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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Program for the Education and Enrichment of Relational Skills (PEERS®)

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi-Ling Chien; Phone Number: +886223123456#66013; Email: chienyiling@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yi-Ling Chien, MD, PhD; Phone Number: +886223123456#66013; Email: chienyiling@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ASD teens and their caregiver; 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.

Behavioral: Program for the Education and Enrichment of Relational Skills (PEERS®); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 weeks
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	7 weeks
Autism Spectrum Quotient (AQ)	50 statement scoring from 1 to 4. higher the score, worse the syptom	7 weeks
Friendship Quality Scale (FQS)	23 questions scoring from 1 to 5. Higher the score, better the quality of friendship	7 weeks
The Assessing Emotions Scale (AES)	score range from 33 to 165. higher the score, better the emotional intelligence	7 weeks
Social Responsiveness Scale (SRS)	65 questions range from 1 to 4. higher the score, worse the symptom.	7 weeks
Social Adjustment Inventory for Children and Adolescents (SAICA)	17 scenarios scoring from 1 to 4. Higher the score, better the capability	7 weeks
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	7 weeks
Test of Adolescents Social Skills Knowledge (TASSK)	score range from 0 to 22. Higher the score, greater the knowledge of taught social skills	7 weeks
Empathy Quotient (EQ)	60 questions score from 0 to 3. Higher the score, greater the empathy	7 weeks
Friendship Questionnaire (FQ)	score from 0 to 135. higher the score, the more enjoyment of friendship	7 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): July 12, 2027
• Study Completion (Anticipated): July 12, 2027

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: 202109033RIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No