Back to resultsAn Intervention Targeting Daily Adaptive Skills Through Executive Function Training for Adults With ASD
Primary Purpose
Autism Spectrum Disorder, High-functioning Autism, Autism
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Skills for Adaptive Functioning through Executive training (SAFE; tentative title)
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, High-functioning Autism, Autism, Executive Function, Intervention
Eligibility Criteria
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.
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SAFE intervention
Arm Description
The single group received the SAFE intervention for 10 weeks.
Outcomes
Primary Outcome Measures
The change in the Korean version of Barkley Deficits in Executive Functioning Scale (K-BDEFS)
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.
The change in the Korean version of Vineland Adaptive Behavior Scale-II (K-Vineland-II)
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.
The change in the Community Integration Skills Assessment-2 (CISA-2)
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.
The change in the Cognitive Flexibility Inventory (CFI)
The Cognitive Flexibility Inventory assesses cognitive flexibility. The score range is 19-113. Higher score indicates better cognitive flexibility.
Secondary Outcome Measures
Full Information
NCT ID
NCT04418492
First Posted
May 21, 2020
Last Updated
June 7, 2020
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04418492
Brief Title
An Intervention Targeting Daily Adaptive Skills Through Executive Function Training for Adults With ASD
Official Title
An Intervention Program Targeting Daily Adaptive Skills Through Executive Function Training for Adults With Autism Spectrum Disorder: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 11, 2019 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
March 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, High-functioning Autism, Autism
Keywords
Autism Spectrum Disorder, High-functioning Autism, Autism, Executive Function, Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAFE intervention
Arm Type
Experimental
Arm Description
The single group received the SAFE intervention for 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Skills for Adaptive Functioning through Executive training (SAFE; tentative title)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change in the Korean version of Barkley Deficits in Executive Functioning Scale (K-BDEFS)
Description
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.
Time Frame
1 week before the intervention, between 5th and 6th session of the intervention and 1-3 week after the intervention.
Title
The change in the Korean version of Vineland Adaptive Behavior Scale-II (K-Vineland-II)
Description
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.
Time Frame
1 week before the intervention and 1-3 week after the intervention.
Title
The change in the Community Integration Skills Assessment-2 (CISA-2)
Description
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.
Time Frame
1 week before the intervention and 1-3 week after the intervention.
Title
The change in the Cognitive Flexibility Inventory (CFI)
Description
The Cognitive Flexibility Inventory assesses cognitive flexibility. The score range is 19-113. Higher score indicates better cognitive flexibility.
Time Frame
1 week before the intervention and 1-3 week after the intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Jeong Yoo
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Intervention Targeting Daily Adaptive Skills Through Executive Function Training for Adults With ASD
We'll reach out to this number within 24 hrs