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Effectiveness of Social Skills Training Group for Children With Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
social skill group
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Autism Spectrum Disorder focused on measuring Autism,autism spectrum disorder,social skill training

Eligibility Criteria

5 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Clinical diagnosis of Autism spectrum disorder
  • Must be able to understand 3-steps verbal commands

Exclusion criteria:

  • Mental retardation
  • Seizure

Sites / Locations

  • National Taiwan University Hospital
  • NTUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

social skill training group

control group

Arm Description

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

Regular therapy

Outcomes

Primary Outcome Measures

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.
Vineland Adaptive Behavior Scale
to assess the socialization skill of the children.

Secondary Outcome Measures

Full Information

First Posted
September 3, 2020
Last Updated
August 16, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04551313
Brief Title
Effectiveness of Social Skills Training Group for Children With Autism Spectrum Disorder
Official Title
Effectiveness of Social Skills Training Group for Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
July 27, 2022 (Actual)
Study Completion Date
July 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism,autism spectrum disorder,social skill training

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
social skill training group
Arm Type
Experimental
Arm Description
We plan to address basic interactional and conversational skills first, then focus on teaching perspective-taking and theory of mind skills.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Regular therapy
Intervention Type
Behavioral
Intervention Name(s)
social skill group
Intervention Description
We plan to address basic interactional and conversational skills first, then focus on teaching perspective-taking and theory of mind skills.
Primary Outcome Measure Information:
Title
GAS (Goal attainment scale)
Description
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.
Time Frame
the first week and the 15th week of the duration
Title
Vineland Adaptive Behavior Scale
Description
to assess the socialization skill of the children.
Time Frame
the first week and the 15th week of the duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Clinical diagnosis of Autism spectrum disorder Must be able to understand 3-steps verbal commands Exclusion criteria: Mental retardation Seizure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fu-Mei Chiang, MAMS
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
NTUH
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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Effectiveness of Social Skills Training Group for Children With Autism Spectrum Disorder

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