Theory of Mind-based Social Competence Group Intervention
NCT Number: NCT06509152
Acronym: ToM-SCGI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism Spectrum Disorder
Interventions: BEHAVIORAL: Theory of mind-based social competence group intervention
Sponsor: National Cheng-Kung University Hospital
Sex: ALL
Age: CHILD
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-01
Completion Date: 2029-12-31

Summary:
This clinical study introduces a novel intervention, the Theory of Mind-Based Social Competence Group Intervention (ToM-SCGI), designed to improve theory of mind and social competence in children with autism spectrum disorder (ASD). Investigators hypothesize that the ToM-SCGI, which focuses on enhancing the ability to understand others' thoughts and feelings-known as "theory of mind"-will positively impact children's theory of mind abilities, application of these abilities, and overall social competence.

In a carefully structured randomized controlled trial (RCT), investigators aim to validate the effectiveness of the ToM-SCGI. Additionally, investigators will examine if a child's verbal IQ and social interaction style can influence the effectiveness of the ToM-SCGI. Through three comprehensive phases-developing and piloting the intervention, conducting the RCT, and examining the mediation and moderation effects-investigators expect that the ToM-SCGI will provide lasting benefits in the social development of children with ASD.

Primary Outcome Measures: Observational Social Competence Assessment, OSCA, This study will utilize the OSCA to assess children's social competencies. The OSCA is a semi-structured assessment tool designed to evaluate the social competencies of children with Autism Spectrum Disorder (ASD) aged 3 to 12, and it can also measure the effectiveness of interventions., Up to 1 week before the intervention, up to 1 week after completing the intervention, and 3 months after completing the intervention.|Theory of Mind Assessment, ToMA, ToMA will be used to evaluate children's theory of mind capabilities. ToMA was based on the multidimensional framework of theory of mind. ToMA consists of 26 items that comprehensively cover cognitive and affective dimensions of theory of mind development for children aged 3 to 12. It spans three developmental stages: early, basic, and advanced, assessing elements such as emotional recognition, differing desires, basic false beliefs about unexpected contents and locations, hidden emotions, second-order false beliefs, lying, white lies, sarcasm, faux pas, and third-order false beliefs. The assessment is designed as a series of linked cartoon storybooks presented on a computer, integrating developmental elements into natural contexts to make the assessment interactive, engaging, and captivating for children, thereby maintaining their focus throughout the testing process., Up to 1 week before the intervention, up to 1 week after completing the intervention, and 3 months after completing the intervention.|Theory of Mind Task Battery, ToMTB, Children's theory of mind capabilities will be assessed using the ToMTB. Suitable for ages 3 to 12, ToMTB consists of 9 subtests with a total of 15 items. The assessment is conducted in a one-on-one setting where scenarios are presented in a storybook format, allowing children to respond either through gestures or verbally. The subtests are arranged in increasing order of difficulty and include recognition questions, confirmation questions, and control questions. Control questions aim to exclude the effects of attention, memory, and verbal comprehension and are not included in the overall score. The ToMTB takes about 20 minutes to complete and is validated for high internal consistency and test-retest reliability., Up to 1 week before the intervention, up to 1 week after completing the intervention, and 3 months after completing the intervention.|Theory of Mind Inventory-Second Edition, ToMI-2, ToMI-2 will be utilized to assess children's theory of mind performance. ToMI-2 primarily consists of a caregiver-completed questionnaire that provides insights into children's naturalistic behaviors. The inventory features 60 questions. Scoring is done on a continuous scale, with caregivers marking a vertical line along a 20 cm line that ranges from 'completely disagree' to 'completely agree', to indicate the degree of a child's theory of mind performance., Up to 1 week before the intervention, up to 1 week after completing the intervention, and 3 months after completing the intervention.|Vineland Adaptive Behavior Scales, Third Edition, VABS-3, VABS-3 will be employed to assess children's everyday social adaptation behaviors. The VABS-3 is a semi-structured interview questionnaire filled out by primary caregivers, applicable to children aged 3 to 12 years. The overall composite standard scores of the scale provide a comprehensive assessment of a child's personal and social competencies. The VABS-3 Socialization domain provides standard scores, percentile ranks, adaptive levels, and age-equivalent scores for a child's adaptive behaviors in social areas and subdomains, as well as a strengths and weaknesses analysis of adaptive behavior performances., Up to 1 week before the intervention, up to 1 week after completing the intervention, and 3 months after completing the intervention.