Physical Exercise to Reduce Anxiety in Underserved Children With ASD (PETRA)

April 3, 2023 updated by: Jean Gehricke, University of California, Irvine

Physical Exercise to Reduce Anxiety in Underserved Children With Autism Spectrum Disorders

Anxiety is one of the most frequent comorbidities in children with ASD leading to poor clinical outcomes. Physical exercise has been shown to be a promising and easy to implement intervention for reducing anxiety. However, little is known about the feasibility and efficacy of physical exercise to reduce anxiety in children with ASD from underserved, low-income families. Children with ASD, ages 6 - 12 years old from low-income and Latino families will be recruited for the study and assigned to an exercise intervention group and a sedentary control group. The physical exercise program is an eight-week program, administered three times per week in small groups. Compliance, parent-rated anxiety, and salivary cortisol will be measured before and after completion of the exercise and control group interventions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

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

  • United States
    • California
      • Santa Ana, California, United States, 92705
        • 2500 Red Hill Avenue
    • Missouri
      • Columbia, Missouri, United States, 65211
        • Thompson Center for Autism

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

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Autism Spectrum Disorder (ASD) Diagnosis 6-12 years old
  • ≥ 93rd percentile on CBCL or total score of ≥ 25 on SCARED
  • Able to attend 3x/week for 8 consecutive weeks
  • Able to follow instructions
  • CalOptima Insurance or Medicaid and ability to participate in moderate physical exercise

Exclusion Criteria:

  • Danger to themselves or others
  • Medical conditions that may pose a risk during exercise
  • Unable to participate in moderate physical exercise
  • Joining a regular physical exercise program in the last 4 weeks or planning to start or discontinue a regular physical exercise program in the next 8 weeks
  • Unable to attend 3x/week for 8 consecutive weeks
  • Visual, auditory or motor impairments, which would preclude participation in study activities

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical Exercise Condition
An eight week physical exercise intervention
Behavioral: Physical Exercise
An eight week physical exercise intervention
Active Comparator: Control Condition
An eight week control condition consisting of sedentary activities
Behavioral: Control Intervention
An eight week sedentary control intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety rating
Time Frame: Change from baseline at Week 8
Anxiety rating on the Child Behavior Checklist
Change from baseline at Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary Cortisol
Time Frame: Change from baseline at Week 8
Physiological parameter
Change from baseline at Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Massachusetts General Hospital
University of Missouri-Columbia

Investigators

  • Study Chair: Jean Gehricke, Ph.D., University of California, Irvine
  • Principal Investigator: Lea Ann Lowery, OTD/OTR-L, University of Missouri-Columbia

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)

October 1, 2016

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS 2016-2859

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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