Clinical trial NCT05341011: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder High-Functioning
Keywords: autism spectrum disorder
social skills training program
adolescents
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Autism spectrum disorders (ASD) is a neurodevelopmental disorder characterized by persistent deficits in social communication and social interaction, and the presence of restricted, repetitive behavior and interests. Their social relationships with peers may remain a challenge or even worsen for individuals with ASD throughout the school years and beyond. Adolescence may be a particularly difficult developmental period, as they may have greater motivation or desire to engage with peers but also have greater awareness of their social disability. Adolescents with ASD are reported to experience greater loneliness and mood disturbances, and have poorer friendship quality and social network status than their typically developing peers. Moreover, a growing body of literature indicating that students with ASD have increased risk at all kinds of bullying involvement. These findings underscore the importance of providing social skills training. One of the empirically supported intervention program that targets adolescents with ASD is the Program for the Education and Enrichment of Relational Skills (PEERS®). 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. Moreover, caregiver attendance at the same time in the caregiver group was a mandatory component to enhance the child/s generalization of social skills.

Adolescents with ASD and normal IQ will be recruit to attend the 14-week PEERS® group training together with a parent. The participants will be stratified by gender and randomized to a treatment (TX) group or delayed treatment control (DTC) group. A team member uninvolved in the program made the random allocation with random digit generated by computer.

This study investigated the acceptability, feasibility and effectiveness of the Taiwanese adolescent PEERS® program.

Detailed description: The PEERS® group will be run by PI and the special education teacher (one is the leader for teen session and the other is the leader for parent session) both with substantial experience conducting social skills programs for children and adolescents, and parent education groups related to ASD, under the on-site supervision of co-PI with comprehensive training through the UCLA PEERS® Clinic by the program developer. Three research assistants (one is a psychiatrist, another is an occupational therapist, and the other is a social worker) will take the part of role-play (following the social scenario script) during PEERS® intervention.

The TX group received 14 weeks of the PEERS® intervention immediately following a baseline assessment, while the DTC group received the same intervention after a 14-week waiting period. Parents and teens attended concurrent sessions held in separate rooms.

Eligibility criteria: Inclusion Criteria:

* Teens:

  1. currently enrolled in school
  2. clinical diagnosis of Autism Spectrum Disorder (ASD)
  3. experiencing social difficulties
  4. scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ)
  5. verbal fluency in Chinese
  6. with a full-scale IQ \> 70 on WAIS-IV
  7. with motivation to participate in the intervention
* Parents:

  1. verbal fluency in Chinese
  2. with motivation to participate in the intervention

Exclusion Criteria:

