Treatment of Severe Destructive Behavior: Functional Communication Training Versus Wait-List Control
Phase: NA
Conditions: Aggression, Self-Injurious Behavior
Sponsor: University of Nebraska

 
 
Munroe-Meyer Institute 
985450 Nebraska Medical Center, Omaha, NE 68198-5450 
04/15/2019 
 
Enclosed is the Institutional Review Board application for our study evaluating the treatment of severe 
destructive behavior: FCT versus wait-list control (363-15-FB; NCT02483572). This document was last 
approved by our Institutional Review Board on February 28, 2018 and downloaded on April 15, 2019. 
Note that the watermark indicates the application is “Inactive” because we closed the study’s application 
through our Institutional Review Board. 
 
 
 

I R B P R O T O C O L # 3 6 3- 1 5- F B
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P e di atri c B e h a vi or al a n d S o ci al S ci e n c e R e s e ar c h
S E C TI O N I
1. St at u s:  
♦ N e w S u b mi s si o n
R e vi s e d el e ctr o ni c I R B A p pli c ati o n; I R B # 
I niti al el e ctr o ni c s u b mi s si o n of a n e xi sti n g e x p e dit e d I R B a p pr o v e d pr ot o c ol; I R B # 
2. Titl e of Pr ot o c ol:  
Tr e at m e nt of s e v er e d e str u cti v e b e h a vi or: A r a n d o mi z e d cli ni c al tri al of f u n cti o n al
c o m m u ni c ati o n tr ai ni n g v er s u s w ait-li st c o ntr ol
3. R e s p o n si bl e P er s o n n el:  
A. Pri n ci p al I n v e sti g at or ( PI):
Fi s h er, W a y n e W - M MI Ctr f or A uti s m S p e c Di s or d - 4 0 2- 5 5 9- 8 8 6 3 - wfi s h er @ u n m c. e d u -
alt #: 4 0 2- 5 5 9- 8 8 6 3 - d e gr e e: P h. D., B C B A- D - a d dr e s s: M MI 2 0 6 7 A ( Zi p 5 4 5 0) - p h o n e:
9- 8 8 6 3
B. S e c o n d ar y I n v e sti g at or ( SI):
Gr e er, Bri a n D - M MI Ctr f or A uti s m S p e c Di s or d - 4 0 2- 5 5 9- 3 5 6 3 - bri a n. gr e er @ u n m c. e d u -
alt #: 4 0 2- 5 5 9- 8 8 6 3 - d e gr e e: P h. D., B C B A- D - a d dr e s s: H B M 1 0 2 5 ( Zi p 5 4 5 0) - p h o n e:
9- 8 8 7 0
Pi a z z a, C at hl e e n C - M MI Ctr f or P e d F e e di n g Di s or d - 4 0 2- 5 5 9- 8 8 6 3 - c pi a z z a @ u n m c. e d u
- alt #: 4 0 2- 5 5 9- 2 2 6 1 - d e gr e e: P h D, L P, B C B A- D - a d dr e s s: M MI 2 0 6 7 D ( Zi p 5 4 5 0) -
p h o n e: 9- 8 8 6 3
Z a n grill o, A m a n d a N - M MI Ctr f or A uti s m S p e c Di s or d - 4 0 2- 5 5 9- 8 8 6 6 -
a m a n d a. z a n grill o @ u n m c. e d u - alt #: 4 0 2- 5 5 9- 8 8 6 6 - d e gr e e: P s y D, B C B A D - a d dr e s s:
M MI 1 0 2 5 B ( Zi p 5 4 5 0) - p h o n e: 9- 8 8 6 6
C. P arti ci p ati n g P er s o n n el:
Bl o w er s, A n dr e w Pi er c e - M MI Ctr f or A uti s m S p e c Di s or d - 4 0 2- 5 5 9- 8 1 6 5 -
a n dr e w. bl o w er s @ u n m c. e d u - alt #: 4 0 2- 5 5 9- 8 1 6 4 - d e gr e e: M. A., B C B A - a d dr e s s: - p h o n e:
C h a m b erl ai n, N at a s h a M - M MI Ctr f or A uti s m S p e c Di s or d - 4 0 2- 5 5 9- 3 5 6 3 -
n at a s h a. c h a m b erl ai n @ u n m c. e d u - alt #: 4 0 2- 5 5 9- 3 5 6 3 - d e gr e e: B. S. - a d dr e s s: M MI 1 0 4 5
( Zi p 5 4 5 0) - p h o n e: 9- 3 5 6 3
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IRB PROTOCOL # 363-15-FB
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Clements, Andrea C - MMI CASD Early Intervention - 402-559-2432 -
aclements@unmc.edu - alt #: 402-559-2432 - degree: M.S.. BCBA - address: MMI 1082
(Zip 5450) - phone: 9-2432
Cole, Melinda K - MMI Ctr for Autism Spec Disord - 402-559-2403 -
melinda.cole@unmc.edu - alt #: 402-559-2403 - degree: B.A. - address: HBM 1027 (Zip
5450) - phone: 9-2403
Epperson, Danielle N - MMI CASD Severe Behavior - 402-559-3563 -
danielle.epperson@unmc.edu - alt #: 402-559-3563 - degree: n/a - address: HBM Room
1045 (Zip 5450) - phone: 9-3563
Guerrero, Lisa A - MMI Administration - 954-907-4795 - lisa.guerrero@unmc.edu - alt #:
402-559-8165 - degree: MA - address: 10315 NW 24 Pl Apt 310 Sunrise, FL (33322) -
phone: 954-907-4795
Hardee, Alexandra (Alex) M - MMI Ctr for Autism Spec Disord - 402-559-6341 -
alex.hardee@unmc.edu - alt #: 402-559-8164 - degree: BGS - address: MMI Room 2070
(Zip 5450) - phone: 402-559-8863
Hollie, Roshawn D - MMI CASD Severe Behavior - 402-559-6341 -
roshawn.hollie@unmc.edu - alt #: 402-559-3563 - degree: n/a - address: - phone:
Hurd, Alyssa M - MMI CASD Severe Behavior - 402-559-3563 - alyssa.hurd@unmc.edu - alt
#: 402-559-3563 - degree: B.A - address: HBM Room 1045 (Zip 5450) - phone: 9-3563
Iniguez, Adan - MMI CASD Severe Behavior - 402-559-3563 - adan.iniguez@unmc.edu - alt
#: 402-559-3563 - degree: B.A - address: HBM Room 1045 (Zip 5450) - phone: 9-3563
Jones, Jamie K - MMI Administration - 402-210-5806 - jamie.jones@unmc.edu - alt #:
402-559-8165 - degree: BA - address: 1135 Park Ave Apt 2 Omaha (68105) - phone:
402-210-5806
Kappel, Andrew P - MMI Ctr for Autism Spec Disord - 402-559-3563 -
andrew.kappel@unmc.edu - alt #: 402-559-3563 - degree: BSW - address: MMI-Behavior
Technician Room 1045 (Zip 5450) - phone: 9-3563
Keevy, Madeleine Diane - MMI Ctr for Autism Spec Disord - 402-559-8165 -
madeleine.keevy@unmc.edu - alt #: 402-559-8164 - degree: MA - address: MMI Room
CASD (Zip 5450) - phone: 402-559-8165
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IRB PROTOCOL # 363-15-FB
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Kimball, Ryan Taylor - MMI Ctr for Autism Spec Disord - 402-559-8164 -
ryan.kimball@unmc.edu - alt #: 402-559-8164 - degree: M.A., BCBA - address: MMI 1007
(Zip 5450) - phone: 402-559-8164
Lichtblau, Katherine (Katie) R - MMI Ctr for Ped Feeding Disord - 402-559-8898 -
katie.lichtblau@unmc.edu - alt #: 402-559-8898 - degree: MA, BCBA - address: HBM 1007
(Zip 5450) - phone: 402-559-8898
Luczynski, Kevin (Kevin) C - MMI CASD Virtual Care - 402-559-4056 -
kevin.luczynski@unmc.edu - alt #: 402-559-9056 - degree: Ph.D., BCBA - address: MMI
2065 (Zip 5450) - phone: 9-4056
Malugen, Emily C - MMI Administration - 402-559-6408 - emily.malugen@unmc.edu - alt #:
402-559-8165 - degree: MA - address: 9111 Clayton Rd St Louis, MO (63124) - phone:
314-954-2362
McKeown, Ciobha Anne - MMI Ctr for Autism Spec Disord - 402-559-8164 -
ciobha.mckeown@unmc.edu - alt #: 402-559-8165 - degree: MS - address: MMI 1007 (Zip
5450) - phone: 402-559-8164
McPheters, Malika J - MMI Ctr for Ped Feeding Disord - 402-559-6341 -
malika.mcpheters@unmc.edu - alt #: 402-559-8164 - degree: BA - address: MMI 1045 (Zip
5450) - phone: 9-6341
Miller, Cati R - MMI Ctr for Autism Spec Disord - 402-559-3563 - cati.miller@unmc.edu - alt
#: 402-559-3563 - degree: B.S. - address: MMI 1045 (Zip 5450) - phone: 9-3563
Mitteer, Daniel (Dan) R - MMI Ctr for Autism Spec Disord - 402-559-8165 -
dan.mitteer@unmc.edu - alt #: 402-559-8164 - degree: MA, BCBA - address: HBM 1007
(Zip 5450) - phone: 9-3563
Mohs, Ryan J - MMI Ctr for Autism Spec Disord - 402-559-3563 - ryan.mohs@unmc.edu -
alt #: 402-559-3563 - degree: BA - address: - phone:
Morris, Amanda M - MMI Ctr for Autism Spec Disord - 402-559-3563 -
amanda.morris@unmc.edu - alt #: 402-559-8164 - degree: N/A - address: HBM Room 1045
(Zip 5450) - phone: 9-3563
O'Donnell, Alexander J - MMI Ctr for Autism Spec Disord - 402-559-3563 -
alexander.odonnell@unmc.edu - alt #: 402-559-3563 - degree: B.S. - address: - phone:
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Owen, Todd M - MMI Ctr for Autism Spec Disord - 402-559-3563 - towen@unmc.edu - alt #:
402-559-3563 - degree: MA, BCBA - address: MMI 1050 (Zip 5450) - phone: 9-3563
Phillips, Lauren Amanda - MMI Ctr for Autism Spec Disord - 402-559-5939 -
lauren.phillips@unmc.edu - alt #: 402-559-8164 - degree: M.A., BCBA - address: MMI 1045
(Zip 5450) - phone: 402-559-5939
Ramirez, Paola P - MMI Ctr for Autism Spec Disord - 402-559-3563 -
paola.ramirez@unmc.edu - alt #: 402-559-8164 - degree: BA - address: MMI-HBM 1045
(Zip 5450) - phone: 9-3563
Randall, Kayla Rechelle - MMI Ctr for Autism Spec Disord - 402-559-8165 -
kayla.randall@unmc.edu - alt #: 402-559-8164 - degree: MEd, BCBA - address: MMI Room
1007 (Zip 5450) - phone: 402-559-8165
Retzlaff, Billie Jean - MMI Ctr for Autism Spec Disord - 402-559-8165 -
billie.klein@unmc.edu - alt #: 402-559-8165 - degree: M.A., BCBA - address: MMI 1045 (Zip
5450) - phone: 9-8165
Rowe, Sarah E - MMI Administration - 920-350-2412 - se.rowe@unmc.edu - alt #:
