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临床试验/CTRI/2024/09/074306
CTRI/2024/09/074306
尚未招募
不适用

Development and pilot validation of an Indian instrument for severity of sensory reactivity in children with autism spectrum disorder

Indian Council of Medical Research, New Delhi1 个研究点 分布在 1 个国家目标入组 620 人开始时间: 2024年11月1日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Indian Council of Medical Research, New Delhi
入组人数
620
试验地点
1
主要终点
To explore, describe and characterize the sensory reactivity in children with Autism spectrum disorder.

概览

简要总结

Background: Autism Spectrum disorder (ASD) is a neuro-developmental condition of childhood characterized by qualitative impairment in social and communicative behavior. In our clinical experience, a significant number of children who have been diagnosed with autism have sensory issues. The study of sensory and motor issues in autism is a relatively new frontier for research in ASD. Assessment of sensory symptoms and associated behavioral construct is important as it can help to ascertain the sensory strategies used to regulate the sensory reactivity of a child with ASD.  The current assessment measures have issues related to cultural and clinical applicability, which makes them difficult to be consistently applied in the Indian context. Thus, there is a need for a locally relevant and simple instrument for identification of sensory reactivity in children with ASD.

Novelty: This would be an indigenously developed severity instrument for sensory symptoms in ASD through a consultative approach, which will be tested with parents of ASD and professionals.

Aims & Objectives:

The overall aim will be to capture the parental experiences and expert perspectives on patterns of sensory reactivity in children with ASD and translate them into a validated severity tool.Primary objective (s):

  1. To explore, describe and characterize the sensory reactivity in children with ASD.

  2. To develop and pilot test a valid & reliable instrument for identification and severity of sensory issues in children with ASD.

Methods: A step wise approach would be taken for completion of the work. The steps are as follows:

  1. Preparation of in-depth interview and focused group discussion guide (Identification of domains) via literature review and consultative iterations

  2. Development of a questionnaire/ checklist based upon the inputs from parents of ASD & professionals/ early interventionist

  3. Reviewing of a questionnaire/ checklist by professionals/ early interventionist for content validity and modifications based upon concerns

  4. Application of the instrument among parents of children with ASD & parents of typical developing children for pilot validation

Expected outcome: A severity instrument will be developed for sensory symptoms in ASD children that will be simple, validated, reliable and available in public domain for easy application. It will be precise, more focused and will provide accurate information about sensory issues in children with ASD. So, that we can plan individualized treatment strategy for them.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Inclusion criteria:
  • All children clinically diagnosed with ASD as per DSM-5, between the age range of 2 to 6 years.
  • Parents who are willing to provide written informed consent or assent by children.

排除标准

  • Exclusion criteria:
  • significant medical or sensory/motor impairments such as blindness or deafness.
  • Any genetic/ neurological condition.

结局指标

主要结局

To explore, describe and characterize the sensory reactivity in children with Autism spectrum disorder.

时间窗: Baseline

次要结局

  • To develop & test a valid & reliable instrument for identification & severity of sensory issues in children with Autism spectrum disorder.(Baseline)

研究者

发起方
Indian Council of Medical Research, New Delhi
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Rajeev Ranjan

All India Institute of Medical Sciences, Patna

研究点 (1)

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