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

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status

Completed

Conditions

Physical Exercise Condition
Control Condition

Treatments

Behavioral: Physical Exercise
Behavioral: Control Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02902952
HS 2016-2859

Details and patient eligibility

About

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.

Enrollment

148 patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

148 participants in 2 patient groups

Physical Exercise Condition
Experimental group
Description:
An eight week physical exercise intervention
Treatment:
Behavioral: Physical Exercise
Control Condition
Active Comparator group
Description:
An eight week control condition consisting of sedentary activities
Treatment:
Behavioral: Control Intervention

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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