- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01501058
Parent-supported Social Skills Training for Teens With Autism Spectrum Disorders (PEERS-K)
May 27, 2013 updated by: Seoul National University Hospital
Parent-Assisted Social Skill Training Program in the Adolescents With Autism Spectrum Disorder
This study aims to develop a parent-assisted social skills training program for adolescents with autism spectrum disorder(ASD) and verify therapeutic effects of the program through case-control study.
- Both the case and the control of this study shall be a high-functioning group consisting of adolescents aged 11 to 18 years with ASD and an IQ of 80 or over. A total of 40 adolescents will be recruited and divided into two groups of twenty. One will be the case group and the other will be the waitlist control group. Again, the case will be divided into two sub-groups of ten and carry out this new developed program for both parents and adolescents. 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 some of the survey will be retried in order to see mid- and long-term effects three months after the completion of the program.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seongnam, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 11 to 18 years with ASD and an IQ of 65 or over
Exclusion Criteria:
- Adolescents who are hard to understand the content of treatment and carry out the task due to their IQs or limited linguistic abilities
- Adolescents who are uncooperative in the treatment, lack motives and are hard to participate voluntarily
- Adolescents who have behavior problems so clinically significant that they affects the therapeutic procedure or problems in controlling their emotion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: case group
|
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.
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Other: waitlist control group
For this group, same intervention with the Experimental group will be provided after waiting for 14 weeks.
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Intervention is provided to Waitlist Control Group after waiting for 14 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Test of Adolescent Social Skills Knowledge(TASSK) at 3month
Time Frame: baseline,3month
|
The TASSK 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,3month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Social Skills Rating Scale (SSRS) at 3 month
Time Frame: baseline,3month
|
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.
|
baseline,3month
|
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Change from baseline in Friendship Qualities Scale (FQS) at 3month
Time Frame: baseline,3month
|
The FQS is a teen self-report measure that assesses the quality of best friendships.
It consists of 23 yes/no questions from five different subscales (Companionship, Closeness, Help, Security, and Conflict) and took approximately 10 min to complete.
Teens were instructed to identify their best friend and keep this friendship in mind while completing this measure.
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baseline,3month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Anticipated)
September 1, 2013
Study Registration Dates
First Submitted
December 19, 2011
First Submitted That Met QC Criteria
December 25, 2011
First Posted (Estimate)
December 29, 2011
Study Record Updates
Last Update Posted (Estimate)
May 29, 2013
Last Update Submitted That Met QC Criteria
May 27, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEERSK2011
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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