NCT01501058

Brief 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. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

6 months

First QC Date

December 19, 2011

Last Update Submit

May 27, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Change from baseline in Social Skills Rating Scale (SSRS) at 3 month

    baseline,3month

  • Change from baseline in Friendship Qualities Scale (FQS) at 3month

    baseline,3month

Study Arms (2)

case group

EXPERIMENTAL
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.

Behavioral: Delayed intervention

Interventions

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.

case group

Intervention is provided to Waitlist Control Group after waiting for 14 weeks

waitlist control group

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 18 years with ASD and an IQ of 65 or over

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2011

First Posted

December 29, 2011

Study Start

December 1, 2011

Primary Completion

June 1, 2012

Study Completion

September 1, 2013

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations