Autism Spectrum DisorderNCT06859541
Culturally Adapted Play-Based Behavioural Intervention for Autism
A study testing Culturally Adapted Play-Based Behavioural Intervention and Applied Behaviour Analysis in people with Autism Spectrum Disorder, run by Saveetha University at 1 site in India.
Trial summary
This study compared Culturally Adapted Play-Based Behavioural Intervention (PPBI) and Applied Behaviour Analysis (ABA) for children with Autism Spectrum Disorder (ASD) in semi-rural Tamil Nadu through a double-blinded randomized controlled trial with 56 participants. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Culturally Adapted Play-Based Behavioural Intervention and Applied Behaviour Analysis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIndia
- Study dates
- 5 Aug 2024to 7 Dec 2024
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 8 to 12 years diagnosed with Autism Spectrum Disorder (ASD) (mild to moderate severity).
- Diagnosis confirmed using the Indian Scale for Assessment of Autism (ISAA). Classified as Level I to III in the Communication Function Classification System.
- Attended regular sessions throughout the 12-week intervention. Parents or guardians provided informed consent and participated in training sessions.
- Completion of behavioral assessments using the Strengths and Difficulties Questionnaire (SDQ).
Who cannot join
- Children with severe ASD or comorbid neurological/psychiatric disorders. Those undergoing intensive behavioral therapy or other structured interventions.
- Children with uncorrected sensory impairments (e.g., hearing or visual deficits) that could interfere with intervention activities.
- Families unable to commit to the full 12-week study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Culturally Adapted Play-Based Behavioural Intervention Among Children With Autism Spectrum Disorder in Semi-Rural Tamil Nadu: A Randomized Controlled Trial
This study compared Culturally Adapted Play-Based Behavioural Intervention (PPBI) and Applied Behaviour Analysis (ABA) for children with Autism Spectrum Disorder (ASD) in semi-rural Tamil Nadu through a double-blinded randomized controlled trial with 56 participants.
The PPBI approach integrated traditional Tamil games such as Paandi (hopscotch), Kuzhi Thanda (hole-and-peg game), and Paramapadham (snakes and ladders) to encourage social interaction, cooperative play, motor skill development, and emotional self-regulation. Activities were structured to progress through various developmental goals, including turn-taking, gesture-based communication, sensory-motor coordination, language expression, peer collaboration, and real-life scenario practice. Additionally, storytelling, music-based play, and movement exercises were included to enhance communication and social awareness.
On the other hand, the ABA-based program utilized structured techniques focused on positive reinforcement, imitation training, guided communication, and step-by-step skill-building. The primary goal was to reduce problem behaviors while reinforcing desirable social and communication skills. Parents and teachers were provided with structured training on how to apply ABA strategies consistently at home and school.
Read the detailed description
This research investigated the effectiveness of a Culturally Adapted Play-Based Behavioural Intervention (PPBI) in comparison to Applied Behaviour Analysis (ABA) for improving behavioral and social skills in children diagnosed with Autism Spectrum Disorder (ASD) in a semi-rural region of Tamil Nadu. Recognizing the challenges children with ASD face in communication, emotional regulation, and social interaction, the study aimed to explore whether an intervention rooted in traditional play-based methods could provide better engagement and outcomes.
A double-blinded randomized controlled trial was conducted, involving 56 children between the ages of 8 and 12, who were evenly divided into two groups: PPBI and ABA. Both programs ran five days a week over a 12-week period, with behavioral assessments conducted using the Strengths and Difficulties Questionnaire (SDQ). Parents and teachers provided input at multiple time points to capture changes in home and school environments. The research took place at Aadhuraa Special School in Kanchipuram, Tamil Nadu, ensuring the intervention was delivered in a setting that aligned with the children's cultural background.
