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临床试验/CTRI/2025/11/096943
CTRI/2025/11/096943尚未招募不适用

Effectiveness of a Five-Component Multimodal Intervention on Executive Function in Children with Autism Spectrum Disorder: A Randomized Controlled Trial

Kazi Md Azman Hossain1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2025年11月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
195
试验地点
1

研究概览

简要总结

This randomized controlled trial will investigate the effectiveness of a 12-week, five-component multimodal intervention on executive function in children with Autism Spectrum Disorder (ASD). A total of 112 participants aged 4–18 years will be randomly assigned to either an intervention or a wait-list control group. 65 children without ASD will also be recruited as a healthy control group. The program integrates yoga, aerobic exercise, strengthening, neurocognitive tasks, and music-based mindfulness. Primary outcomes include executive function measures, while secondary outcomes assess social responsiveness and autism-related behaviors at baseline, 12, and 24 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 18.00 Year(s)(—)
性别
Male

入选标准

  • Participants will be included if aged between 4 and 18 years, including both boys and girls, who will have been diagnosed with Autism Spectrum Disorder (ASD) in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), based on clinical assessment and confirmed by evaluation using the Childhood Autism Rating Scale, Second Edition (CARS-2), conducted by a child psychiatrist.
  • Consent to participate in a 12-week intervention period.

排除标准

  • Participants will be excluded if they have cerebral palsy, Down syndrome, or attention deficit/hyperactivity disorder (ADHD).
  • Additionally, any participant who reports, or whose parent reports, a recent (within the past six months) muscle injury or other conditions—such as muscle sprain, head injury, or skin laceration—that may interfere with study outcomes or exercise participation will also be excluded.

研究者

发起方
Kazi Md Azman Hossain
申办方类型
Other [self-funded]
责任方
Principal Investigator
主要研究者

Kazi Md Azman Hossain

Jashore University of Science and Technology (JUST)

研究点 (1)

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