About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 4 to 10 years, of any biological sex.
Confirmed clinical diagnosis of Autism Spectrum Disorder (ASD).
Cognitive ability: Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT) results indicating borderline to normal cognitive function, with a Developmental Quotient (DQ) >= 70.
Socio-emotional ability: CDIIT socio-emotional subscale indicating borderline development, with a Developmental Quotient (DQ) between 70 and 84.
Disqualifiers
Inability to comprehend or engage in interactive activities involving the Kebbi Air robot or physical board games.
Presence of other primary diagnoses affecting emotional or social functioning, such as severe neurodevelopmental disorders, psychiatric disorders, or ASD with severe emotional disturbances that prevent participation in intervention activities (CDIIT DQ < 70).
Inability to commit to regular weekly intervention sessions, or parental unwillingness to participate in required observational assessments and questionnaire completion.
Strong behavioral resistance or severe aversion to digital interactive tools or board game activities.
Trial design
Parallel
Treatments tested in this trial
Social Robot-Assisted Board Game Intervention
BehavioralComprises 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.
Conventional Occupational Therapy
BehavioralStandard 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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).
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