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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: CrossFit KAMP Group 1
14 weeks of CrossFit Kids exercise program
Behavioral: CrossFit Kids exercise program
Participants will be actively participating in a 14 week twice weekly CrossFit Kids exercise program.
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
Behavioral: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Davis

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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