Parent-supported Social Skills Training for Teens With Autism Spectrum Disorders (PEERS-K)

Autism Spectrum Disorders Clinical Trial

Official title:

Parent-Assisted Social Skill Training Program in the Adolescents With Autism Spectrum Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01501058
• Other study ID #: PEERSK2011
• Status: Active, not recruiting
• Phase: N/A
• First received: December 19, 2011
• Last updated: May 27, 2013
• Start date: December 2011
• Est. completion date: September 2013

Study information

• Verified date: May 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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 some of the survey will be retried in order to see mid- and long-term effects three months after the completion of the program.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: September 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• parent-assisted social skills training program for adolescents 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.
• Delayed intervention
Intervention is provided to Waitlist Control Group after waiting for 14 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline,3month	No
Secondary	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.	baseline,3month	No
Secondary	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.	baseline,3month	No