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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05857813
• Other study ID #: 202109033RIND
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: July 12, 2027

Study information

• Verified date: August 2022
• Source: National Taiwan University Hospital
• Contact: Yi-Ling Chien
• Phone: +886223123456#66013
• Email: chienyiling[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 12, 2027
• Est. primary completion date: July 12, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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