Physical Exercise ConditionPETRANCT02902952
Physical Exercise to Reduce Anxiety in Underserved Children With ASD
A study testing Physical Exercise in people with Physical Exercise Condition and Control Condition, run by University of California, Irvine at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Exercise Condition, Control Condition
- What is being tested?
- Physical Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2016to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Thompson Center for Autism
Columbia, Missouri, 65211
2500 Red Hill Avenue
Santa Ana, California, 92705
About this study
Official title: Physical Exercise to Reduce Anxiety in Underserved Children With Autism Spectrum Disorders
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
- Being tested
- Physical Exercise, Control Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExerciseBehavioural
An eight week physical exercise intervention
Control InterventionBehavioural
An eight week sedentary control intervention
| Study group | Role | What they receive |
|---|---|---|
| Physical Exercise Condition | Experimental | An eight week physical exercise intervention Receives: Behavioral: Physical Exercise |
| Control Condition | Active comparator | An eight week control condition consisting of sedentary activities Receives: Behavioral: Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety rating
Anxiety rating on the Child Behavior Checklist
Measured: Change from baseline at Week 8
Secondary outcomes (1)
Salivary Cortisol
Physiological parameter
Measured: Change from baseline at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Exercise ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, University of Missouri-Columbia
- Responsible party
- Principal investigator, Jean Gehricke, University of California, Irvine
- Investigators
- Jean Gehricke, Ph.D., Study chair, University of California, IrvineLea Ann Lowery, OTD/OTR-L, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902952
- Sponsor's protocol ID
- HS 2016-2859
- Acronym
- PETRA
- Status last verified
- Apr 2023
- First submitted
- 8 Sep 2016
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise to Reduce Anxiety in Underserved Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02902952
- Acronym / sponsor ID
- PETRA / HS 2016-2859
- Conditions
- Physical Exercise Condition, Control Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, University of Missouri-Columbia
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Exercise Condition | Experimental | Behavioral: Physical ExerciseAn eight week physical exercise intervention |
| Control Condition | Active comparator | Behavioral: Control InterventionAn eight week control condition consisting of sedentary activities |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ExerciseAn eight week physical exercise intervention | Behavioural | Physical Exercise Condition |
| Control InterventionAn eight week sedentary control intervention | Behavioural | Control Condition |
Primary outcome
Anxiety rating
Time frame: Change from baseline at Week 8
Anxiety rating on the Child Behavior Checklist
1 secondary outcome
Salivary Cortisol
Time frame: Change from baseline at Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Gehricke, Ph.D. study chair
University of California, Irvine
Lea Ann Lowery, OTD/OTR-L principal investigator
University of Missouri-Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise in people with Physical Exercise Condition and Control Condition, run by University of California, Irvine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety rating (time frame: Change from baseline at Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.