NCT03693313

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

12 months

First QC Date

June 6, 2018

Last Update Submit

October 29, 2019

Conditions

Keywords

ASD, Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

  • 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.

    40 weeks

  • 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.

    40 weeks

  • 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.

    40 weeks

Study Arms (2)

CrossFit KAMP Group 1

EXPERIMENTAL

14 weeks of CrossFit Kids exercise program

Behavioral: CrossFit Kids exercise program

CrossFit KAMP Wait-list Group

ACTIVE COMPARATOR

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

Interventions

Participants will be actively participating in a 14 week twice weekly CrossFit Kids exercise program.

CrossFit KAMP Group 1CrossFit KAMP Wait-list Group

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis MIND Institute

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized Wait List Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2018

First Posted

October 2, 2018

Study Start

September 4, 2018

Primary Completion

August 30, 2019

Study Completion

September 30, 2019

Last Updated

October 31, 2019

Record last verified: 2019-10

Locations