402-559-8164 - degree: N/A - address: HBM Room 1045 (Zip 5450) - phone: 9-3563
Smallwood, Kendra M - MMI Ctr for Autism Spec Disord - 402-559-3563 -
kendra.smallwood@unmc.edu - alt #: 402-559-3563 - degree: BA - address: MMI-Severe
Behavior Room 1045 (Zip 5450) - phone: 9-3563
Smoot, Ashley L - MMI CASD Severe Behavior - 402-559-3563 - ashley.smoot@unmc.edu -
alt #: 402-559-3563 - degree: n/a - address: HBM Room 1045 (Zip 5450) - phone: 9-3563
Sodawasser, Andrew J - MMI Ctr for Autism Spec Disord - 402-559-2441 -
andrew.sodawasser@unmc.edu - alt #: 402-559-3563 - degree: B.A. - address: MMI 1045
(Zip 5450) - phone: 9-2441
Swanson, Alicia J - MMI Ctr for Autism Spec Disord - 402-559-3563 -
alicia.swanson@unmc.edu - alt #: 402-559-3563 - degree: B.A. - address: HBM Room1045
(Zip 5450) - phone: 9-3563
Weber, Jessie K - MMI CASD Severe Behavior - 402-559-3563 - jessie.weber@unmc.edu -
alt #: 402-559-3563 - degree: BA - address: HBM Room 1045 (Zip 5450) - phone: 9-3563
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Z el e n y, J a s o n R o b ert - M MI Ctr f or P e d F e e di n g Di s or d - 4 0 2- 5 5 9- 7 3 6 3 -
jr z el e n y @ u n m c. e d u - alt #: 4 0 2- 5 5 9- 5 7 4 0 - d e gr e e: M A - a d dr e s s: M MI 2 0 6 7 B ( Zi p 5 4 5 0) -
p h o n e: 9- 7 3 6 3
Z e m a nti c, P atri ci a K - M MI A d mi ni str ati o n - - p atri ci a. z e m a nti c @ u n m c. e d u - alt #:
4 0 2- 5 5 9- 8 1 6 5 - d e gr e e: M A - a d dr e s s: 2 8 7 Cl u b h o u s e R d L e n o ur or, C T ( 0 6 2 4 9)
D. L e a d C o or di n at or:
F u hr m a n, A s hl e y M ari e - M MI Ctr f or A uti s m S p e c Di s or d - 4 0 2- 5 5 9- 3 5 6 3 -
a s hl e y.f u hr m a n @ u n m c. e d u - alt #: 4 0 2- 5 5 9- 3 5 6 3 - d e gr e e: M. A., B C B A, P L M H P - a d dr e s s:
H B M 1 0 5 0 ( Zi p 5 4 5 0) - p h o n e: 9- 3 5 6 3
E. C o or di n at or( s):
Willi a m s, C hri st y A n n - M MI Ctr f or A uti s m S p e c Di s or d - 4 0 2- 5 5 9- 8 8 6 3 -
c a willi 1 @ u n m c. e d u - alt #: 4 0 2- 5 5 9- 8 8 6 3 - d e gr e e: N/ A - a d dr e s s: H B M 2 0 7 0 ( Zi p 5 4 5 0) -
p h o n e: 9- 8 8 6 3
F. D at a a n d A d mi ni str ati v e P er s o n n el:
G o d s e y, A m b er J - M MI Ctr f or A uti s m S p e c Di s or d - 4 0 2- 5 5 9- 3 5 6 3 -
a m b er. g o d s e y @ u n m c. e d u - alt #: 4 0 2- 5 5 9- 3 5 6 3 - d e gr e e: B S - a d dr e s s: H B M 1 0 5 0 ( Zi p
5 4 5 0) - p h o n e: 9- 3 5 6 3
G. Ar e y o u a st u d e nt ?
N o
4. F u n di n g S o ur c e:  
C h e c k all t h at a p pl y a n d pr o vi d e t h e s o ur c e of t h e f u n di n g.
Gr a nt - Pr o vi d e S o ur c e: 
C o m m er ci al - Pr o vi d e c o m p a n y n a m e: 
D e p art m e nt of D ef e n s e 
♦ Ot h er - Pr o vi d e S o ur c e:  D e p art m e nt al f u n d s
C e nt er f or Cli ni c al a n d Tr a n sl ati o n s R e s e ar c h ( C C T R) 
5. C o ntr a ct:  
I s t h er e a c o ntr a ct or a gr e e m e nt a s s o ci at e d wit h t hi s st u d y ?
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N o
6. F u n di n g A g e n c y D e a dli n e f or I R B A p pr o v al:  
Y e s 
♦ N o
7. St u d y Sit e s:  
A. Pr o vi d e t h e n a m e s a n d l o c ati o n s of all st u d y sit e s w h er e t hi s r e s e ar c h will b e
c o n d u ct e d u n d er t h e o v er si g ht of t h e J oi nt P e di atri c I R B.
U ni v er sit y of N e br a s k a M e di c al C e nt er' s M u nr o e- M e y er I n stit ut e
B. I s t hi s a m ulti- sit e st u d y ?
N o
C. D o e s t hi s st u d y i n v ol v e a n y i nt er n ati o n al sit e s w h er e t h e PI will eit h er c o n d u ct or
s u p er vi s e t h e st u d y ?
N o
8. Pri n ci p al I n v e sti g at or A s s ur a n c e
T h e PI u n d er st a n d s a n d a c c e pt s t h e f oll o wi n g o bli g ati o n s t o pr ot e ct t h e ri g ht s
a n d w elf ar e of r e s e ar c h s u bj e ct s i n t hi s st u d y:  
I c ertif y t h at I h a v e c ar ef ull y r e vi e w e d t hi s a p pli c ati o n a n d all s u p p orti n g
d o c u m e nt s. I h a v e d et er mi n e d t h at t h e a p pli c ati o n i s a c c ur at e, c o m pl et e a n d
r e a d y f or s u b mi s si o n t o t h e I R B.
I c ertif y t h at I, a n d all li st e d r e s e ar c h p er s o n n el, h a v e t h e n e c e s s ar y
q u alifi c ati o n s a n d e x p erti s e t o c o n d u ct t hi s st u d y i n a m a n n er w hi c h f ull y
pr ot e ct s t h e ri g ht s a n d w elf ar e of r e s e ar c h s u bj e ct s.
I c ertif y t h at all li st e d r e s e ar c h p er s o n n el will b e gi v e n a c o p y of t h e fi n al I R B
a p pr o v e d a p pli c ati o n a n d a n y ot h er r el e v a nt st u d y r el at e d d o c u m e nt s i n
a c c or d a n c e wit h t h eir d efi n e d r e s p o n si biliti e s.
I r e c o g ni z e t h at a s t h e PI it i s m y r e s p o n si bilit y t o e n s ur e t h at t hi s r e s e ar c h a n d
t h e a cti o n s of all r e s e ar c h p er s o n n el i n v ol v e d i n c o n d u cti n g t h e st u d y will
c o m pl y f ull y wit h t h e I R B- a p pr o v e d pr ot o c ol, all a p pli c a bl e f e d er al r e g ul ati o n s,
st at e l a w s, a n d H R P P p oli ci e s.
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I recognize that it is my responsibility to ensure that valid informed
consent/assent has been obtained, as appropriate, from all research subjects or
their legally authorized representative (LARs). I will ensure that all research
personnel involved in the process of consent/assent are properly trained and
are fully aware of their responsibilities relative to the obtainment of informed
consent/assent according to applicable federal regulations, state laws, and
HRPP policies.
I certify that the minimum amount of protected health information (PHI) or other
identifiers necessary will be used and disclosed to conduct this research study
(if applicable). I will implement reasonable safeguards to protect the PHI/other
identifiers at all times.
I will promptly inform the IRB of any unanticipated problems involving risk to
the subjects or to others, as required within the time frame defined by HRPP
policies. I will analyze each reported problem to determine if it impacts the
risk-benefit relationship of the study, the safety of the subjects, or informed
consent.
I will promptly inform the IRB if I become aware of 1) any complaints from
research subjects, LARs, or others about research participation, 2) violations of
federal regulations or state law, 3) violations of the HIPAA Rule, or 4) violations
of HRPP policies.
I will not initiate any change in protocol without IRB approval except when it is
necessary to reduce or eliminate a risk to the subject, in which case the IRB will
be notified as soon as possible.
I certify that there are, or will be, adequate resources and facilities to safely
initiate, carry out and complete this research at the study sites specified in
Section I.7. This includes sufficient staff, funding, space, record keeping
capability, and resources necessary to address any unanticipated problems
involving risk to the subject or others. If the necessary resources become
unavailable I will promptly notify the IRB.
I will promptly inform the IRB of any significant negative change in the
risk/benefit relationship of the research as originally presented in the protocol
and approved by the IRB.
I understand that continuing review by the IRB is required at least annually in
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I R B P R O T O C O L # 3 6 3- 1 5- F B
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or d er t o m ai nt ai n a p pr o v al st at u s. I will m ai nt ai n I R B a p pr o v al a s l o n g a s t hi s
st u d y i s a cti v e.
I c ertif y t h at I a n d all ot h er p er s o n n el li st e d i n S e cti o n I. 3 A- E of t h e I R B
A p pli c ati o n h a v e di s cl o s e d all p ot e nti al fi n a n ci al c o nfli ct s of i nt er e st a s r e q uir e d
a n d ar e i n f ull c o m pli a n c e wit h t h e U N M C C o nfli ct of I nt er e st P oli c y a n d H R P P
p oli c y. I f urt h er c ertif y t h at all p ot e nti al fi n a n ci al c o nfli ct s of i nt er e st ar e
a p pr o pri at el y m a n a g e d i n or d er t o e n s ur e pr ot e cti o n of t h e ri g ht s a n d w elf ar e of
s u bj e ct s.
I will m ai nt ai n all r e q uir e d r e s e ar c h r e c or d s o n fil e a n d I r e c o g ni z e t h at
r e pr e s e nt ati v e s fr o m t h e I R B, O H R P, H H S, a n d ot h er F e d er al D e p art m e nt s or
A g e n ci e s m a y i n s p e ct t h e s e r e c or d s i n a c c or d a n c e wit h gr a nt e d a ut h orit y.
I u n d er st a n d t h at f ail ur e t o c o m pl y wit h t h e C o m m o n R ul e, a p pli c a bl e S u b p art s
B, C, a n d D of H H S r e g ul ati o n s at 4 5 C F R 4 6, t h e HI P A A R ul e, a p pli c a bl e st at e
l a w, H R P P p oli ci e s, a n d t h e pr o vi si o n s of t h e I R B- a p pr o v e d pr ot o c ol m a y r e s ult
i n s u s p e n si o n or t er mi n ati o n of I R B A p pr o v al of m y r e s e ar c h pr oj e ct a n d/ or
ot h er a d mi ni str ati v e or l e g al a cti o n s.
Fi s h er, W a y n e W - 2 0 1 8- 0 8- 3 0 0 9: 4 0: 0 0. 0 0 0
1 0. Pri n ci p al I n v e sti g at or Fi n a n ci al I nt er e st Di s cl o s ur e  
A. A s t h e PI, I c ertif y t h at I a m i n f ull c o m pli a n c e wit h U N M C C o nfli ct of I nt er e st P oli c y
# 8 0 1 0 a n d I d e cl ar e:
♦ I h a v e n o fi n a n ci al i nt er e st i n t hi s r e s e ar c h.
I h a v e a fi n a n ci al i nt er e st i n t hi s r e s e ar c h. I h a v e c o m pl et e d t h e U N M C Di s cl o s ur e of
P ot e nti al C o nfli ct of I nt er e st F or m  a n d o bt ai n e d all r e q uir e d si g n at ur e s. T h e ori gi n al
di s cl o s ur e f or m i s att a c h e d t o t hi s a p pli c ati o n. 
B. A s t h e PI,
♦ I u n d er st a n d t h at if t h er e i s a n y c h a n g e i n m y fi n a n ci al i nt er e st d uri n g t h e c o ur s e of t hi s
r e s e ar c h, I will u p d at e a n d s u b mit t h e U N M C Di s cl o s ur e of P ot e nti al C o nfli ct of I nt er e st
F or m wit hi n fi v e ( 5) b u si n e s s d a y s fr o m t h e ti m e t h e c h a n g e b e c o m e s k n o w n.
C. A s t h e PI w h o i s ulti m at el y r e s p o n si bl e f or t h e pr o p er c o n d u ct of t hi s r e s e ar c h, I al s o
c ertif y t h at:
♦ N o R e s p o n si bl e P er s o n n el h a v e a fi n a n ci al i nt er e st i n t hi s r e s e ar c h.
T h e R e s p o n si bl e P er s o n n el li st e d b el o w h a v e i nf or m e d m e t h at t h e y h a v e a fi n a n ci al
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interest in this research. 
D. I have informed all Responsible Personnel that if there is any change in their
financial interests during the course of this study it must be disclosed by submitting or
updating the required UNMC Disclosure of Potential Conflict of Interest Form.
Fisher, Wayne W - 2018-08-30 09:40:00.000
11. Scientific/Scholarly Merit and Resource Review Certification  
A. Scientific Reviewer:
Leibowitz, J (J Michael) Michael - Munroe-Meyer Institute - 402-559-5702 -
mleibowi@unmc.edu - alt #: 402-559-5702 - degree: PhD - address: - phone:
B. My signature certifies that this application has been reviewed for scientific/scholarly
merit and available resources. It has been determined that the application merits
consideration by the IRB based upon the following:
1) The proposal has an acceptable level of scientific/scholarly merit which
justifies the use of human subjects.
2) The proposal has a sound research design in consideration of the stated
objectives,
3) The PI has the necessary qualifications and experience to conduct this
research.
4) The PI has, or will have, the necessary funding to support this research.
5) There is or will be adequate physical space required for the research
interventions at all study sites specified in Section I.7. In addition, there is
adequate laboratory and clerical support, data storage capability, and any other
resources necessary to complete this research.
6) At all study sites specified in Section I.7, there are provisions to respond
promptly to unanticipated problems involving risk to the subject or others.
7) I will promptly notify the IRB if the necessary resources to support this
research become unavailable.
I am not listed as study personnel in Section I of this application.
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Leibowitz, J (J Michael) Michael - 2015-05-11 13:32:00.000
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SECTION II
PROTOCOL ABSTRACT
1. Provide a brief (less than 400 words) abstract of the research protocol.  
This summary should include: 1) the title of the protocol, 2) a brief description of the
purpose of the study, 3) eligibility criteria, 4) interventions and evaluations and 5)
follow-up.
Treatment of Severe Destructive Behavior: Functional Communication Training Versus
Waitlist Control
Children with an intellectual disability often display severe destructive behavior (e.g.,
aggression, self-injury) that pose risks to themselves or others and represent barriers to
community integration. Destructive behaviors are often treated with behavioral interventions
derived from a functional analysis, which is used to identify the antecedents and
consequences that occasion and reinforce the destructive behavior. One such treatment is
called functional communication training (FCT), which involves extinction of destructive
behavior and reinforcement of an alternative communication response with the
consequence that previously reinforced destructive behavior. Results from epidemiological
studies and meta-analyses indicate that treatments based on functional analysis, like FCT,
typically reduce destructive behavior by 90% or more and are more effective than other
treatments. However, many if not all of these studies have used within-subject experimental
designs to demonstrate control of the treatment effects. Replication of the effects of FCT is
typically shown on a subject-by-subject basis with relatively small numbers of patients (e.g.,
one to four patients). To our knowledge, no study has demonstrated the effectiveness of
FCT for treatment of destructive behavior across a large group of children.
The goal of this study is to compare FCT (which is used clinically with the majority of our
patients and is considered best practice for treating destructive behavior that occurs for
social reasons [e.g., to access attention, preferred toys, or to escape from unpleasant
activities]) to a waitlist control group across a large number of children with destructive
behavior to evaluate the generality of FCT effectiveness. We will evaluate rates of
destructive behavior with each patient during a pretest baseline and again following FCT
(approximately four months later) and/or the waitlist control duration (again, approximately
four months later). All children assigned to the waitlist-control condition will be offered FCT
services by our clinic at the end of the four-month waitlist period. These children will again
be tested following four months of FCT (i.e., posttest). Therefore, children assigned to the
FCT condition will be tested twice (one pretest and one posttest), and children assigned to
the waitlist-control condition will be tested thrice (one pretest, a second pretest following a
four-month waitlist period, and one posttest).
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We will pair participants to dyads and randomly assign one participant to the FCT condition
and one participant to the waitlist control condition. The exact duration of the waitlist
condition for one participant will be matched to the duration of the FCT participants
admission. Historically, most children complete FCT within four months.
PURPOSE OF THE STUDY AND BACKGROUND
2. Purpose of the Study  
What are the specific scientific objectives of the research?
The purpose of the current investigation is to evaluate the generality of FCT as treatment for
severe destructive behavior. Again, the effectiveness of FCT in treating destructive behavior
has been demonstrated repeatedly both in our clinic and in other clinics. We are specifically
interested in examining the percentage of this population that might benefit from FCT, as
well as identifying the subject characteristics of children for whom FCT is and is not
effective.
3. Background and Rationale  
Describe the background of the study. Include a critical evaluation of existing
knowledge and specifically identify the information gaps that the project is intended to
fill.
Children with an intellectual disability often display severe destructive behaviors (e.g.,
aggression, self-injury) that pose significant risks to self or others and represent
overwhelming barriers to community integration. These destructive behaviors are often
treated with behavioral interventions derived from a functional analysis, which is used to
identify the environmental antecedents and consequences that occasion and reinforce the
destructive behavior (Iwata, Dorsey, Slifer, Bauman, & Richman, 1982/1994). One such
treatment is called functional communication training (FCT), which involves extinction of
destructive behavior and reinforcement of an alternative communication response with the
consequence that previously reinforced destructive behavior (Carr & Durand, 1985). Results
from epidemiological studies and meta-analyses indicate that treatments based on
functional analysis, like FCT, typically reduce destructive behavior by 90% or more and are
much more effective than other treatments (Tiger, Hanley, & Bruzek, 2008). Despite these
impressive findings, there have been no randomized, controlled trials evaluating the
effectiveness of FCT. The goal of this study is to determine the robustness of FCT in
reducing severe destructive behavior as compared to a waitlist control group.
CHARACTERISTICS OF THE SUBJECT POPULATION
4. Accrual  
A. Is this study conducted solely at sites under the oversight of the Joint Pediatric IRB
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(e.g. UNMC, TNMC, CH&MC, UNO)?
Yes
1) What is the total number of subjects (per group, as applicable) needed to complete
the research in order to achieve the scientific objectives of the research?
We will initially randomize four participants to the immediate-treatment condition and four
participants to the wait-list control condition (total of 8 initial participants). Following these
eight participants, we will then conduct a power analysis to determine how many additional
participants are needed to achieve statistical power. Though our statistical analysis will
guide how many total participants we will need, we expect no more than 30 total children
(15 in each condition) will be needed to complete this study.
2) What is the statistical or other justification for the total number of subjects needed to
complete the research in order to achieve the scientific objectives of the research?
The total number of participants will be guided by our statistical power analysis. This power
analysis will be conducted following eight participants to determine if we need additional
data. We acknowledge that this may require a change in protocol in section II.4 (accrual).
3) Based on the anticipated number of subject withdrawals or other factors, what is the
maximum number of subjects that will need to be consented in order to achieve the
scientific objectives of the research?
We expect a maximum of 30 participants will be consented.
5. Gender of the Subjects  
A. Are there any enrollment restrictions based on gender?
No
6. Age Range of Subjects  
A. What is the justification for inclusion of children in this research?
All participants will be between 3 and 18 years of age when they are enrolled in the project.
We chose this age range because most individuals with severe destructive behavior are
initially referred at or around this age. The Severe Behavior Disorders Program primarily
serves children and youths and is specifically designed for this group.
B. What is the age range for the child subjects, and what is the justification for
selecting this age range?
The age range is 3-18 years old. We chose this age range because most individuals with
severe destructive behavior are initially referred at or around this age.
