier is intended as a measure of participation. Performance describes what a person does in their current setting. The current environment brings with it a social context. As a result, performance determines how involved an individual is in his or her living environment and life experience. The ability to do a task or action is known as capacity, which denotes the highest functional level that may be achieved at any moment and in every setting. Capacity is measured in a consistent or standard setting. Therefore, it reflects the individually adjusted ability of the individual. The child's physical and social environment has an impact on their capacity. For instance, while the child can stand up on his own in a standardized clinical setting, he might not be able to do the same after falling during physical exercise in a school context or in public.
According to the ICF-CY, disability is not only related to body structure and function but also to activity constraints and participation restrictions in various situations. An objective assessment demonstrates how performance has changed over time and encourages children to enhance their own abilities. These examinations need to meet psychometric standards before being used with children. In addition, the results of research studies provide useful information about the natural developmental steps expected, especially in childhood disability subgroups. There isn't a valid and reliable scale in Turkish literature that assesses children's capacity and performance in activities at home, school, and in play environments. The goals of our research are to demonstrate the reliability and validity of the ASK, a tool that assesses children's participation and activity levels at play, school, and at home. Families and medical professionals will be guided by this scale.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with special needs Group | – | –Children who have diagnosed neurodevelopment disorders including cerebral palsy, autism spectrum disorder, |
| Control Group | – | –Typically developing children |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children who have diagnosed neurodevelopment disorders
Key inclusion criteria (5 listed)
- Age between 5 years and 15 years;
- Diagnosed with neurodevelopmental disorders.
- To have the cognitive ability to answer questions for assessment.
- Completing the test-retest assessment.
- To be able to read and speak Turkish
Key exclusion criteria (1 listed)
- Patients with unmanageable psychological disorders (schizophrenia, bipolar disorder, major depressive disorder) would be excluded from 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.
Primary outcome
Activities Scales for Kids
Time frame: Baseline
The Activities Scales for Kids scale measures pediatric functionality from the perspective of the children. These are ASK-Performance (ASKp) and ASK-Capacity (ASKc). ach version consists of 30 items, including personal care (3 items), dressing (4 items), other skills (4 items), locomotion (7 items), play (2 items), standing (5 items), and transfers (5 items). ASKc evaluates what the child "can do", and ASKp evaluates what the child "usually does". A percentage score (with a range of 0-100) is calculated by dividing this average by 4. On this scale, 100% indicates full physical function.
1 secondary outcome
Participation and Environment- Children and Youth
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Background: PubMed 10729684Young NL, Williams JI, Yoshida KK, Wright JG. Measurement properties of the activities scale for kids. J Clin Epidemiol. 2000 Feb;53(2):125-37. doi: 10.1016/s0895-4356(99)00113-4.
- Background: PubMed 37105695Santamaria-Vazquez M, Guijo-Blanco V, Puente-Martinez A, Ubillos-Landa S. Psychometric properties of the Spanish version of the Activities Scale for Kids (ASK): reliability, validity and the Rasch model. BMJ Open. 2023 Apr 27;13(4):e069248. doi: 10.1136/bmjopen-2022-069248.
- Background: PubMed 36444144de Oliveira VGC, Balau LC, Arrebola LS, Young NL, Yi LC. Translation, cross-cultural adaptation, validity and reliability of the Brazilian Portuguese version of Activity Scale for Kids questionnaire. Child Care Health Dev. 2023 Jul;49(4):725-731. doi: 10.1111/cch.13085. Epub 2022 Dec 8.
- Background: PubMed 35708828Shakya R, Suwal R, Adhikari I, Shrestha J, Gyawali S, Shrestha A. Cross cultural adaptation and validation of Nepali Version of Activity Scale for Kids (ASK). J Patient Rep Outcomes. 2022 Jun 16;6(1):68. doi: 10.1186/s41687-022-00479-2.
- Background: PubMed 27240035Fabbri L, Neviani R, Festini F, Costi S. Transcultural validation of Activities Scale for Kids (ASK): translation and pilot test. Acta Biomed. 2016 May 26;87 Suppl 2:70-9.
- Background: PubMed 27151375Paixao D, Cavalheiro LM, Goncalves RS, Ferreira PL. Portuguese cultural adaptation and validation of the Activities Scale for Kids (ASK). J Pediatr (Rio J). 2016 Jul-Aug;92(4):367-73. doi: 10.1016/j.jped.2015.09.010. Epub 2016 May 3.
- Background: PubMed 32508188Costi S, Mecugni D, Beccani L, Alboresi S, Bressi B, Paltrinieri S, Ferrari A, Pelosin E. Construct Validity of the Activities Scale for Kids Performance in Children with Cerebral Palsy: Brief Report. Dev Neurorehabil. 2020 Oct;23(7):474-477. doi: 10.1080/17518423.2020.1764649. Epub 2020 Jun 7.
- Background: PubMed 32776565Kaya Kara O, Turker D, Kara K, Yardimci-Lokmanoglu BN. Psychometric properties of the Turkish version of Participation and Environment Measure for Children and Youth. Child Care Health Dev. 2020 Nov;46(6):711-722. doi: 10.1111/cch.12801. Epub 2020 Aug 19.
- Background: PubMed 34415225Costi S, Filippi MC, Braglia L, Beccani L, Corradi I, Bruzzi E, Signorelli C, Pelosin E. Reliability and construct validity of the Activities Scale for Kids in Italian children with cerebral palsy. Disabil Rehabil. 2022 Oct;44(21):6445-6451. doi: 10.1080/09638288.2021.1966519. Epub 2021 Aug 20.
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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, Assoc. Prof. contact
Ozgun Kaya Kara, Assoc. Prof. principal investigator
Akdeniz University
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 Neurodevelopmental Disorders, run by Akdeniz 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 5 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ishak Isık, Prof. Dr. (02422494400, etik.kurul.07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activities Scales for Kids (time frame: Baseline). 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 NCT05898906, which also lists 9 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 6 Jul 2023.