Physical Exercise to Reduce Anxiety in Underserved Children With ASD

Not Applicable

Completed

• Conditions: Control Condition; Physical Exercise Condition
• Interventions: Behavioral: Control Intervention; Behavioral: Physical Exercise

• Registration Number: NCT02902952
• Lead Sponsor: University of California, Irvine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Study Start: 2016-10
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Condition	Control Intervention	An eight week control condition consisting of sedentary activities
Physical Exercise Condition	Physical Exercise	An eight week physical exercise intervention

Primary Outcome Measures

Name	Time	Method
Anxiety rating	Change from baseline at Week 8	Anxiety rating on the Child Behavior Checklist

Secondary Outcome Measures

Name	Time	Method
Salivary Cortisol	Change from baseline at Week 8	Physiological parameter

Trial Locations

Locations (2)

2500 Red Hill Avenue; 🇺🇸 Santa Ana, California, United States

Thompson Center for Autism; 🇺🇸 Columbia, Missouri, United States