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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

NCT ID NCT07814040

NEW Sponsor: Saveetha University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

120 people

The number who actually took part.

Started

Jan 2026

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Autism Spectrum Disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder

Contacts and locations

Locations

  • Saveetha Medical College and Hospital

    Chennai, Tamil Nadu, 602105, India

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