NCT06859541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

February 23, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

Adaptive BehaviourAutism Spectrum DisorderBehaviour TherapyPlay TherapySemi-Rural Tamil Nadu

Outcome Measures

Primary Outcomes (1)

  • Strengths and Difficulties Questionnaire (SDQ)

    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.

    Baseline, 4th week, 8th week, 12th week

Study Arms (2)

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.

Behavioral: Culturally Adapted Play-Based Behavioural Intervention

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.

Behavioral: Applied Behaviour Analysis

Interventions

The Culturally Adapted Play-Based Behavioural Intervention (PPBI) integrates traditional Tamil games and folk storytelling to enhance social, emotional, and communication skills in children with Autism Spectrum Disorder (ASD). This 12-week structured program focuses on engagement, motor development, language, emotional regulation, social interaction, and real-world skill application, making it a culturally relevant and accessible intervention for improving adaptive behaviours.

Culturally Adapted Play-Based Behavioural Intervention Group

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.

Applied Behaviour Analysis

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aadhuraa Special School

Kanchipuram, Tamil Nadu, 631501, India

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Madhanraj S

    Tutor

    PRINCIPAL INVESTIGATOR
  • Jeevarathinam Thirumalai

    Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2025

First Posted

March 5, 2025

Study Start

August 5, 2024

Primary Completion

November 16, 2024

Study Completion

December 7, 2024

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations