- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07505290
Efficacy of the Korean PEERS® for Preschoolers (PEERS®-PS-K) Social Skills Intervention: A Randomized Controlled Trial for Children With Autism Spectrum Disorder (PEERS®-PS-K)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Dongdaemun-gu
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Seoul, Dongdaemun-gu, South Korea, 02447
- Kyung Hee University Medical Center
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, South Korea, 13620
- Seoul National University Bundang Hospital
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Seocho-gu
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Seoul, Seocho-gu, South Korea, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: PEERS®-PS-K Intervention Group
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.
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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.
Other Names:
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Other: Waitlist Control Group
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from Baseline in SRS-2 Total T-score at 16 weeks
Time Frame: Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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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.
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Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Korean version of Vineland Adaptive Behavior Scales-III (K-Vineland-III) score
Time Frame: Baseline, 16 weeks, 32 weeks
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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.
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Baseline, 16 weeks, 32 weeks
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Change in Social Communication Questionnaire (SCQ) score
Time Frame: Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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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.
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Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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Change in Quality of Socialization Questionnaire (QSQ) score
Time Frame: Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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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.
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Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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Change in Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P) score
Time Frame: Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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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.
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Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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Change in Emotion Regulation Checklist (ERC) score
Time Frame: Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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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.
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Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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Change in Child Behavior Checklist (CBCL 1.5-5) score
Time Frame: Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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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.
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Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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Change in Preschool Anxiety Scale (PAS) score
Time Frame: Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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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.
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Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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Change in State-Trait Anxiety Inventory (STAI) score
Time Frame: Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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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.
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Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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Change in Beck Depression Inventory-II (BDI-II) score
Time Frame: Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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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.
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Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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Change from Baseline in Korean Parent Efficacy Test (K-PET) score
Time Frame: Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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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.
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Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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Change in Parenting Stress Index-4-Short Form (PSI-4-SF) score
Time Frame: Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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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.
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Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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Change in Child-Parent Relationship Scale (CPRS) score
Time Frame: Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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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.
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Baseline, Post-intervention (16 weeks), and Follow-up (32 weeks)
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Collaborators and Investigators
Investigators
- Principal Investigator: Jae Hyun Han, MD, PhD Candidate, Seoul National University Bundang Hospital, Seoul National University College of Medicine
- Study Director: Hee Jeong Yoo, MD, PhD, Seoul National University Bundang Hospital, Seoul National University College of Medicine
Publications and helpful links
General Publications
- 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.
- 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.
- Taylor JL, Seltzer MM. Employment and post-secondary educational activities for young adults with autism spectrum disorders during the transition to adulthood. J Autism Dev Disord. 2011 May;41(5):566-74. doi: 10.1007/s10803-010-1070-3.
- Buescher AV, Cidav Z, Knapp M, Mandell DS. Costs of autism spectrum disorders in the United Kingdom and the United States. JAMA Pediatr. 2014 Aug;168(8):721-8. doi: 10.1001/jamapediatrics.2014.210.
- Bauminger N, Kasari C. Loneliness and friendship in high-functioning children with autism. Child Dev. 2000 Mar-Apr;71(2):447-56. doi: 10.1111/1467-8624.00156.
- Kenworthy L, Anthony LG, Naiman DQ, Cannon L, Wills MC, Luong-Tran C, Werner MA, Alexander KC, Strang J, Bal E, Sokoloff JL, Wallace GL. Randomized controlled effectiveness trial of executive function intervention for children on the autism spectrum. J Child Psychol Psychiatry. 2014 Apr;55(4):374-83. doi: 10.1111/jcpp.12161. Epub 2013 Nov 21.
- Khachadourian V, Mahjani B, Sandin S, Kolevzon A, Buxbaum JD, Reichenberg A, Janecka M. Comorbidities in autism spectrum disorder and their etiologies. Transl Psychiatry. 2023 Feb 25;13(1):71. doi: 10.1038/s41398-023-02374-w.
- Demetriou EA, Lampit A, Quintana DS, Naismith SL, Song YJC, Pye JE, Hickie I, Guastella AJ. Autism spectrum disorders: a meta-analysis of executive function. Mol Psychiatry. 2018 May;23(5):1198-1204. doi: 10.1038/mp.2017.75. Epub 2017 Apr 25.
- Corbett BA, Swain DM, Coke C, Simon D, Newsom C, Houchins-Juarez N, Jenson A, Wang L, Song Y. Improvement in social deficits in autism spectrum disorders using a theatre-based, peer-mediated intervention. Autism Res. 2014 Feb;7(1):4-16. doi: 10.1002/aur.1341. Epub 2013 Oct 22.
- Warreyn P, Roeyers H, De Groote I. Early social communicative behaviours of preschoolers with autism spectrum disorder during interaction with their mothers. Autism. 2005 Oct;9(4):342-61. doi: 10.1177/1362361305056076.
- Wallace GL, Kenworthy L, Pugliese CE, Popal HS, White EI, Brodsky E, Martin A. Real-World Executive Functions in Adults with Autism Spectrum Disorder: Profiles of Impairment and Associations with Adaptive Functioning and Co-morbid Anxiety and Depression. J Autism Dev Disord. 2016 Mar;46(3):1071-83. doi: 10.1007/s10803-015-2655-7.
- Tripathi I, Estabillo JA, Moody CT, Laugeson EA. Long-Term Treatment Outcomes of PEERS(R) for Preschoolers: A Parent-Mediated Social Skills Training Program for Children with Autism Spectrum Disorder. J Autism Dev Disord. 2022 Jun;52(6):2610-2626. doi: 10.1007/s10803-021-05147-w. Epub 2021 Jul 24.
- Pickles A, Le Couteur A, Leadbitter K, Salomone E, Cole-Fletcher R, Tobin H, Gammer I, Lowry J, Vamvakas G, Byford S, Aldred C, Slonims V, McConachie H, Howlin P, Parr JR, Charman T, Green J. Parent-mediated social communication therapy for young children with autism (PACT): long-term follow-up of a randomised controlled trial. Lancet. 2016 Nov 19;388(10059):2501-2509. doi: 10.1016/S0140-6736(16)31229-6. Epub 2016 Oct 25.
- McClelland MM, Gonzales CR, Cameron CE, Geldhof GJ, Bowles RP, Nancarrow AF, Merculief A, Tracy A. The Head-Toes-Knees-Shoulders Revised: Links to Academic Outcomes and Measures of EF in Young Children. Front Psychol. 2021 Sep 7;12:721846. doi: 10.3389/fpsyg.2021.721846. eCollection 2021.
- Isella C, Gasparini A, Lucca G, Ielmini M, Caselli I, Poloni N, Dajelli Ermolli C, Caravati F, Castiglioni B, De Ponti R, Callegari C. Resilience, Cardiological Outcome, and Their Correlations With Anxious-Depressive Symptoms and Quality of Life in Patients With an Implantable Cardioverter Defibrillator. Front Psychiatry. 2021 Nov 24;12:763726. doi: 10.3389/fpsyt.2021.763726. eCollection 2021.
- Kim JH, Kim YA, Song DY, Cho HB, Lee HB, Park JH, Lim JI, Hong MH, Chae PK, Yoo HJ. An Intervention Program Targeting Daily Adaptive Skills Through Executive Function Training for Adults with Autism Spectrum Disorder: A Pilot Study. Psychiatry Investig. 2021 Jun;18(6):513-522. doi: 10.30773/pi.2020.0423. Epub 2021 Jun 24.
- Kim YS, Leventhal BL, Koh YJ, Fombonne E, Laska E, Lim EC, Cheon KA, Kim SJ, Kim YK, Lee H, Song DH, Grinker RR. Prevalence of autism spectrum disorders in a total population sample. Am J Psychiatry. 2011 Sep;168(9):904-12. doi: 10.1176/appi.ajp.2011.10101532. Epub 2011 May 9.
- Vaasjo E, Black SR, Pastor A, Whiteside DP. ASSESSING THE HUMORAL RESPONSE TO AND SAFETY OF A COMMERCIALLY AVAILABLE EQUINE WEST NILE VIRUS VACCINE IN A ZOO-BASED CONSERVATION BREEDING POPULATION OF ENDANGERED GREATER SAGE-GROUSE (CENTROCERCUS UROPHASIANUS). J Zoo Wildl Med. 2021 Jun;52(2):732-736. doi: 10.1638/2020-0076.
