The Effects of ProFoveate on Reducing Self-Stimulating Behaviors

Not Applicable

Terminated

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

• Registration Number: NCT02088047
• Lead Sponsor: University of Arkansas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-14
• Study Start: 2014-08-30
• Primary Completion: 2018-10-04
• Study Completion: 2018-10-04
• Results First Submitted: 2020-03-31
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-14
• Last Update Submitted: 2020-09-14
• Results First Posted: 2020-10-09
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Profoveate	ProFoveate	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.

Primary Outcome Measures

Name	Time	Method
Numbers of Self-stimulating Behaviors	Baseline to 4 Weeks	Only 4 participants completed enrollment.Only 3 participants completed study. Study was terminated due to low enrollment.

Trial Locations

Locations (1)

University of Arkansas at Little Rock Speech and Hearing Clinic; 🇺🇸 Little Rock, Arkansas, United States