Trial Outcomes & Findings for The Effects of ProFoveate on Reducing Self-Stimulating Behaviors (NCT NCT02088047)
NCT ID: NCT02088047
Last Updated: 2020-10-09
Results Overview
Only 4 participants completed enrollment.Only 3 participants completed study. Study was terminated due to low enrollment.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
Baseline to 4 Weeks
Results posted on
2020-10-09
Participant Flow
Participant milestones
| Measure |
Profoveate
The experimental group will receive the ProFoveate™ intervention along with pre (baseline) and post (end line)intervention assessment.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Profoveate
The experimental group will receive the ProFoveate™ intervention along with pre (baseline) and post (end line)intervention assessment.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
The Effects of ProFoveate on Reducing Self-Stimulating Behaviors
Baseline characteristics by cohort
| Measure |
Profoveate
n=3 Participants
The experimental group will receive the ProFoveate™ intervention along with pre (baseline) and post (end line)intervention assessment.
|
NonProFoveate
n=1 Participants
Participants in the control group will have no intervention. They will receive the initial pre testing (baseline) followed by post testing after 4 weeks.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 WeeksPopulation: 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.
Only 4 participants completed enrollment.Only 3 participants completed study. Study was terminated due to low enrollment.
Outcome measures
| Measure |
Profoveate
n=3 Participants
The experimental group will receive the ProFoveate™ intervention along with pre (baseline) and post (end line)intervention assessment.
|
NonProFoveate
n=1 Participants
Participants in the control group will have no intervention. They will receive the initial pre testing (baseline) followed by post testing after 4 weeks.
|
|---|---|---|
|
Numbers of Self-stimulating Behaviors
|
40 behaviors
Standard Deviation 7.24
|
27 behaviors
Standard Deviation 1.6
|
Adverse Events
Profoveate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NonProFoveate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Betholyn Gentry
University of Arkansas for Medical Sciences
Phone: (501) 603-1010
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place