- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04551313
Effectiveness of Social Skills Training Group for Children With Autism Spectrum Disorder
Socio-communicative impairments are core deficits in individuals with autism spectrum disorder (ASD). Individuals with ASD have difficulty understanding eye contact, facial expressions, body language, and different tones of voice when communicating with others. They can't interpret the thoughts and feelings of others, or predict social events, and the impaired social skills may lead to rejection of peers and poor participation in school.
Social skills training targets the core symptoms of ASD. Empirical support is building for cognitive-behavioral intervention approach, social skills training group for verbally fluent, school-aged children with ASD. Several studies have shown the efficacy of the social story intervention. It is usually provided individually, but we want to use it in the group.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Many different intervention program have been used throughout the world. One alternative method used to teach children is the social stories method, which was created by Gray (1993) to address the social difficulties of children with ASD. The theoretical framework of the social stories is based on theory of mind (TOM) hypothesis. Difficulties associated with the impaired TOM was addressed by explaining the complex social concepts in simple words and often include the description of perspectives of others. Several studies have shown the efficacy of the social story intervention. It is usually provided individually, but we want to use it in the group.
In this study, we plan to randomly assign thirty-six 5-7-year-old children with ASD to one of two kinds of social skills groups: the social skills group or the play activities group (control condition). Group met for 16 weeks, one time per week, one hour each time. Participants were recruited between October 2020 and September 2023. Assessment were conducted at baseline and endpoint (16 weeks). To empower parents, we would also ask parents of participants to attend our treatment and lecture.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Taipei, Taiwan, 100
- NTUH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Clinical diagnosis of Autism spectrum disorder
- Must be able to understand 3-steps verbal commands
Exclusion criteria:
- Mental retardation
- Seizure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: social skill training group
We plan to address basic interactional and conversational skills first, then focus on teaching perspective-taking and theory of mind skills.
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We plan to address basic interactional and conversational skills first, then focus on teaching perspective-taking and theory of mind skills.
|
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Active Comparator: control group
Regular therapy
|
We plan to address basic interactional and conversational skills first, then focus on teaching perspective-taking and theory of mind skills.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GAS (Goal attainment scale)
Time Frame: the first week and the 15th week of the duration
|
interview caregivers about specific social interaction goals for the children and give rating 1-5 to calculate the extent to which a parent's goals are met.
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the first week and the 15th week of the duration
|
|
Vineland Adaptive Behavior Scale
Time Frame: the first week and the 15th week of the duration
|
to assess the socialization skill of the children.
|
the first week and the 15th week of the duration
|
Collaborators and Investigators
Investigators
- Principal Investigator: Fu-Mei Chiang, MAMS, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202006158RINA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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