Physical Exercise to Reduce Anxiety in Underserved Children With ASD

Study Overview
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Brief Summary
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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.

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

Conditions
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Physical Exercise Condition, Control Condition

Intervention / Treatment
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* Behavioral: Physical Exercise
* Behavioral: Control Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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