Developmental DisabilitiesNCT02057809
"Family-centered" Pediatric Rehabilitation Services in Children With Developmental Disabilities
An observational study of Developmental Disabilities and Autistic Spectrum Disorder, run by Chang Gung University at 1 site in Taiwan.
Trial summary
Developmental disability is a severe chronic disabled condition caused by mental or physical impairments. Children with developmental disabilities may face life-long difficulties in motor functioning, self-care, condition, communication, and independent living. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Developmental Disabilities, Autistic Spectrum Disorder
- How many people
- 130 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Dec 2014
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with developmental disabilities (DD) aged 2-12 years. Children with DD refer to a diverse group of severe, chronic disability that is attributed to mental and/or physical impairments, resulting in substantial functional limitations in major life activity.
Who may be able to join
- children aged 2 to 12 years.
- children with a primary diagnose or condition associated with developmental disabilities, including attention deficit hyperactivity disorder, autism, intellectual disability, Down syndrome, learning disorders, cerebral palsy, and other developmental delay.
- parents agree to participate in this study.
Who cannot join
- children with unstable physical conditions, such as cancer, having surgery within 3 months, infection, or other active medical conditions.
- children with progressive disease (e.g. neuromuscular disease) or degenerative disorders (e.g. degenerative seizures).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of "Family-centered" Pediatric Rehabilitation Services Received by Children With Developmental Disabilities
Developmental disability is a severe chronic disabled condition caused by mental or physical impairments. Children with developmental disabilities may face life-long difficulties in motor functioning, self-care, condition, communication, and independent living. They often receive rehabilitation services to promote daily functions and participation in home, school, and community lives.
"Family-centered" service has been considered as "best practice" in pediatric rehabilitation. Therapists encourage children with developmental disabilities and their parents to participate in decision making and implementing process of intervention, and provide intervention plan that best fit their family needs. Research shows that for children with developmental disabilities, family-centered services can enhance children's development, decrease parenting stress, promote emotional wellness, and increase parental satisfaction to services. Though the "family-centered" concept has been considered as relevant in pediatric rehabilitation, there are still difficulties, as well as a lack of evidence regarding its implementation in practice.
Read more
Reflecting the trend of family-centered medical care, the benefits of national health insurance in Taiwan for early intervention outpatient care will emphasize on family-centered intervention. The range of benefits may include communication with parents, parental education, consultation and instructions for home programs. Besides, outcomes of family-centered intervention will be treated as an important index for monitoring the quality of medical services.
Given that there is a lack of investigation regarding the family-centered pediatric rehabilitation, the purposes of this one-year research project are to investigate the implementation of family-centered pediatric rehabilitation for children with developmental disabilities and to identify related influencing factors. This study will provide empirical evidence for family-centered services in Taiwan.
- Keywords
- Developmental Disabilities, Family-centered services, Pediatric rehabilitation
- Medical subject headings
- Developmental Disabilities, Autism Spectrum Disorder
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 |
|---|---|---|
| Parent-child dyad | Children with Developmental Disabilities and their parents | |
| Therapits | Therapists experienced in serving children with developmental disabilities |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Measure of Processes of Care-20
Measured: 1 year
Secondary outcomes (4)
Measure of Processes of Care- for Service Providers
Measured: 1 year
Children and Adolescent Factor Inventory
Measured: 1 year
Assessment of Preschool Children's Participation (APCP)
Measured: 1 year
Children's Assessment of Participation and Enjoyment (CAPE)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DisabilitiesStudies 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 130 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, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057809
- Sponsor's protocol ID
- 102-3767B
- Status last verified
- Aug 2018
- First submitted
- 22 Dec 2013
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of "Family-centered" Pediatric Rehabilitation Services Received by Children With Developmental Disabilities
- ClinicalTrials.gov ID
- NCT02057809
- Acronym / sponsor ID
- 102-3767B
- Keywords
- Developmental Disabilities, Family-centered services, Pediatric rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Feb 2014 (estimated)
- 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.
Developmental disability is a severe chronic disabled condition caused by mental or physical impairments. Children with developmental disabilities may face life-long difficulties in motor functioning, self-care, condition, communication, and independent living. They often receive rehabilitation services to promote daily functions and participation in home, school, and community lives.
"Family-centered" service has been considered as "best practice" in pediatric rehabilitation. Therapists encourage children with developmental disabilities and their parents to participate in decision making and implementing process of intervention, and provide intervention plan that best fit their family needs. Research shows that for children with developmental disabilities, family-centered services can enhance children's development, decrease parenting stress, promote emotional wellness, and increase parental satisfaction to services. Though the "family-centered" concept has been considered as relevant in pediatric rehabilitation, there are still difficulties, as well as a lack of evidence regarding its implementation in practice.
Reflecting the trend of family-centered medical care, the benefits of national health insurance in Taiwan for early intervention outpatient care will emphasize on family-centered intervention. The range of benefits may include communication with parents, parental education, consultation and instructions for home programs. Besides, outcomes of family-centered intervention will be treated as an important index for monitoring the quality of medical services.
Given that there is a lack of investigation regarding the family-centered pediatric rehabilitation, the purposes of this one-year research project are to investigate the implementation of family-centered pediatric rehabilitation for children with developmental disabilities and to identify related influencing factors. This study will provide empirical evidence for family-centered services in Taiwan.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent-child dyad | – | –Children with Developmental Disabilities and their parents |
| Therapits | – | –Therapists experienced in serving children with developmental disabilities |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with developmental disabilities (DD) aged 2-12 years. Children with DD refer to a diverse group of severe, chronic disability that is attributed to mental and/or physical impairments, resulting in substantial functional limitations in major life activity.
Key inclusion criteria (3 listed)
- children aged 2 to 12 years.
- children with a primary diagnose or condition associated with developmental disabilities, including attention deficit hyperactivity disorder, autism, intellectual disability, Down syndrome, learning disorders, cerebral palsy, and other developmental delay.
- parents agree to participate in this study.
Key exclusion criteria (2 listed)
- children with unstable physical conditions, such as cancer, having surgery within 3 months, infection, or other active medical conditions.
- children with progressive disease (e.g. neuromuscular disease) or degenerative disorders (e.g. degenerative seizures).
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
The Measure of Processes of Care-20
Time frame: 1 year
4 secondary outcomes
Measure of Processes of Care- for Service Providers
Time frame: 1 year
Children and Adolescent Factor Inventory
Time frame: 1 year
Assessment of Preschool Children's Participation (APCP)
Time frame: 1 year
Children's Assessment of Participation and Enjoyment (CAPE)
Time frame: 1 year
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 17 Aug 2018.
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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
Chang 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 Disabilities and Autistic Spectrum Disorder, 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 3 inclusion and 2 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 17 Aug 2018. 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?
The Measure of Processes of Care-20 (time frame: 1 year). 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 17 Aug 2018.