- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05054829
Establishment of Social Skills Training Group in Adults With Autism Spectrum Disorder and Effectiveness Analysis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yi-Ling Chien, doctor
- Phone Number: 66013 +886-2-23123456
- Email: chienyiling@gmail.com
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Yi-Ling Chien, doctor
- Phone Number: 66013 +886-2-23123456
- Email: chienyiling@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Controls
|
providing evidence-based social skills treatment to preschoolers, adolescents, and young adults with autism spectrum disorder (ASD)
|
Experimental: PEERS
|
providing evidence-based social skills treatment to preschoolers, adolescents, and young adults with autism spectrum disorder (ASD)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Outcome analysis
Time Frame: after intervention 12 weeks
|
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. |
after intervention 12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201612185RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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