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C. Will t hi s st u d y e nr oll w ar d s of t h e st at e ?
N o
D. Will a d ult s ( 1 9 y e ar s of a g e or ol d er) b e i n cl u d e d i n t hi s r e s e ar c h ?
Y e s
1) W h at i s t h e j u stifi c ati o n f or i n cl u di n g a d ult s i n t h e r e s e ar c h ?
T h e c hil d' s p ar e nt s/ c ar e gi v er s will b e i n cl u d e d i n t h e r e s e ar c h t o c o n d u ct pr et e st a n d
p o stt e st s e s si o n s. T h e p ur p o s e of t h e i n cl u si o n of a d ult s i s t o c o nfir m t h at F C T eff e ct s
g e n er ali z e fr o m t h e t h er a pi st s t o t h e c ar e gi v er s.
2) W h at i s t h e a g e r a n g e of t h e a d ult s u bj e ct s t o b e i n cl u d e d i n t h e r e s e ar c h ?
1 9 t o 7 0 y e ar s ol d
3) W h at i s t h e r ati o n al e f or t h e a g e r a n g e of t h e s u bj e ct s ?
T hi s r a n g e e n c o m p a s s e s t h e a g e s of l e g al g u ar di a n s of c hil dr e n ( p ar e nt s or gr a n d p ar e nt s)
s e e n i n o ur cli ni c.
7. R a c e a n d Et h ni cit y  
Ar e t h er e a n y s u bj e ct e nr oll m e nt r e stri cti o n s b a s e d u p o n r a c e or et h ni c ori gi n ?
N o
8. V ul n er a bl e S u bj e ct s  
A. Will a n y of t h e f oll o wi n g v ul n er a bl e p o p ul ati o n s b e all o w e d t o p arti ci p at e i n t hi s
r e s e ar c h ? C h e c k all t h at a p pl y.
Pr e g n a nt i n di vi d u al s; f et u s e s 
Pri s o n er s 
♦ N o n e
B. Will a n y of t h e f oll o wi n g v ul n er a bl e p o p ul ati o n s ( St u d e nt s of t h e i n v e sti g at or,
E d u c ati o n all y di s a d v a nt a g e d i n di vi d u al s, S o ci all y or e c o n o mi c all y di s a d v a nt a g e d
i n di vi d u al s, I n di vi d u al s wit h a sti g m ati zi n g ill n e s s or c o n diti o n, Ot h er) b e s p e cifi c all y
r e cr uit e d f or e nr oll m e nt i n t hi s r e s e ar c h ?
N o
9. I n cl u si o n Crit eri a  
W h at ar e t h e s p e cifi c i n cl u si o n crit eri a ?
C hil d S u bj e ct s:
1.
B o y s a n d girl s b et w e e n t h e a g e s of 3 a n d 1 8;
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2. Destructive behavior (e.g., aggression, property destruction, SIB) that has been the
focus of outpatient behavioral and pharmacological treatment but continues to occur,
on average, more than once per hour;
3. Destructive behavior reinforced by social consequences (i.e., significantly higher and
stable rates of the behavior in one or more social test conditions of a functional
analysis [e.g., attention, escape] relative to the control condition [play] and the test
condition for automatic reinforcement [alone or ignore]);
4. On a stable psychoactive drug regimen (or drug free) for at least 10 half-lives of
each medicationwith no anticipated changes;
5. Stable educational plan and placement, with no anticipated changes during the
study.
6. Currently enrolled or on the waiting list for the Severe Behavior Clinic.
Adult Subjects (Caregivers):
1. Men and women between the ages of 19 and 70;
2. Who do not have any physical limitations that would prohibit them from conducting
sessions with their child (i.e., pregnant);
3. Have a child who is currently enrolled or on the waiting list for the Severe Behavior
Clinic.
10. Exclusion Criteria  
What are the specific exclusion criteria?
Child Subjects:
1. Children not meeting the inclusion criteria above;
2. Children currently receiving intensive (15 or more hours per week), function-based,
behavioral treatment for their destructive behavior through the school or another
program;
3. DSM-V diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn
error of metabolism);
4. Presence of a comorbid health condition (e.g., blindness) or major mental disorder
(e.g., bipolar disorder) that would interfere with participation in the study (e.g.,
requiring frequent hospitalizations);
5. Children with SIB who, based on the results of the risk assessment, cannot be
exposed to baseline conditions without placing them at risk of serious or permanent
harm (e.g., detached retinas);
6. Children requiring changes in drug treatment (but such children will be invited to
participate if they meet the above criteria 3 months after a stable drug regimen is
achieved).
Adult Subjects (Caregivers):
1. Adults who are outside the age range of 19 to 70
2. Pregnant mothers (for safety purposes)
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METHODS AND PROCEDURES
11. Methods and Procedures Applied to Human Subjects  
A. Describe sequentially all procedures, interventions, evaluations and tests.
Parent Baseline Pretest
Prior to FCT treatment or waitlist-control assignment, children and their parents will attend
clinic for 1 hour to conduct approximately 8 sessions that are each 5 minutes. During these
sessions, parents will interact with their children within four conditions. Therapists will use a
Bluetooth device to instruct the parents to implement the functional-analysis test conditions
(described in the sections below) as intended. During the attention condition, the parent will
be instructed to fill out relevant clinic documents rather than playing with the child and the
child's toy. Following target problem behavior, the therapist will prompt the parent to provide
20-s of attention. During the escape condition, the parent will be instructed to deliver a
variety of tasks or chores to the child that the parent reported as problematic according to a
3-step guided compliance procedure. Following target problem behavior, the therapist will
prompt the parent to provide a 20-s break. During the tangible condition, the parent will
remove a preferred toy from the child's reach and interact with the toy. Following problem
behavior, the therapist will prompt the parent to provide 20-s access to the toy. During the
toyplay (control) condition, parents will play with their children and provide continuous
access to the preferred toy from the tangible condition, a continuous break from instructions,
and attention every 30 s. Therapists will prompt parents to continue playing with the child if
the child engages in target problem behavior. Therapists will conduct approximately 15 to 30
sessions during each clinic visit for each child. Participants will be seen for 1.5 to 3 hour
visits, 1 to 5 days per week (depending on the client and parent's schedules) for 8 to 12
weeks. Parents typically spend 3 hours in the clinic during the first week of treatment in
order to determine goals for the child, to review treatment procedures, and to interact with
the child under controlled observations to inform assessment and treatment protocols.
We may also ask parents to complete a battery of tests to provide additional information on
the child's level of problem behavior prior to treatment. Specifically, we hope to obtain
additional information on the nature of the participant's problem behavior, how the problem
behavior affects the life of the participant and family, and any psychological stress or
difficulties as a result of the participant's problem behavior. The specific assessments used
will be the: (1) Home Situations Questionnaire, (2) Parental Stress Inventory, (3) Nisonger
Child Behavior Rating Form, (4) Vineland Adaptive Behavior Scales II, and (5) Functional
Analysis Screening Tool. Please see the attached documents for a copy of these
assessments. Each assessment will take caregivers a maximum of 30 minutes to complete,
for a maximum total duration of 2.5 hours. Each questionnaire, except for the Functional
Analysis Screening Tool (FAST) will be completed twice, once prior to admission and once
following successful treatment. We will offer the option for caregivers to complete these
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questionnaires over the course of two days each time we administer the questionnaires (at
the beginning and end of admission). The FAST will not be administered twice, as the
functional variables maintaining the child's problem behavior typically do not change in the
brief time the child is seen for treatment. With parental permission, we will also work with the
participant's school to acquire previously implemented inventories on communication skills,
grade level equivalence, intelligence quotient, and general school performance information.
Acquiring additional information of this sort is becoming best clinical practice in the Center
for Autism Spectrum Disorders. If the parent responds in a way that indicates high stress on
the Parental Stress Inventory and these scores remain high following successful treatment
and parent training, we may consult with the caregiver to determine what specific variables
are contributing to the maintenance of high stress and offer resources or referrals
accordingly. For example, if the parent's stress seems to stem from lack of time for other
siblings, work, or personal matters and this continues following successful treatment, we
may consult with the parent and make a referral to Munroe-Meyer Institute's Mark Smith to
learn about respite services for which the family might qualify.
Generalization probes (5 or 10 minute sessions) will be conducted regularly throughout the
session, equating to less than an hour of parent commitment. Finally, the last week of
treatment will consist of 8-15 hours of direct parent training in clinic and at home to ensure
that treatment effects generalize to the home environment with the clients' parents. The
amount of time required of the client and parent are the standards for typical clinical cases
in the Center for Autism Spectrum Disorders.
We will use controlled, single-case experimental designs (multi-element, reversal) to
conduct analyses and test clinical hypotheses for each child. We will interpret assessment
and treatment results for each child using structured, visual inspection criteria developed
and refined by our research team, which have demonstrated reliability, validity, and power to
detect differences between test and control conditions with individual children (Fisher,
Kelley, & Lomas, 2003; Hagopian et al., 1997). Any sessions recorded will only be obtained
for data collection purposes and will be maintained up to a month following a given session
on an encrypted UNMC server. After being maintained for up to a month following a given
session, recordings will be erased.
Functional analysis. We will conduct a functional analysis to determine if the child meets
inclusion criteria. Sessions will be 5 min in duration and the assessment should take about 1
week with 2-3 hour appointments 1-5 days a week. The functional analysis will take 1-3
weeks to complete (approximately 3 to 9, 2 to 3-hour study visits). The functional analysis
will include at least three test conditions (social attention, demand, and alone/ignore) and
one control condition (play). In accordance with best practice, we will include an additional
test condition (tangible) if the caregiver reports or is observed to provide preferred tangible
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items following destructive behavior. In the attention condition, the therapist will read while
asking the child to play with a moderately preferred toy. If the child emits a destructive
behavior, the therapist will deliver vocal (e.g., Stop that, you'll hurt yourself) and physical
(e.g., rubs the child's head) attention. In the demand condition, the therapist will deliver
non-preferred demands using sequential verbal, modeled, and physical prompts every 10 s.
Compliance will produce praise, noncompliance will result in physical guidance and no
praise, and destructive behavior will produce a 20-s break from demands. In the alone
condition, the child will be alone in a treatment room without any toys or materials. If the
child displays aggression, we will conduct an ignore condition instead of an alone condition,
during which a therapist will be in the room but will not interact with or respond to child
behavior. In the tangible condition, the therapist will give the child a highly preferred toy for 2
min prior to the session. The therapist will withdraw the toy at the start of the session and
return it to the child for 20 s contingent on destructive behavior. In the control condition
(play), the therapist will play with the child and deliver attention every 30 s for the absence
of destructive behavior. Children showing destructive behavior maintained by social
reinforcement (using the Hagopian et al. [1997] criteria), and who meet the other
inclusion/exclusion criteria described above, will be invited to participate in this project.
