Theory of Mind-based Social Competence Group Intervention
NCT ID: NCT06509152
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-07-01
2029-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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ToM-SCGI-12
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.
Theory of mind-based social competence group intervention
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:
1. Warm-up Activities(5-10 minutes): review the previous group session and prepare for the current group activities.
2. Theory of Mind Instruction(10-15 minutes): based on the developmental stage of the children's theory of mind, using thought bubbles to teach corresponding elements of theory of mind development.
3. Social Skills Group Games(30-35 minutes): design social scenario-based group games that allow children to practice applying the acquired theory of mind abilities into expressions and applications of theory of mind and social competence.
4. Summary(5-10 minutes): summarize the children's performance in the group and assign homework.
ToM-SCGI-6
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.
Theory of mind-based social competence group intervention
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:
1. Warm-up Activities(5-10 minutes): review the previous group session and prepare for the current group activities.
2. Theory of Mind Instruction(10-15 minutes): based on the developmental stage of the children's theory of mind, using thought bubbles to teach corresponding elements of theory of mind development.
3. Social Skills Group Games(30-35 minutes): design social scenario-based group games that allow children to practice applying the acquired theory of mind abilities into expressions and applications of theory of mind and social competence.
4. Summary(5-10 minutes): summarize the children's performance in the group and assign homework.
Control group
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.
No interventions assigned to this group
Interventions
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Theory of mind-based social competence group intervention
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:
1. Warm-up Activities(5-10 minutes): review the previous group session and prepare for the current group activities.
2. Theory of Mind Instruction(10-15 minutes): based on the developmental stage of the children's theory of mind, using thought bubbles to teach corresponding elements of theory of mind development.
3. Social Skills Group Games(30-35 minutes): design social scenario-based group games that allow children to practice applying the acquired theory of mind abilities into expressions and applications of theory of mind and social competence.
4. Summary(5-10 minutes): summarize the children's performance in the group and assign homework.
Eligibility Criteria
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Inclusion Criteria
2. diagnosed with Autism Spectrum Disorder (ASD), Autism, Asperger's Syndrome, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) according to DSM-5 or the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) criteria by a trained psychiatrist or pediatrician;
3. absence of additional neurological or psychiatric conditions;
4. a T-score of 60 or higher on the Social Responsiveness Scale-Second Edition (SRS-2) and a score of 30 or higher on the Childhood Autism Rating Scale™, Second Edition (CARS™2);
5. a Verbedal Comprehension Index (VCI) score of 70 or higher on the Wechsler Preschool and Primary Scale of Intelligence IV (WPPSI-IV) or the Wechsler Intelligence Scale for Children IV (WISC-IV).
Exclusion Criteria
2. symptoms related to organic brain dysfunction (e.g., epilepsy);
3. uncorrectable auditory or visual impairments.
3 Years
10 Years
ALL
No
Sponsors
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National Cheng-Kung University Hospital
OTHER
Responsible Party
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Principal Investigators
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Kuan-Lin Chen, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Nattional Cheng Kung University
Central Contacts
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Other Identifiers
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B-BR-112-082
Identifier Type: -
Identifier Source: org_study_id