Status:
NOT_YET_RECRUITING
Theory of Mind-based Social Competence Group Intervention
Lead Sponsor:
National Cheng-Kung University Hospital
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
3-10 years
Phase:
NA
Brief 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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- chronological age between 3 and 10 years;
- 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;
- absence of additional neurological or psychiatric conditions;
- 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);
- 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
- inability to follow instructions or complete the entire assessment process;
- symptoms related to organic brain dysfunction (e.g., epilepsy);
- uncorrectable auditory or visual impairments.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06509152
Start Date
July 1 2025
End Date
December 31 2029
Last Update
December 18 2024
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