Play Based Approach Among Autism

NCT07814040 | Completed DMC

• 1 other identifier: 001/12/2025/ISRB/FR/SCPT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study evaluates the effectiveness of the B.A.S.I.C.S. framework, a multimodal play-based intervention designed for children with autism spectrum disorder (ASD). The framework integrates balance, autonomy, social interaction, cognition, and self-reliance through structured, play-based therapeutic activities. The intervention combines motor, sensory, cognitive, communication, and peer-based activities within a therapeutic setting. Children with ASD aged 6-12 years who met the predefined eligibility criteria participated in the intervention. Participants received 45-minute multimodal play therapy sessions three times per week for six weeks. Activities were individualized and progressively graded according to each child's tolerance and performance. The effectiveness of the intervention was evaluated by comparing pre-intervention and post-intervention scores on the WeeFIM (Functional Independence Measure for Children) and the Paediatric Balance Scale. The primary purpose was to determine whether participation in the B.A.S.I.C.S. framework was associated with improvements in functional independence and balance among children with ASD. This study provides preliminary evidence regarding the potential effectiveness of a structured multimodal play-based approach that integrates motor, sensory, cognitive, and social components to support functional outcomes in children with ASD.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Children with Autism; Play-Based Intervention; B.A.S.I.C.S. Framework; Paediatric Balance; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Paediatric Balance Scale (PBS)

  The Paediatric Balance Scale (PBS) is a 14-item functional balance assessment used to evaluate static and dynamic balance in children. Each item is scored on a 5-point ordinal scale from 0 to 4, with higher scores indicating better balance performance and greater independence. The total score ranges from 0 to 56. The PBS assesses functional balance abilities including standing, reaching, turning, and stepping. Scores are assessed before and after the intervention to determine changes in balance performance.

  baseline, 6 weeks, 12 weeks, post follow-up (24th week)

• Functional Independence Measure for Children (WeeFIM)

  The WeeFIM (Functional Independence Measure for Children) is an 18-item assessment used to evaluate functional independence in children across self-care, mobility, and cognition. Each item is scored on a 7-point ordinal scale from 1 (total assistance) to 7 (complete independence), with a total score ranging from 18 to 126. Higher scores indicate greater functional independence.

  baseline, 6 weeks, 12 weeks, 24th week

Secondary Outcomes (1)

• Social Skills Improvement System (SSIS) Rating Scales

  baseline, 6 weeks, 12 weeks, 24th week

Study Arms (2)

B.A.S.I.C.S FRAMEWORK

EXPERIMENTAL

Participants in this arm received the B.A.S.I.C.S. multimodal play-based intervention, a structured therapeutic program integrating Balance, Autonomy, Social Interaction, Cognition, and Self-reliance. The intervention incorporated cognitive-motor integration tasks, goal-oriented perceptual-motor activities, peer-based balance activities, synchronized auditory-movement activities, Picture Exchange Communication System (PECS)-based activities, and sensory-motor fine-motor activities with cognitive tasks. Activities were individualized and progressively graded according to each child's tolerance and performance. Participants received 45-minute sessions, three times per week for six weeks.

Behavioral: B.A.S.I.C.S FRAMEWORK

Conventional Physiotherapy

ACTIVE COMPARATOR

Conventional physiotherapy consisting of therapeutic exercises and activities primarily targeting gross and fine motor skills, balance, coordination, and postural control. The intervention focuses on improving motor performance and physical functional abilities through routine physiotherapy techniques.

Behavioral: Conventional Physiotherapy

Interventions

B.A.S.I.C.S FRAMEWORK BEHAVIORAL

The B.A.S.I.C.S. framework is a structured multimodal play-based intervention integrating five domains: Balance, Autonomy, Social Interaction, Cognition, and Self-reliance. The intervention combines motor, sensory, cognitive, communication, and peer-based activities through structured therapeutic play. Activities include cognitive-motor obstacle courses, perceptual-motor tasks, peer-based balance activities, synchronized rhythmic movements, PECS-based functional communication activities, and sensory-motor fine-motor activities with cognitive tasks. Activities are individualized and progressively graded according to the child's tolerance and performance.

B.A.S.I.C.S FRAMEWORK

Conventional Physiotherapy BEHAVIORAL

Conventional physiotherapy consisting of therapeutic exercises and activities primarily targeting gross and fine motor skills, balance, coordination, and postural control. The intervention focuses on improving motor performance and physical functional abilities through routine physiotherapy techniques.

Conventional Physiotherapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children diagnosed with Autism Spectrum Disorder (ASD) according to DSM-5 criteria
• Age 6-12 years
• Both genders
• Able to understand simple commands
• Mini-Mental State Examination (MMSE) score \>24

You may not qualify if:

• ASD associated with moderate-to-severe intellectual disability
• Neurological disorders
• Musculoskeletal deformities
• Severe visual impairment
• Severe hearing impairment

Sponsors & Collaborators

• Saveetha University: lead

Study Sites (1)

Saveetha Medical College and Hospital

Chennai, Tamil Nadu, 602105, India

Location

Related Publications (1)

• Thirumalai J, Sekar M, Ramalingam V, Bhuvaneshwar S, Gajendran K, Jeslin GN. Culturally adapted play-based behavioral intervention among children with autism spectrum disorder in semi-rural Tamil Nadu: A randomized controlled trial. Journal of Mental Health and Human Behaviour. 2025 Jul 1;30(2):90-7.

  BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

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

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 10, 2026
• Study Start: January 3, 2026
• Primary Completion: July 30, 2026
• Study Completion: July 30, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)