Intervention Details:
The PPBI approach integrated traditional Tamil games such as Paandi (hopscotch), Kuzhi Thanda (hole-and-peg game), and Paramapadham (snakes and ladders) to encourage social interaction, cooperative play, motor skill development, and emotional self-regulation. Activities were structured to progress through various developmental goals, including turn-taking, gesture-based communication, sensory-motor coordination, language expression, peer collaboration, and real-life scenario practice. Additionally, storytelling, music-based play, and movement exercises were included to enhance communication and social awareness.
On the other hand, the ABA-based program utilized structured techniques focused on positive reinforcement, imitation training, guided communication, and step-by-step skill-building. The primary goal was to reduce problem behaviors while reinforcing desirable social and communication skills. Parents and teachers were provided with structured training on how to apply ABA strategies consistently at home and school.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Culturally Adapted Play-Based Behavioural Intervention, Applied Behaviour Analysis
- Keywords
- Adaptive Behaviour, Autism Spectrum Disorder, Behaviour Therapy, Play Therapy, Semi-Rural Tamil Nadu
- 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.
Culturally Adapted Play-Based Behavioural InterventionBehavioural
The Culturally Adapted Play-Based Behavioural Intervention (PPBI) integrates traditional Tamil games and folk storytelling to enhance social, emotional, and communication skills in children with Autism Spectrum Disorder (ASD). This 12-week structured program focuses on engagement, motor development, language, emotional regulation, social interaction, and real-world skill application, making it a culturally relevant and accessible intervention for improving adaptive behaviours.
Applied Behaviour AnalysisBehavioural
The ABA-based program utilized structured techniques focused on positive reinforcement, imitation training, guided communication, and step-by-step skill-building. The primary goal was to reduce problem behaviors while reinforcing desirable social and communication skills. Parents and teachers were provided with structured training on how to apply ABA strategies consistently at home and school.
| Study group | Role | What they receive |
|---|---|---|
| Culturally Adapted Play-Based Behavioural Intervention Group | Experimental | The Culturally Adapted Play-Based Behavioural Intervention (PPBI) incorporated traditional Tamil games and folk storytelling to enhance social awareness, emotional regulation, and language development. Over 12 weeks, the program progressed through key developmental areas:
Weeks 1-2: Focused on engagement and communication through interactive activities.
Weeks 3-4: Developed sensory and motor skills using creative play. Weeks 5-6: Strengthened language and expression with role-playing and storytelling.
Weeks 7-8: Addressed emotional regulation through structured games and music therapy.
Weeks 9-10: Encouraged social interaction with group play and problem-solving tasks.
Weeks 11-12: Emphasized real-world application through community-based activities. Receives: Behavioral: Culturally Adapted Play-Based Behavioural Intervention |
| Applied Behaviour Analysis | Active comparator | The Applied Behaviour Analysis (ABA) program was structured into progressive stages, each targeting specific behavioral improvements.
Weeks 1 \& 2: Introduced structured learning techniques, focusing on basic commands, eye contact training, and reinforcement strategies, such as reward-based motivation systems.
Weeks 3 \& 4: Emphasized early communication development, incorporating imitation exercises, visual schedules, and simple verbal response training.
Weeks 5 \& 6: Implemented behavior modification techniques, including token-based reinforcement, redirection methods, and gradual shaping of desired behaviors.
Weeks 9 \& 10: Focused on independent task execution, covering self-care routines such as dressing, eating, and personal hygiene, with structured multi-step guidance.
Weeks 11 \& 12: Aimed at generalizing learned behaviors, ensuring that children could apply their skills effectively in home, school, and social environments. Receives: Behavioral: Applied Behaviour Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strengths and Difficulties Questionnaire (SDQ)
The 25 item Strengths and Difficulties Questionnaire (SDQ) measures behavioral and emotional function. These 25 items are divided into 5 subscales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. The Strengths and Difficulties Questionnaire is scored on a 3-point Likert-type scale, with total scores (excluding the prosocial scale) ranging from 0 to 40. Higher scores reflect greater behavioral and emotional difficulties and lower scores reflects lesser behavioural and emotional difficulties.
