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Theory of Mind-based Social Competence Group Intervention

NCT06509152 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-12-18

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    lead OTHER

Principal Investigators

  • Kuan-Lin Chen, Ph.D · Nattional Cheng Kung University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-07-31
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06509152 on ClinicalTrials.gov