Dependent variables and measurement. The primary dependent measure will be the rate
of destructive behavior (aggression, property destruction, SIB) assessed via direct
observation. Aggression will be defined as forceful pushing or striking others with body parts
(e.g., pushing, hitting, kicking, head-butting), hitting others with objects or throwing objects
at others, pinching, scratching, or biting. Property destruction will be defined as forceful
banging, throwing, overturning, tearing or climbing on objects not made for that purpose.
SIB will be defined as forceful striking, scratching, rubbing, poking or biting ones own body
parts such that repetition of the behavior has or will cause bodily injury (e.g., head punching
or banging, eye-poking).
Observation, blinding, reliability and validity of dependent and procedural-integrity
measures. Trained observers will collect data on child destructive behavior and therapist (or
caregiver) implementation of the assessment and treatment protocols to assess procedural
integrity using DataPal®, software developed in our lab. A second observer will score at
least one third of sessions independently to assess data accuracy (reliability). The second
data collector will be blind to the projects research questions and hypotheses for one half
(17%) of these sessions. For at least one third of sessions, observers will collect
procedural-integrity data to determine whether the assessment and treatment protocols are
implemented as planned. That is, we will collect data on whether therapists correctly
implemented the planned antecedents, prompts, and consequences for each target
response. We will then transform the data into a percentage-correct measure by dividing the
number of correct therapist responses by the number of opportunities for a correct
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response.
The reliability of direct-observation measures is typically established through measurement
of inter-observer agreement. To calculate inter-observer agreement, sessions will be
partitioned into successive, 10-s intervals (e.g., seconds 0-9, 10-19, 20-29). In each 10-s
interval, we will determine whether the observers agreed or disagreed on the frequency of
each target behavior. An exact agreement will be defined as both observers recording the
same frequency of a target behavior in a given 10-s interval. We then calculate the
percentage of exact agreements per session. Inter-observer agreement in our program
averages above 90%, and observers undergo retraining if agreement levels fall below 80%
for 3 consecutive sessions.
We recently completed the first calibration study to determine the accuracy of continuous
recording of direct-observation measures of behavior (Mudford, Zeleny, Fisher, Klum, &
Owen, 2011). In this study, five novice and five experienced observers recorded response
samples on laptop computers with a priori determined response rates ranging from 0 to 8
responses per minute, which covered the range of 90% of the data sets published in the 
Journal of Applied Behavior Analysis. Results showed that the experienced observers
recorded rates that were accurate to within ± 0.2 responses per minute (M = ± 0.12).
Observers for this project will be comparably experienced and accurate.
In addition to its accuracy, direct-observation measures have several advantages over other
assessments (e.g., rating scales) in terms of validity. Because target behaviors are directly
measured, issues related to construct and predictive validity are not relevant (i.e., no need
to predict or estimate a criterion variable when it is measured directly). Instead,
direct-observation measures are judged primarily in terms of their face validity (e.g., the
operational definition of aggression matches the everyday meaning of the term) and content
validity (e.g., the topographies of destructive behavior measured in this project adequately
cover the ones included in prior investigations; Nunnally, 1978). We developed the current
definitions of destructive behavior based on recommendations of an NIH (1989) consensus
conference and subsequent reviews of the literature.
Participant attrition and intent-to-treat principle. We will also follow the intent-to-treat
principle and make every effort to follow up, complete assessments, and report on children
who withdraw from the study. Over the last 5 years, we have retained over 95% of our
patients (about one early withdrawal per year), thus we anticipate very low attrition and
conservatively expect that at least 36 children will complete the project (about 9 per study).
Baseline. The baseline will be identical to the functional-analysis condition associated with
the highest levels of destructive behavior (e.g., the attention condition for
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attention-reinforced destructive behavior). To obtain stable rates of destructive behavior,
data collection will continue for at least five sessions until the data meet the following
stability criteria: (a) The standard deviation of the baseline will be no greater than 50% of its
mean (e.g., M = 2, SD <= 0.8); (b) The trend for the baseline will be flat (slope <= | .05 |) or
in the direction opposite the goal for treatment; and (c) No more than 20% of the baseline
data points will be in the range targeted for treatment (i.e., 90% to 100% lower than the
baseline mean).
FCT training. Once the above stability criteria have been reached in each condition, FCT
training will begin in a separate stimulus. A card touch will be used as the FCR because it
can be effectively prompted using gentle physical guidance regardless of the childs
functioning level. FCT training will be identical to baseline, except that the therapist will (a)
not provide reinforcement for destructive behavior (extinction; EXT) and (b) use gentle
physical guidance to prompt the card-touch FCR once in every 30-s interval of the session
starting with a 0-s prompt delay and progressing to 2-, 5-, 10-, and 20-s delays. The 0-s
delay will be in effect for the first two sessions. Thereafter, we will lengthen the delay
interval after the child emits prompted or independent FCRs in at least 90% of the 30-s
intervals. The therapist will deliver the reinforcer that previously maintained destructive
behavior (e.g., attention) for the remainder of each 30-s interval contingent on a prompted or
independent FCR. FCT training will continue until the participant emits independent FCRs in
at least 90% of the 30-s intervals for two consecutive sessions.
FCT. Once FCT training is completed, FCT will be introduced in the context in which the
baseline was conducted. During FCT, the therapist will (a) discontinue reinforcement for
destructive behavior (EXT) and (b) deliver reinforcement for the FCR until destructive
behavior decreases by 90% (relative to the baseline mean) for two consecutive sessions.
B. Identify all procedures, interventions, evaluations and tests that are performed 
solely for research purposes.
Functional analyses and FCT are common clinical components in the assessment and
treatment of problem behavior. These components would be implemented regardless of
participation in this research study.
Although caregiver pretests and posttests are common components of clinical cases, we will
not bill for these procedures. For behavioral interventions, we obtain authorizations from
insurance companies that cover a span of time (e.g., a month, two months, four months)
rather than authorization for specific tests (e.g., the pretest). To gain additional time with a
client, we then have to request a reauthorization that often varies in time from the initial
authorization. Thus, for the waitlist-control group, this would mean that obtaining
authorization to conduct the pretest would use up one of the client's authorization periods
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d uri n g t h e w ait p eri o d d e s pit e t h e cli e nt n ot r e c ei vi n g s er vi c e s d uri n g t hi s ti m e, a n d
r e a ut h ori z ati o n t o bill f or t h e p o stt e st s e v er al m o nt h s l at er. T h er ef or e, w e will c o n si d er all of
t h e pr et e st s a n d p o stt e st s a s pr o c e d ur e s f or r e s e ar c h a n d o nl y bill f or t h e cli ni c al s er vi c e s
r e c ei v e d d uri n g t h e tr e at m e nt p orti o n of t h e a d mi s si o n.
C. I d e ntif y all pr o c e d ur e s, i nt er v e nti o n s, e v al u ati o n s a n d t e st s t h at ar e p erf or m e d m or e
fr e q u e ntl y t h a n t h e y w o ul d b e if t h e s u bj e ct w a s n ot p arti ci p ati n g i n t h e r e s e ar c h.
T h e pr et e st s a n d p o stt e st s ar e b ei n g c o n d u ct e d f or r e s e ar c h p ur p o s e s a n d t h e a d diti o n al
pr et e st f or t h e w ait-li st c o ntr ol gr o u p i s o c c urri n g m or e fr e q u e ntl y (i. e., t wi c e) t h a n w h at
w o ul d o c c ur t y pi c all y i n a cli ni c al a d mi s si o n.
D. D e s cri b e bri efl y t h e st ati sti c al m et h o d s u s e d t o a n al y z e t h e d at a.
Wit hi n- p arti ci p a nt d at a a n al y si s
W e will u s e b ot h str u ct ur e d vi s u al i n s p e cti o n a n d a p pr o pri at e st ati sti c al m et h o d s t o a n al y z e
e a c h p arti ci p a nt s si n gl e- c a s e d at a s et s. T h e vi s u al-i n s p e cti o n pr o c e d ur e s d e v el o p e d a n d
v ali d at e d b y m e m b er s of o ur t e a m ar e hi g hl y r eli a bl e (I O A ≥ . 9 5). I n a d diti o n, w e will u s e t h e
Alli s o n a n d G or m a n ( 1 9 9 3) r e gr e s si o n pr o c e d ur e t o c al c ul at e si g nifi c a n c e l e v el s a n d eff e ct
si z e s f or si n gl e- c a s e d e si g n s. C o m pl eti n g t h e s e a n al y s e s wit h i n di vi d u al c hil dr e n will all o w
u s t o d et er mi n e, wit h a hi g h d e gr e e of c ert ai nt y, h o w m a n y c hil dr e n r e s p o n d e d i n t h e
pr e di ct e d p att er n.
Gr o u p st ati sti c s
T o c o m p ar e t h e c h a n g e s fr o m pr et e st t o p o stt e st, w e will c o n d u ct a n al y s e s of gr o u p
diff er e n c e s ( F C T tr e at m e nt v s. w ait li st) o n t h e pri m ar y d e p e n d e nt v ari a bl e s u si n g a n
a n al y si s of c o v ari a n c e wit h t h e p ar e nt b a s eli n e pr et e st a s t h e c o v ari a bl e a n d t h e p ar e nt
b a s eli n e p o stt e st t h e d e p e n d e nt v ari a bl e.
C O N FI D E N TI A LI T Y A N D P RI V A C Y
1 2. C o nfi d e nti alit y a n d Pri v a c y  
A. Will r e s e ar c h d at a b e st or e d:
1) O n a s e c ur e s er v er at U N M C/ T N M C/ C H & M C/ U N O ?
Y e s
2) O n a l o c al h ar d dri v e ?
N o
3) O n a p ort a bl e c o m p ut er ?
Y e s
V er si o n 1 3 - P R O T O C O L # 3 6 3- 1 5- F B
  P a g e 2 1 of 3 9

I R B P R O T O C O L # 3 6 3- 1 5- F B
  P a g e 2 2 of 3 9
a) I s t h e p ort a bl e c o m p ut er e n cr y pt e d a n d p a s s w or d pr ot e ct e d ?
Y e s
4) O n a fl a s h dri v e ?
N o
5) I n a d at a b a s e a c c e s si bl e t hr o u g h t h e i nt er n et ?