Measured: Baseline, 4th week, 8th week, 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start5 Aug 2024
- Primary completion16 Nov 2024
- Study completion7 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saveetha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhanraj Sekar, Saveetha University
- Investigators
- Madhanraj S, Principal investigator, TutorJeevarathinam Thirumalai, Principal investigator, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859541
- Sponsor's protocol ID
- 322/07/2024/ISRB/UGSR/SCPT
- Status last verified
- Jul 2025
- First submitted
- 23 Feb 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kumar A, Bhattacharya S. Unveiling autism spectrum disorder in South East Asia through a public health Lens. Front Child Adolesc Psychiatry. 2024 Dec 4;3:1489269. doi: 10.3389/frcha.2024.1489269. eCollection 2024.
PubMed 39816604Chauhan A, Singh M, Jaiswal N, Agarwal A, Sahu JK, Singh M. Prevalence of Cerebral Palsy in Indian Children: A Systematic Review and Meta-Analysis. Indian J Pediatr. 2019 Dec;86(12):1124-1130. doi: 10.1007/s12098-019-03024-0. Epub 2019 Jul 13.
PubMed 31300955Dey I, Chakrabarty S, Nandi R, Shekhar R, Singhi S, Nayar S, Ram JR, Mukerji S, Chakrabarti B. Autism community priorities in diverse low-resource settings: A country-wide scoping exercise in India. Autism. 2024 Jan;28(1):187-198. doi: 10.1177/13623613231154067. Epub 2023 Mar 31.
PubMed 36999343Leaf JB, Leaf R, McEachin J, Taubman M, Ala'i-Rosales S, Ross RK, Smith T, Weiss MJ. Applied Behavior Analysis is a Science and, Therefore, Progressive. J Autism Dev Disord. 2016 Feb;46(2):720-31. doi: 10.1007/s10803-015-2591-6.
PubMed 26373767Deniz E, Francis G, Torgerson C, Toseeb U. Parent-mediated play-based interventions to improve social communication and language skills of preschool autistic children: A systematic review and meta-analysis protocol. PLoS One. 2022 Aug 15;17(8):e0270153. doi: 10.1371/journal.pone.0270153. eCollection 2022.
PubMed 35969530
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Play-Based Behavioural Intervention Among Children With Autism Spectrum Disorder in Semi-Rural Tamil Nadu: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06859541
- Acronym / sponsor ID
- 322/07/2024/ISRB/UGSR/SCPT
- Conditions
- Autism Spectrum Disorder
- Keywords
- Adaptive Behaviour, Autism Spectrum Disorder, Behaviour Therapy, Play Therapy, Semi-Rural Tamil Nadu
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Saveetha UniversityUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 16 Nov 2024 (actual)
- Study completion
- 7 Dec 2024 (actual)
- First posted
- 5 Mar 2025 (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 study compared Culturally Adapted Play-Based Behavioural Intervention (PPBI) and Applied Behaviour Analysis (ABA) for children with Autism Spectrum Disorder (ASD) in semi-rural Tamil Nadu through a double-blinded randomized controlled trial with 56 participants.
The PPBI approach integrated traditional Tamil games such as Paandi (hopscotch), Kuzhi Thanda (hole-and-peg game), and Paramapadham (snakes and ladders) to encourage social interaction, cooperative play, motor skill development, and emotional self-regulation. Activities were structured to progress through various developmental goals, including turn-taking, gesture-based communication, sensory-motor coordination, language expression, peer collaboration, and real-life scenario practice. Additionally, storytelling, music-based play, and movement exercises were included to enhance communication and social awareness.
On the other hand, the ABA-based program utilized structured techniques focused on positive reinforcement, imitation training, guided communication, and step-by-step skill-building. The primary goal was to reduce problem behaviors while reinforcing desirable social and communication skills. Parents and teachers were provided with structured training on how to apply ABA strategies consistently at home and school.
