An interventional study of Social Robot-Assisted Board Game Intervention and Conventional Occupational Therapy in Autism Spectrum Disorder and Child Development Disorders, Pervasive, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
This pilot randomized controlled trial evaluates the effectiveness of combining social robot-assisted intervention with physical board games to improve socio-emotional skills in children with Autism Spectrum Disorder (ASD).
Children with ASD often face challenges in emotion recognition, emotional regulation, and social interaction. This study aims to investigate whether integrating an interactive social robot (Kebbi) into board game activities can enhance children's social engagement, emotional comprehension, and cooperative behaviors compared to conventional occupational therapy. Participants will be randomly assigned to either the robot-assisted board game group or the conventional occupational therapy group.
BACKGROUND AND OBJECTIVES:
Children with Autism Spectrum Disorder (ASD) often encounter challenges in emotion recognition, emotional regulation, and social interactions. This pilot randomized controlled trial investigates the preliminary efficacy and feasibility of integrating a commercially available interactive social robot (Kebbi Air) with customized physical acrylic board games to enhance socio-emotional functioning in children with ASD, compared to conventional occupational therapy.
INTERVENTION PROTOCOL:
Participants are randomly allocated into one of two 8-week intervention programs (1 session per week, 30 minutes per session):
Experimental Group (Robot-Assisted Board Game Intervention):
Participants interact with the Kebbi Air social robot running a dedicated application developed in collaboration with digital media specialists. The curriculum comprises 14 structured social scenarios addressing basic emotion recognition (happiness, anger, sadness, fear, liking, jealousy, longing), appropriate social responses, and non-verbal cues. The robot utilizes facial expressions, body movements, and dynamic voice cues to present 10 interactive questions per script. Children collect 5 modular acrylic puzzle pieces per scenario representing body postures, clothing, dialogue, background, and objects, assembling them onto an emotion puzzle board. A certified occupational therapist facilitates the session by scaffolding comprehension and guiding peer interactions. The robot serves purely as an interactive instructional tool and does not record or store personal identifiable data.
Participants receive standard, therapist-led occupational therapy targeting sensory-motor integration, emotional regulation, and social participation. Activities include sensory-based equipment (e.g., swings, therapy rollers, jumping mats) and structured social games (turn-taking, rule-following, and collaborative tasks) without robotic devices or specialized emotion puzzle board games.
OUTCOME MEASURES:
Standardized assessments are administered at baseline (pre-intervention) and immediately post-intervention (Week 8) via parent-reported questionnaires:
SAMPLE SIZE AND RANDOMIZATION:
A total of 20 children aged 4 to 10 years with a confirmed clinical diagnosis of ASD (and meeting CDIIT developmental criteria) will be recruited and randomized (1:1 ratio) to either the experimental or control group.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 20 is below the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive an 8-week social robot-assisted intervention combined with physical acrylic emotion puzzle board games (1 session per week, 30 minutes per session), facilitated by a certified occupational therapist.
Behavioral: Social Robot-Assisted Board Game Intervention
Conventional Occupational Therapy Group
Behavioral: Conventional Occupational Therapy
Comprises 14 structured social-emotional scenario scripts using the Kebbi Air interactive robot and a custom mobile application, paired with 5-piece modular acrylic emotion puzzle boards covering 7 basic and complex emotions.
Standard occupational therapy utilizing sensory integration equipment (e.g., swings, therapy rollers, jumping mats) and therapist-guided social interactive activities targeting emotional regulation and peer interaction.
Change from Baseline in Social Responsiveness Scale, Second Edition (SRS-2) Total T-Score at Week 8
The SRS-2 is a 65-item parent-reported questionnaire evaluating social communication, social motivation, and autistic behaviors in children. Items are rated on a 4-point Likert scale. Raw scores are converted to standardized T-scores (mean = 50, SD = 10). Higher T-scores indicate more severe social responsiveness impairment (T-scores ≥ 60 indicate clinically significant impairment). Outcome is assessed as the score change from baseline to post-intervention (Week 8).
Time frame: Baseline (pre-intervention) and post-intervention at Week 8
Change from Baseline in Achenbach System of Empirically Based Assessment (ASEBA) Total Problems T-Score at Week 8
The ASEBA (Child Behavior Checklist) is a standardized parent-completed instrument assessing emotional, behavioral, and social adaptive competencies. Raw scores yield standardized T-scores for internalizing, externalizing, and total behavioral problems (mean = 50, SD = 10). Higher T-scores indicate greater behavioral or emotional difficulties (T-scores ≥ 64 indicate clinical concern). Outcome is assessed as the score change from baseline to post-intervention (Week 8).
Time frame: Baseline (pre-intervention) and post-intervention at Week 8
Plan to share: No
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