Autism Spectrum DisorderNCT03912896
Taekwondo for Children With Autism Spectrum Disorder
A study testing Taekwondo in people with Autism Spectrum Disorder, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Taekwondo
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2019to 10 Feb 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Physical disabilities that would prevent participation in taekwondo (e.g. wheelchair bound)
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma LInda University Health
Loma Linda, California, 92354
About this study
Official title: Taekwondo for Children With Autism Spectrum Disorder: The Impact on Social Interaction Skills in Everyday Life
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Taekwondo
- Keywords
- taekwondo, Autism Spectrum Disorder, occupational therapy, Social interaction skills, child participants
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaekwondoBehavioural
Children will participate in a 7-week taekwondo program.
| Study group | Role | What they receive |
|---|---|---|
| Children with autism spectrum disorder | Experimental | Not described Receives: Behavioral: Taekwondo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between baseline and week 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start11 Jun 2019
- Primary completion20 Nov 2019
- Study completion10 Feb 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 Loma Linda UniversityThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Kugel, Loma Linda University
- Investigators
- Julie Kugel, Principal investigator, Loma Linda University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912896
- Sponsor's protocol ID
- 5180418
- Status last verified
- Mar 2020
- First submitted
- 9 Apr 2019
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- 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 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taekwondo for Children With Autism Spectrum Disorder: The Impact on Social Interaction Skills in Everyday Life
- ClinicalTrials.gov ID
- NCT03912896
- Acronym / sponsor ID
- 5180418
- Conditions
- Autism Spectrum Disorder
- Keywords
- taekwondo, Autism Spectrum Disorder, occupational therapy, Social interaction skills, child participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 11 Apr 2019 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with autism spectrum disorder | Experimental | Behavioral: Taekwondo |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Physical disabilities that would prevent participation in taekwondo (e.g. wheelchair bound)
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 |
|---|---|---|
| TaekwondoChildren will participate in a 7-week taekwondo program. | Behavioural | Children with autism spectrum disorder |
Primary outcome
Subject response to taekwondo
Time frame: Change between baseline and week 7.
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.
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 6 Mar 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.
Julie Kugel principal investigator
Loma Linda University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taekwondo in people with Autism Spectrum Disorder, run by Loma Linda University at 1 site in United States.
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 4 inclusion and 1 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 6 Mar 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 United States. 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?
Subject response to taekwondo (time frame: Change between baseline and week 7.). 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 6 Mar 2020.