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临床试验/NCT03721913
NCT03721913已完成不适用

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

Chang Gung University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年10月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Change in the Canadian Occupational Performance Measure (COPM) performance and satisfaction scores

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes assessor will be masked for assessments of family empowerment

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lin-Ju Kang

Assistant Professor

Chang Gung University

研究点 (2)

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