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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04551313
Other study ID # 202006158RINA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2020
Est. completion date July 27, 2022

Study information

Verified date August 2023
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date July 27, 2022
Est. primary completion date July 27, 2022
Accepts healthy volunteers No
Gender All
Age group 5 Years to 6 Years
Eligibility Inclusion criteria: - Clinical diagnosis of Autism spectrum disorder - Must be able to understand 3-steps verbal commands Exclusion criteria: - Mental retardation - Seizure

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
social skill group
We plan to address basic interactional and conversational skills first, then focus on teaching perspective-taking and theory of mind skills.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei
Taiwan NTUH Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary GAS (Goal attainment scale) 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. the first week and the 15th week of the duration
Primary Vineland Adaptive Behavior Scale to assess the socialization skill of the children. the first week and the 15th week of the duration
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