N o
6) I n h ar d c o p y ?
N o
7) Ot h er ?
N o
B. Will a n y of t h e f oll o wi n g s u bj e ct i d e ntifi er s b e r e c or d e d ( at a n y ti m e) i n a s s o ci ati o n
wit h t h e r e s e ar c h d at a ?
Y e s
1) I n di c at e t h e s u bj e ct i d e ntifi er s t h at will b e r e c or d e d:
♦ N a m e
♦ P o st al a d dr e s s i nf or m ati o n: str e et a d dr e s s, cit y, c o u nt y, pr e ci n ct, ZI P c o d e
♦ All el e m e nt s of d at e s ( e x c e pt y e ar) r el at e d t o a n i n di vi d u al ( e. g. birt h, a d mi s si o n,
di s c h ar g e)
♦ T el e p h o n e n u m b er s
F a x n u m b er s 
♦ El e ctr o ni c m ail a d dr e s s e s
S o ci al S e c urit y n u m b er s 
♦ M e di c al R e c or d n u m b er s
♦ H e alt h pl a n b e n efi ci ar y n u m b er s
A c c o u nt n u m b er s 
C ertifi c at e/li c e n s e n u m b er s 
V e hi cl e i d e ntifi er s a n d s eri al n u m b er s, i n cl u di n g li c e n s e pl at e n u m b er s 
D e vi c e i d e ntifi er s a n d s eri al n u m b er s 
W e b U ni v er s al R e s o ur c e L o c at or s ( U R L s) 
I nt er n et Pr ot o c ol (I P) a d dr e s s n u m b er s 
Bi o m etri c i d e ntifi er s, i n cl u di n g fi n g er a n d v oi c e pri nt s 
♦ F ull f a c e p h ot o gr a p hi c i m a g e s [ a n d a n y c o m p ar a bl e i m a g e s]
N o i d e ntifi er s will b e m ai nt ai n e d 
V er si o n 1 3 - P R O T O C O L # 3 6 3- 1 5- F B
  P a g e 2 2 of 3 9

I R B P R O T O C O L # 3 6 3- 1 5- F B
  P a g e 2 3 of 3 9
2) Will a u ni q u e s u bj e ct i d e ntif yi n g n u m b er, c h ar a ct eri sti c or c o d e b e u s e d t o pr ot e ct
t h e c o nfi d e nti alit y of t h e d at a ? T hi s i n cl u d e s c o d e s a s si g n e d b y t h e i n v e sti g at or t o li n k
d at a t o ot h er i d e ntifi er s li k e t h e s u bj e ctˆ s n a m e or m e di c al r e c or d n u m b er ?
Y e s
a) W h er e will t h e k e y, t h at li n k s t h e u ni q u e s u bj e ct i d e ntifi c ati o n c o d e t o t h e s u bj e ctˆ s
n a m e or ot h er i d e ntifi er, b e st or e d ?
A m a st er li st wit h p arti ci p a nt n u m b er s a n d n a m e s will b e k e pt s e p ar at e fr o m ot h er d at a i n a
l o c k e d c a bi n et i n t h e pri n ci p al i n v e sti g at or s offi c e.
3) W h at i s t h e j u stifi c ati o n f or r e c or di n g t h e s p e cifi c i d e ntifi er s li st e d a b o v e ?
S c h e d ul e a p p oi nt m e nt s 
F oll o w- u p wit h s u bj e ct s 
♦ Ot h er. E x pl ai n.  P arti ci p a nt s will b e c urr e ntl y e nr oll e d i n t h e S e v er e B e h a vi or Di s or d er s
Cli ni c i n t h e C e nt er f or A uti s m S p e ctr u m Di s or d er s at t h e M u nr o e- M e y er I n stit ut e. T h e
pri n ci p al i n v e sti g at or will h a v e a c c e s s t o t h e p arti ci p a nt i d e ntifi er s i n or d er t o f oll o w u p wit h
s u bj e ct s a n d s c h e d ul e a p p oi nt m e nt s.
4) H o w l o n g will t h e s u bj e ct i d e ntifi er s b e m ai nt ai n e d i n a s s o ci ati o n wit h t h e r e s e ar c h
d at a ?
S u bj e ct i d e ntifi er s will b e m ai nt ai n e d f or a mi ni m u m of s e v e n y e ar s.
5) H o w will t h e r e s e ar c h d at a b e ar c hi v e d or d e str o y e d w h e n t h e d at a i s n o l o n g er
r e q uir e d ?
R e s e ar c h d at a will b e ar c hi v e d o n a n e n cr y pt e d U N M C s er v er. Vi d e o r e c or di n g s f or d at a
c oll e cti o n p ur p o s e s will b e m ai nt ai n e d u p t o a m o nt h f oll o wi n g a gi v e n s e s si o n b ef or e b ei n g
d el et e d.
6) Will r e s e ar c h d at a t h at c o nt ai n s u bj e ct i d e ntifi er s b e di s cl o s e d t o a n y ot h er
i n v e sti g at or s at U N M C, T N M C, U N O or C H & M C w h o i s n ot li st e d i n S e cti o n I of t hi s
a p pli c ati o n ?
N o
7) Will r e s e ar c h d at a t h at c o nt ai n s u bj e ct i d e ntifi er s b e di s cl o s e d t o a n y i n v e sti g at or s 
o ut si d e  of U N M C, T N M C, U N O or C H & M C ?
N o
8) Will r e s e ar c h d at a t h at c o nt ai n s u bj e ct i d e ntifi er s b e di s cl o s e d t o a n y c o m m er ci al
s p o n s or or c o ntr a ct r e s e ar c h or g a ni z ati o n ( C R O) ?
V er si o n 1 3 - P R O T O C O L # 3 6 3- 1 5- F B
  P a g e 2 3 of 3 9

I R B P R O T O C O L # 3 6 3- 1 5- F B
  P a g e 2 4 of 3 9
N o
9) Will r e s e ar c h d at a t h at c o nt ai n s u bj e ct i d e ntifi er s b e di s cl o s e d t o a n y ot h er e xt er n al
or g a ni z ati o n or e ntit y ?
N o
C. W h at pr o vi si o n s will b e i n pl a c e t o pr ot e ct t h e s u bj e ct' s pri v a c y ? C h e c k all t h at
a p pl y.
♦ O bt ai ni n g c o n s e nt i n a pri v at e c o nf er e n c e r o o m or ar e a
♦ E n s uri n g t h at o nl y p er s o n n el li st e d o n t h e I R B a p pli c ati o n S e cti o n I. 3( A- E) ar e pr e s e nt
d uri n g t h e c o n s e nt pr o c e s s
♦ E n s uri n g t h at t h e f e w e st n u m b er of i n di vi d u al s p o s si bl e ar e a w ar e of t h e s u bj e ct' s
p arti ci p ati o n i n t h e r e s e ar c h
♦ E n s uri n g t h at t h e r e s e ar c h a cti viti e s ar e p erf or m e d i n a s pri v at e of a pl a c e a s p o s si bl e
Ot h er. E x pl ai n. 
D. D o e s t hi s r e s e ar c h i n v ol v e d at a b a n ki n g at U N M C, T N M C, U N O or C H & M C f or f ut ur e
r e s e ar c h t h at i s n ot r el at e d t o t hi s st u d y ?
N o
E. D o e s t hi s r e s e ar c h i n v ol v e d at a b a n ki n g b y a n o ut si d e  or g a ni z ati o n ( e. g. N CI
C o o p er ati v e Gr o u p, p h ar m a c e uti c al c o m p a n y) f or f ut ur e, u n s p e cifi e d r e s e ar c h t h at ar e
n ot i nt e gr al t o t h e c urr e nt r e s e ar c h ?
N o
RI S K/ B E N E FI T A S S E S S M E N T
1 3. P ot e nti al Ri s k s  
W h at ar e t h e p ot e nti al ri s k s a s s o ci at e d wit h e a c h  r e s e ar c h pr o c e d ur e, i nt er v e nti o n,
e v al u ati o n a n d/ or t e st ? If d at a i s a v ail a bl e, e sti m at e t h e pr o b a bilit y t h at a gi v e n h ar m
m a y o c c ur a n d it s p ot e nti al r e v er si bilit y.
T h er e i s a p ot e nti al f or c hil d a n d t h er a pi st i nj ur y a s a r e s ult of t h e c hil d s pr o bl e m b e h a vi or.
Pr o bl e m b e h a vi or s u c h a s a g gr e s si o n, pr o p ert y d e str u cti o n, or s elf-i nj ur y m a y b e
o c c a si o n e d b y pr e s e nti n g diffi c ult d e m a n d s, r e stri cti n g a c c e s s t o pr ef err e d it e m s, or
a cti viti e s or r e stri cti n g a c c e s s t o c ar e gi v er att e nti o n. All t h er a pi st s p arti ci p ati n g i n t h e st u d y
h a v e r e c ei v e d f or m al tr ai ni n g o n h o w t o a p pr o pri at el y a n d s af el y bl o c k pr o bl e m b e h a vi or i n
a m a n n er t h at mi ni mi z e s t h e s e ri s k s. If t h e c hil d e n g a g e s i n pr o bl e m b e h a vi or t h at m a y
r e s ult i n i nj ur y t o t h e t h er a pi st, t h e t h er a pi st will h a v e t h e o pti o n t o w e ar pr ot e cti v e
e q ui p m e nt d uri n g t h e a s s e s s m e nt ( e. g., ar m g u ar d s, c h e st a n d s h o ul d er p a d s, et c.). If t h e
V er si o n 1 3 - P R O T O C O L # 3 6 3- 1 5- F B
  P a g e 2 4 of 3 9

I R B P R O T O C O L # 3 6 3- 1 5- F B
  P a g e 2 5 of 3 9
c hil d' s pr o bl e m b e h a vi or a p p e ar s t o e s c al at e t o u n s af e l e v el s, t h e s e s si o n will b e e n d e d a n d
cli ni c all y- a p pr o v e d m e a s ur e s will b e i m pl e m e nt e d t o e n s ur e t h e s af et y of t h e c hil d. I n t h e
s e v e n y e ar s w e h a v e s er v e d t hi s p o p ul ati o n at M MI n o c hil dr e n h a v e s u st ai n e d i nj uri e s t h at
h a v e r e q uir e d m e di c al att e nti o n.
