Clinical trial NCT06859541: Culturally Adapted Play-Based Behavioural Intervention for Autism
Official title: Culturally Adapted Play-Based Behavioural Intervention Among Children With Autism Spectrum Disorder in Semi-Rural Tamil Nadu: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Adaptive Behaviour
Autism Spectrum Disorder
Behaviour Therapy
Play Therapy
Semi-Rural Tamil Nadu
Lead sponsor: Saveetha University
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 56
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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).

Exclusion Criteria:

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.

Primary outcomes:
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Baseline, 4th week, 8th week, 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Kanchipuram
country: India
facility: Aadhuraa Special School
state: Tamil Nadu
Study officials:
affiliation: Tutor
name: Madhanraj S
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar A, Bhattacharya S. Unveiling autism spectrum disorder in South East Asia through a public health Lens. Front Child Adolesc Psychiatry. 2024 Dec 4;3:1489269. doi: 10.3389/frcha.2024.1489269. eCollection 2024.
citation: Chauhan A, Singh M, Jaiswal N, Agarwal A, Sahu JK, Singh M. Prevalence of Cerebral Palsy in Indian Children: A Systematic Review and Meta-Analysis. Indian J Pediatr. 2019 Dec;86(12):1124-1130. doi: 10.1007/s12098-019-03024-0. Epub 2019 Jul 13.
citation: Dey I, Chakrabarty S, Nandi R, Shekhar R, Singhi S, Nayar S, Ram JR, Mukerji S, Chakrabarti B. Autism community priorities in diverse low-resource settings: A country-wide scoping exercise in India. Autism. 2024 Jan;28(1):187-198. doi: 10.1177/13623613231154067. Epub 2023 Mar 31.
citation: Leaf JB, Leaf R, McEachin J, Taubman M, Ala'i-Rosales S, Ross RK, Smith T, Weiss MJ. Applied Behavior Analysis is a Science and, Therefore, Progressive. J Autism Dev Disord. 2016 Feb;46(2):720-31. doi: 10.1007/s10803-015-2591-6.
citation: Deniz E, Francis G, Torgerson C, Toseeb U. Parent-mediated play-based interventions to improve social communication and language skills of preschool autistic children: A systematic review and meta-analysis protocol. PLoS One. 2022 Aug 15;17(8):e0270153. doi: 10.1371/journal.pone.0270153. eCollection 2022.