Autism Spectrum DisorderNCT07814040
Play Based Approach Among Autism
A study testing B.A.S.I.C.S FRAMEWORK and Conventional Physiotherapy in people with Autism Spectrum Disorder, run by Saveetha University at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- B.A.S.I.C.S FRAMEWORK and Conventional Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 3 Jan 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- ASD associated with moderate-to-severe intellectual disability
- Neurological disorders
- Musculoskeletal deformities
- Severe visual impairment
- Severe hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- B.A.S.I.C.S FRAMEWORK, Conventional Physiotherapy
- Keywords
- Autism Spectrum Disorder, Children with Autism, Play-Based Intervention, B.A.S.I.C.S. Framework, Paediatric Balance, Rehabilitation
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B.A.S.I.C.S FRAMEWORKBehavioural
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 PhysiotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, 6 weeks, 12 weeks, 24th week
Secondary outcomes (1)
Social Skills Improvement System (SSIS) Rating Scales
A standardized assessment of social skills and social functioning in children, including cooperation, communication, assertion, responsibility, empathy, and self-control.
Measured: baseline, 6 weeks, 12 weeks, 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start3 Jan 2026
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saveetha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeevarathinam Thirumalai, Saveetha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814040
- Sponsor's protocol ID
- 001/12/2025/ISRB/FR/SCPT
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07814040
- Acronym / sponsor ID
- 001/12/2025/ISRB/FR/SCPT
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Children with Autism, Play-Based Intervention, B.A.S.I.C.S. Framework, Paediatric Balance, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Saveetha UniversityUniversity, hospital or other
- Study start
- 3 Jan 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B.A.S.I.C.S FRAMEWORK | Experimental | Behavioral: B.A.S.I.C.S FRAMEWORKParticipants 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. |
| Conventional Physiotherapy | Active comparator | Behavioral: Conventional PhysiotherapyConventional 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- ASD associated with moderate-to-severe intellectual disability
- Neurological disorders
- Musculoskeletal deformities
- Severe visual impairment
- Severe hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B.A.S.I.C.S FRAMEWORKThe 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. | Behavioural | B.A.S.I.C.S FRAMEWORK |
| Conventional PhysiotherapyConventional 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. | Behavioural | Conventional Physiotherapy |
Primary outcome
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.
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.
1 secondary outcome
Social Skills Improvement System (SSIS) Rating Scales
Time frame: baseline, 6 weeks, 12 weeks, 24th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- BackgroundThirumalai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B.A.S.I.C.S FRAMEWORK and Conventional Physiotherapy in people with Autism Spectrum Disorder, run by Saveetha University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paediatric Balance Scale (PBS) (time frame: baseline, 6 weeks, 12 weeks, post follow-up (24th week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07814040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.