NCT06859541Completed
Culturally Adapted Play-Based Behavioural Intervention for Autism
Culturally Adapted Play-Based Behavioural Intervention Among Children With Autism Spectrum Disorder in Semi-Rural Tamil Nadu: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 30 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 23 Feb 2025
- Start date
- 5 Aug 2024
- Primary completion date
- 16 Nov 2024
- Lead sponsor
- Saveetha University
- Diseases
- Autism
- NCT number
- NCT06859541
What you commit to
- Study type: Interventional
- Participants enrolled: 56
- From 5 Aug 2024 to the primary completion date, 16 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Children with severe ASD or comorbid neurological/psychiatric disorders. Those undergoing intensive behavioral therapy or other structured interventions.
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 8 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aadhuraa Special School Coordinator of this site? Confirm its status | Kanchipuram | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.