NCT03912896

Brief Summary

This study uses a mixed methods design to understand the effectiveness of using taekwondo as an intervention for children with ASD and its effect on social interaction skills and everyday life. Qualitative research emphasizes that meaning can be explained and interpreted only by those who experience it. A pretest-posttest design will be used to describe what occurs after the introduction of the taekwondo intervention and understand the changes that occur after exposure. Collecting information through the lived experiences and observations from the parents will be collated with the pre and post results of the children participants' social interaction skills. Qualitative data will be collected through pre and post semi-structured interviews with the parents to understand their observations of their child before and after completing the taekwondo program. Interviews will also be conducted with the child to understand their perspectives on physical activity participation. Interview questions will also explore how the effectiveness of the program has impacted the children's engagement in daily activities. Quantitative research will be collected through pre and post results from the Autism Social Skills Profile-2 (\[ASSP\] assessment that will be completed by the parents. The ASSP-2 provides a comprehensive measure of social functioning for children and adolescents with ASD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 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

First Submitted

Initial submission to the registry

April 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 11, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

April 9, 2019

Last Update Submit

March 4, 2020

Conditions

Keywords

taekwondoAutism Spectrum Disorderoccupational therapySocial interaction skillschild participants

Outcome Measures

Primary Outcomes (1)

  • Subject response to taekwondo

    Autism Social Skills Profile-2 (ASSP-2) will be administered at baseline prior to taekwondo instruction and then administered again at week 7. The ASSP-2 has 49 items and each are rated on a 4-point Likert scale with a minimum score of 1 representing never and a maximum score 4 representing very often for each item. This is a composite measurement. The scale ranges from a total raw score of 49 to a maximum of 196. There are three subscales: 20 social/emotional reciprocity (SER) items, 11 structured play activity (SPA) items, and 11 detrimental social behaviors (DSB) items. One component skill is measured as both an SER and SPA subscale. Standard scores have a mean of 100 and a standard deviation of 15. The higher the scores for each section means that the child does not have difficulties with social skills for that subscale. The lower the scores shows a deficit in each area.

    Change between baseline and week 7.

Study Arms (1)

Children with autism spectrum disorder

EXPERIMENTAL
Behavioral: Taekwondo

Interventions

TaekwondoBEHAVIORAL

Children will participate in a 7-week taekwondo program.

Children with autism spectrum disorder

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Formal diagnosis of autism spectrum disorder (ASD)
  • Able to follow and understand English verbal instructions during the screening process.
  • No experience or prior experience with martial arts.
  • Able to walk and move without using adaptive equipment

You may not qualify if:

  • Physical disabilities that would prevent participation in taekwondo (e.g. wheelchair bound)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma LInda University Health

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Julie Kugel

    Loma Linda University Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, OTD Program Director

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 11, 2019

Study Start

June 11, 2019

Primary Completion

November 20, 2019

Study Completion

February 10, 2020

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations