Autism Spectrum Disorders, Exhibit Self- Stimulating or Ritualistic Behaviors, Normal Hearing, Normal Intelligence
Conditions
Keywords
Autism, Self-Stimulating behaviors, Autism Spectrum Disorders
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.
Interventions
DEVICEProFoveate
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.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Profoveate The experimental group will receive the ProFoveate™ intervention along with pre (baseline) and post (end line)intervention assessment. | 3 |
| NonProFoveate Participants in the control group will have no intervention. They will receive the initial pre testing (baseline) followed by post testing after 4 weeks. | 1 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Profoveate | NonProFoveate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Numbers of Self-stimulating Behaviors
Only 4 participants completed enrollment.Only 3 participants completed study. Study was terminated due to low enrollment.
Time frame: Baseline to 4 Weeks
Population: Students were given a Social Skills Improvement System (SSiS). Only 4 participants completed enrollment. Only 3 participants completed study. Study was terminated due to low enrollment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Profoveate | Numbers of Self-stimulating Behaviors | 40 behaviors | Standard Deviation 7.24 |
| NonProFoveate | Numbers of Self-stimulating Behaviors | 27 behaviors | Standard Deviation 1.6 |