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Clinical Trials/NCT03721913
NCT03721913
Completed
Not Applicable

Efficacy of Participation-based Intervention on Community Participation and Parent Empowerment for Children With Autism Spectrum Disorder

Chang Gung University1 site in 1 country24 target enrollmentOctober 23, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Chang Gung University
Enrollment
24
Locations
1
Primary Endpoint
Change in the Canadian Occupational Performance Measure (COPM) performance and satisfaction scores
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Community participation of children with ASD is affected by child (including body function and personal factors), family and environmental factors. This study proposes an innovative Participation-based intervention based on the principles of self-determined, family-centered, strength-based, and solution-focused approaches. This intervention targets on promoting children's community participation, and forms solution strategies from analyzing the strength and needs of child, family, and environment. The aim of this study is to investigate the efficacy of participation-based intervention on community participation and family empowerment for children with ASD 6-10 years of age.

Detailed Description

Children with Autism Spectrum Disorder (ASD) have social interaction and communication disorders, restricted interests and repetitive behaviors, which may further restrict daily activities and participation. Participation of children with ASD often are more restricted in the community than at home and school, due to problems such as environmental barriers and resources inadequacy. Research showed that school-age children with ASD participated less in social, leisure and sports activities than children with typical development, thus may result in loneness or social isolation and impact on long-term physical and psychological health. Community participation of children with ASD is affected by child (including body function and personal factors), family and environmental factors. This study proposes an innovative Participation-based intervention based on the principles of self-determined, family-centered, strength-based, and solution-focused approaches. This intervention targets on promoting children's community participation, and forms solution strategies from analyzing the strength and needs of child, family, and environment. The aim of this study is to investigate the efficacy of participation-based intervention on community participation and family empowerment for children with ASD 6-10 years of age. This study is proposed as a 2-year project that will use a stratified randomized controlled trial design to examine the efficacy of participation-based intervention (experimental group) in comparison to no additional intervention (control group). The study period includes 12-week intervention phase and 12-week follow-up phase, and 3 outcome measures: pre-test, post-test, and follow-up. The primary outcomes are children's community participation, the secondary outcomes are parental empowerment, family quality of life, and satisfaction with partnerships. This study will have great impact on promoting collaboration among child, family and therapists, and supporting full inclusion in society of children with ASD and their families.

Registry
clinicaltrials.gov
Start Date
October 23, 2018
End Date
December 30, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lin-Ju Kang

Assistant Professor

Chang Gung University

Eligibility Criteria

Inclusion Criteria

  • Children are elementary school students between the ages of 6 and 10
  • Diagnosed with Autism spectrum disorder by DSM-V with a medical certificate, and reached the cut-off score (7 points) of Autism Behavior Checklist-Taiwan version(ABC-T).
  • Children have an IQ of at least 70 (as measured by Wechsler Intelligence Scale for Children).
  • Parents agree to participate in this study and sign the consent form.
  • Children over 7 years should provide written consent form.

Exclusion Criteria

  • Children with unstable physical conditions within 3 months, such as cancer, having surgery, infection, or other active medical conditions.
  • Children have known genetic conditions (e.g., Down syndrome, Fragile X Syndrome).
  • Children have diagnosis associated with physical disability (e.g. cerebral palsy, congenital malformations, or musculoskeletal disorders)
  • Children have significant sensory impairments such as visual or hearing impairments.

Outcomes

Primary Outcomes

Change in the Canadian Occupational Performance Measure (COPM) performance and satisfaction scores

Time Frame: From baseline to post-intervention at 12 weeks and follow-up at 24 weeks

The COPM is a measure for identifying children's participation problems and prioritizing the goals. The parents will be asked to use a 10-point rating scales (1-10: higher scores indicating better performance and higher satisfaction) to rate their perception of performance and satisfaction of the goals.

Change in the Goal Attainment Scaling (GAS) scores

Time Frame: From baseline to post-intervention at 12 weeks and follow-up at 24 weeks

The GAS is a measure for evaluating the goal attainment. It is a five level scale ranged from -2 to +2 where -2 represented the level of performance before intervention, 0 the expected level of attainment after intervention and +2 represented a level of attainment that exceeded expectations.

Secondary Outcomes

  • Chinese version of Family-Professional Partnership Scale (FPPS-P-C)(post-intervention at 12 weeks and follow-up at 24 weeks)
  • Family Quality of Life (FaQoL)(Baseline, post-intervention at 12 weeks and follow-up at 24 weeks)
  • Parent Empowerment and Efficacy Measure (PEEM)(Baseline, post-intervention at 12 weeks and follow-up at 24 weeks)

Study Sites (1)

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