Physical Exercise to Reduce Anxiety in Underserved Children With ASD

Control Condition Clinical Trial

— PETRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902952
• Other study ID #: HS 2016-2859
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: January 2020

Study information

• Verified date: April 2023
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Control Condition
• Disease
• Physical Exercise Condition

Intervention

Behavioral:
• Physical Exercise
An eight week physical exercise intervention
• Control Intervention
An eight week sedentary control intervention

Locations

Country	Name	City	State
United States	Thompson Center for Autism	Columbia	Missouri
United States	2500 Red Hill Avenue	Santa Ana	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Irvine	Massachusetts General Hospital, University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety rating	Anxiety rating on the Child Behavior Checklist	Change from baseline at Week 8
Secondary	Salivary Cortisol	Physiological parameter	Change from baseline at Week 8