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Completed

NCT Number: NCT07814040

Play Based Approach Among Autism

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saveetha Medical College and Hospital

Chennai, Tamil Nadu, 602105, India

About this study

The B.A.S.I.C.S. framework is a structured multimodal play-based therapeutic approach developed to address multiple functional domains relevant to children with autism spectrum disorder (ASD). The framework integrates Balance, Autonomy, Social Interaction, Cognition, and Self-reliance within a single therapeutic program.

The intervention uses play as a therapeutic medium to facilitate active participation and engagement while integrating motor, sensory, cognitive, perceptual-motor, communication, and peer-interaction components. Activities are individualized and progressively graded according to the child's tolerance and performance.

The multimodal program incorporates cognitive-motor integration through structured obstacle-course activities, goal-oriented perceptual-motor activities, peer-based balance activities, synchronized rhythmic movement activities, Picture Exchange Communication System (PECS)-based communication activities, and sensory-motor fine-motor activities incorporating cognitive tasks.

The cognitive-motor integration component combines gross motor activities such as stepping, crawling, jumping, balance-beam activities, and rocker-board activities with simple cognitive tasks including colour identification and object sorting. Goal-oriented perceptual-motor activities incorporate motor sequencing, stepping, jumping, and turning. Peer-based activities involve cooperative balance tasks to encourage postural control and social engagement. Synchronized movement activities use rhythmic movements and music to facilitate joint attention, turn-taking, recall, and social reciprocity.

The communication component incorporates visual picture cards to facilitate functional communication and choice-making. Sensory-motor fine-motor activities involve manipulation of play clay and moulding tools together with cognitive tasks such as colour, shape, and counting activities.

The overall framework is intended to provide an integrated therapeutic environment in which motor skills are practiced alongside cognitive engagement, sensory experiences, communication, social interaction, and functional participation. The study provides preliminary evidence regarding the effectiveness of this multimodal play-based framework in improving functional independence and balance among children with ASD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Paediatric Balance Scale (PBS)

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

    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.

  2. Functional Independence Measure for Children (WeeFIM)

    Time frame: baseline, 6 weeks, 12 weeks, 24th week

    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.

Secondary outcomes

  1. Social Skills Improvement System (SSIS) Rating Scales

    Time frame: baseline, 6 weeks, 12 weeks, 24th week

    A standardized assessment of social skills and social functioning in children, including cooperation, communication, assertion, responsibility, empathy, and self-control.

Sponsors and collaborators

Lead sponsor

Saveetha University

Other

Registry information

Official study title

Effectiveness of the B.A.S.I.C.S. Framework as a Multimodal Play-Based Intervention for Children With Autism Spectrum Disorder: A Retrospective Cohort Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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