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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03310775
Other study ID # B-1611-371-303
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 9, 2016
Est. completion date October 30, 2018

Study information

Verified date November 2016
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date October 30, 2018
Est. primary completion date October 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 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.
baseline,4 month
Secondary 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
baseline,4 month
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