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

NCT06757673 | Not Yet Recruiting

• 1 other identifier: 202410030RINE
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Emotional Regulation; Sensory Integration Dysfunction

Keywords

Autism Spectrum Disorder; Sensory Integration; Robot-Assisted Therapy; Social-Emotional Skills; Early Intervention; Occupational Therapy

Outcome Measures

Primary Outcomes (2)

• Social-Emotional Regulation Skills

  Changes in emotional regulation, including anxiety, withdrawal, and aggression, were assessed using the Achenbach System of Empirically Based Assessment (ASEBA), specifically the Child Behavior Checklist for Ages 1½-5 (CBCL/1½-5). This caregiver-reported tool evaluates behavioral and emotional functioning in children aged 1.5 to 5 years. It assesses seven syndrome scales, including Emotional Reactivity, Anxiety/Depression, Somatic Complaints, Withdrawal, Attention Problems, Aggressive Behavior, and Sleep Problems. DSM-oriented scales identify issues such as affective, anxiety, and attention-deficit/hyperactivity problems. Items are rated on a 3-point Likert scale (0 = Not True, 1 = Somewhat True, 2 = Very True), with higher scores indicating greater severity. This tool tracks changes in emotional regulation over time.

  Baseline (pre-intervention) and after 12 weeks (post-intervention).

• Sensory Processing Abilities

  Sensory processing challenges and their impact on social participation were evaluated using the Sensory Processing Measure (SPM), a standardized tool for children aged 5 to 12 years. The SPM identifies sensory difficulties across domains: Social Participation, Vision, Hearing, Touch, Body Awareness (Proprioception), Balance and Motion (Vestibular), and Planning and Ideas (Praxis). Items are rated on a 4-point Likert scale (1 = Never, 4 = Always). Scores are categorized as Typical, Some Problems, or Definite Dysfunction, with higher scores indicating greater challenges. The SPM provides insights into how sensory processing affects a child's behavior and participation across various environments.

  Baseline (pre-intervention) and after 12 weeks (post-intervention).

Study Arms (2)

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.

Device: Robot-Assisted Therapy using Kebbi Air

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.

Behavioral: Sensory Integration Therapy

Interventions

Robot-Assisted Therapy using Kebbi Air DEVICE

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.

Robot-Assisted Intervention

Sensory Integration Therapy 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.

Sensory Integration Therapy

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Yunlin University of Science and Technology: collaborator

MeSH Terms

Conditions

Autism Spectrum Disorder; Emotional Regulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Central Study Contacts

LIAO SHUYI, O.T.R

CONTACT

+886963180066; Y01843@ms1.ylh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 3, 2025
• Study Start: January 7, 2025
• Primary Completion: January 31, 2025
• Study Completion: August 31, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01