Autism Spectrum Disorder
Conditions
Keywords
Social Skills Training, Parent Coaching, Preschoolers, PEERS, Randomized Controlled Trial, Early Intervention, Autism Spectrum Disorder
Brief summary
This study aims to evaluate the efficacy of the Korean version of the PEERS® for Preschoolers (PEERS®-PS-K), a parent-assisted social skills intervention for preschool-aged children with Autism Spectrum Disorder (ASD). Participants will be randomly assigned to either the intervention group, receiving the PEERS®-PS-K program, or a wait-list control group. The study focuses on improving social skills, such as making friends and interacting with peers, through structured lessons and parent coaching.
Detailed description
The Korean PEERS® for Preschoolers (PEERS®-PS-K) is a culturally adapted version of the original PEERS® program developed at UCLA. This randomized controlled trial (RCT) will investigate the social communication improvements in preschoolers with ASD. The intervention consists of weekly 90-minute sessions for 16 weeks. Children learn social skills through puppet shows and role-playing, while parents receive concurrent coaching to support their children's social interactions in natural settings. Data will be collected at baseline, post-intervention, and follow-up to assess social responsiveness and behavioral changes.
Interventions
BEHAVIORALThe Korean version of PEERS® for Preschoolers (PEERS®-PS-K)
The Korean version of PEERS® for Preschoolers (PEERS®-PS-K) is a 16-week, parent-assisted social skills intervention for preschoolers with ASD. The program consists of weekly 90-minute sessions. Children are taught social skills through puppet shows, role-playing, and structured play, focusing on making friends, playing with peers, and managing conflicts. Concurrently, parents receive coaching sessions to learn how to facilitate their children's social interactions and manage playdates in natural settings. Weekly homework is assigned to generalize the learned skills.
Sponsors
Seoul National University Bundang Hospital
Kyung Hee University Hospital
Seoul St. Mary's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the wait-list control design, participants and care providers cannot be masked as they are aware of the timing of the intervention. However, outcomes will be assessed by independent assessors who are blinded to the group assignment.
Intervention model description
The control group is a wait-list control; they will receive the same PEERS®-PS-K intervention after the initial 16-week assessment period.
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 4 to 6 years (at least 4 years 0 months and less than 7 years diagnosed with Autism Spectrum Disorder (ASD) through standardized diagnostic tools(K-ADOS-2 / K-ADI-R). * Verbal Intelligence Quotient (VIQ) of 70 or higher on the Korean Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI). * Native Korean speakers with sufficient verbal fluency to communicate in full sentences appropriate for their age. * Capable of participating in group activities and language-based interventions as determined through a screening procedure. * Parents or legal guardians who understand the study's purpose and provide voluntary informed consent for both themselves and their child.
Exclusion criteria
* Parents or legal guardians who do not consent to their child's participation in the study. * Presence of intellectual disability or other comorbid psychiatric conditions that may interfere with study participation. * Children exhibiting clinically significant challenging behaviors that could disrupt group sessions. * Other clinically significant neurological, medical, visual, or hearing impairments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in SRS-2 Total T-score at 16 weeks | Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks) | The SRS-2 includes five subscales: Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests and Repetitive Behavior. Each subscale provides a T-score to identify specific areas of social impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Korean version of Vineland Adaptive Behavior Scales-III (K-Vineland-III) score | Baseline, 16 weeks, 32 weeks | The Korean version of Vineland Adaptive Behavior Scales, Third Edition (K-Vineland-III) is a standardized assessment of adaptive functioning in communication, daily living skills, and socialization domains. Standard scores (Mean=100, SD=15) are used, where higher scores indicate better adaptive functioning in daily life. |
| Change in Social Communication Questionnaire (SCQ) score | Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks) | The Social Communication Questionnaire (SCQ) is a parent-report screening tool for Autism Spectrum Disorder (ASD) symptoms. It assesses social interaction and communication skills. Higher total scores indicate more severe social communication deficits. |
| Change in Quality of Socialization Questionnaire (QSQ) score | Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks) | The Quality of Socialization Questionnaire (QSQ) measures the number and quality of an individual's friendships and the frequency of social interactions. Higher scores reflect a higher quality and frequency of social involvement. |
| Change in Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P) score | Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks) | The Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) assesses executive function behaviors in preschool-aged children, including inhibition, shifting, and emotional control. Higher T-scores indicate greater executive function impairment. |
| Change in Emotion Regulation Checklist (ERC) score | Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks) | The Emotion Regulation Checklist (ERC) is a parent-report measure of a child's emotional regulation and lability. Higher scores on the Emotion Regulation subscale indicate better emotional control, while higher scores on the Lability/Negativity subscale indicate greater emotional instability. |
| Change in Child Behavior Checklist (CBCL 1.5-5) score | Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks) | The Child Behavior Checklist (CBCL) for ages 1.5-5 is used to identify emotional and behavioral problems in young children. Higher T-scores on the Internalizing, Externalizing, and Total Problems scales indicate more significant behavioral challenges. |
| Change in Preschool Anxiety Scale (PAS) score | Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks) | The Preschool Anxiety Scale (PAS) is a parent-report measure designed to assess symptoms of anxiety in preschool-aged children. It covers domains such as generalized anxiety, social anxiety, and separation anxiety. Higher total scores indicate a higher level of anxiety symptoms in the child. |
| Change in State-Trait Anxiety Inventory (STAI) score | Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks) | The STAI is a self-report instrument used to measure the presence and severity of current anxiety (state) and a general tendency to be anxious (trait) in adults. Higher scores indicate higher levels of anxiety in parents. |
| Change in Beck Depression Inventory-II (BDI-II) score | Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks) | The BDI-II is a widely used self-report scale to assess the severity of depressive symptoms in adults. Higher total scores reflect more significant depressive symptoms. |
| Change from Baseline in Korean Parent Efficacy Test (K-PET) score | Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks) | The K-PET is a standardized self-report instrument developed by Jung-mi Kim to assess parenting efficacy in parents of children aged 1 to 6 years. It consists of two main domains: the Parent domain (15 items focusing on parenting competence and satisfaction) and the Spouse domain (14 items focusing on co-parenting and spouse support). Total scores are calculated on a 5-point Likert scale, where higher scores reflect a higher sense of parenting efficacy and better co-parenting quality. |
| Change in Parenting Stress Index-4-Short Form (PSI-4-SF) score | Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks) | The PSI-4-SF assesses the level of stress in the parent-child system. Higher total scores indicate a greater degree of stress related to the parenting role and child-rearing. |
| Change in Child-Parent Relationship Scale (CPRS) score | Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks) | The Child-Parent Relationship Scale (CPRS) is a self-report measure for parents to assess their relationship with their child. It evaluates aspects such as closeness and conflict within the parent-child dyad. Higher scores on the closeness subscale and lower scores on the conflict subscale indicate a more positive and secure relationship. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORJae Hyun Han, MD, PhD Candidate
Seoul National University Bundang Hospital, Seoul National University College of Medicine
STUDY_DIRECTORHee Jeong Yoo, MD, PhD
Seoul National University Bundang Hospital, Seoul National University College of Medicine
Outcome results
None listed