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Completed

NCT Number: NCT02902952

Physical Exercise to Reduce Anxiety in Underserved Children With ASD

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.

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Key information

Conditions

Physical Exercise Condition Control Condition

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2500 Red Hill Avenue, Santa Ana, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercise

Behavioral

An eight week physical exercise intervention

Control Intervention

Behavioral

An eight week sedentary control intervention

Primary outcomes

  1. Anxiety rating

    Time frame: Change from baseline at Week 8

    Anxiety rating on the Child Behavior Checklist

Secondary outcomes

  1. Salivary Cortisol

    Time frame: Change from baseline at Week 8

    Physiological parameter

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Massachusetts General Hospital
  • University of Missouri-Columbia

Registry information

Official study title

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

Acronym: PETRA

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2016
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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