- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04418492
An Intervention Targeting Daily Adaptive Skills Through Executive Function Training for Adults With ASD
June 7, 2020 updated by: Seoul National University Hospital
An Intervention Program Targeting Daily Adaptive Skills Through Executive Function Training for Adults With Autism Spectrum Disorder: A Pilot Study
The current study is a single group pilot study of a novel intervention program which targets improvements in executive functions and adaptive skills in transition age young adults with high-functioning autism spectrum disorder.
The main aim of the study is to test the effectiveness of the intervention using a pretest-posttest comparison.
It is hypothesised that there will be an increase in executive functions and adaptive skills after the intervention.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The participants engaged in a 10-week group-based intervention program which aims to improve daily adaptive skills based on executive functions and help the transition into adulthood in young adults with ASD.
Before and after the intervention, the participants and their parents completed questionnaires that measure executive functions and adaptive skills, and the participants additionally completed an assessment of social adaptive skills.
The differences between pre- and post-intervention scores of the outcome measures were analyzed using Wilcoxon signed-rank tests to evaluate the effect of the program.
Study Type
Interventional
Enrollment (Actual)
7
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
-
-
Gyeonggi-do
-
Seongnam, Gyeonggi-do, Korea, Republic of
- Seoul National University Bundang Hospital
-
-
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
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A clinical diagnosis of ASD as measured by the Autism Diagnostic Observation Schedule and the Autism Diagnostic Interview-Revised
- Full-scale IQ of 70 or above as measured by the Weschler Adult Intelligence Scale
Exclusion Criteria:
- Full-scale IQ less than 70
- Uncooperative and lacking motivation to participate in the programme
- Reporting clinically significant behavioural problems, emotion regulation problems, psychotic symptoms, risk of self-harm or harm to others which can affect the participation to the programme, which is screened by the screening assessments and interviews.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SAFE intervention
The single group received the SAFE intervention for 10 weeks.
|
An intervention program to improve adaptive skills and executive functions in young adults with high-functioning autism spectrum disorder was administered weekly for 10 weeks to the participants.
The participants also completed pre-, mid- and post-intervention assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in the Korean version of Barkley Deficits in Executive Functioning Scale (K-BDEFS)
Time Frame: 1 week before the intervention, between 5th and 6th session of the intervention and 1-3 week after the intervention.
|
The Korean version of Barkley Deficits in Executive Functioning Scale measures executive functions of adults in everyday life.
The score range is 89-356.
Higher score indicates worse executive functioning.
|
1 week before the intervention, between 5th and 6th session of the intervention and 1-3 week after the intervention.
|
The change in the Korean version of Vineland Adaptive Behavior Scale-II (K-Vineland-II)
Time Frame: 1 week before the intervention and 1-3 week after the intervention.
|
The Korean version of Vineland Adaptive Behavior Scale-II measures adaptive behavior.
The scores are converted into a standard score with a mean of 100 and a standard deviation of 15.
Higher score indicates better adaptive functioning.
|
1 week before the intervention and 1-3 week after the intervention.
|
The change in the Community Integration Skills Assessment-2 (CISA-2)
Time Frame: 1 week before the intervention and 1-3 week after the intervention.
|
The Community Integration Skills Assessment-2 measures adaptive skills necessary for people with developmental disorders to integrate into the community.
The scores are converted into a standard score with a mean of 100 and a standard deviation of 15.
Higher score indicates better community integration skills.
|
1 week before the intervention and 1-3 week after the intervention.
|
The change in the Cognitive Flexibility Inventory (CFI)
Time Frame: 1 week before the intervention and 1-3 week after the intervention.
|
The Cognitive Flexibility Inventory assesses cognitive flexibility.
The score range is 19-113.
Higher score indicates better cognitive flexibility.
|
1 week before the intervention and 1-3 week after the intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hee Jeong Yoo, Seoul National University Bundang Hospital
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 (Actual)
December 11, 2019
Primary Completion (Actual)
March 11, 2020
Study Completion (Actual)
March 11, 2020
Study Registration Dates
First Submitted
May 21, 2020
First Submitted That Met QC Criteria
June 2, 2020
First Posted (Actual)
June 5, 2020
Study Record Updates
Last Update Posted (Actual)
June 9, 2020
Last Update Submitted That Met QC Criteria
June 7, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1904/537-302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Autism Spectrum Disorder
-
Stanford UniversityCalifornia Department of Developmental ServicesRecruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
-
Hoffmann-La RocheActive, not recruitingAutism Spectrum Disorder (ASD)United States, Canada, Italy, Spain
-
Axial Therapeutics, Inc.Active, not recruitingAutism Spectrum Disorder (ASD)United States, Australia, New Zealand
-
Technion, Israel Institute of TechnologyCompleted
-
Stanford UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedAutism | Autism Spectrum Disorder (ASD)United States
-
Corporacion Parc TauliUnknown
-
Institut de Recherches Internationales ServierADIR, a Servier Group companyTerminatedAutism Spectrum Disorder (ASD)Spain, United States, Hungary, Poland, Australia, United Kingdom, Brazil, Czechia, France, Italy, Portugal, Slovakia
-
Florida Gulf Coast UniversityCompletedAutism Spectrum Disorder High-FunctioningUnited States
-
Hospital Universitario Dr. Jose E. GonzalezUnknownAutism | Autism SpectrumMexico
-
National Taiwan University HospitalCompletedAutism Spectrum Disorder High-FunctioningTaiwan