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The Effect of Korean Version of PEERS Social Skills Training for Young Adults (PEERS-YA-K) With Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder, Autism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Parent-assisted social skills training program for young adult with ASD
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Social skill training, PEERS

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18~35 years of age with ASD and IQ of 70 or over

Exclusion Criteria:

  • Young adults who are hard to understand the content of treatment and carry out the task due to their IQs or limited linguistic abilities
  • Young adults who are uncooperative in the treatment, lack motives and are hard to participate voluntarily
  • Young adults who have behavior problems so clinically significant that they affects the therapeutic procedure or problems in controlling their emotion and have psychotic symptoms

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    case group

    waitlist control group

    Arm Description

    Behavioral: parent-assisted social skills training program for young adults with autism spectrum disorder The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects.

    For this group, same intervention with the Experimental group will be provided after waiting for 16 weeks. Behavioral: Delayed intervention Intervention is provided to Waitlist Control Group after waiting for 16 weeks

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Autism Diagnostic Observation Schedule(ADOS) at 4 Month
    The ADOS is a play-based, semistructured, standardized assessment of communication, social interaction, and play (i.e. imaginative use of materials) for individuals with a suspected diagnosis of autism or ASD. The ADOS consists of four modules, each of which can be selected on the basis of the participant's expressive language skills and hronological age. Module 4 of the ADOS is designed for adolescents and adults with fluent speech, and includes 10 essential and 5 optional activities. The scores from each activity are coded as well as those for five subdomains: language and communication, reciprocal social interaction, imagination, stereotyped behaviors and restricted interests, and other abnormal behaviors. minimum 0, maximum 18, higherscores mean a worse outcome.
    Change From Baseline in Test of Young Adult Social Skills Knowledge(TYASSK) at 4 Month
    The TYASSK is a 22-item criterion-referenced test developed for this study to assess the teen's knowledge about the specific social skills taught during the intervention. Two items were derived from key elements of each of the 11 didactic lessons. Teens were presented with sentence stems and asked to choose the best option from two possible answers. Scores range from 0 to 22, with higher scores reflecting greater knowledge of teen social skills.
    Change From Baseline in Korean Version of the Social Skills Rating System (K-SSRS) at 4 Month
    The SSRS consists of 38-items and took approximately 10 min to complete. Questionnaires were completed independently by the teen's parent and teacher. For example, items included ''Starts conversations rather than waiting for someone to talk first.'' The items were rated as either ''Never,'' ''Sometimes,'' or ''Very Often.'' The Social Skills and Problem Behaviors scales were derived from factor analysis. minimum 50 and maximum 163, and higherscores mean a better outcome
    Change From Baseline in Social Responsiveness Scale-2 (SRS-2) at 4 Month
    The SRS is a 65-item questionnaire that assesses the various dimensions of interpersonal behavior, communication, and repetitive/stereotypic behavior that are characteristics of ASD. minimum 92, maximum 200, higherscores mean a worse outcome

    Secondary Outcome Measures

    Korean Version of the Vineland Adaptive Behavior Scale, Second Edition
    The K-VABS is an interviewed survey and measures adaptive behaviors of individuals such as personal and social skills, used for everyday living from birth to age 90. These are based on the reports of primary caregivers and teachers. The K-VABS contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior (optional). Behaviors are rated on a 0 (a skill that is not used by the individual) - 2 (a skill used most of the time) rating scale. The current study used only the communication, daily living skills, and socialization domains. minimum 25, maximum 108, higherscores mean a better outcome.
    Change From Baseline in Beck Depression Inventory (BDI) at 4month
    The BDI consists of 21 items measuring the severity of subjective symptoms of depression, with emotional, cognitive, motivational, and physiological symptom profiles for adults. Each question has four possible answer choices, scored from 0 (no symptoms) to 3 (the most severe symptoms). minimum 1, maximum 45, higherscores mean a worse outcome

