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Physical Exercise to Reduce Anxiety in Underserved Children With ASD

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02902952
Acronym
PETRA
Enrollment
148
Registered
2016-09-16
Start date
2016-10-31
Completion date
2020-01-31
Last updated
2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Control Condition, Physical Exercise Condition

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.

Interventions

BEHAVIORALPhysical Exercise

An eight week physical exercise intervention

BEHAVIORALControl Intervention

An eight week sedentary control intervention

Sponsors

Massachusetts General Hospital
CollaboratorOTHER
University of Missouri-Columbia
CollaboratorOTHER
University of California, Irvine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Anxiety ratingChange from baseline at Week 8Anxiety rating on the Child Behavior Checklist

Secondary

MeasureTime frameDescription
Salivary CortisolChange from baseline at Week 8Physiological parameter

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026