- Kim JH, Song DY, Han HS, Yoon NH, Cho HB, Lee HB, Choi KH, Chae PK, Bong G, Ahn S, Yoo HJ. Improving adaptive behaviors for autistic adults without intellectual disability through executive function training. Asian J Psychiatr. 2023 Jun;84:103579. doi: 10.1016/j.ajp.2023.103579. Epub 2023 Apr 5.
- Sabharwal V, Demos R, Snyder-Cappione J, Parker SE, Shaik-Dasthagirisaheb Y, Hunnewell J, Boateng J, Clarke K, Yuen R, Barnett E, Yarrington C, Taglauer E, Wachman EM. Cytokine levels in maternal and infant blood after COVID-19 vaccination during pregnancy in comparison with unvaccinated controls. J Reprod Immunol. 2023 Mar;156:103821. doi: 10.1016/j.jri.2023.103821. Epub 2023 Jan 29.
- Kasari C, Freeman S, Paparella T. Joint attention and symbolic play in young children with autism: a randomized controlled intervention study. J Child Psychol Psychiatry. 2006 Jun;47(6):611-20. doi: 10.1111/j.1469-7610.2005.01567.x.
- Jacob A, Scott M, Falkmer M, Falkmer T. The Costs and Benefits of Employing an Adult with Autism Spectrum Disorder: A Systematic Review. PLoS One. 2015 Oct 7;10(10):e0139896. doi: 10.1371/journal.pone.0139896. eCollection 2015.
- Hong M, Lee SM, Park S, Yoon SJ, Kim YE, Oh IH. Prevalence and Economic Burden of Autism Spectrum Disorder in South Korea Using National Health Insurance Data from 2008 to 2015. J Autism Dev Disord. 2020 Jan;50(1):333-339. doi: 10.1007/s10803-019-04255-y.
- Novak AM, Katz A, Bitan M, Lev-Ari S. The Association between the Sense of Coherence and the Self-Reported Adherence to Guidelines during the First Months of the COVID-19 Pandemic in Israel. Int J Environ Res Public Health. 2022 Jun 30;19(13):8041. doi: 10.3390/ijerph19138041.
- Gao H, Xu S, Yang L, Hu X. The double-edged sword effect of argumentative scaffolding on group discussion in an adaptive discussion system. Front Psychol. 2022 Nov 10;13:997522. doi: 10.3389/fpsyg.2022.997522. eCollection 2022.
- Factor RS, Rea HM, Laugeson EA, Scarpa A. Examining Feasibility and Outcomes of the PEERS(R) for Preschoolers Program. J Autism Dev Disord. 2023 May;53(5):1821-1833. doi: 10.1007/s10803-022-05502-5. Epub 2022 Mar 10.
- Factor RS, Glass L, Baertschi D, Laugeson EA. Remote PEERS(R) for preschoolers: A pilot parent-mediated social skills intervention for young children with social challenges over telehealth. Front Psychiatry. 2022 Nov 29;13:1008485. doi: 10.3389/fpsyt.2022.1008485. eCollection 2022.
- Antezana L, Albright J, Scarpa A, Richey JA, Laugeson EA, Factor RS. PEERS(R) for Preschoolers preliminary outcomes and predictors of treatment response. J Autism Dev Disord. 2023 Dec;53(12):4671-4684. doi: 10.1007/s10803-022-05724-7. Epub 2022 Sep 14.
- Oh M, Laugeson E, Kim JH, Lee K, Kim J, Lee S, Lim B, Cha S, Bong G, Yoon NH, Bahn GH, Yoo HJ. A Randomized Controlled Trial of the Korean Version of the Program for the Education and Enrichment of Relational Skills for Young Adults (PEERS(R)-YA-K) With Autism Spectrum Disorder: A Pilot Study. Front Psychiatry. 2021 Oct 6;12:730448. doi: 10.3389/fpsyt.2021.730448. eCollection 2021.
- Son C, Yoo HJ, Kim JH, Oh M. Mood and Emotional Changes After PEERS(R) Program in Parents of Young Adults With Autism Spectrum Disorder. J Korean Acad Child Adolesc Psychiatry. 2023 Jan 1;34(1):30-36. doi: 10.5765/jkacap.220023.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-2601-1021-001
- 02-2025-0004 (Other Grant/Funding Number: Seoul National University Bundang Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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