    Full Information

    First Posted
    July 12, 2017
    Last Updated
    September 6, 2020
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03310775
    Brief Title
    The Effect of Korean Version of PEERS Social Skills Training for Young Adults (PEERS-YA-K) With Autism Spectrum Disorder
    Official Title
    The Effect of Korean Version of PEERS Social Skills Training for Young Adults (PEERS-YA-K) With Autism Spectrum Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 9, 2016 (Actual)
    Primary Completion Date
    October 30, 2018 (Actual)
    Study Completion Date
    October 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Despite the psychosocial difficulties common among young adults with autism spectrum disorders(ASD), little to no evidence-based social skills interventions exist for this population. Using a randomized controlled trial(RCT) design, the current study tested the effectiveness of an evidence-based, caregiver-assisted social skills intervention known as PEERS for Young Adults with high-functioning young adults with ASD using self- and caregiver-report measures.
    Detailed Description
    Both the case and the control of this study shall be a high-functioning group consisting of young adults aged 18 to 35 years with ASD and an IQ of 70 or over. A total of 48 young adults will be recruited and divided into two groups. One will be the case group and the other will be the waitlist control group. And the study will be going on 3 institutions. Again, the case will be divided into two sub-groups of ten and carry out this new developed program for both parents and young adult. That is, the program will be carried out two times in each of both groups. The waitlist control group will be allowed to receive personal outpatient treatment and general therapeutic intervention from community while waiting. Effects of the program will be measured both at the case and the control by using a scale which measures social interaction, quality of peer relationship, disposition of autism and social anxiety. Equal assessments for both the case and the control will be conducted right before the beginning of the program and right after the completion of the program and four months after the completion of the program.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder, Autism
    Keywords
    Social skill training, PEERS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    case group
    Arm Type
    Experimental
    Arm Description
    Behavioral: parent-assisted social skills training program for young adults with autism spectrum disorder The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects.
    Arm Title
    waitlist control group
    Arm Type
    Experimental
    Arm Description
    For this group, same intervention with the Experimental group will be provided after waiting for 16 weeks. Behavioral: Delayed intervention Intervention is provided to Waitlist Control Group after waiting for 16 weeks
    Intervention Type
    Behavioral
    Intervention Name(s)
    Parent-assisted social skills training program for young adult with ASD
    Other Intervention Name(s)
    PEERS
    Intervention Description
    The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Autism Diagnostic Observation Schedule(ADOS) at 4 Month
    Description
    The ADOS is a play-based, semistructured, standardized assessment of communication, social interaction, and play (i.e. imaginative use of materials) for individuals with a suspected diagnosis of autism or ASD. The ADOS consists of four modules, each of which can be selected on the basis of the participant's expressive language skills and hronological age. Module 4 of the ADOS is designed for adolescents and adults with fluent speech, and includes 10 essential and 5 optional activities. The scores from each activity are coded as well as those for five subdomains: language and communication, reciprocal social interaction, imagination, stereotyped behaviors and restricted interests, and other abnormal behaviors. minimum 0, maximum 18, higherscores mean a worse outcome.
    Time Frame
    baseline, after the completion of the treatment, 4 month
    Title
    Change From Baseline in Test of Young Adult Social Skills Knowledge(TYASSK) at 4 Month
    Description
    The TYASSK is a 22-item criterion-referenced test developed for this study to assess the teen's knowledge about the specific social skills taught during the intervention. Two items were derived from key elements of each of the 11 didactic lessons. Teens were presented with sentence stems and asked to choose the best option from two possible answers. Scores range from 0 to 22, with higher scores reflecting greater knowledge of teen social skills.
    Time Frame
    baseline, 4 month
    Title
    Change From Baseline in Korean Version of the Social Skills Rating System (K-SSRS) at 4 Month
    Description
    The SSRS consists of 38-items and took approximately 10 min to complete. Questionnaires were completed independently by the teen's parent and teacher. For example, items included ''Starts conversations rather than waiting for someone to talk first.'' The items were rated as either ''Never,'' ''Sometimes,'' or ''Very Often.'' The Social Skills and Problem Behaviors scales were derived from factor analysis. minimum 50 and maximum 163, and higherscores mean a better outcome
    Time Frame
    baseline,4 month
    Title
    Change From Baseline in Social Responsiveness Scale-2 (SRS-2) at 4 Month
    Description
    The SRS is a 65-item questionnaire that assesses the various dimensions of interpersonal behavior, communication, and repetitive/stereotypic behavior that are characteristics of ASD. minimum 92, maximum 200, higherscores mean a worse outcome
    Time Frame
    baseline,4 month
    Secondary Outcome Measure Information:
    Title
    Korean Version of the Vineland Adaptive Behavior Scale, Second Edition
    Description
    The K-VABS is an interviewed survey and measures adaptive behaviors of individuals such as personal and social skills, used for everyday living from birth to age 90. These are based on the reports of primary caregivers and teachers. The K-VABS contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior (optional). Behaviors are rated on a 0 (a skill that is not used by the individual) - 2 (a skill used most of the time) rating scale. The current study used only the communication, daily living skills, and socialization domains. minimum 25, maximum 108, higherscores mean a better outcome.
    Time Frame
    baseline,4 month
    Title
    Change From Baseline in Beck Depression Inventory (BDI) at 4month
    Description
    The BDI consists of 21 items measuring the severity of subjective symptoms of depression, with emotional, cognitive, motivational, and physiological symptom profiles for adults. Each question has four possible answer choices, scored from 0 (no symptoms) to 3 (the most severe symptoms). minimum 1, maximum 45, higherscores mean a worse outcome
    Time Frame
    baseline,4 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18~35 years of age with ASD and IQ of 70 or over Exclusion Criteria: Young adults who are hard to understand the content of treatment and carry out the task due to their IQs or limited linguistic abilities Young adults who are uncooperative in the treatment, lack motives and are hard to participate voluntarily Young adults who have behavior problems so clinically significant that they affects the therapeutic procedure or problems in controlling their emotion and have psychotic symptoms

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34690837
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    The Effect of Korean Version of PEERS Social Skills Training for Young Adults (PEERS-YA-K) With Autism Spectrum Disorder

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