W hil e c o m pl eti n g q u e sti o n n air e s, s u c h a s t h e P ar e nt al Str e s s I n d e x, s o m e of t h e q u e sti o n s
m a y m a k e c ar e gi v er s u n c o mf ort a bl e. W e will i nf or m c ar e gi v er s t h at t h e y ar e fr e e t o
t er mi n at e t h e q u e sti o n n air e s or t h e st u d y at a n y p oi nt a n d still r e c ei v e s er vi c e s t hr o u g h o ur
S e v er e B e h a vi or Di s or d er s cli ni c.
1 4. Ri s k Cl a s sifi c ati o n  
W h at i s t h e o v er all ri s k cl a s sifi c ati o n of t h e r e s e ar c h ?
Mi ni m al ri s k 
♦ Gr e at er t h a n mi ni m al ri s k
1 5. Mi ni mi z ati o n of Ri s k  
A. Will t h e r e s e ar c h utili z e pr o c e d ur e s t h at w o ul d alr e a d y b e p erf or m e d o n t h e s u bj e ct s
e v e n if t h e y c h o s e n ot t o p arti ci p at e i n t h e r e s e ar c h ?
Y e s
D e s cri b e t h e pr o c e d ur e s.
F u n cti o n al a n al y s e s a n d F C T ar e b e st pr a cti c e f or i d e ntif yi n g t h e f u n cti o n of s o ci all y
m ai nt ai n e d d e str u cti v e b e h a vi or a n d d e v el o pi n g tr e at m e nt b a s e d u p o n t h e t ar g et f u n cti o n.
B. D e s cri b e h o w t h e s u bj e ct s of t h e r e s e ar c h will b e m o nit or e d b y t h e i n v e sti g at or s a n d
ot h er r e s e ar c h p er s o n n el t o e n s ur e t h eir s af et y.
P arti ci p a nt s will h a v e t h e i n v e sti g at or s c o nt a ct i nf or m ati o n if a n y sit u ati o n o c c ur s i n w hi c h
t h e y ar e c o n c er n e d. A d diti o n all y, if s o m et hi n g h a p p e n s i n t h e h o m e a n d t h e c hil d s
d e str u cti v e b e h a vi or e s c al at e s, t h e c ar e gi v er s ar e i n str u ct e d t o pr o c e e d a s t h e y t y pi c all y
w o ul d i n c o nt a cti n g t h e p oli c e f or i m m e di at e h el p. Al s o, if a n y o n e s u st ai n s c o n c er ni n g
i nj uri e s o ut si d e of t h e cli ni c h o ur s, t h e c ar e gi v er s will b e i n str u ct e d t o c o nt a ct a n ur g e nt c ar e
or e m er g e n c y c ar e f a cilit y, a n d f oll o w u p wit h t h e i n v e sti g at or s t h e f oll o wi n g d a y.
A d diti o n all y, w e e kl y m e eti n g s will b e s c h e d ul e d t o a d dr e s s a n y c ar e gi v er c o n c er n s.
C. D e s cri b e t h e pr o c e s s b y w hi c h t h e PI will b e i nf or m e d a n d h o w t h e PI, i n t ur n, will
i nf or m ot h er r e s e ar c h st aff a b o ut e v e nt s c o n c er ni n g s u bj e ct s af et y (i n cl u di n g ( a)
i nt eri m r e s ult s; ( b) u n a nti ci p at e d pr o bl e m s i n v ol vi n g ri s k s t o s u bj e ct s or ot h er s; ( c)
n o n c o m pli a n c e; ( d) c o m pl ai nt s).
1) At U N M C/ T N M C/ C H & M C a n d/ or U N O ( c h e c k all t h at a p pl y)
V er si o n 1 3 - P R O T O C O L # 3 6 3- 1 5- F B
  P a g e 2 5 of 3 9

I R B P R O T O C O L # 3 6 3- 1 5- F B
  P a g e 2 6 of 3 9
N ot a p pli c a bl e. T h e PI i s t h e o nl y p er s o n li st e d i n S e cti o n I of t h e I R B A p pli c ati o n. 
♦ B y e m ail or c a m p u s m ail (f or e v e nt s w hi c h d o n ot c o n stit ut e i m m e di at e s u bj e ct s af et y
h a z ar d s)
♦ B y p h o n e
♦ B y i n- p er s o n m e eti n g
Ot h er. E x pl ai n. 
2) At e xt er n al st u d y sit e s u n d er t h e o v er si g ht of t h e J oi nt P e di atri c I R B a s a p pli c a bl e
( c h e c k all t h at a p pl y)
B y e m ail or m ail (f or e v e nt s w hi c h d o n ot c o n stit ut e i m m e di at e s u bj e ct s af et y h a z ar d s) 
B y p h o n e 
B y i n- p er s o n m e eti n g or t el e c o nf er e n c e 
♦ Ot h er. E x pl ai n.  T h e c urr e nt i n v e sti g ati o n will n ot o c c ur at e xt er n al sit e s.
D. D e s cri b e t h e a u diti n g pl a n f or r e s e ar c h c o n d u ct e d:
1) Wit hi n t h e Or g a ni z ati o n ( U N M C, T N M C, U N O or C H & M C), i d e ntif y w h o will c o n d u ct
t h e a u dit s a n d s p e cif y t h e a u dit fr e q u e n c y..
All st u d y p er s o n n el will c o n d u ct o n g oi n g r e vi e w of c o m pli a n c e wit h t h e pr ot o c ol. A n y
vi ol ati o n s of t h e pr ot o c ol will b e i m m e di at el y r e p ort e d t o t h e Pri n ci p al I n v e sti g at or a n d t h e
I R B. All st u d y p er s o n n el will al s o c o n d u ct a c o m pr e h e n si v e r etr o s p e cti v e r e vi e w of
c o m pli a n c e wit h t h e pr ot o c ol at t h e c o m pl eti o n of e a c h c o h ort (f or a t ot al of 5
c o m pr e h e n si v e r etr o s p e cti v e r e vi e w s of c o m pli a n c e wit h t h e pr ot o c ol). A n y vi ol ati o n s of t h e
pr ot o c ol will b e i m m e di at el y r e p ort e d t o t h e Pri n ci p al I n v e sti g at or a n d t h e I R B.
2) At e xt er n al st u d y sit e s u n d er t h e o v er si g ht of t h e J oi nt P e di atri c I R B, i d e ntif y w h o
will c o n d u ct t h e a u dit s a n d s p e cif y t h e a u dit fr e q u e n c y.
T h e c urr e nt i n v e sti g ati o n will n ot o c c ur at e xt er n al sit e s.
E. D e s cri b e t h e d at a m o nit ori n g pl a n.
1) W h o will p erf or m t h e o n g oi n g d at a a n d s af et y a n al y si s ?
T h e pri m ar y i n v e sti g at or a n d tr e at m e nt t e a m will m e et o n a d ail y b a si s t o r e vi e w t h e d at a
a n d t h e s af et y of p arti ci p a nt s.
2) W h at i s t h e fr e q u e n c y of d at a a n al y si s ?
T h e pri m ar y i n v e sti g at or will gr a p h t h e d at a f or all p arti ci p a nt s d ail y.
F. D e s cri b e t h e s p e cifi c crit eri a b y w hi c h t h e i n v e sti g at or w o ul d wit h dr a w i n di vi d u al
s u bj e ct s fr o m t h e r e s e ar c h.
If t h e c hil d e x hi bit s s e v er e pr o bl e m b e h a vi or c a u si n g b o dil y d a m a g e t o t h e m s el v e s or
V er si o n 1 3 - P R O T O C O L # 3 6 3- 1 5- F B
  P a g e 2 6 of 3 9

I R B P R O T O C O L # 3 6 3- 1 5- F B
  P a g e 2 7 of 3 9
ot h er s, t h e i n v e sti g at or s will di s c u s s c o nti n u e d p arti ci p ati o n i n t h e st u d y wit h t h e c hil d s
p ar e nt s a n d t e a c h er s. If p arti ci p a nt s c o nti n u o u sl y mi s s a p p oi nt m e nt s wit h o ut r e a s o n a bl e
e x c u s e s ( e. g., 2 c o n s e c uti v e u n e x pl ai n e d a b s e n c e s) t h e p ar e nt s will b e w ar n e d t h at t h eir
p arti ci p ati o n i n t h e st u d y m a y b e t er mi n at e d.
G. D e s cri b e t h e s p e cifi c crit eri a f or h alti n g or e arl y t er mi n ati o n of t h e st u d y.
W h e n u n e x p e ct e d pr o bl e m s ar e e n c o u nt er e d ( e. g., u n e x p e ct e d ri s k t o t h e p arti ci p a nt s ar e
o b s er v e d), t h e r e s e ar c h pr oj e ct will b e h alt e d a n d t h e p arti ci p a nt s c o nti n u e d p arti ci p ati o n i n
t h e st u d y will b e di s c u s s e d wit h hi s/ h er l e g al g u ar di a n( s).
1 6. P ot e nti al B e n efit s t o t h e S u bj e ct  
Ar e t h er e p ot e nti al b e n efit s t o t h e s u bj e ct s t h at m a y r e a s o n a bl y b e e x p e ct e d fr o m
p arti ci p ati o n i n t h e r e s e ar c h ?
Y e s
D e s cri b e.
P arti ci p a nt s will r e c ei v e tr e at m e nt of d e str u cti v e b e h a vi or a n d t e a c hi n g of f u n cti o n al
c o m m u ni c ati o n s kill s.
1 7. P ot e nti al B e n efit s t o S o ci et y  
W h at ar e t h e a nti ci p at e d b e n efit s (i. e., v al u e) t o s o ci et y t h at m a y r e a s o n a bl y b e
e x p e ct e d t o r e s ult fr o m t hi s r e s e ar c h ?
T h e r e s ult s of t h e c urr e nt i n v e sti g ati o n m a y e xt e n d t h e lit er at ur e o n t h e eff e cti v e n e s s of F C T
f or i n di vi d u al s wit h s e v er e d e str u cti v e b e h a vi or b y i d e ntif yi n g t h e g e n er alit y of F C T
eff e cti v e n e s s.
1 8. Alt er n ati v e s t o P arti ci p ati o n  
Ar e t h er e a n y r e a s o n a bl y a v ail a bl e alt er n ati v e s i n t h e n o n-r e s e ar c h c o nt e xt w hi c h
w o ul d h a v e t h e p ot e nti al f or pr o vi di n g t h e s a m e b e n efit s t o s u bj e ct s ?
N ot a p pli c a bl e. T h er e ar e n o dir e ct b e n efit s t o s u bj e ct s; t h e alt er n ati v e i s t o n ot p arti ci p at e i n
t h e r e s e ar c h. 
