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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04418492
Other study ID # B-1904/537-302
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 11, 2019
Est. completion date March 11, 2020

Study information

Verified date May 2020
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date March 11, 2020
Est. primary completion date March 11, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

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

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 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. 1 week before the intervention, between 5th and 6th session of the intervention and 1-3 week after the intervention.
Primary 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. 1 week before the intervention and 1-3 week after the intervention.
Primary 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. 1 week before the intervention and 1-3 week after the intervention.
Primary 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. 1 week before the intervention and 1-3 week after the intervention.
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