NCT05898906

Brief 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. 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.

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 Jul 2023

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

June 2, 2023

Last Update Submit

July 5, 2023

Conditions

Neurodevelopmental Disorders

Keywords

ActivitiesParticipationChildren

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (1)

  • Participation and Environment- Children and Youth

    Baseline

Study Arms (2)

Children with special needs Group

Children who have diagnosed neurodevelopment disorders including cerebral palsy, autism spectrum disorder,

Control Group

Typically developing children

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children who have diagnosed neurodevelopment disorders

You may qualify if:

  • 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

You may not qualify if:

  • Patients with unmanageable psychological disorders (schizophrenia, bipolar disorder, major depressive disorder) would be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

Related Publications (9)

  • 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.

    PMID: 10729684BACKGROUND

  • Santamaria-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.

    PMID: 37105695BACKGROUND

  • de 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.

    PMID: 36444144BACKGROUND

  • Shakya 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.

    PMID: 35708828BACKGROUND

  • Fabbri 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.

    PMID: 27240035BACKGROUND

  • Paixao 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.

    PMID: 27151375BACKGROUND

  • Costi 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.

    PMID: 32508188BACKGROUND

  • Kaya 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.

    PMID: 32776565BACKGROUND

  • Costi 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.

    PMID: 34415225BACKGROUND

MeSH Terms

Conditions

Neurodevelopmental DisordersMotor Activity

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Study Officials

  • Ozgun Kaya Kara, Assoc. Prof.

    Akdeniz University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ishak Isık, Prof. Dr.

CONTACT

02422494400etik.kurul.07@gmail.com

Ozgun Kaya Kara, Assoc. Prof.

CONTACT

ozgun_kaya@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PhD

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 12, 2023

Study Start

July 20, 2023

Primary Completion

September 20, 2023

Study Completion

September 30, 2023

Last Updated

July 6, 2023

Record last verified: 2023-07

Locations

TU(1)