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临床试验/NCT06859541
NCT06859541已完成不适用

Culturally Adapted Play-Based Behavioural Intervention Among Children With Autism Spectrum Disorder in Semi-Rural Tamil Nadu: A Randomized Controlled Trial

Saveetha University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年8月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Strengths and Difficulties Questionnaire (SDQ)

研究概览

简要总结

This study compared Culturally Adapted Play-Based Behavioural Intervention (PPBI) and Applied Behaviour Analysis (ABA) for children with Autism Spectrum Disorder (ASD) in semi-rural Tamil Nadu through a double-blinded randomized controlled trial with 56 participants.

The PPBI approach integrated traditional Tamil games such as Paandi (hopscotch), Kuzhi Thanda (hole-and-peg game), and Paramapadham (snakes and ladders) to encourage social interaction, cooperative play, motor skill development, and emotional self-regulation. Activities were structured to progress through various developmental goals, including turn-taking, gesture-based communication, sensory-motor coordination, language expression, peer collaboration, and real-life scenario practice. Additionally, storytelling, music-based play, and movement exercises were included to enhance communication and social awareness.

On the other hand, the ABA-based program utilized structured techniques focused on positive reinforcement, imitation training, guided communication, and step-by-step skill-building. The primary goal was to reduce problem behaviors while reinforcing desirable social and communication skills. Parents and teachers were provided with structured training on how to apply ABA strategies consistently at home and school.

详细描述

This research investigated the effectiveness of a Culturally Adapted Play-Based Behavioural Intervention (PPBI) in comparison to Applied Behaviour Analysis (ABA) for improving behavioral and social skills in children diagnosed with Autism Spectrum Disorder (ASD) in a semi-rural region of Tamil Nadu. Recognizing the challenges children with ASD face in communication, emotional regulation, and social interaction, the study aimed to explore whether an intervention rooted in traditional play-based methods could provide better engagement and outcomes.

A double-blinded randomized controlled trial was conducted, involving 56 children between the ages of 8 and 12, who were evenly divided into two groups: PPBI and ABA. Both programs ran five days a week over a 12-week period, with behavioral assessments conducted using the Strengths and Difficulties Questionnaire (SDQ). Parents and teachers provided input at multiple time points to capture changes in home and school environments. The research took place at Aadhuraa Special School in Kanchipuram, Tamil Nadu, ensuring the intervention was delivered in a setting that aligned with the children's cultural background.

Intervention Details:

The PPBI approach integrated traditional Tamil games such as Paandi (hopscotch), Kuzhi Thanda (hole-and-peg game), and Paramapadham (snakes and ladders) to encourage social interaction, cooperative play, motor skill development, and emotional self-regulation. Activities were structured to progress through various developmental goals, including turn-taking, gesture-based communication, sensory-motor coordination, language expression, peer collaboration, and real-life scenario practice. Additionally, storytelling, music-based play, and movement exercises were included to enhance communication and social awareness.

On the other hand, the ABA-based program utilized structured techniques focused on positive reinforcement, imitation training, guided communication, and step-by-step skill-building. The primary goal was to reduce problem behaviors while reinforcing desirable social and communication skills. Parents and teachers were provided with structured training on how to apply ABA strategies consistently at home and school.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children aged 8 to 12 years diagnosed with Autism Spectrum Disorder (ASD) (mild to moderate severity).
  • •Diagnosis confirmed using the Indian Scale for Assessment of Autism (ISAA). Classified as Level I to III in the Communication Function Classification System.
  • •Attended regular sessions throughout the 12-week intervention. Parents or guardians provided informed consent and participated in training sessions.
  • •Completion of behavioral assessments using the Strengths and Difficulties Questionnaire (SDQ).

排除标准

  • •Children with severe ASD or comorbid neurological/psychiatric disorders. Those undergoing intensive behavioral therapy or other structured interventions.
  • •Children with uncorrected sensory impairments (e.g., hearing or visual deficits) that could interfere with intervention activities.
  • •Families unable to commit to the full 12-week study period.

研究组 & 干预措施

Culturally Adapted Play-Based Behavioural Intervention Group

Experimental

The Culturally Adapted Play-Based Behavioural Intervention (PPBI) incorporated traditional Tamil games and folk storytelling to enhance social awareness, emotional regulation, and language development. Over 12 weeks, the program progressed through key developmental areas:

Weeks 1-2: Focused on engagement and communication through interactive activities.

Weeks 3-4: Developed sensory and motor skills using creative play. Weeks 5-6: Strengthened language and expression with role-playing and storytelling.

Weeks 7-8: Addressed emotional regulation through structured games and music therapy.

Weeks 9-10: Encouraged social interaction with group play and problem-solving tasks.

Weeks 11-12: Emphasized real-world application through community-based activities.

干预措施: Culturally Adapted Play-Based Behavioural Intervention (Behavioral)

Applied Behaviour Analysis

Active Comparator

The Applied Behaviour Analysis (ABA) program was structured into progressive stages, each targeting specific behavioral improvements.

Weeks 1 & 2: Introduced structured learning techniques, focusing on basic commands, eye contact training, and reinforcement strategies, such as reward-based motivation systems.

Weeks 3 & 4: Emphasized early communication development, incorporating imitation exercises, visual schedules, and simple verbal response training.

Weeks 5 & 6: Implemented behavior modification techniques, including token-based reinforcement, redirection methods, and gradual shaping of desired behaviors.

Weeks 9 & 10: Focused on independent task execution, covering self-care routines such as dressing, eating, and personal hygiene, with structured multi-step guidance.

Weeks 11 & 12: Aimed at generalizing learned behaviors, ensuring that children could apply their skills effectively in home, school, and social environments.

干预措施: Applied Behaviour Analysis (Behavioral)

结局指标

主要结局

Strengths and Difficulties Questionnaire (SDQ)

时间窗: Baseline, 4th week, 8th week, 12th week

The 25 item Strengths and Difficulties Questionnaire (SDQ) measures behavioral and emotional function. These 25 items are divided into 5 subscales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. The Strengths and Difficulties Questionnaire is scored on a 3-point Likert-type scale, with total scores (excluding the prosocial scale) ranging from 0 to 40. Higher scores reflect greater behavioral and emotional difficulties and lower scores reflects lesser behavioural and emotional difficulties.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Madhanraj Sekar

Principal Investigator

Saveetha University

研究点 (1)

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