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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02057809
Other study ID # 102-3767B
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date December 2014

Study information

Verified date August 2018
Source Chang Gung University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 2 Years to 12 Years
Eligibility Inclusion Criteria:

1. children aged 2 to 12 years.

2. 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.

3. parents agree to participate in this study.

Exclusion Criteria:

1. children with unstable physical conditions, such as cancer, having surgery within 3 months, infection, or other active medical conditions.

2. children with progressive disease (e.g. neuromuscular disease) or degenerative disorders (e.g. degenerative seizures).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Chang Gung University Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Measure of Processes of Care-20 1 year
Secondary Measure of Processes of Care- for Service Providers 1 year
Secondary Children and Adolescent Factor Inventory 1 year
Secondary Assessment of Preschool Children's Participation (APCP) 1 year
Secondary Children's Assessment of Participation and Enjoyment (CAPE) 1 year
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