1. major mental illness
2. sever visual or hearing impairment

Primary outcomes:
measure: Test of Adolescents Social Skills Knowledge (TASSK)
timeFrame: Baseline and Pre-Intervention
measure: Test of Adolescents Social Skills Knowledge (TASSK)
timeFrame: During the Intervention
measure: Test of Adolescents Social Skills Knowledge (TASSK)
timeFrame: Immediately after the Intervention
measure: Test of Adolescents Social Skills Knowledge (TASSK)
timeFrame: Change from Post-Intervention at 4 months
measure: Test of Adolescents Social Skills Knowledge (TASSK)
timeFrame: Change from Post-Intervention at 8 months
measure: Test of Adolescents Social Skills Knowledge (TASSK)
timeFrame: Change from Post-Intervention at 16 months
measure: Quality of Play Questionnaire (QPQ)
timeFrame: Baseline and Pre-Intervention
measure: Quality of Play Questionnaire (QPQ)
timeFrame: During the Intervention
measure: Quality of Play Questionnaire (QPQ)
timeFrame: Immediately after the Intervention
measure: Quality of Play Questionnaire (QPQ)
timeFrame: Change from Post-Intervention at 4 months
measure: Quality of Play Questionnaire (QPQ)
timeFrame: Change from Post-Intervention at 8 months
measure: Quality of Play Questionnaire (QPQ)
timeFrame: Change from Post-Intervention at 16 months
measure: Chinese version of the School Bullying Experience Questionnaire (C-SBEQ)
timeFrame: Baseline and Pre-Intervention
measure: Chinese version of the School Bullying Experience Questionnaire (C-SBEQ)
timeFrame: During the Intervention
measure: Chinese version of the School Bullying Experience Questionnaire (C-SBEQ)
timeFrame: Immediately after the Intervention
measure: Chinese version of the School Bullying Experience Questionnaire (C-SBEQ)
timeFrame: Change from Post-Intervention at 4 months
measure: Chinese version of the School Bullying Experience Questionnaire (C-SBEQ)
timeFrame: Change from Post-Intervention at 8 months
measure: Chinese version of the School Bullying Experience Questionnaire (C-SBEQ)
timeFrame: Change from Post-Intervention at 16 months
Secondary outcomes:
measure: Swanson, Nolan, and Pelham, version IV (SNAP-IV)
timeFrame: Baseline and Pre-Intervention, immediate Post-Intervention, and the 4th-, 8th- and 16th-month follow-up
measure: Social Adjustment Inventory for Children and Adolescents (SAICA)
timeFrame: Baseline and Pre-Intervention, immediate Post-Intervention, and the 4th-, 8th- and 16th-month follow-up
measure: Empathy Quotient (EQ)
timeFrame: Baseline and Pre-Intervention, immediate Post-Intervention, and the 4th-, 8th- and 16th-month follow-up
measure: Friendship Questionnaire (FQ)
timeFrame: Baseline and Pre-Intervention, immediate Post-Intervention, and the 4th-, 8th- and 16th-month follow-up
measure: Friendship Quality Scale (FQS)
timeFrame: Baseline and Pre-Intervention, immediate Post-Intervention, and the 4th-, 8th- and 16th-month follow-up
measure: Assessing Emotions Scale (AES)
timeFrame: Baseline and Pre-Intervention, immediate Post-Intervention, and the 4th-, 8th- and 16th-month follow-up
measure: Youth Self Report (YSR)
timeFrame: Baseline and Pre-Intervention, immediate Post-Intervention, and the 4th-, 8th- and 16th-month follow-up
measure: Child Behavior Checklist (CBCL)
timeFrame: Baseline and Pre-Intervention, immediate Post-Intervention, and the 4th-, 8th- and 16th-month follow-up
measure: World Health Organization Quality of Life (WHOQoL-BREF)
timeFrame: Baseline and Pre-Intervention, immediate Post-Intervention, and the 4th-, 8th- and 16th-month follow-up
measure: Parenting Stress Index - Short Form (PSI-SF)
timeFrame: Baseline and Pre-Intervention, immediate Post-Intervention, and the 4th-, 8th- and 16th-month follow-up
measure: Parental Bonding Instrument (PBI)
timeFrame: Baseline and Pre-Intervention, immediate Post-Intervention, and the 4th-, 8th- and 16th-month follow-up
measure: Communicative Behavior Observatory Scale (CBOS) Behavior Observatory Scale (CBOS)
timeFrame: During the Intervention
measure: Social Responsiveness Scale (SRS)
timeFrame: Baseline and Pre-Intervention, immediate Post-Intervention, and the 4th-, 8th- and 16th-month follow-up
measure: Autism Spectrum Quotient (AQ)
timeFrame: Baseline and Pre-Intervention, immediate Post-Intervention, and the 4th-, 8th- and 16th-month follow-up
measure: Autism Diagnostic Observation Schedule (ADOS)
timeFrame: Baseline and Pre-Intervention and immediate Post-Intervention
measure: Autism Diagnostic Interview-Revised (ADI-R)
timeFrame: Baseline
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Mei-Ni Hsiao, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laugeson EA, Frankel F, Gantman A, Dillon AR, Mogil C. Evidence-based social skills training for adolescents with autism spectrum disorders: the UCLA PEERS program. J Autism Dev Disord. 2012 Jun;42(6):1025-36. doi: 10.1007/s10803-011-1339-1.
citation: Laugeson EA, Frankel F, Mogil C, Dillon AR. Parent-assisted social skills training to improve friendships in teens with autism spectrum disorders. J Autism Dev Disord. 2009 Apr;39(4):596-606. doi: 10.1007/s10803-008-0664-5. Epub 2008 Nov 18.
citation: Rao PA, Beidel DC, Murray MJ. Social skills interventions for children with Asperger's syndrome or high-functioning autism: a review and recommendations. J Autism Dev Disord. 2008 Feb;38(2):353-61. doi: 10.1007/s10803-007-0402-4. Epub 2007 Jul 20.
citation: Schroeder JH, Cappadocia MC, Bebko JM, Pepler DJ, Weiss JA. Shedding light on a pervasive problem: a review of research on bullying experiences among children with autism spectrum disorders. J Autism Dev Disord. 2014 Jul;44(7):1520-34. doi: 10.1007/s10803-013-2011-8.
citation: Andanson J, Pourre F, Maffre T, Raynaud JP. [Social skills training groups for children and adolescents with Asperger syndrome: A review]. Arch Pediatr. 2011 May;18(5):589-96. doi: 10.1016/j.arcped.2011.02.019. Epub 2011 Apr 1. French.
citation: Yoo HJ, Bahn G, Cho IH, Kim EK, Kim JH, Min JW, Lee WH, Seo JS, Jun SS, Bong G, Cho S, Shin MS, Kim BN, Kim JW, Park S, Laugeson EA. A randomized controlled trial of the Korean version of the PEERS((R)) parent-assisted social skills training program for teens with ASD. Autism Res. 2014 Feb;7(1):145-61. doi: 10.1002/aur.1354. Epub 2014 Jan 9.