Clinical trial NCT04522518: Self-identified Participation and Environment of Children With Disabilities
Official title: To Hear Diverse Voices: Self-identified Participation Goals and Environmental Supports and Barriers of Children With Disabilities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Disability
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 538
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with disabilities 6-12 years old and their parents or primary caregivers; age-matched children with typical development and their caregivers

Brief summary: Picture My Participation (PmP) is a child self-report tool for children and adolescents with disabilities. The PmP uses pictures that enable children to identify participation frequencies, participation goals, and environmental supports/barriers to a home, school, and community activities. The PmP has been translated to different languages and cultures, including Traditional Chinese for the use in Taiwan. Given the advances and popularity of mobile technologies, the PmP-Traditional Chinese version has been developed into App software (PmP-C App) to provide a fun and user-friendly interface to promote communication and active engagement in the assessment process. The PmP-C App version would be need to establish the usability, reliability and validity in children with various types of disabilities.

The purposes of this study are to: establish usability, reliability, and validity using the PMP App version, and characterize child-identified participation goals and identify environmental supports and barriers in children with and without disabilities. Data will be collected by examination and interviews using the PmP-C App and other measures for validation.

Detailed description: This is a two-year cross-sectional study to explore the use of the PmP-C App version with children with and without disabilities. The estimated participants are 160 pairs of children with disabilities 6-12 years of age and their caregivers and 160 age-matched peers with typical development and their caregivers (a total of 640 participants). The design enables validation of the responses of children with disabilities with various sources (i.e. caregivers' responses, children without disabilities, and other child-report measures). Findings of reliability and validity will provide a basis for reporting child-identified participation goals and environmental factors. The COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guideline is used to design a high-quality validation study. To characterize child-perceived participation and environment, the data are collected for two groups: one group of children with disabilities (the DD group) and one group of children without disabilities (the TD group). The design enables examination of how prioritized activities and frequent encountered environmental supports and barriers may vary given different capabilities of children with disabilities and peers with typical development.

Eligibility criteria: Children with disabilities

Inclusion Criteria:

* children aged 6 to 12 years old
* children with an identified disability or health conditions through early intervention or Disability Evaluation System in Taiwan
* children have a cognitive level of at least 5 years developmental age in receptive language based on the Peabody Picture Vocabulary Test-Revised (PPVT-R) test
* children are able to make choices between 4 options (tested by three trial questions) and are able to express their thoughts verbally, in writing/typing, or with Augmentative and Alternative Communication (AAC)
* both the child and caregiver agree to join this study

Exclusion Criteria:

* children with unstable health conditions, such as cancer, having surgery within 3 months, infection, or other active medical conditions that affect their recent daily lives
* children with progressive disease (e.g. neuromuscular disease) or degenerative disorders (e.g. degenerative seizures)
* children who are non-communicable, with uncorrected vision or hearing impairments that cannot see the instruments or hear the interview questions
* children and/or caregivers who do not understand Chinese well and thus cannot complete the instruments

Children with typical development

Inclusion criteria:

* children aged 6 to 12 years old
* children without identified disability, physical or mental health conditions related to developmental disabilities
* children are able to make choices between 4 options (tested by three trial questions) and are able to express their thoughts verbally
* both the child and caregiver agree to participate in this study

Exclusion criteria:

* children with unstable health or medical conditions (e.g. trauma or infection)
* children and/or caregivers who do not understand Chinese well and thus cannot complete the instruments

Primary outcomes:
measure: Traditional Chinese version of Picture my Participation (PmP-C) frequency scores
timeFrame: day 1
measure: Traditional Chinese version of Picture my Participation (PmP-C) frequency scores
timeFrame: 1 week since day 1 for test-retest reliability
measure: Traditional Chinese version of Picture my Participation (PmP-C) involvement scores
timeFrame: day 1
measure: Traditional Chinese version of Picture my Participation (PmP-C) involvement scores
timeFrame: 1 week since day 1 for test-retest reliability
measure: Traditional Chinese version of Picture my Participation (PmP-C) important activities
timeFrame: day 1
measure: Traditional Chinese version of Picture my Participation (PmP-C) important activities
timeFrame: 1 week since day 1 for test-retest reliability
Secondary outcomes:
measure: Perceived Efficacy and Goal Setting (PEGS) scores
timeFrame: day 1
Other outcomes:
measure: Usability questionnaire
timeFrame: day 1
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
affiliation: Chung Gung University
name: Lin-Ju Kang, PhD
role: PRINCIPAL_INVESTIGATOR
References: