- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04522518
Self-identified Participation and Environment of Children With Disabilities
To Hear Diverse Voices: Self-identified Participation Goals and Environmental Supports and Barriers of Children With Disabilities
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Taoyuan, Taiwan, 333
- Chang Gung University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
DD group
160 pairs of children with disabilities 6-12 years of age and their caregivers (n=320)
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The key features of PmP-C App include: "About Me" (entering child's demographic data e.g.
age, gender, family members), "My participation" (answering frequency and involvement of activities), and "My goal" (selecting 3 important activities they desire to change and identify things that made them easy or hard to do, i.e. participation goals and environmental supports or barriers).
The App is to be manipulated adult interviewers but also can be manipulated by the child if they are able to.
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TD group
160 pairs of typically developing children 6-12 years of age and their caregivers (n=320)
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The key features of PmP-C App include: "About Me" (entering child's demographic data e.g.
age, gender, family members), "My participation" (answering frequency and involvement of activities), and "My goal" (selecting 3 important activities they desire to change and identify things that made them easy or hard to do, i.e. participation goals and environmental supports or barriers).
The App is to be manipulated adult interviewers but also can be manipulated by the child if they are able to.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Traditional Chinese version of Picture my Participation (PmP-C) frequency scores
Time Frame: day 1
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The PmP-C participation frequency is scored on a 4-point scale (1=never to 4=always), a higher score indicating the higher frequency of attending in an activity.
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day 1
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Traditional Chinese version of Picture my Participation (PmP-C) frequency scores
Time Frame: 1 week since day 1 for test-retest reliability
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The PmP-C participation frequency is scored on a 4-point scale (1=never to 4=always), a higher score indicating the higher frequency of attending in an activity.
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1 week since day 1 for test-retest reliability
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Traditional Chinese version of Picture my Participation (PmP-C) involvement scores
Time Frame: day 1
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The PmP-C level of involvement is scored on a 3-point scale (1= minimally involved to 3= very involved), a higher score indicating the higher perceived level of involvement when attending an activity.
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day 1
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Traditional Chinese version of Picture my Participation (PmP-C) involvement scores
Time Frame: 1 week since day 1 for test-retest reliability
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The PmP-C level of involvement is scored on a 3-point scale (1= minimally involved to 3= very involved), a higher score indicating the higher perceived level of involvement when attending an activity.
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1 week since day 1 for test-retest reliability
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Traditional Chinese version of Picture my Participation (PmP-C) important activities
Time Frame: day 1
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The participants select up to 3 important activities among the PmP-C items, the item numbers will be reported.
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day 1
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Traditional Chinese version of Picture my Participation (PmP-C) important activities
Time Frame: 1 week since day 1 for test-retest reliability
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The participants select up to 3 important activities among the PmP-C items, the item numbers will be reported.
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1 week since day 1 for test-retest reliability
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Efficacy and Goal Setting (PEGS) scores
Time Frame: day 1
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The PEGS is designed for children with disabilities 5-9 years of age to indicate their perceived competence in performing 24 daily activities and to identify goals for therapy intervention.
A higher score indicates higher perceived competence.
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day 1
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability questionnaire
Time Frame: day 1
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The questionnaire is a 5-point Likert scale designed specifically for this study, a higher score indicating better user's perceptions on the usability.
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day 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lin-Ju Kang, PhD, Chung Gung University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201812ES010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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