The Effects of ProFoveate on Reducing Self-Stimulating Behaviors

Study Overview
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Brief Summary
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This study is designed to pilot an intervention technique to reduce the self-stimulating behaviors seen in individuals with autism spectrum disorders using intervention with ProFoveate pellets. Self-stimulating behaviors like hand flapping, eye blinking, and rocking, can interfere with the individual's ability to interact with their peers. Participants will wear the pellets for four week and measures with taken again. Another group of participants will not get the pellets. Both groups will be tested at the beginning and end of the study. Any variations in self-stimulating behaviors will be documented through parent report, Observational data. The investigators hypothesize that they will see changes in self- stimulating behaviors as a result of the strategic placement of the ProFoveate™ pellets on the ears of one group of the participants.

Official Title
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The Effects of ProFoveate on Reducing Self-Stimulating Behaviors in Children Diagnosed With Autism Spectrum Disorders

Conditions
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Autism Spectrum Disorders, Normal Hearing, Normal Intelligence, Exhibit Self- Stimulating or Ritualistic Behaviors

Intervention / Treatment
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* Device: ProFoveate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a documented diagnosis of high functioning autism spectrum disorders (autism, Asperger's syndrome, or Pervasive Development Disorder (PDD) as reported by specialists who use the established criteria (American Psychiatric Association,2000) Pass a hearing screening at 25 decibels for the frequencies 1000, 2000 and 4000 hertz Score 85 or above on the Test of Nonverbal Intelligence- 4 (TONI-4; Brown, Sherbenou & Johnsen, 2009) Exhibit noticeable self- stimulating or ritualistic behaviors (i.e., scratching, hand flapping, eye blinks, etc.) and/or visual characteristics of Autism Spectrum Disorder (ASD) (sensitivity to light, visual fixations, poor eye contact, etc.) as reported by parents and/or observed on videos taken during assessment. Exclusion Criteria: Known history of latex allergy Intelligence Score below 85 Fail the hearing screening

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Profoveate<br>The experimental group will receive the ProFoveate™ intervention along with pre (baseline) and post (end line)intervention assessment. Steel pellets (1.2 mm) will be placed strategically on ears following instructions on how to use the ProFoveate™ pellets. Parents will be provided with a Patient Diary Sheet and will be instructed to perform and document daily checks for placement of the pellets. Parents will be given a one month supply of stainless steel pellets at the initial study visit. Child participants will wear the stainless steel ProFoveate™ pellets for four weeks. | Device: ProFoveate<br>* ProFoveate™ intervention for nystagmus is a management approach comprised of non-magnetic, 1.2 mm spheres that can be made from either stainless steel, gold plated stainless steel or titanium, placed strategically about the face and ears and a set of exercises designed to support improved vision for patients with nystagmus.The spheres (i.e., stimulating press balls or pellets) are supplied in packages of 20 with each sphere supplied on a transparent hypoallergenic adhesive tape approximately 7.6 mm in diameter. Within each package, all spheres are individually contained on a single paper backing measuring approximately 8.5 cm by 1.7 cm. Individual pellets (with adhesive tape) are removed from the backing as needed according to the prescribed treatment regimen.<br>|
| No Intervention: NonProFoveate<br>Participants in the control group will have no intervention. They will receive the initial pre testing (baseline) followed by post testing after 4 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of Self-stimulating Behaviors | Only 4 participants completed enrollment.Only 3 participants completed study. Study was terminated due to low enrollment. | Baseline to 4 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism, Self-Stimulating behaviors, Autism Spectrum Disorders