An Intervention-Based single blind study to evaluate the effectiveness of an Al based learning platform in enhancing skills in cognitive development, enhancing social relationships, improving speech, language, and communication and addressing sensory aspects in children with autism spectrum disorder, intellectual disability and developmental delay
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- It is expected that children in the Experimental group will show
研究概览
简要总结
Brief Introduction: The aim of this research is to evaluate the effectiveness of an AI-based learning platform in enhancing skills in cognitive development, enhancing social relationships, improving speech, language, and communication and addressing motor aspects in children with Autism Spectrum Disorder (ASD), Developmental Delay (DD) and Intellectual disability (ID).
Existing Gaps: Conventional therapies, though effective, face challenges related to therapy availability, therapist-child ratios, consistency in therapy, and parental involvement. The current gap lies in scalable, accessible, and personalized interventions that can supplement conventional therapy. While digital solutions are emerging, data on their scientific validation remains sparse, particularly in the Indian context.
Justification for Study: The proposed study aims to evaluate the feasibility and effectiveness of an Artificial Intelligence (AI)-based learning platform—CognitiveBotics—as a supplementary intervention tool for children with mild to moderate ASD, DD, and ID. By leveraging technology, this study proposes a structured and measurable digital intervention that can enhance therapy access and outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 2.00 Day(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with a Mental Age of 2 to 6 years or a chronological age of 2 to 8 years.
- •Children with mild to moderate levels of developmental delay or intellectual disability and Autism Spectrum Disorder and are currently undergoing conventional therapy.
- •Children who are able to engage in short duration digital activities with parental guidance.
- •Parents who have access to touch based laptops, tablets, or smartphones with a good internet connection.
- •Parents or caregivers must provide informed consent and be willing to support the child s participation.
排除标准
- •Children with severe cognitive impairment and/or co-occurring neurological disorders.
- •Presence of comorbid conditions that might impact cognitive or physical functioning.
- •Children with sensory impairments that prevent them from using the AI-based learning platform (e.g., blindness, severe hearing loss).
- •Children with the diagnosis of ADHD.
- •Parents or caregivers who wouldn’t consent to be part of the study.
- •Parents or caregivers unwilling to comply with therapy schedules or follow-up assessments.
- •Parents who do not meet the requirements for the device specifications to be part of the study.
- •Children who are currently enrolled in an ongoing clinical trial.
结局指标
主要结局
It is expected that children in the Experimental group will show
时间窗: 6 months
measurable improvements in cognitive, social, and communication skills compared to the control group.
时间窗: 6 months
acquisition in children who can engage with structured digital
时间窗: 6 months
The AI-based learning platform is anticipated to promote skill
时间窗: 6 months
learning experiences.
时间窗: 6 months
次要结局
未报告次要终点