Autism Spectrum DisorderNCT04418492
An Intervention Targeting Daily Adaptive Skills Through Executive Function Training for Adults With ASD
A study testing Skills for Adaptive Functioning through Executive training (SAFE; tentative title) in people with Autism Spectrum Disorder and High-functioning Autism, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Autism Spectrum Disorder, High-functioning Autism, Autism
- What is being tested?
- Skills for Adaptive Functioning through Executive training (SAFE; tentative title)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Dec 2019to 11 Mar 2020
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, High-functioning Autism, Autism
- Being tested
- Skills for Adaptive Functioning through Executive training (SAFE; tentative title)
- Keywords
- Autism Spectrum Disorder, High-functioning Autism, Autism, Executive Function, Intervention
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills for Adaptive Functioning through Executive training (SAFE; tentative title)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SAFE intervention | Experimental | The single group received the SAFE intervention for 10 weeks. Receives: Behavioral: Skills for Adaptive Functioning through Executive training (SAFE; tentative title) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 1 week before the intervention and 1-3 week after the intervention.
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.
Measured: 1 week before the intervention and 1-3 week after the intervention.
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.
Measured: 1 week before the intervention and 1-3 week after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start11 Dec 2019
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee Jeong Yoo, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418492
- Sponsor's protocol ID
- B-1904/537-302
- Status last verified
- May 2020
- First submitted
- 21 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention Program Targeting Daily Adaptive Skills Through Executive Function Training for Adults With Autism Spectrum Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT04418492
- Acronym / sponsor ID
- B-1904/537-302
- Conditions
- Autism Spectrum Disorder, High-functioning Autism, Autism
- Keywords
- Autism Spectrum Disorder, High-functioning Autism, Autism, Executive Function, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 5 Jun 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAFE intervention | Experimental | Behavioral: Skills for Adaptive Functioning through Executive training (SAFE; tentative title)The single group received the SAFE intervention for 10 weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Skills for Adaptive Functioning through Executive training (SAFE; tentative title)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. | Behavioural | SAFE intervention |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Hee Jeong Yoo principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skills for Adaptive Functioning through Executive training (SAFE; tentative title) in people with Autism Spectrum Disorder and High-functioning Autism, 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 2 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: finished, as of the sponsor's last update on 9 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 study lists 4 primary outcomes in all. 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 9 Jun 2020; AzTrials last refreshed its copy on 28 Oct 2026.