NCT02057809

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

December 22, 2013

Last Update Submit

August 15, 2018

Conditions

Keywords

Developmental DisabilitiesFamily-centered servicesPediatric rehabilitation

Outcome Measures

Primary Outcomes (1)

  • The Measure of Processes of Care-20

    1 year

Secondary Outcomes (4)

  • Measure of Processes of Care- for Service Providers

    1 year

  • Children and Adolescent Factor Inventory

    1 year

  • Assessment of Preschool Children's Participation (APCP)

    1 year

  • Children's Assessment of Participation and Enjoyment (CAPE)

    1 year

Study Arms (2)

Parent-child dyad

Children with Developmental Disabilities and their parents

Therapits

Therapists experienced in serving children with developmental disabilities

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Developmental DisabilitiesAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersChild Development Disorders, Pervasive

Study Officials

  • Lin-Ju Kang, PhD

    Chang Gung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 22, 2013

First Posted

February 7, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations