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临床试验/CTRI/2025/04/084488
CTRI/2025/04/084488尚未招募1 期

Eclectic Therapy on Mothers Psychological Well-Being and Resilience Impacting Skill Development in Their Children with Autism Spectrum Disorder

Sirisha M1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年4月30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
45
试验地点
1
主要终点
Psychological Well being

研究概览

简要总结

Three groups will be made according to the inclusion and Exclusion criteria Experimental Group 1, Experimental group 2 , waitlist or control group

Group A Experimental Group 1 will receive Eclectic therapy+ Stress management techniques + Home-based management training for their children with Autism.

Group B Experimental Group 2 will receive Stress management techniques + Home-based management training for their children with Autism.

Group C Waitlist or control Group   will receive only   Home-based management training for their children with Autism.

Data will be analyzed with an appropriate statistical too after post assessment 1, 8 weeks of no intervention period will be maintained and post assessment  2 will be conducted.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
25.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Mothers aged 25-40 years.
  • Mothers whose education qualification should be minimum 12th grade Mothers of children who are recently (more than 1 month and less than 6 months) diagnosed as mild Autism by any rehabilitation & clinical professionals Child can be both male or female Mothers who are biological parent and primary care taker of children Diagnosed with Autism spectrum Disorder (not adopted or caretaker/guardian).
  • Both working mothers, non-working mothers, single parenting mothers will be included in the study (The group differences or variances in the results will be later analysed separately) Mothers having single child and multiple children will also be included in the study (the variances in the results will be analyzed separately) inclusive criteria for children taken for intervention: Children aged 3 year – 6 years Children with Intelligent Quotient ranging from 50 – 69 (Mild level of IQ) will be included in the study.
  • Children who are diagnosed recently (more than 1 month and less than 6 months) as mild Autism with ISAA tool score ranging 70-106), Child can be both male or female.
  • children who already got admission to regular schools or special schools or whom not yet enrolled in schools will also be included in the study.

排除标准

  • exclusive criteria of mothers Mother with any acute clinical depression or psychiatric condition or physical disability.
  • Previous experience with any type of therapeutic intervention training or any other type of contemplative or other practices such as ongoing in the previous 6 months.
  • Mothers of children diagnosed with Autism and along with any Other comorbid conditions are excluded like genetic disorders physical disability or TBI.
  • exclusive criteria of children Children whom are under medication for generalized seizures/epilepsy Children with Autism and along with any Other comorbid conditions, psychiatric conditions are excluded like genetic disorders, physical disability Previous exposure with any type of therapeutic training ongoing in the previous 6 months.
  • children who are currently taking any other therapies (Behavior therapy, Occupational therapy, Speech therapy) for more than 1 month.

结局指标

主要结局

Psychological Well being

时间窗: 16th week and 25th week

Resilience

时间窗: 16th week and 25th week

次要结局

  • skill development in children with autism(Behavioral changes)

研究者

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

Sirisha M

Mahatma Gandhi University of Medical Sciences and TechnologyJaipur

研究点 (1)

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