An interventional study of B.A.S.I.C.S FRAMEWORK and Conventional Physiotherapy in Autism Spectrum Disorder, sponsored by Saveetha University. Completed at 1 site in India. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Saveetha University · Not applicable, Interventional, and Treatment
Among 11 studies in Autism Spectrum Disorder with a site in India — 3 open to participants now, 4 under way, 1 of them phase 3. Autism Spectrum Disorder · India.
Among the 11 studies in Autism Spectrum Disorder with a site in India, this one is one of 4 that started in 2026, is one of 5 with no phase, and was the 11th registered.
1,726 studies on the registry are indexed under Autism Spectrum Disorder; 501 are open to participants now.
Browse Autism Spectrum Disorder studies →3 of the 11 studies in Autism Spectrum Disorder with a site in India are open now. Recruiting first, the newest first:
Bristol-Myers Squibb · Sites in India, United States, France and 7 more countries
Ages 5–17
All India Institute of Medical Sciences · Sites in India
Ages 3–8
Saveetha University · Sites in India
Ages 3–12
A study can be open while its sites in India have not opened yet or have stopped. Only those recruiting at a site in India →
Of the 350 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 295 (84%) stop at 75 or younger; 298 take children under 18; 92 take healthy volunteers.
This study: 6 Years to 12 Years · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 120 is above the median of 51 across 1,369 interventional studies indexed under Autism Spectrum Disorder.
Median enrollment 54 across the 9 interventional studies, 569 across the 2 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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1 of 11 have an industry lead sponsor. The 9 most frequent:
Saveetha University is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Saveetha University has 3 studies filed under Autism Spectrum Disorder — fewer than ten, so there is no comparison to draw.
1 of the studies in Autism Spectrum Disorder with a site in India that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07646808Saveetha UniversityGut Microbiome Characteristics and Neurodevelopmental Functioning in Children With Autism Spectrum Disorder | 2026-12-31 |
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Among the 11 studies in Autism Spectrum Disorder with a site in India, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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 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.
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.
Time frame: 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.
Time frame: baseline, 6 weeks, 12 weeks, 24th week
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.
Time frame: baseline, 6 weeks, 12 weeks, 24th week
Plan to share: No
Ran from Jan 2026 to primary completion in Jul 2026, 6 months.
Of 801 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 6 months is below that.
Counting every sponsor, half of 824 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Saveetha University