NCT04418492

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 11, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
Last Updated

June 9, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

May 21, 2020

Last Update Submit

June 7, 2020

Conditions

Keywords

Autism Spectrum DisorderHigh-functioning AutismAutismExecutive FunctionIntervention

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (1)

SAFE intervention

EXPERIMENTAL

The single group received the SAFE intervention for 10 weeks.

Behavioral: Skills for Adaptive Functioning through Executive training (SAFE; tentative title)

Interventions

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.

SAFE intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Hee Jeong Yoo

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2020

First Posted

June 5, 2020

Study Start

December 11, 2019

Primary Completion

March 11, 2020

Study Completion

March 11, 2020

Last Updated

June 9, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations