- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03310775
The Effect of Korean Version of PEERS Social Skills Training for Young Adults (PEERS-YA-K) With Autism Spectrum Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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:
|
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 |
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Autism Diagnostic Observation Schedule(ADOS) at 4 Month
Time Frame: 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. |
baseline, after the completion of the treatment, 4 month
|
Change From Baseline in Test of Young Adult Social Skills Knowledge(TYASSK) at 4 Month
Time Frame: 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.
|
baseline, 4 month
|
Change From Baseline in Korean Version of the Social Skills Rating System (K-SSRS) at 4 Month
Time Frame: 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 |
baseline,4 month
|
Change From Baseline in Social Responsiveness Scale-2 (SRS-2) at 4 Month
Time Frame: 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 |
baseline,4 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Korean Version of the Vineland Adaptive Behavior Scale, Second Edition
Time Frame: 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. |
baseline,4 month
|
Change From Baseline in Beck Depression Inventory (BDI) at 4month
Time Frame: 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 |
baseline,4 month
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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-1611-371-303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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