NCT03310775

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Status
completed

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 Start

First participant enrolled

November 9, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

September 9, 2020

Completed
Last Updated

September 9, 2020

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

July 12, 2017

Results QC Date

March 6, 2019

Last Update Submit

September 6, 2020

Conditions

Keywords

Social skill trainingPEERS

Outcome Measures

Primary Outcomes (4)

  • 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.

    baseline, after the completion of the treatment, 4 month

  • 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.

    baseline, 4 month

  • 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

    baseline,4 month

  • 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

    baseline,4 month

Secondary Outcomes (2)

  • Korean Version of the Vineland Adaptive Behavior Scale, Second Edition

    baseline,4 month

  • Change From Baseline in Beck Depression Inventory (BDI) at 4month

    baseline,4 month

Study Arms (2)

case group

EXPERIMENTAL

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.

Behavioral: Parent-assisted social skills training program for young adult with ASD

waitlist control group

EXPERIMENTAL

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

Behavioral: Parent-assisted social skills training program for young adult with ASD

Interventions

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.

Also known as: PEERS
case groupwaitlist control group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Dr. Miae Oh
Organization
Kyunghee university hospital, Seoul, South Korea

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2017

First Posted

October 16, 2017

Study Start

November 9, 2016

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

September 9, 2020

Results First Posted

September 9, 2020

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share