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临床试验/NCT02496819
NCT02496819已完成不适用

Metacognitive Self-regulated Learning and Sensory Integrative Approaches for Children With Autism Spectrum Disorders

University of Western Sydney2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
School-related task performance on the School Function Assessment - change from baseline after the intervention

研究概览

简要总结

Children with Autism Spectrum Disorder (ASD) are increasing each year. There are about 1 in 160 children for the age group of 6-12 years old in Australia are diagnosed with ASD. Children with ASD have impairment in two common areas including: i) social and communication and ii) repetitive and stereotypical patterns of behaviours. These common features result in behavioural problems which negatively impact children's participation in school, activities of daily living and social engagement.

Therefore, there is a need for effective interventions to overcome the behavioural problems in children with ASD.

The purpose of the study is to investigate the effect of sensory integration (SI) and self-regulated learning versus an activity-based control programme in reducing behavioural problems in children with ASD that interfere with their daily livings, school, and social engagement.

The study will adopt a randomized controlled trial design with three intervention groups: I) self-regulated learning, II) sensory integration and III) activity-based intervention as the control group.

详细描述

Children with Autism Spectrum Disorder (ASD) are commonly associated with behavioural problems which may negatively impact on their participation in school, activities of daily livings and social engagement. In order to minimise the impact on the daily functioning of these children, overcoming the behavioural problems in these children is essential.

Two intervention approaches will be used in this study. These are i) self-regulated learning and ii) sensory integration. Sensory integration is commonly used for children with developmental problems. Self-regulated learning has been used to promote children's self-directed learning and in people with brain injuries.

However, the evidence towards the effectiveness of these two interventions in alleviating the effects of behavioural problems on participation in school, daily and social activities for children with ASD is limited and inconclusive.

Self-regulated learning theory:

The origin of self-regulated learning approach came from Albert Bandura's social cognitive theory. The theory states that intervention affects one's learning by modifying the personal, environmental and behavioural factors. The personal factor refers to one's beliefs and attitudes. The environment factor comprises of feedback, instructions, information gathered from teachers or instructors and also from the assistance of parents and peers. The behavioural factor includes past performance that are socially unacceptable. The key of self-regulated learning is to ensure that children make use of a cognitive strategy to facilitate behaviour learning by helping them to bring problems and solutions towards own consciousness. Several studies had used self-regulated learning in children and adults population. It was found a significant improvement in task performance for children with Attention Deficit Hyperactive Disorders (ADHD). The positive effect was also shown in another study showing improvements in performance measures of reading and intelligence quotient among children with moderate learning disabilities. Similar results were also seen in adults with brain injury in various studies. They suggested that self-regulated learning could enhance the active learning of participants.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with ASD meeting the requirements of the Diagnostic and Statistical Manual of Mental Disorders without dual diagnoses such as physical disabilities
  • Overall score ≥ 70 in Part I and Part II of the Vineland Adaptive Behaviour Scales (VABS-II) (2nd ed.). These parts of the scale will assess:.
  • Problem behaviours Part I (internalizing, externalizing, other behaviours): 36 items
  • Problem behaviours Part II (critical items): 14 items
  • Have an IQ greater than
  • This is indicative of a normal intelligence quotient (IQ) to moderate grade intellectual disability. This is required so they are able to follow verbal instructions.

排除标准

  • 未提供

研究组 & 干预措施

Metacognitive self-regulated learning intervention

Experimental

It involves training of daily tasks using a self-correct strategy. Participants' performance will be video-taped and they will then watch the video playback for reflection and self-correction under the guidance of the occupational therapist.

干预措施: Meta-cognitive self-regulated learning intervention (Other)

Sensory Integration intervention

Experimental

It involves active, fun physical activity completing 8 stations of activities involving tactile, proprioceptive and vestibular tasks. Frequent breaks will be given to avoid exhaustion and fatigue throughout the activities.

干预措施: Sensory integration intervention (Other)

Activity-Based Intervention

Active Comparator

It provides constructional, drawing and crafts activity. Participants are guided to complete these tasks

干预措施: Activity-based intervention (Other)

结局指标

主要结局

School-related task performance on the School Function Assessment - change from baseline after the intervention

时间窗: Baseline and after the intervention (12 weeks)

Social skills on the Walker Mc-Connell scale - change from baseline after the intervention

时间窗: Baseline and after the intervention (12 weeks)

Social skills on the Walker Mc-Connell scale - change from baseline at one month after the intervention completed

时间窗: Baseline and one month after the intervention completed (16 weeks)

Adaptive behaviour on the Vineland Adaptive Behaviour Scales - change from baseline after the intervention

时间窗: Baseline and after the intervention (12 weeks)

Executive function behaviours on the Behaviour Rating Inventory of Executive Function - change from baseline after the intervention

时间窗: Baseline and after the intervention (12 weeks)

Executive function behaviours on the Behaviour Rating Inventory of Executive Function - change from baseline at one month after the intervention completed

时间窗: Baseline and one month after the intervention completed (16 weeks)

Adaptive behaviour on the Vineland Adaptive Behaviour Scales - change from baseline at one month after the intervention completed

时间窗: Baseline and one month after the intervention completed (16 weeks)

School-related task performance on the School Function Assessment - change from baseline at one month after the intervention completed

时间窗: Baseline and one month after the intervention completed (16 weeks)

次要结局

  • Sensory processing patterns and effects on functional performance on the Sensory Profile - change from baseline at one month after the intervention completed(Baseline and one month after the intervention completed (16 weeks))
  • Sensory processing difficulties on the Sensory Processing Measures - change from baseline after the intervention(Baseline and after the intervention (12 weeks))
  • Sensory processing difficulties on the Sensory Processing Measures - change from baseline at one month after the intervention completed(Baseline and one month after the intervention completed (16 weeks))
  • Sensory processing patterns and effects on functional performance on the Sensory Profile - change from baseline after the intervention(Baseline and after the intervention (12 weeks))

研究者

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

Karen Liu

Associate Professor

University of Western Sydney

研究点 (2)

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