Detailed description
This research investigated the effectiveness of a Culturally Adapted Play-Based Behavioural Intervention (PPBI) in comparison to Applied Behaviour Analysis (ABA) for improving behavioral and social skills in children diagnosed with Autism Spectrum Disorder (ASD) in a semi-rural region of Tamil Nadu. Recognizing the challenges children with ASD face in communication, emotional regulation, and social interaction, the study aimed to explore whether an intervention rooted in traditional play-based methods could provide better engagement and outcomes.
A double-blinded randomized controlled trial was conducted, involving 56 children between the ages of 8 and 12, who were evenly divided into two groups: PPBI and ABA. Both programs ran five days a week over a 12-week period, with behavioral assessments conducted using the Strengths and Difficulties Questionnaire (SDQ). Parents and teachers provided input at multiple time points to capture changes in home and school environments. The research took place at Aadhuraa Special School in Kanchipuram, Tamil Nadu, ensuring the intervention was delivered in a setting that aligned with the children's cultural background.
Intervention Details:
The PPBI approach integrated traditional Tamil games such as Paandi (hopscotch), Kuzhi Thanda (hole-and-peg game), and Paramapadham (snakes and ladders) to encourage social interaction, cooperative play, motor skill development, and emotional self-regulation. Activities were structured to progress through various developmental goals, including turn-taking, gesture-based communication, sensory-motor coordination, language expression, peer collaboration, and real-life scenario practice. Additionally, storytelling, music-based play, and movement exercises were included to enhance communication and social awareness.
On the other hand, the ABA-based program utilized structured techniques focused on positive reinforcement, imitation training, guided communication, and step-by-step skill-building. The primary goal was to reduce problem behaviors while reinforcing desirable social and communication skills. Parents and teachers were provided with structured training on how to apply ABA strategies consistently at home and school.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally Adapted Play-Based Behavioural Intervention Group | Experimental | Behavioral: Culturally Adapted Play-Based Behavioural InterventionThe Culturally Adapted Play-Based Behavioural Intervention (PPBI) incorporated traditional Tamil games and folk storytelling to enhance social awareness, emotional regulation, and language development. Over 12 weeks, the program progressed through key developmental areas: Weeks 1-2: Focused on engagement and communication through interactive activities. Weeks 3-4: Developed sensory and motor skills using creative play. Weeks 5-6: Strengthened language and expression with role-playing and storytelling. Weeks 7-8: Addressed emotional regulation through structured games and music therapy. Weeks 9-10: Encouraged social interaction with group play and problem-solving tasks. Weeks 11-12: Emphasized real-world application through community-based activities. |
| Applied Behaviour Analysis | Active comparator | Behavioral: Applied Behaviour AnalysisThe Applied Behaviour Analysis (ABA) program was structured into progressive stages, each targeting specific behavioral improvements. Weeks 1 \& 2: Introduced structured learning techniques, focusing on basic commands, eye contact training, and reinforcement strategies, such as reward-based motivation systems. Weeks 3 \& 4: Emphasized early communication development, incorporating imitation exercises, visual schedules, and simple verbal response training. Weeks 5 \& 6: Implemented behavior modification techniques, including token-based reinforcement, redirection methods, and gradual shaping of desired behaviors. Weeks 9 \& 10: Focused on independent task execution, covering self-care routines such as dressing, eating, and personal hygiene, with structured multi-step guidance. Weeks 11 \& 12: Aimed at generalizing learned behaviors, ensuring that children could apply their skills effectively in home, school, and social environments. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 8 to 12 years diagnosed with Autism Spectrum Disorder (ASD) (mild to moderate severity).
- Diagnosis confirmed using the Indian Scale for Assessment of Autism (ISAA). Classified as Level I to III in the Communication Function Classification System.
- Attended regular sessions throughout the 12-week intervention. Parents or guardians provided informed consent and participated in training sessions.
- Completion of behavioral assessments using the Strengths and Difficulties Questionnaire (SDQ).
Key exclusion criteria (3 listed)
- Children with severe ASD or comorbid neurological/psychiatric disorders. Those undergoing intensive behavioral therapy or other structured interventions.
