staRt: Enhancing Speech Treatment With Smartphone-delivered Biofeedback
Phase: NA
Conditions: Speech Sound Disorder
Sponsor: New York University

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
staRt: Enhancing Speech Treatment With Smartphone-delivered Biofeedback 
 
Protocol NCT04474691 
Document generated June 10, 2020 
 
 

Section 4 - Protocol Synopsis (Study 187633)
	

	
		 		
	
!			"#
$
$%%
$	
	 			&$' $$
(	$%%)$*		$
	
		!			
	+$	 
		 $	$			



"
*
Type
Name
Description
,- 


 
'

./
"	

"			
		
	 
*			
	0$ 	


$	1$		
					
2
	
,- 


 
'

./
3	
*	 	
-	
			
/	$	
	

'.-'	.	/
	
,	
%%
2
	-45/ 
$	'.
+	
$452
"
$
			
$	#
	$	#45
1$		$


	67	

		


Is this an NIH-defined Phase III Clinical Trial?
❍
Yes
●
No
*8	
9
	+	
4.1.f. Masking
●
Yes
❍
No
❏Participant
❏Care Provider
❏Investigator
❏
✔Outcomes Assessor
4.1.g. Allocation
Randomized
:98
Type
Name
Time Frame
Brief Description
Tracking Number: GRANT12381145
Funding Opportunity Number: PA16-303 Received Date: Wed Apr 05
00:00:00 EDT 2017
McAllister Byun, Tara
Page 28
Final RPPR
                         Human Subject Report (staRt: Enhancing speech treatment with smartphone-delivered biofeedback)


;
	

%%$	
,	
$		
%%
!$	
		&$
		
!	"!		
			 
$	
	!
2-4 4: 45/%
%		454:	 $
%% 


5	$
<<$	
#
:$
4.5. Will the study use an FDA-regulated intervention?
❍
Yes
●
No
(*
 	
*
	-*/	*=$-*=/%
*!-*/
4.6. Is this an applicable clinical trial under FDAAA? (SEE
SECTION 6.6)
4.7. Dissemination Plan
McAllister_dissemination_plan.pdf
Tracking Number: GRANT12381145
Funding Opportunity Number: PA16-303 Received Date: Wed Apr 05
00:00:00 EDT 2017
McAllister Byun, Tara
Page 29
Final RPPR
                         Human Subject Report (staRt: Enhancing speech treatment with smartphone-delivered biofeedback)