[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574314":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":39,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":26,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":26,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":79,"locationsCount":26},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Robot-Assisted Intervention","EXPERIMENTAL","Participants in this group will engage with the Kebbi Air smart robot, which delivers scripted social-emotional skill-building activities over a 12-week period.",[13],"Device: Robot-Assisted Therapy using Kebbi Air",{"label":15,"type":16,"description":17,"interventionNames":18},"Sensory Integration Therapy","ACTIVE_COMPARATOR","Participants in this group will receive traditional sensory integration therapy, guided by occupational therapists, focusing on improving sensory processing and social-emotional regulation.",[19],"Behavioral: Sensory Integration Therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Robot-Assisted Therapy using Kebbi Air","Participants in this group will engage with the Kebbi Air smart robot, which is programmed with interactive scripts designed to enhance social-emotional regulation skills. The intervention includes weekly 30-minute sessions over a 12-week period, where the robot simulates real-life social scenarios and provides verbal and visual responses to guide participants in developing emotional and social skills. Occupational therapists will supervise these sessions to ensure the appropriateness of interactions and provide additional support as needed.",[9],null,{"type":28,"name":15,"description":29,"armGroupLabels":30,"otherNames":26},"BEHAVIORAL","Participants in this group will receive traditional sensory integration therapy guided by occupational therapists. The therapy focuses on improving sensory processing and emotional regulation through structured activities targeting visual, auditory, and tactile stimuli. Each session is conducted weekly, lasting 30 minutes, for a total of 12 weeks. The therapy aims to help children adapt to sensory inputs and enhance their ability to engage in social interactions and manage emotions effectively.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"LIAO SHUYI, O.T.R","CONTACT","+886963180066","Y01843@ms1.ylh.gov.tw",{"type":38,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[40],{"name":41,"class":42},"National Yunlin University of Science and Technology","UNKNOWN","100574314","effectiveness-of-robot-assisted-intervention-and-sensory-integration-therapy-in-enhancing-social-emotional-skills-in-children-with-autism-100574314",false,"NCT06757673","Effectiveness of Robot-Assisted Intervention and Sensory Integration Therapy in Enhancing Social-Emotional Skills in Children With Autism","Effectiveness of Robot-assisted Interaction Compared to Sensory Integration for Social Emotion Control in Autism Spectrum Disorder","Inclusion Criteria:\n\n1. Children aged 4-6 years, regardless of gender.\n2. Diagnosed with autism spectrum disorder (ASD) or suspected ASD.\n3. Cognitive ability: Developmental Quotient (DQ) ≥ 70, as assessed by the Comprehensive 4. Developmental Inventory for Infants and Toddlers (CDIIT).Social-emotional ability: DQ \\\u003C 85, as assessed by CDIIT, indicating challenges in emotional regulation and social skills.\n\n5\\. No significant physical or psychological conditions that could interfere with participation in the intervention.\n\nExclusion Criteria:\n\n1. Children younger than 4 years or older than 6 years.\n2. Cognitive ability: DQ \\\u003C 70, as assessed by CDIIT, indicating limited learning potential.\n3. Social-emotional ability: DQ ≥ 85, as assessed by CDIIT, indicating normal emotional and social functioning.\n4. Any physical or psychological condition deemed by the investigators to interfere with the intervention or assessments.",true,"ALL","4 Years","6 Years",{"count":55,"type":56},12,"ESTIMATED","INTERVENTIONAL",[59],"NA","This study is designed to evaluate and compare the impact of robot-assisted intervention using a smart robot (Kebbi Air) and traditional sensory integration therapy on improving social-emotional skills in children diagnosed with autism spectrum disorder (ASD) or suspected ASD. The study will enroll children aged 4 to 6 years, who will be randomly assigned to one of two groups: the experimental group, which will participate in guided interactions with the smart robot, or the control group, which will receive sensory integration therapy tailored to enhance emotional and social functioning.\n\nThe research aims to explore whether interactions with the robot, which are designed to simulate real-world social scenarios, can provide comparable or enhanced benefits compared to traditional sensory integration methods. Pre- and post-intervention assessments will be conducted over a 12-week period, using tools like the Achenbach System of Empirically Based Assessment (ASEBA) and the Sensory Processing Measure (SPM) to measure changes in emotional regulation, sensory processing abilities, and social engagement. The study hypothesizes that the robot-assisted intervention will offer a novel, engaging, and effective approach to supporting the developmental needs of children with ASD.",[62,63,64],"Autism Spectrum Disorder","Emotional Regulation","Sensory Integration Dysfunction",[62,66,67,68,69,70],"Sensory Integration","Robot-Assisted Therapy","Social-Emotional Skills","Early Intervention","Occupational Therapy","NOT_YET_RECRUITING","2025-01-07",{"date":74,"type":75},"2025-01-09","ACTUAL",{"date":72,"type":56},{"date":78,"type":56},"2025-08-31",{"name":5,"class":6}]