- Children with uncorrected sensory impairments (e.g., hearing or visual deficits) that could interfere with intervention activities.
- Families unable to commit to the full 12-week study period.
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 |
|---|---|---|
| Culturally Adapted Play-Based Behavioural InterventionThe Culturally Adapted Play-Based Behavioural Intervention (PPBI) integrates traditional Tamil games and folk storytelling to enhance social, emotional, and communication skills in children with Autism Spectrum Disorder (ASD). This 12-week structured program focuses on engagement, motor development, language, emotional regulation, social interaction, and real-world skill application, making it a culturally relevant and accessible intervention for improving adaptive behaviours. | Behavioural | Culturally Adapted Play-Based Behavioural Intervention Group |
| Applied Behaviour AnalysisThe ABA-based program utilized structured techniques focused on positive reinforcement, imitation training, guided communication, and step-by-step skill-building. The primary goal was to reduce problem behaviors while reinforcing desirable social and communication skills. Parents and teachers were provided with structured training on how to apply ABA strategies consistently at home and school. | Behavioural | Applied Behaviour Analysis |
Primary outcome
Strengths and Difficulties Questionnaire (SDQ)
Time frame: Baseline, 4th week, 8th week, 12th week
The 25 item Strengths and Difficulties Questionnaire (SDQ) measures behavioral and emotional function. These 25 items are divided into 5 subscales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. The Strengths and Difficulties Questionnaire is scored on a 3-point Likert-type scale, with total scores (excluding the prosocial scale) ranging from 0 to 40. Higher scores reflect greater behavioral and emotional difficulties and lower scores reflects lesser behavioural and emotional difficulties.
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 30 Jul 2025.
- Results publication: PubMed 39816604Kumar A, Bhattacharya S. Unveiling autism spectrum disorder in South East Asia through a public health Lens. Front Child Adolesc Psychiatry. 2024 Dec 4;3:1489269. doi: 10.3389/frcha.2024.1489269. eCollection 2024.
- Results publication: PubMed 31300955Chauhan A, Singh M, Jaiswal N, Agarwal A, Sahu JK, Singh M. Prevalence of Cerebral Palsy in Indian Children: A Systematic Review and Meta-Analysis. Indian J Pediatr. 2019 Dec;86(12):1124-1130. doi: 10.1007/s12098-019-03024-0. Epub 2019 Jul 13.
- Results publication: PubMed 36999343Dey I, Chakrabarty S, Nandi R, Shekhar R, Singhi S, Nayar S, Ram JR, Mukerji S, Chakrabarti B. Autism community priorities in diverse low-resource settings: A country-wide scoping exercise in India. Autism. 2024 Jan;28(1):187-198. doi: 10.1177/13623613231154067. Epub 2023 Mar 31.
- Results publication: PubMed 26373767Leaf JB, Leaf R, McEachin J, Taubman M, Ala'i-Rosales S, Ross RK, Smith T, Weiss MJ. Applied Behavior Analysis is a Science and, Therefore, Progressive. J Autism Dev Disord. 2016 Feb;46(2):720-31. doi: 10.1007/s10803-015-2591-6.
- Results publication: PubMed 35969530Deniz E, Francis G, Torgerson C, Toseeb U. Parent-mediated play-based interventions to improve social communication and language skills of preschool autistic children: A systematic review and meta-analysis protocol. PLoS One. 2022 Aug 15;17(8):e0270153. doi: 10.1371/journal.pone.0270153. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Recruiting
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
Autism Spectrum Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
RecruitingObservational study
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Autism Spectrum Disorder
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.
Madhanraj S principal investigator
Tutor
Jeevarathinam Thirumalai principal investigator
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Adapted Play-Based Behavioural Intervention and Applied Behaviour Analysis 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 4 inclusion and 3 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 30 Jul 2025. 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?
Strengths and Difficulties Questionnaire (SDQ) (time frame: Baseline, 4th week, 8th week, 12th week). 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 NCT06859541, which also lists 5 linked publications.
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 30 Jul 2025.