Autism Spectrum DisordersNCT01501058
Parent-supported Social Skills Training for Teens With Autism Spectrum Disorders (PEERS-K)
A study testing parent-assisted social skills training program for adolescents with autism spectrum disorder and Delayed intervention in people with Autism Spectrum Disorders, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. 1. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- parent-assisted social skills training program for adolescents with autism spectrum disorder and Delayed intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 11 to 18 years with ASD and an IQ of 65 or over
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, 463-707
About this study
Official title: 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.
- Conditions
- Autism Spectrum Disorders
- Being tested
- parent-assisted social skills training program for adolescents with autism spectrum disorder, Delayed intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parent-assisted social skills training program for adolescents with autism spectrum disorderBehavioural
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.
Delayed interventionBehavioural
Intervention is provided to Waitlist Control Group after waiting for 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| case group | Experimental | Not described Receives: Behavioral: parent-assisted social skills training program for adolescents with autism spectrum disorder |
| waitlist control group | Other | For this group, same intervention with the Experimental group will be provided after waiting for 14 weeks. Receives: Behavioral: Delayed intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Test of Adolescent Social Skills Knowledge(TASSK) at 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.
Measured: baseline,3month
Secondary outcomes (2)
Change from baseline in Social Skills Rating Scale (SSRS) at 3 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.
Measured: baseline,3month
Change from baseline in Friendship Qualities Scale (FQS) at 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.
Measured: baseline,3month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501058
- Sponsor's protocol ID
- PEERSK2011
- Status last verified
- May 2013
- First submitted
- 19 Dec 2011
- Last updated
- 29 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-Assisted Social Skill Training Program in the Adolescents With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT01501058
- Acronym / sponsor ID
- PEERSK2011
- Conditions
- Autism Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2013 (estimated)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | Experimental | Behavioral: parent-assisted social skills training program for adolescents with autism spectrum disorder |
| waitlist control group | Other | Behavioral: Delayed interventionFor this group, same intervention with the Experimental group will be provided after waiting for 14 weeks. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 11 to 18 years with ASD and an IQ of 65 or over
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parent-assisted social skills training program for adolescents with autism spectrum disorderThe 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. | Behavioural | case group |
| Delayed interventionIntervention is provided to Waitlist Control Group after waiting for 14 weeks | Behavioural | waitlist control group |
Primary outcome
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.
2 secondary outcomes
Change from baseline in Social Skills Rating Scale (SSRS) at 3 month
Time frame: baseline,3month
Change from baseline in Friendship Qualities Scale (FQS) at 3month
Time frame: baseline,3month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parent-assisted social skills training program for adolescents with autism spectrum disorder and Delayed intervention in people with Autism Spectrum Disorders, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Test of Adolescent Social Skills Knowledge(TASSK) at 3month (time frame: baseline,3month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013.