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

NCT05857813 | Recruiting

• 1 other identifier: 202109033RIND
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (1)

ASD teens and their caregiver

EXPERIMENTAL

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®)

Interventions

Program for the Education and Enrichment of Relational Skills (PEERS®) BEHAVIORAL

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.

ASD teens and their caregiver

Eligibility Criteria

• Age: 11 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Yi-Ling Chien

CONTACT

+886223123456#66013; chienyiling@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 15, 2023
• Study Start: January 1, 2022
• Primary Completion (Estimated): July 12, 2027
• Study Completion (Estimated): July 12, 2027
• Last Updated: May 15, 2023

Record last verified: 2022-08

Locations

TW (1)