Back to resultsEstablishment of Social Skills Training Group in Adolescents With Autism Spectrum Disorder and Effectiveness Analysis
Primary Purpose
Autism Spectrum Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Program for the Education and Enrichment of Relational Skills (PEERS®)
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria: aged 11-20 years, currently enrolled in school between the sixth grade of elementary school and the third year of high school with a clinical diagnosis of ASD from a licensed mental health or medical professional based on DSM-5 experiencing social difficulties as reported by parents in a structured intake interview scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD demonstrating verbal fluency in Chinese with a full-scale IQ > 70 on WAIS-IV with motivation to participate in the intervention; with a caregiver who was fluent in Chinese and willing to participate as a social coach in the study. Exclusion Criteria: a history of major mental illness (e.g., bipolar affective disorder, schizophrenia, or psychosis) or neurological diseases that might hinder participation in the treatment visual impairment and/or hearing impairment that would preclude participation in group-based social activities.
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ASD teens and their caregiver
Arm Description
Teens: (1) aged 11-20 years, currently enrolled in school between the sixth grade of elementary school and the third year of high school; (2) with a clinical diagnosis of ASD from a licensed mental health or medical professional based on DSM-5; (3) experiencing social difficulties as reported by parents in a structured intake interview; (4) scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD (5) demonstrating verbal fluency in Chinese (6) with a full-scale IQ > 70 on WAIS-IV; (7) with motivation to participate in the intervention; (8) with a caregiver who was fluent in Chinese and willing to participate as a social coach in the study. Parents: (1) demonstrating verbal fluency in Chinese (2) with motivation to participate in the intervention and assist their children to do the homework assignments.
Outcomes
Primary Outcome Measures
Autism Diagnostic Interview-Revised (ADI-R)
Interview with caregiver of autistic participants. Total of 93 items coding from 1 to 9. Higher the score, worse the syptom
The Autism Diagnostic Observation Schedule (ADOS)
Observe the autistic participant during the interview. the examinee's condition is classified as autism spectrum if the combined score across two domains of social interaction and communication is ≥7, and as autism if the combined score is ≥12. In Module 2, a combined score of ≥8 corresponds to autism spectrum, and a combined score of ≥12 corresponds to autism
Autism Spectrum Quotient (AQ)
50 statement scoring from 1 to 4. higher the score, worse the syptom
Friendship Quality Scale (FQS)
23 questions scoring from 1 to 5. Higher the score, better the quality of friendship
The Assessing Emotions Scale (AES)
score range from 33 to 165. higher the score, better the emotional intelligence
Social Responsiveness Scale (SRS)
65 questions range from 1 to 4. higher the score, worse the symptom.
Social Adjustment Inventory for Children and Adolescents (SAICA)
17 scenarios scoring from 1 to 4. Higher the score, better the capability
Quality of Play Questionnaire (QPQ)
10 questions scoring from 0 to 3. Higher the score, worse the quality of play. Also, asked for frequency and number of participant in the play
Test of Adolescents Social Skills Knowledge (TASSK)
score range from 0 to 22. Higher the score, greater the knowledge of taught social skills
Empathy Quotient (EQ)
60 questions score from 0 to 3. Higher the score, greater the empathy
Friendship Questionnaire (FQ)
score from 0 to 135. higher the score, the more enjoyment of friendship
Secondary Outcome Measures
Full Information
NCT ID
NCT05857813
First Posted
April 13, 2023
Last Updated
May 4, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05857813
Brief Title
Establishment of Social Skills Training Group in Adolescents With Autism Spectrum Disorder and Effectiveness Analysis
Official Title
Establishment of Social Skills Training Group in Adolescents With Autism Spectrum Disorder and Effectiveness Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
July 12, 2027 (Anticipated)
Study Completion Date
July 12, 2027 (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
5. Study Description
Brief Summary
Autism spectrum disorders (ASD) is a neurodevelopmental disorder characterized by persistent deficits in social communication and social interaction across multiple contexts, and the presence of restricted, repetitive behavior and interests, affecting 1 in 68 children. Although atypical social deficits onset in early childhood, their social relationships with peers may remain a challenge or even worsen for individuals with ASD throughout the school years and beyond, as social contexts increase in complexity and pose higher social expectations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ASD teens and their caregiver
Arm Type
Experimental
Arm Description
Teens: (1) aged 11-20 years, currently enrolled in school between the sixth grade of elementary school and the third year of high school; (2) with a clinical diagnosis of ASD from a licensed mental health or medical professional based on DSM-5; (3) experiencing social difficulties as reported by parents in a structured intake interview; (4) scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD (5) demonstrating verbal fluency in Chinese (6) with a full-scale IQ > 70 on WAIS-IV; (7) with motivation to participate in the intervention; (8) with a caregiver who was fluent in Chinese and willing to participate as a social coach in the study.
