跳至主要内容
临床试验/CTRI/2023/05/052869
CTRI/2023/05/052869尚未招募不适用

Development of an intervention protocol for children with Autism Spectrum Disorder aged 6 – 12 years

Dr Monica Juneja1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年1月3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
68
试验地点
1
主要终点
Difference between mean change in SRS-2 score between the two groups

研究概览

简要总结

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by persistent deficits in social communication and social interaction and the presence of restricted, repetitive patterns of behavior, interests, or activities which impacts an individual across lifespan. Early diagnosis and timely initiation of evidence based therapies have shown to optimize developmental outcomes. Children with autism spectrum disorder above 6 years of age require a different skill set than toddlers and pre-schoolers to deal with the socializing element of life and to better adapt to the forthcoming academic demands. However, studies on interventions in children with ASD have largely focused on early intervention in toddlers and preschool age children and only few have evaluated the interventions for children with ASD beyond 6 years of life.

As established by research, children with ASD are educable and outcomes depend on timely institution of early interventions. As these children transition from toddler and preschool ages to childhood, they face differing challenges and difficulties, requiring a change in intervention strategies. Involvement of families and caregivers is vital for enabling continuation of therapies especially in a resource limited country like India, where there is a shortage of trained therapists. Since there is a paucity of studies evaluating interventions and their outcomes specifically for children aged 6-12 years, this study was planned. We intend to develop a caregiver mediated intervention protocol for children with Autism Spectrum Disorder of age 6-12 years and compare its efficacy with standard care.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Not Applicable

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children aged 6 to 12 years diagnosed with Autism Spectrum Disorder by DSM-V criteria having a mental age more than or equal to 3 years and functional speech of at least 3-word sentences with i)The primary caregiver willing to attend training sessions on specified dates, during the study period.
  • ii)Primary caregiver willing to spend at least 3 hours daily with their child for therapy related activities, during the study period.

排除标准

  • 1.Children with co-morbid neurodevelopmental disabilities, namely cerebral palsy, significant hearing impairment, significant visual impairment, poorly controlled seizures or neuro degenerative disorders.
  • 2.Children with chronic systemic illnesses like chronic lung disease, chronic liver disease, congenital heart disease etc.
  • 3.Children with syndromic ASD 4.Primary caregiver doesn’t understand either Hindi or English.

结局指标

主要结局

Difference between mean change in SRS-2 score between the two groups

时间窗: Baseline, and after 1 year of intervention

次要结局

  • 1.Difference between mean change in CARS-2 score(2.Difference between mean change in VABS-3 score)

研究者

发起方
Dr Monica Juneja
申办方类型
Other [(self)]

研究点 (1)

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