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The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP) (CrossFit KAMP)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CrossFit Kids exercise program
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring ASD, Autism Spectrum Disorder

Eligibility Criteria

8 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • UC Davis MIND Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CrossFit KAMP Group 1

CrossFit KAMP Wait-list Group

Arm Description

14 weeks of CrossFit Kids exercise program

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

Outcomes

Primary Outcome Measures

Improvement in social skills in children with ASD
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.
Improvement in behavioral symptoms in children with ASD
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.
Improvement in repetitive behaviors in children with ASD
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.

Secondary Outcome Measures

Full Information

First Posted
June 6, 2018
Last Updated
October 29, 2019
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03693313
Brief Title
The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)
Acronym
CrossFit KAMP
Official Title
The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
ASD, Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized Wait List Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CrossFit KAMP Group 1
Arm Type
Experimental
Arm Description
14 weeks of CrossFit Kids exercise program
Arm Title
CrossFit KAMP Wait-list Group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
CrossFit Kids exercise program
Intervention Description
Participants will be actively participating in a 14 week twice weekly CrossFit Kids exercise program.
Primary Outcome Measure Information:
Title
Improvement in social skills in children with ASD
Description
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.
Time Frame
40 weeks
Title
Improvement in behavioral symptoms in children with ASD
Description
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.
Time Frame
40 weeks
Title
Improvement in repetitive behaviors in children with ASD
Description
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.
Time Frame
40 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Facility Information:
Facility Name
UC Davis MIND Institute
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

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The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)

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