- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03693313
The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP) (CrossFit KAMP)
October 29, 2019 updated by: University of California, Davis
The Centers for Disease Control and Prevention estimates that 1 in 59 U.S. children have been diagnosed with an autism spectrum disorder (ASD).
Peer relationships, social skills, and repetitive behaviors are a challenge for those with ASD.
Exercise in the ASD population has been examined as a means to improve some of these challenges for children with ASD.
This research study will try to see if a structured exercise program called CrossFit Kids can help with these challenges.
This study is potentially beneficial in developing an exercise program for children with ASD that can help promote social skill development, reduce stereotypical behaviors, and provide overall health benefits.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- UC Davis MIND Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 11 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical Diagnosis of Autism Spectrum Disorder
- Full Scale IQ >80 on standardized testing
- English speaking
- Parents must be able to bring children to class twice a week for 14 weeks.
Exclusion Criteria:
- Non-English speaking
- Medical condition or physical impairment precluding them from safely participating in classes (eg. spastic quadriplegic cerebral palsy, critical congenital heart disease, uncontrolled asthma, uncontrolled seizure disorder, etc.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CrossFit KAMP Group 1
14 weeks of CrossFit Kids exercise program
|
Participants will be actively participating in a 14 week twice weekly CrossFit Kids exercise program.
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ACTIVE_COMPARATOR: CrossFit KAMP Wait-list Group
Waitlist group that waits 14 weeks while group 1 does exercise program.
After first 14 weeks will then participate in 14 weeks of CrossFit Kids exercise program
|
Participants will be actively participating in a 14 week twice weekly CrossFit Kids exercise program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in social skills in children with ASD
Time Frame: 40 weeks
|
The Social Responsiveness Scale, 2nd edition is a parent questionnaire that describes difficulties in socialization, communication, and repetitive/restricted interests.
The SRS includes parent and teacher evaluations and provides quantitative subscales that can distinguish the presence of ASD from other child psychiatric conditions.
Scale will be administered pre CrossFit Kids intervention, after the 14 weeks of CrossFit Kids and then 8 weeks after the intervention of CrossFit Kids.
Total T-score ranges 59 and below=within normal limits; 60-65 =mild range, 66-75 =moderate range, 76 or higher = severe range.
Lower T-score means participant is less affected.
|
40 weeks
|
Improvement in behavioral symptoms in children with ASD
Time Frame: 40 weeks
|
The Behavioral Symptoms Index on the Behavioral Assessment System for Children, 3rd edition (BASC-3).
Parent report is a parent rating scale that will be used as a general behavioral screen for comorbidities (hyperactivity, other externalizing behaviors, depression, etc.).
Scale will be administered pre CrossFit Kids intervention, after the 14 weeks of CrossFit Kids and then 8 weeks after the intervention of CrossFit Kids.
T scores are as follows 60 or less= within normal limits, 60-70 =at risk, 70 or higher= clinically significant.
Lower T-score means less behavioral symptoms.
|
40 weeks
|
Improvement in repetitive behaviors in children with ASD
Time Frame: 40 weeks
|
The Repetitive Behavior Scale Revised (RBS-R) is a parent questionnaire that measures six subscales of repetitive behavior including: Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Routine Behavior, Sameness Behavior, and Restricted Behavior in those with ASD.
Scale will be administered pre CrossFit Kids intervention, after the 14 weeks of CrossFit Kids and then 8 weeks after the intervention of CrossFit Kids.
Higher total scores on repetitive behavior scale are associated with higher amounts of repetitive behaviors.
|
40 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 4, 2018
Primary Completion (ACTUAL)
August 30, 2019
Study Completion (ACTUAL)
September 30, 2019
Study Registration Dates
First Submitted
June 6, 2018
First Submitted That Met QC Criteria
October 1, 2018
First Posted (ACTUAL)
October 2, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 31, 2019
Last Update Submitted That Met QC Criteria
October 29, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1235533
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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