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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03310775
• Collaborator: (none)
• Enrollment: 47
• Arms: 2
• Actual Duration (Months): 23.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder; Autism	Behavioral: Parent-assisted social skills training program for young adult with ASD	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: The Effect of Korean Version of PEERS Social Skills Training for Young Adults (PEERS-YA-K) With Autism Spectrum Disorder
• Actual Study Start Date: Nov 9, 2016
• Actual Primary Completion Date: Oct 30, 2018
• Actual Study Completion Date: Oct 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: case group 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; 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.; Other Names: PEERS
Experimental: waitlist control group 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; 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.; Other Names: PEERS

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Autism Diagnostic Observation Schedule(ADOS) at 4 Month [baseline, after the completion of the treatment, 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.

2. Change From Baseline in Test of Young Adult Social Skills Knowledge(TYASSK) at 4 Month [baseline, 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.

3. Change From Baseline in Korean Version of the Social Skills Rating System (K-SSRS) at 4 Month [baseline,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

4. Change From Baseline in Social Responsiveness Scale-2 (SRS-2) at 4 Month [baseline,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

1. Korean Version of the Vineland Adaptive Behavior Scale, Second Edition [baseline,4 month]

   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.

2. Change From Baseline in Beck Depression Inventory (BDI) at 4month [baseline,4 month]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 6, 2020

More Information

Publications

None provided.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03310775
• Other Study ID Numbers: B-1611-371-303
• First Posted: Oct 16, 2017
• Last Update Posted: Sep 9, 2020
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seoul National University Hospital: Social skill training; PEERS
• Additional relevant MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive

Study Results

Participant Flow

Recruitment Details	The participants were recruited from the Child and Adolescent Psychiatric Clinic at Seoul National University Bundang Hospital, through advertisements at the Smile Together Foundation (a local advocacy institute of ASD), a community of child and adolescent psychiatrists, an internet group of families of youth with ASD.
Pre-assignment Detail	Ten participants were excluded during the randomization procedure; six were not adequately motivated, one did not meet the diagnosis of ASD, one had difficulty understanding self-report scales, one had a problem with school, and one had to fulfill a military commitment.

Arm/Group Title	Case Group	Waitlist Control Group
Arm/Group 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. Parent-assisted social skills training program for young adult with ASD: 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.	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 Parent-assisted social skills training program for young adult with ASD: 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.
Period Title: Overall Study
STARTED	19	18
COMPLETED	17	14
NOT COMPLETED	2	4

Baseline Characteristics

Arm/Group Title	Case Group	Waitlist Control Group	Total
Arm/Group 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. Parent-assisted social skills training program for young adult with ASD: 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.	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 Parent-assisted social skills training program for young adult with ASD: 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.	Total of all reporting groups
Overall Participants	19	18	37
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	19 100%	18 100%	37 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.3 (3.7)	23.5 (4.1)	23.4 (4.2)
Sex: Female, Male (Count of Participants)
Female	0 0%	1 5.6%	1 2.7%
Male	19 100%	17 94.4%	36 97.3%
Race/Ethnicity, Customized (Count of Participants)
Korean	19 100%	18 100%	37 100%
Region of Enrollment (Count of Participants)
South Korea	19 100%	18 100%	37 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Case Group	Waitlist Control Group
Arm/Group 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. Parent-assisted social skills training program for young adult with ASD: 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.	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 Parent-assisted social skills training program for young adult with ASD: 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.
Measure Participants	17	14
communication	3.3 (1.0)	3.6 (1.3)
social interaction	7.5 (2.1)	8.8 (2.3)
Stereotyped behaviors and restricted interests	1.0 (0.2)	1.1 (0.2)
Imagination	0.4 (0.6)	0.6 (0.1)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Case Group	Waitlist Control Group
Arm/Group 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. Parent-assisted social skills training program for young adult with ASD: 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.	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 Parent-assisted social skills training program for young adult with ASD: 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.
Measure Participants	17	14
Mean (Standard Deviation) [score on a scale]	17.5 (4.3)	21.7 (3.4)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Case Group	Waitlist Control Group
Arm/Group 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. Parent-assisted social skills training program for young adult with ASD: 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.	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 Parent-assisted social skills training program for young adult with ASD: 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.
Measure Participants	17	14
Mean (Standard Deviation) [score on a scale]	115.7 (32.5)	108.4 (26.3)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Case Group	Waitlist Control Group
Arm/Group 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. Parent-assisted social skills training program for young adult with ASD: 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.	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 Parent-assisted social skills training program for young adult with ASD: 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.
Measure Participants	17	14
Mean (Standard Deviation) [score on a scale]	146.5 (22.9)	147.9 (24.3)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Case Group	Waitlist Control Group
Arm/Group 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. Parent-assisted social skills training program for young adult with ASD: 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.	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 Parent-assisted social skills training program for young adult with ASD: 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.
Measure Participants	17	14
communication	75.0 (13.4)	70.5 (16.4)
daily living skills	78.3 (16.5)	74.4 (20.9)
socialization	71.9 (18.3)	65.9 (12.7)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Case Group	Waitlist Control Group
Arm/Group 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. Parent-assisted social skills training program for young adult with ASD: 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.	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 Parent-assisted social skills training program for young adult with ASD: 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.
Measure Participants	17	14
Mean (Standard Deviation) [score on a scale]	12.8 (10.2)	14.5 (11.4)

Adverse Events

Time Frame	no adverse event through study completion, an average of 1 year
Arm/Group Title	Case Group		Waitlist Control Group
Arm/Group 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. Parent-assisted social skills training program for young adult with ASD: 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.		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 Parent-assisted social skills training program for young adult with ASD: 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.
All Cause Mortality
	Case Group		Waitlist Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/18 (0%)
Serious Adverse Events
	Case Group		Waitlist Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Case Group		Waitlist Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.