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临床试验/NCT06079632
NCT06079632尚未招募不适用

Telehealth Parent Coaching to Improve Activity Participation for Young Children With Autism Spectrum Disorder and Sensory Processing Disorders: A Prospective Study

National Taiwan University Hospital0 个研究点目标入组 68 人开始时间: 2023年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
68
主要终点
The child's social communication ability

研究概览

简要总结

This clinical trial aims to develop parent-child interaction strategy coaching and sensory processing strategy coaching via Telehealth and examine the feasibility and efficacy of the interventions in young children with autism spectrum disorder who have sensory processing disorder.

In the first experiment, the investigators will apply a single-subject research design and one-group pre-post test design to explore the feasibility of the coaching interventions. In the second experiment, RCT design will be used to examine the effectiveness of parent coaching. Sixty-five children with ASD and their parents will be randomly assigned to the intervention or control group. The intervention group will receive weekly parent-child interaction and sensory processing strategy coaching for 12 weeks. The control group will be provided with weekly self-learning materials and group discussion session for 12 weeks. Additionally, the follow-up test will be administered three months after the intervention.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The child is 3 to 5 years old
  • The child is diagnosed with ASD by a child psychiatrist or specialist in psychology based on the DSM-5's diagnostic criteria
  • The child's score falls within the category of dysfunction in one or more sensory processing functions in the Sensory Profile (3-10 years old version)

排除标准

  • Children diagnosed with major neuromuscular dysfunction or other disease diagnoses, such as epilepsy or other genetic diseases
  • Children whose parents could not speak Hokkenese or Chinese and read in Chinese
  • Individuals who have participated in the first year of this study

结局指标

主要结局

The child's social communication ability

时间窗: through study completion, an average of 4 months

Measured by the self-developed measurement - the Social Communication Rating Scale for young children in the single subject experiment. The score could range from 0 to 38, with higher scores implied greater social communication ability.

The performance and satisfaction with the child's daily participation

时间窗: up to 25 weeks

Measured by the Canadian Occupational Performance Measure in the RCT experiment. The score could range from 1 to 10, with higher scores implied greater performance and higher satisfaction with the child's daily participation.

The parent's parent-child interaction strategy utilization

时间窗: through study completion, an average of 4 months

Measured by the self-developed measurement - the Parental Parent-Child Interaction Strategy Rating Scale in the single subject experiment. The score could range from 20 to 80, with higher scores implied greater parent-child interaction strategy utilization.

次要结局

  • The social functioning and adaptive behavior of the child(up to 25 weeks)
  • The child's performance in social communication(up to 25 weeks)
  • The parent's self-perceived parental competence(through study completion, an average of 4 months)
  • The parent's self-perceived life quality within the last two weeks(up to 25 weeks)
  • The child's social communication ability(up to 25 weeks)
  • The attainment of the selected goal related to issues with the child's sensory processing disorder(through study completion, an average of 4 months)
  • The parent's self-perceived stress within the family system(up to 25 weeks)
  • The parent's parent-child interaction strategy utilization(up to 25 weeks)
  • The performance and satisfaction with the child's daily participation(through study completion, an average of 4 months)

研究者

申办方类型
Other
责任方
Sponsor

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