NCT07505290

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Feb 2026

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Feb 2026Mar 2027

Study Start

First participant enrolled

February 19, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

March 26, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

Social Skills TrainingParent CoachingPreschoolersPEERSRandomized Controlled TrialEarly InterventionAutism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in SRS-2 Total T-score at 16 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.

    Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)

Secondary Outcomes (12)

  • Change in Korean version of Vineland Adaptive Behavior Scales-III (K-Vineland-III) score

    Baseline, 16 weeks, 32 weeks

  • Change in Social Communication Questionnaire (SCQ) score

    Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)

  • Change in Quality of Socialization Questionnaire (QSQ) score

    Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)

  • Change in Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P) score

    Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)

  • Change in Emotion Regulation Checklist (ERC) score

    Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)

  • +7 more secondary outcomes

Study Arms (2)

PEERS®-PS-K Intervention Group

EXPERIMENTAL

Participants in this group will receive the Korean version of the PEERS® for Preschoolers (PEERS®-PS-K) intervention immediately. This includes 16 weekly 90-minute sessions of social skills training for children and concurrent coaching sessions for parents.

Behavioral: The Korean version of PEERS® for Preschoolers (PEERS®-PS-K)

Waitlist Control Group

OTHER

Participants will not receive any specialized social skills intervention during the first 16 weeks (control period). After the post-control assessment is completed, these participants will receive the same 16-week PEERS®-PS-K intervention.

Behavioral: The Korean version of PEERS® for Preschoolers (PEERS®-PS-K)

Interventions

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.

Also known as: Social Skills Training, Parent-Assisted Social Skills Intervention
PEERS®-PS-K Intervention GroupWaitlist Control Group

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kyung Hee University Medical Center

Seoul, Dongdaemun-gu, 02447, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Seocho-gu, 06591, South Korea

Location

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MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Jae Hyun Han, MD, PhD Candidate

    Seoul National University Bundang Hospital, Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR
  • Hee Jeong Yoo, MD, PhD

    Seoul National University Bundang Hospital, Seoul National University College of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The control group is a wait-list control; they will receive the same PEERS®-PS-K intervention after the initial 16-week assessment period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

March 26, 2026

First Posted

April 1, 2026

Study Start

February 19, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect the privacy and confidentiality of the study participants, who are young children with neurodevelopmental disorders. The informed consent obtained from parents does not include provisions for the public sharing of raw individual data.

Locations