Physical Exercise to Reduce Anxiety in Underserved Children With ASD

NCT02902952 | Completed DMC

• 1 other identifier: HS 2016-2859
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

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.

Conditions

Physical Exercise Condition; Control Condition

Outcome Measures

Primary Outcomes (1)

• Anxiety rating

  Anxiety rating on the Child Behavior Checklist

  Change from baseline at Week 8

Secondary Outcomes (1)

• Salivary Cortisol

  Change from baseline at Week 8

Study Arms (2)

Physical Exercise Condition

EXPERIMENTAL

An eight week physical exercise intervention

Behavioral: Physical Exercise

Control Condition

ACTIVE COMPARATOR

An eight week control condition consisting of sedentary activities

Behavioral: Control Intervention

Interventions

Physical Exercise BEHAVIORAL

An eight week physical exercise intervention

Physical Exercise Condition

Control Intervention BEHAVIORAL

An eight week sedentary control intervention

Control Condition

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• Massachusetts General Hospital: collaborator
• University of Missouri-Columbia: collaborator

Study Sites (2)

2500 Red Hill Avenue

Santa Ana, California, 92705, United States

Location

Thompson Center for Autism

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jean Gehricke, Ph.D.

  University of California, Irvine

  STUDY CHAIR

• Lea Ann Lowery, OTD/OTR-L

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 16, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)