跳至主要内容
临床试验/CTRI/2024/03/063821
CTRI/2024/03/063821尚未招募1 期

Effectiveness of a Parent-Mediated Intervention Program for Children with Autism Spectrum Disorder

Pinky Chetia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月15日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1.A low cost , culturally appropriate ,naturalistic behavioral intervention parent mediated module which will be tested for test its .

研究概览

简要总结

Background : Autism Spectrum Disorder is a lifelong Neurodevelopmental disability characterized by impairment in social communication and interactions as well as the presence of restricted interest and stereotyped behavior. The prevalence of ASD in India is between 0.4-1.2% which roughly translates into approximately 1.7 million individuals with ASD in the country. The difficulties and challenges that accompany the child"s impairment can lead  to considerable parenting stress and caregiving burden , further disrupts the parental psychological wellbeing and quality of life. In such a scenario for parent -mediated early intervention programs is amplified. Parent mediated intervention is a cost effective model to fill the existing gap . These are tecnique -focused intervention where the parent is the agent of change and the child is the direct beneficiary of the treatment . Parent mediated intervention can enhance social communication , adaptive behavior , cognition and language. Thus the researcher felt the need of conceptualizing the present study to highlight the implementation of a manualized evidenced - based parent intervention adapted to the cultural context of a clinical setting in India and test the effectiveness on child and parent outcome.

The present study aims to develop a module on parent mediated intervention and to assess the effectiveness of the module on child and parent outcome

At the end of the study , the final results will be published at the indexed journal of UGC Care List as per Ph.D requirement

研究设计

研究类型
Interventional
分配方式
Na
盲法
Investigator Blinded

入排标准

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

入选标准

  • (a) Children had a diagnosis of ASD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or ICD 10 (b) Children aged 3–6 years (c) Parents aged 18–60 years (e) Parents living with the diagnosed children during the intervention period (f) Children’s who have not yet received any early behavioural interventions.

排除标准

  • (a) Parents were diagnosed with other mental diseases that may affect their participation (b) Parents had more than one child diagnosed with ASD.

结局指标

主要结局

1.A low cost , culturally appropriate ,naturalistic behavioral intervention parent mediated module which will be tested for test its .

时间窗: Baseline , 8 weeks & 12 weeks

Impact on Pre-linguistic skills of the child

时间窗: Baseline , 8 weeks & 12 weeks

If the intervention is found out to be effective, the module will be translated to local language and made available for use in the public domain free of cost

时间窗: Baseline , 8 weeks & 12 weeks

2.Impact on Parental stress

时间窗: Baseline , 8 weeks & 12 weeks

3.Impact on Parental Self-efficacy

时间窗: Baseline , 8 weeks & 12 weeks

次要结局

  • 1.A low cost , culturally appropriate ,naturalistic(behavioral intervention parent mediated module)

研究者

发起方
Pinky Chetia
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Pinky Chetia

Lokapriya Gopinath Bordoloi Regional Institute of Mental Health

研究点 (1)

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