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临床试验/CTRI/2025/08/093887
CTRI/2025/08/093887尚未招募2 期

Multimodal Parent-Mediated Intervention Module for School – Age Children with Autism Spectrum Disorder: A Development, Feasibility, and Effectiveness Trial

National Institute of Mental Health and Neurosciences1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
25
试验地点
1
主要终点
Social Communication

研究概览

简要总结

The study aims to develop a Parent-Mediated Intervention for school-aged children (6–10 years) with Autism Spectrum Disorder (ASD) and to evaluate its feasibility and effectiveness. The intervention is being developed and tested in two phases. Phase 1 focuses on the development of the intervention. In Step 1, existing resources are reviewed. In Step 2, interviews are conducted with 20 participants, including parents of children with ASD, mental health professionals, and special educators, to identify key needs and suitable techniques. Based on these insights, Step 3 involves designing the content and structure of the intervention. In Step 4, expert evaluation is carried out to establish face and content validity of the screening scale and assessment battery. Finally, in Step 5, the intervention is piloted with 3 children with ASD. Phase 2 assesses the feasibility and effect of the intervention by recruiting 25 children with ASD aged 6 to 10 years with an IQ above 80. Baseline assessments are conducted using standardized tools, followed by the introduction of a multimodal intervention. Mid-intervention and post-intervention assessments are conducted after two weeks, with a follow-up assessment at two months.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
6.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • For Children,
  • Children aged 6 to 10 years, all genders.
  • Clinically diagnosed ASD of mild to moderate severity (INDT ASD and ISAA)
  • Social Intelligence quotient (IQ/SIQ) greater than 80, on VSMS or CPM)
  • Availability of at least one parent
  • Speaks and comprehend English and Hindi
  • Parent’s written consent and children’s assent For Parents,
  • Education till 10th std.
  • Parents staying with their child for a minimum of three years.

排除标准

  • Children having clinical/medical diagnosis and of comorbid psychiatric conditions apart from mild to moderate ADHD.
  • For Parents, parents with medical conditions that significantly impair their ability to participate in the study activities.

结局指标

主要结局

Social Communication

时间窗: 4 time points. Pre Intervention, Mid Intervention, Post Intervention and 2 month follow up

次要结局

  • Parent’s stress and coping style.
  • Autism severity.(Three time points - Screening, Post and Follow up.)
  • Perspective taking(Pre Intervention, Mid Point, Post Intervention and Follow up)
  • Metacognition(Pre Intervention, Mid Point, Post Intervention and Follow up)
  • Adaptive Behaviour(Pre Intervention, Mid Intervention, Post Intervention and Follow up.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Ankita Dhiman

National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore

研究点 (1)

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