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Not yet recruiting NCT06757673

Effectiveness of Robot-Assisted Intervention and Sensory Integration Therapy in Enhancing Social-Emotional Skills in Children With Autism

No phase Interventional Autism Spectrum Disorder Emotional Regulation Sensory Integration Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robot-Assisted Therapy using Kebbi Air, Sensory Integration Therapy.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder, Emotional Regulation, Sensory Integration Dysfunction. Basic parameters: 4 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effectiveness of Robot-assisted Interaction Compared to Sensory Integration for Social Emotion Control in Autism Spectrum Disorder

Overview

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. The 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.

Detailed description

This study aims to evaluate the effectiveness of robot-assisted intervention compared to traditional sensory integration therapy in improving social-emotional regulation skills in children aged 4-6 years diagnosed with autism spectrum disorder (ASD) or suspected ASD. The research is designed as a randomized controlled trial with 12 participants divided into two groups: the experimental group and the control group.

Participants in the experimental group will interact with a smart robot (Kebbi Air) equipped with interactive scripts tailored to simulate real-life social scenarios. These interactions aim to teach emotional regulation and social skills through structured, engaging activities. The control group will receive sensory integration therapy provided by occupational therapists, focusing on enhancing sensory processing and emotional stability through activities targeting visual, auditory, and tactile stimuli.

The intervention will be conducted over a period of 12 weeks, with participants attending weekly 30-minute sessions. Assessments will be conducted before and after the intervention to measure its impact. Tools such as the Achenbach System of Empirically Based Assessment (ASEBA) and the Sensory Processing Measure (SPM) will be used to evaluate changes in emotional regulation, sensory processing, and social skills.

This study hypothesizes that the robot-assisted intervention will be as effective as or even superior to traditional sensory integration therapy, offering an engaging alternative for children with ASD. By combining cutting-edge technology with therapeutic strategies, the research seeks to provide insights into innovative approaches for supporting children's development, with the potential to inform future practices and interventions.

Interventions

  • 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 interac
  • Behavioral Sensory Integration Therapy
    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.

Primary outcome measures

  • Social-Emotional Regulation Skills [Time frame: Baseline (pre-intervention) and after 12 weeks (post-intervention).]
  • Sensory Processing Abilities [Time frame: Baseline (pre-intervention) and after 12 weeks (post-intervention).]

Eligibility criteria

Inclusion criteria

  • Children aged 4-6 years, regardless of gender.
  • Diagnosed with autism spectrum disorder (ASD) or suspected ASD.
  • Cognitive ability: Developmental Quotient (DQ) ≥ 70, as assessed by the Comprehensive 4. Developmental Inventory for Infants and Toddlers (CDIIT).Social-emotional ability: DQ < 85, as assessed by CDIIT, indicating challenges in emotional regulation and social skills.

5\. No significant physical or psychological conditions that could interfere with participation in the intervention.

Exclusion criteria

  • Children younger than 4 years or older than 6 years.
  • Cognitive ability: DQ < 70, as assessed by CDIIT, indicating limited learning potential.
  • Social-emotional ability: DQ ≥ 85, as assessed by CDIIT, indicating normal emotional and social functioning.
  • Any physical or psychological condition deemed by the investigators to interfere with the intervention or assessments.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06757673 · 202410030RINE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