NCT07775937

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Aug 2026Dec 2026

First Submitted

Initial submission to the registry

August 17, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

August 18, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 17, 2026

Last Update Submit

August 17, 2026

Conditions

Keywords

Social RobotsBoard GamesOccupational TherapySocio-Emotional SkillsEmotion Recognition

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline (pre-intervention) and post-intervention at Week 8

Secondary Outcomes (1)

  • Change from Baseline in Achenbach System of Empirically Based Assessment (ASEBA) Total Problems T-Score at Week 8

    Baseline (pre-intervention) and post-intervention at Week 8

Study Arms (2)

Robot-Assisted Board Game Group

EXPERIMENTAL

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

ACTIVE COMPARATOR

Conventional Occupational Therapy Group

Behavioral: Conventional Occupational Therapy

Interventions

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.

Robot-Assisted Board Game Group

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.

Conventional Occupational Therapy Group

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • Legal guardian provides written informed consent and child provides assent where appropriate.

You may not qualify if:

  • 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.
  • Inability to follow simple two-step verbal instructions after a preliminary 10-minute trial assessment conducted by the occupational therapist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Yunlin Branch

Huwei, Yunlin, Taiwan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum DisorderChild Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Central Study Contacts

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

August 17, 2026

First Posted

August 20, 2026

Study Start

August 18, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 20, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations