跳至主要内容
临床试验/CTRI/2025/03/083171
CTRI/2025/03/083171招募中Phase 3 4

A randomised trial to compare the effectiveness of applied behavioural analysis (ABA) and verbal behavioural approach (VBA) in the management of autism spectrum disorder

Indian Navy1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Compare between 02 groups:

研究概览

简要总结

Study method:

i-                    take informed, written consent

ii-                   assessment with INCLEN-ASD and ISAA done for diagnosing autism spectrum disorder

iii-                 intelligence quotient score will be measured using Seguin Form Board test

iv-                 applying criteria for inclusion and exclusion, the subjects will be included in the study

Randomly allot study participants to two groups, ‘A’ and ‘V’ by chit system where group A is to receive ABA and group V is to receive VBA

ii-                   Baseline function deficit in domain of social communication and interaction of child will be measured by Vineland Social Maturity Scale (VSMS), Vineland Adaptive Behavior Scale (VABS), Aberrant Behavior Checklist (ABC).

iii-                 The participants in the ABA group will receive one-on-one sessions with a Clinical psychologist and Psychiatrist. The sessions will focus on teaching adaptive skills and reducing maladaptive behaviors through positive reinforcement and shaping. The participants in the VBA group will receive one-on-one sessions with a Clinical psychologist and Psychiatrist. The sessions will focus on teaching verbal skills and increasing functional communication through positive reinforcement and shaping . Both groups will receive treatment for 6 months.

iv-                 Continue follow-up for a period of 06 months followed by assessment to measure change in autism severity by ISAA, changes in adaptive skills by Vineland Adaptive Behavior Scale (VABS), changes in social maturity by VSMS (Vineland social maturity scale) and changes in maladaptive behaviors, as measured by the Aberrant Behavior Checklist (ABC).

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 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

  • All children visiting the OPD being diagnosed as a case of ASD as per INCLEN-ASD and ICD 11 whose parents are willing to participate and give informed consent and between the Age group of 03 and 06yrs.

排除标准

  • Children with IQ less than 70.

结局指标

主要结局

Compare between 02 groups:

时间窗: Baseline and after 06 months

severity of autism by ISAA (Indian scale for assessment of autism)

时间窗: Baseline and after 06 months

次要结局

  • social maturity- Vineland Social Maturity Scale (VSMS)(baseline & after 06 months)
  • adaptive skills- Vineland Adaptive Behavior Scale (VABS).(baseline & 06 months)
  • maladaptive behaviors- Aberrant Behavior Checklist (ABC).(baseline & after 06 months)

研究者

发起方
Indian Navy
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Aaditya Pisharadi

Indian Navy

研究点 (1)

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