Developmental DisabilityNCT04522518
Self-identified Participation and Environment of Children With Disabilities
An observational study of Developmental Disability, run by Chang Gung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Disability
- What is being tested?
- PmP-C App
- Type of treatment
- Medical device
- How many people
- 538 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 30 Oct 2021
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children with disabilities 6-12 years old and their parents or primary caregivers; age-matched children with typical development and their caregivers
Who may be able to join
- 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
- children aged 6 to 12 years old
Show all 9Show fewer
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Developmental Disability
- Being tested
- PmP-C App
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PmP-C AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| DD group | 160 pairs of children with disabilities 6-12 years of age and their caregivers (n=320) Receives: Device: PmP-C App | |
| TD group | 160 pairs of typically developing children 6-12 years of age and their caregivers (n=320) Receives: Device: PmP-C App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traditional Chinese version of Picture my Participation (PmP-C) frequency scores
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.
Measured: day 1
Traditional Chinese version of Picture my Participation (PmP-C) frequency scores
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.
Measured: 1 week since day 1 for test-retest reliability
Traditional Chinese version of Picture my Participation (PmP-C) involvement scores
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.
Measured: day 1
Traditional Chinese version of Picture my Participation (PmP-C) involvement scores
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.
Measured: 1 week since day 1 for test-retest reliability
Traditional Chinese version of Picture my Participation (PmP-C) important activities
The participants select up to 3 important activities among the PmP-C items, the item numbers will be reported.
Measured: day 1
Traditional Chinese version of Picture my Participation (PmP-C) important activities
The participants select up to 3 important activities among the PmP-C items, the item numbers will be reported.
Measured: 1 week since day 1 for test-retest reliability
Secondary outcomes (1)
Perceived Efficacy and Goal Setting (PEGS) scores
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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Aug 2019
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DisabilityStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin-Ju Kang, Chang Gung University
- Investigators
- Lin-Ju Kang, PhD, Principal investigator, Chung Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522518
- Sponsor's protocol ID
- 201812ES010
- Status last verified
- Jan 2022
- First submitted
- 12 Aug 2020
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Hear Diverse Voices: Self-identified Participation Goals and Environmental Supports and Barriers of Children With Disabilities
- ClinicalTrials.gov ID
- NCT04522518
- Acronym / sponsor ID
- 201812ES010
- Conditions
- Developmental Disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 21 Aug 2020 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DD group | – | Device: PmP-C App160 pairs of children with disabilities 6-12 years of age and their caregivers (n=320) |
| TD group | – | Device: PmP-C App160 pairs of typically developing children 6-12 years of age and their caregivers (n=320) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children with disabilities 6-12 years old and their parents or primary caregivers; age-matched children with typical development and their caregivers
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| PmP-C AppThe 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. | Device | DD group, TD group |
Primary outcome
Traditional Chinese version of Picture my Participation (PmP-C) frequency scores
Time frame: day 1
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.
Traditional Chinese version of Picture my Participation (PmP-C) frequency scores
Time frame: 1 week since day 1 for test-retest reliability
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.
Traditional Chinese version of Picture my Participation (PmP-C) involvement scores
Time frame: day 1
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.
Traditional Chinese version of Picture my Participation (PmP-C) involvement scores
Time frame: 1 week since day 1 for test-retest reliability
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.
Traditional Chinese version of Picture my Participation (PmP-C) important activities
Time frame: day 1
The participants select up to 3 important activities among the PmP-C items, the item numbers will be reported.
Traditional Chinese version of Picture my Participation (PmP-C) important activities
Time frame: 1 week since day 1 for test-retest reliability
The participants select up to 3 important activities among the PmP-C items, the item numbers will be reported.
1 secondary outcome
Perceived Efficacy and Goal Setting (PEGS) scores
Time frame: day 1
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 19 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
Lin-Ju Kang, PhD principal investigator
Chung Gung 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 Developmental Disability, run by Chang Gung University at 1 site in Taiwan.
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 9 inclusion and 7 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 19 Jan 2022. 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 Taiwan. 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?
Traditional Chinese version of Picture my Participation (PmP-C) frequency scores (time frame: day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2022.