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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.
This study is a single-blind RCT aiming to enroll 120 pairs of participants, comprising 120 children with ASD and caregivers. The participants will be equally divided into two experimental groups and a control group, with 40 pairs each. The experimental groups will participate in the Theory of Mind-Based Social Competence Group Intervention (ToM-SCGI) focusing on theory of mind and social competence, while the control group will engage in regular occupational therapy without a specific focus on theory of mind or social competence. One experimental group will receive the intervention once a week for 12 weeks, while the other will receive it twice a week for 6 weeks.
The study consists of four assessments: T0 screening, T1 pre-intervention, T2 post-intervention, and T3 follow-up three months later. The T0 assessment is conducted to screen and confirm eligibility. Randomization and allocation concealment are managed independently by a researcher not involved in the study, using Random Allocation Software 2.0. Randomly generated numbers and group assignments are placed in consecutively numbered, opaque, sealed envelopes. Once a child and caregiver provide consent and eligibility is confirmed, the envelopes are opened sequentially to assign participants to one of the experimental and control groups.
The T1 assessment establishes baseline data for efficacy evaluations before the interventions. All groups then undergo the respective interventions. The T2 assessment, conducted within one week after completing the interventions, serves as the post-intervention measure. The final T3 follow-up assessment takes place three months after the intervention ends, to evaluate long-term effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ToM-SCGI-12 | Experimental | The ToM-SCGI-12 is designed as a 12-week group intervention, with 60-minute sessions held weekly and led by trained therapists. Each group consists of 3 to 6 children with ASD, assigned based on assessments of children's age, verbal IQ, theory of mind abilities, and social skills. Caregivers can observe the children's performance in the group and document the group's themes and contents using observation and feedback forms. Caregiver meetings are conducted in the 6th and 12th weeks of the intervention to discuss the children's progress, enhance caregivers' interaction skills, and motivate continued practice at home. After the intervention concludes, caregivers' feedback is also collected through questionnaires to emphasize the role of family in the intervention. |
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| ToM-SCGI-6 | Active Comparator | The ToM-SCGI-6 is designed as a 6-week group intervention, with two 60-minute sessions held weekly and led by trained therapists. Each group consists of 3 to 6 children with ASD, assigned based on assessments of children's age, verbal IQ, theory of mind abilities, and social skills. Caregivers can observe the children's performance in the group and document the group's themes and contents using observation and feedback forms. Caregiver meetings are conducted in the 6th and 12th weeks of the intervention to discuss the children's progress, enhance caregivers' interaction skills, and motivate continued practice at home. After the intervention concludes, caregivers' feedback is also collected through questionnaires to emphasize the role of family in the intervention. |
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| Control group | No Intervention | The control group participated in conventional occupational therapy that did not focus on theory of mind or social competence. The duration and length of the intervention were the same as those of the experimental group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theory of mind-based social competence group intervention | Behavioral | The ToM-SCGI is designed as a group intervention, with 60-minute sessions held weekly, either once or twice, and led by trained therapists. Two caregiver meetings are conducted in the middle and end of the interventions. The intervention process for each session is as follows:
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuan-Lin Chen, Ph.D | Contact | +886-6-2353535 | 5906 | klchen@mail.ncku.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Kuan-Lin Chen, Ph.D | Nattional Cheng Kung University | Principal Investigator |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D066107 | Social Skills |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
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| 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. |
| D001519 | Behavior |