Parents: (1) demonstrating verbal fluency in Chinese (2) with motivation to participate in the intervention and assist their children to do the homework assignments.
Intervention Type
Behavioral
Intervention Name(s)
Program for the Education and Enrichment of Relational Skills (PEERS®)
Intervention Description
developed at the University of California, Los Angeles (E. A. Laugeson & F. Frankel, 2010). This is a parent-assisted, manualized social skills training program that addresses crucial areas of social functioning for adolescents. Psycho-education and cognitive-behavioral therapy techniques are employed to help adolescents develop ecologically valid skills for making and maintaining friendships.
Primary Outcome Measure Information:
Title
Autism Diagnostic Interview-Revised (ADI-R)
Description
Interview with caregiver of autistic participants. Total of 93 items coding from 1 to 9. Higher the score, worse the syptom
Time Frame
7 weeks
Title
The Autism Diagnostic Observation Schedule (ADOS)
Description
Observe the autistic participant during the interview. the examinee's condition is classified as autism spectrum if the combined score across two domains of social interaction and communication is ≥7, and as autism if the combined score is ≥12. In Module 2, a combined score of ≥8 corresponds to autism spectrum, and a combined score of ≥12 corresponds to autism
Time Frame
7 weeks
Title
Autism Spectrum Quotient (AQ)
Description
50 statement scoring from 1 to 4. higher the score, worse the syptom
Time Frame
7 weeks
Title
Friendship Quality Scale (FQS)
Description
23 questions scoring from 1 to 5. Higher the score, better the quality of friendship
Time Frame
7 weeks
Title
The Assessing Emotions Scale (AES)
Description
score range from 33 to 165. higher the score, better the emotional intelligence
Time Frame
7 weeks
Title
Social Responsiveness Scale (SRS)
Description
65 questions range from 1 to 4. higher the score, worse the symptom.
Time Frame
7 weeks
Title
Social Adjustment Inventory for Children and Adolescents (SAICA)
Description
17 scenarios scoring from 1 to 4. Higher the score, better the capability
Time Frame
7 weeks
Title
Quality of Play Questionnaire (QPQ)
Description
10 questions scoring from 0 to 3. Higher the score, worse the quality of play. Also, asked for frequency and number of participant in the play
Time Frame
7 weeks
Title
Test of Adolescents Social Skills Knowledge (TASSK)
Description
score range from 0 to 22. Higher the score, greater the knowledge of taught social skills
Time Frame
7 weeks
Title
Empathy Quotient (EQ)
Description
60 questions score from 0 to 3. Higher the score, greater the empathy
Time Frame
7 weeks
Title
Friendship Questionnaire (FQ)
Description
score from 0 to 135. higher the score, the more enjoyment of friendship
Time Frame
7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 11-20 years, currently enrolled in school between the sixth grade of elementary school and the third year of high school
with a clinical diagnosis of ASD from a licensed mental health or medical professional based on DSM-5
experiencing social difficulties as reported by parents in a structured intake interview
scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD
demonstrating verbal fluency in Chinese
with a full-scale IQ > 70 on WAIS-IV
with motivation to participate in the intervention;
with a caregiver who was fluent in Chinese and willing to participate as a social coach in the study.
Exclusion Criteria:
a history of major mental illness (e.g., bipolar affective disorder, schizophrenia, or psychosis) or neurological diseases that might hinder participation in the treatment
visual impairment and/or hearing impairment that would preclude participation in group-based social activities.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Ling Chien
Phone
+886223123456#66013
Email
chienyiling@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Ling Chien, MD, PhD
Phone
+886223123456#66013
Email
chienyiling@gmail.com
12. IPD Sharing Statement
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Establishment of Social Skills Training Group in Adolescents With Autism Spectrum Disorder and Effectiveness Analysis
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