Physical Exercise to Reduce Anxiety in Underserved Children With ASD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2020-01-31

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.

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Detailed Description

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Conditions

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Physical Exercise Condition Control Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Physical Exercise Condition

An eight week physical exercise intervention

Group Type EXPERIMENTAL

Physical Exercise

Intervention Type BEHAVIORAL

An eight week physical exercise intervention

Control Condition

An eight week control condition consisting of sedentary activities

Group Type ACTIVE_COMPARATOR

Control Intervention

Intervention Type BEHAVIORAL

An eight week sedentary control intervention

Interventions

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Physical Exercise

An eight week physical exercise intervention

Intervention Type BEHAVIORAL

Control Intervention

An eight week sedentary control intervention

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes