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Autism Spectrum DisorderNCT03310775

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

A study testing Parent-assisted social skills training program for young adult with ASD in people with Autism Spectrum Disorder and Autism, run by Seoul National University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Autism Spectrum Disorder, Autism
What is being tested?
Parent-assisted social skills training program for young adult with ASD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
No sites listed yet
Study dates
9 Nov 2016to 30 Oct 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

About this study

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.

Read the detailed description
  1. 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.
  2. 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.
Being tested
Parent-assisted social skills training program for young adult with ASD
Keywords
Social skill training, PEERS
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parent-assisted social skills training program for young adult with ASDBehavioural

    Also called PEERS

    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.

Study groups in NCT03310775
Study groupRoleWhat they receive
case groupExperimentalBehavioral: 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.
Receives: Behavioral: Parent-assisted social skills training program for young adult with ASD
waitlist control groupExperimentalFor 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
Receives: Behavioral: Parent-assisted social skills training program for young adult with ASD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline, after the completion of the treatment, 4 month

  2. 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.

    Measured: baseline, 4 month

  3. 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

    Measured: baseline,4 month

  4. 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

    Measured: baseline,4 month

Secondary outcomes (2)

  1. 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.

    Measured: baseline,4 month

  2. 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

    Measured: baseline,4 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2017
  2. Study start9 Nov 2016
  3. Primary completion30 Oct 2018
  4. Study completion30 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03310775
Sponsor's protocol ID
B-1611-371-303
Status last verified
Nov 2016
First submitted
12 Jul 2017
Last updated
9 Sep 2020
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34690837

Questions about this trial

What is this clinical trial studying?

A study testing Parent-assisted social skills training program for young adult with ASD in people with Autism Spectrum Disorder and Autism, run by Seoul National University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Autism Diagnostic Observation Schedule(ADOS) at 4 Month (time frame: baseline, after the completion of the treatment, 4 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03310775, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.

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