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

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ClinicalTrials.gov Identifier: NCT02902952
Recruitment Status : Recruiting
First Posted : September 16, 2016
Last Update Posted : March 29, 2021
Sponsor:
Collaborators:
Massachusetts General Hospital
University of Missouri-Columbia
Information provided by (Responsible Party):
Jean Gehricke, University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Physical Exercise Condition Control Condition Behavioral: Physical Exercise Behavioral: Control Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Exercise to Reduce Anxiety in Underserved Children With Autism Spectrum Disorders
Actual Study Start Date : October 2016
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical Exercise Condition
An eight week physical exercise intervention
Behavioral: Physical Exercise
An eight week physical exercise intervention

Active Comparator: Control Condition
An eight week control condition consisting of sedentary activities
Behavioral: Control Intervention
An eight week sedentary control intervention




Primary Outcome Measures :
  1. Anxiety rating [ Time Frame: Change from baseline at Week 8 ]
    Anxiety rating on the Child Behavior Checklist


Secondary Outcome Measures :
  1. Salivary Cortisol [ Time Frame: Change from baseline at Week 8 ]
    Physiological parameter



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902952


Contacts
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Contact: Jean Gehricke, Ph.D. 949-267-0491 jgehrick@uci.edu

Locations
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United States, California
2500 Red Hill Avenue Recruiting
Santa Ana, California, United States, 92705
Contact: Jean Gehricke, Ph.D.    949-267-0404    jgehrick@uci.edu   
Contact: Sharina Dyan Alejo, BS    949-267-0491    alejos@uci.edu   
Principal Investigator: Jean Gehricke, Ph.D.         
United States, Missouri
Thompson Center for Autism Not yet recruiting
Columbia, Missouri, United States, 65211
Contact: Lea Ann Lowery, OTD/OTR-L    573-884-2139    lowerylh@health.missouri.edu   
Contact: Katie Bellesheim, MA    573-884-7857    bellesheimk@mizzou.edu   
Sponsors and Collaborators
University of California, Irvine
Massachusetts General Hospital
University of Missouri-Columbia
Investigators
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Study Chair: Jean Gehricke, Ph.D. University of California, Irvine
Principal Investigator: Lea Ann Lowery, OTD/OTR-L University of Missouri-Columbia
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Responsible Party: Jean Gehricke, Associate Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02902952    
Other Study ID Numbers: HS 2016-2859
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Disease
Pathologic Processes