Back to resultsEstablishment of Social Skills Training Group in Adults With Autism Spectrum Disorder and Effectiveness Analysis
Primary Purpose
Social Skill Training Group
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PEERS®: program for the education and enrichment of relational skills
Sponsored by
About this trial
This is an interventional other trial for Social Skill Training Group
Eligibility Criteria
Inclusion Criteria:
- Age from 18 to 45 years
- having relational problems
- having motivation to participate
- good chinese speaking
- having a healthy cargiver join together
- IQ > 70 (WAIS)
- Autism Spectrum Quotient > 26
Exclusion Criteria:
- ever had psychosis and neurological diseases
- visual and hiring impairment
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
PEERS
Controls
Arm Description
Outcomes
Primary Outcome Measures
Outcome analysis
Background characteristics, co-existing psychiatric conditions and dropout rates for the two groups are compared using χ2 tests. Differences between two groups' baseline measures are analyzed using two-sided independent t tests.
The comparison will adopt an intention-to-treat principle. The missing data are substituted with last observation carried forward. To analyze the reasons for the attrition, the dropouts will also be compared to the completers on their clinical variables.
Then, repeated-measures analyses of variance (ANOVAs) are used to calculate between- and within-group effects on all continuous variables. Treatment effect calculations (Cohen's d) will be calculated for each indicator. Differences between the interventions in CGI-I will be examined using a one-way ANOVA. Reported change in the follow-up survey was compared between the PEERS group and the controls using independent t tests.
Secondary Outcome Measures
Full Information
NCT ID
NCT05054829
First Posted
September 14, 2021
Last Updated
May 4, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05054829
Brief Title
Establishment of Social Skills Training Group in Adults With Autism Spectrum Disorder and Effectiveness Analysis
Official Title
Establishment of Social Skills Training Group in Adults With Autism Spectrum Disorder and Effectiveness Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
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
This project aims to examine the effectiveness of social skill training group in adults with autism spectrum disorders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Skill Training Group
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEERS
Arm Type
Experimental
Arm Title
Controls
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
PEERS®: program for the education and enrichment of relational skills
Intervention Description
providing evidence-based social skills treatment to preschoolers, adolescents, and young adults with autism spectrum disorder (ASD)
Primary Outcome Measure Information:
Title
Outcome analysis
Description
Background characteristics, co-existing psychiatric conditions and dropout rates for the two groups are compared using χ2 tests. Differences between two groups' baseline measures are analyzed using two-sided independent t tests.
The comparison will adopt an intention-to-treat principle. The missing data are substituted with last observation carried forward. To analyze the reasons for the attrition, the dropouts will also be compared to the completers on their clinical variables.
Then, repeated-measures analyses of variance (ANOVAs) are used to calculate between- and within-group effects on all continuous variables. Treatment effect calculations (Cohen's d) will be calculated for each indicator. Differences between the interventions in CGI-I will be examined using a one-way ANOVA. Reported change in the follow-up survey was compared between the PEERS group and the controls using independent t tests.
Time Frame
after intervention 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age from 18 to 45 years
having relational problems
having motivation to participate
good chinese speaking
having a healthy cargiver join together
IQ > 70 (WAIS)
Autism Spectrum Quotient > 26
Exclusion Criteria:
ever had psychosis and neurological diseases
visual and hiring impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Ling Chien, Doctor
Phone
+886-2-23123456
Ext
66013
Email
chienyiling@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Ling Chien, doctor
Phone
+886-2-23123456
Ext
66013
Email
chienyiling@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Establishment of Social Skills Training Group in Adults With Autism Spectrum Disorder and Effectiveness Analysis
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