The Effects of ProFoveate on Reducing Self-Stimulating Behaviors

University of Arkansas

Status: Terminated

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

Treatments: Device: ProFoveate

Study type: Interventional

Funder types: Other

Identifiers

NCT02088047

202241

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Profoveate

Experimental group

Description:

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.

Treatment:

Device: ProFoveate

NonProFoveate

No Intervention group

Description:

Participants in the control group will have no intervention. They will receive the initial pre testing (baseline) followed by post testing after 4 weeks.