Establishment of Social Skills Training Group in Adults With Autism Spectrum Disorder and Effectiveness Analysis

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05054829
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 75.8
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

This project aims to examine the effectiveness of social skill training group in adults with autism spectrum disorders.

Condition or Disease	Intervention/Treatment	Phase
Social Skill Training Group	Behavioral: PEERS®: program for the education and enrichment of relational skills	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Establishment of Social Skills Training Group in Adults With Autism Spectrum Disorder and Effectiveness Analysis
• Actual Study Start Date: Mar 8, 2017
• Actual Primary Completion Date: Dec 31, 2018
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PEERS	Behavioral: PEERS®: program for the education and enrichment of relational skills; providing evidence-based social skills treatment to preschoolers, adolescents, and young adults with autism spectrum disorder (ASD)
Other: Controls	Behavioral: PEERS®: program for the education and enrichment of relational skills; providing evidence-based social skills treatment to preschoolers, adolescents, and young adults with autism spectrum disorder (ASD)

Outcome Measures

Primary Outcome Measures

1. Outcome analysis [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT05054829
• Other Study ID Numbers: 201612185RIN
• First Posted: Sep 23, 2021
• Last Update Posted: Sep 23, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Autism Spectrum Disorder

Study Results

No Results Posted as of Sep 23, 2021