♦ Y e s. D e s cri b e:  T h e p ar e nt s of p ot e nti al p arti ci p a nt s will b e i nf or m e d t h at t h e y ar e fr e e t o
c h o o s e w h et h er or n ot t o p arti ci p at e i n t h e c urr e nt st u d y. P arti ci p a nt s will h a v e t h e
o p p ort u nit y t o r e c ei v e s er vi c e s fr o m t h e M u nr o e- M e y er I n stit ut e or fr o m ot h er f a ciliti e s,
r e g ar dl e s s of t h eir p arti ci p ati o n i n t hi s st u d y. P ar e nt s of p arti ci p a nt s a s si g n e d t o t h e w aitli st
c o ntr ol c o n diti o n will b e gi v e n a p a c k et of i nf or m ati o n r e g ar di n g l o c al i nt er v e nti o n s er vi c e s
o ut si d e of M u nr o e- M e y er I n stit ut eˆ s C e nt er f or A uti s m S p e ctr u m Di s or d er s.
N o. E x pl ai n: 
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FINANCIAL OBLIGATIONS AND COMPENSATION
19. Financial Obligations of the Subject  
Are there any other financial obligations that the parent(s)/guardians of the subject will
incur as a result of participating in the study (e.g. travel expenses, meals, supplies)?
Yes
Provide additional detail and justification for increased financial obligations to the
parent(s)/guardian(s) of the subject.
Routine clinical services can be billed to the subject's insurance company. No procedures
conducted solely for research purposes will be billed to insurance. The parent/caregiver will
be responsible for all insurance deductibles as they relate to routine clinical services.
20. Compensation to the Subject for Participation  
Will the subject and/or their parent(s)/guardian(s) receive any compensation for
participation?
No
PRIOR REVIEW
21. Prior IRB Review  
A. Has this study (or one substantially similar) been previously submitted to the Joint
Pediatric IRB (or the UNMC IRB) and then withdrawn by the investigator for any
reason?
No
B. To the best of your knowledge, has this study (or one substantially similar) been
considered by another IRB and not granted approval?
No
SUBJECT IDENTIFICATION & RECRUITMENT
22. Method of Subject Identification and Recruitment  
A. Will prospective subjects be identified through initial contact by the investigator?
Yes
1) Identified through (check all that apply):
Previous research participants 
Investigator maintained databases or registries 
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S c h o ol r e c or d s 
S u p p ort gr o u p s 
♦ Ot h er. E x pl ai n.  Pr o s p e cti v e p arti ci p a nt s will b e c hil dr e n t h at ar e c urr e ntl y o n t h e S e v er e
B e h a vi or Pr o gr a m w aiti n g li st
2) D e s cri b e h o w t h e r e s e ar c h st aff h a s et hi c al a c c e s s t o t h e p ot e nti al s u bj e ct s ?
T h e pri m ar y i n v e sti g at or a n d st aff h a v e pr of e s si o n al r el ati o n s hi p s wit h t h e pr o s p e cti v e
p arti ci p a nt s.
B. Will pr o s p e cti v e s u bj e ct s m a k e t h e i niti al c o nt a ct wit h t h e r e s e ar c h p er s o n n el t o
i n q uir e a b o ut t h e st u d y ?
N o
O B T AI N M E N T O F I N F O R M E D C O N S E N T
2 3. W ai v er or Alt er ati o n of I nf or m e d C o n s e nt  
A. I s a w ai v er or alt er ati o n of c o n s e nt r e q u e st e d f or p ar e nt( s)/ g u ar di a n( s) of c hil d
s u bj e ct s or f or a d ult s u bj e ct s ?
N o
B. I s a w ai v er of c hil d a s s e nt r e q u e st e d ?
Y e s
2 4. W ai v er of a Si g n e d C o n s e nt F or m  
I s a w ai v er of t h e r e q uir e m e nt t o o bt ai n a si g n e d c o n s e nt f or m r e q u e st e d ?
N o
2 5. Pr o c e s s of P er mi s si o n (I nf or m e d C o n s e nt) f or P ar e nt( s)/ G u ar di a n( s)  
A. W h e n will t h e p ar e nt( s)/ g u ar di a n( s) of t h e pr o s p e cti v e s u bj e ct b e a p pr o a c h e d
r el ati v e t o t h eir c hil d' s a ct u al p arti ci p ati o n i n t h e st u d y ?
A pri m ar y or s e c o n d ar y i n v e sti g at or will c o nt a ct t h e p ar e nt s vi a t el e p h o n e c all t o di s c u s s
t h eir c hil d' s i n v ol v e m e nt i n t h e st u d y. If i nt er e st e d, t h e i n v e sti g at or s will m e et t h e
p ar e nt s/ g u ar di a n s i n- p er s o n t o di s c u s s t h e p ur p o s e of t h e st u d y. A bri ef d e s cri pti o n of t h e
pr o c e d ur e s will b e pr o vi d e d.
B. W h er e will i nf or m e d c o n s e nt b e o bt ai n e d, a n d h o w will t h e e n vir o n m e nt b e
c o n d u ci v e t o di s c u s si o n a n d t h o u g htf ul c o n si d er ati o n b y t h e p ar e nt( s)/ g u ar di a n( s) ?
I nf or m e d c o n s e nt will b e o bt ai n e d i n a pri v at e c o nf er e n c e r o o m, all o wi n g t h e
p ar e nt s/ g u ar di a n s t o r efl e ct o n t h eir c hil d' s p arti ci p ati o n i n t h e st u d y w hil e i n a q ui et
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environment.
C. Who will be involved in the process of consenting the parent(s)/guardian(s) about
their child's participation in the study and what are their responsibilities?
Secondary investigators (Dr. Brian Greer, Dr. Cathleen Piazza, Dr. Amanda Zangrillo) or the
following participating personnel (Ashley Fuhrman, Todd Owen, Adam Briggs, Daniel
Mitteer, Billie Retzlaff, Lauren Phillips, Ryan Kimball, Kayla Randall, or Madeleine Keevy)
will provide the parents/guardians with an overview of the study and the consent process.
These investigators will ask questions to ensure that the caregivers understand the
documents presented to them and will refer any of their concerns to the primary investigator,
Dr. Wayne Fisher.
D. How much time will be allotted to the process of consent?
Parents/guardians will be allowed as much time as they would like to review the clinical
services that we plan to provide and will be encouraged to take the information home to
make their decisions.
E. How will the process of consent be structured for parent(s)/ guardian(s) who are
likely to be more vulnerable to coercion or undue influence?
We will provide the option for parents to include family, friends, an advocate, or other
confidants. Investigators will question the parents or guardians about each sections of the
consent form to ensure they understand.
F. Will non-English speaking subjects be enrolled in this research and/or will
non-English speaking parent(s)/guardians be consenting for the prospective subject?
Yes
Explain how you will ensure that the language used in the consent process and
consent form is understandable to the subjects and/or parent(s)/guardian(s).
An interpreter will be used to obtain consent from non-English speaking participants. All
printed documents will be translated and will be submitted for review and approval from the
IRB prior to utilization.
G. How will it be determined that the parent(s)/guardian(s) understood the information
presented?
Parents/guardians will be asked questions about each section of the consent form to ensure
all elements are understood. Parents/guardians also will be encouraged to ask any
questions they may have throughout the process.
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H. Will t h er e b e a f or m al pr o c e s s of o n- g oi n g r e- c o n s e nt ( o v er a n d a b o v e r e- c o n s e nt
a s s o ci at e d wit h c h a n g e s i n pr ot o c ol) ?
N o
2 8. D o c u m e nt ati o n of C o n s e nt a n d A s s e nt  
Li st w h o will si g n t h e c o n s e nt f or m a s t h e " P er s o n O bt ai ni n g C o n s e nt ".
Br o w n, K at h eri n e R
Fi s h er, W a y n e W
F u hr m a n, A s hl e y M ari e
Gr e er, Bri a n D
K e e v y, M a d el ei n e Di a n e
Ki m b all, R y a n T a yl or
Mitt e er, D a ni el R o b ert
O w e n, T o d d M
P hilli p s, L a ur e n A m a n d a
Pi a z z a, C at hl e e n C
R a n d all, K a yl a R e c h ell e
R et zl aff, Billi e J e a n
Z a n grill o, A m a n d a N
2 9. C o n s e nt F or m s a n d St u d y I nf or m ati o n S h e et s  
I n di c at e t h e t y p e of c o n s e nt f or m s a n d st u d y i nf or m ati o n s h e et s t o b e u s e d i n t hi s
r e s e ar c h.
♦ P ar e nt al/ G u ar di a n c o n s e nt f or m
Y o ut h St u d y I nf or m ati o n S h e et 
C hil d St u d y I nf or m ati o n S h e et 
S cr e e ni n g c o n s e nt f or m 
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Addendum consent form 
Adult consent form 
Other: 
30. Information Purposely Withheld  
Will any information be purposely withheld from the parent(s)/guardian(s) of the
subject or the subject during the research or after completion of the research?
No
RESOURCES
30. Describe the resources available to safely conduct this study at each sites
specified in Section I.7.  
Departmental funds will be used for this research. These funds will be used to obtain
materials needed to complete the study (e.g., leisure items, instructional materials,
functional communication cards). Sessions will be conducted in a private session room in
the Severe Behavior Disorders clinic at Munroe-Meyer Institute. All data will be stored on a
secure drive accessible only by employees at the Center for Autism Spectrum Disorders at
the Munroe-Meyer Institute. The primary investigator and staff will meet on a daily basis to
review the data and discuss any unanticipated problems that arise. If problems arise, the
primary investigator and staff will meet immediately to discuss possible solutions.
LITERATURE REVIEW
31. References  
Provide a full listing of the key references cited in the background (Section II.3). The
references should clearly support the stated purpose of the study.
Allison, D. B., & Gorman, B. S. (1993). POWCOR: A power analysis and sample size
program for testing differences between dependent and independent correlations. 
Educational and Psychological Measurement, 53, 133-137.
Carr, E. G, & Durand, V. M. (1985). Reducing behavior problems through functional
communication training. Journal of Applied Behavior Analysis, 18, 111-126.
Fisher, W. W., Kelley, M. E., & Lomas, J. E. (2003). Visual aids and structured criteria for
improving visual inspection and interpretation of single-case designs. Journal of Applied
Behavior Analysis, 36, 387-406. doi:10.1901/jaba.2003.36-387
Hagopian, L. P., Fisher, W. W., Thompson, R. H., Owen-DeSchryver, J., Iwata, B. A, &
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Wacker, D. P. (1997). Toward the development of structured criteria for interpretation of
functional analysis data. Journal of Applied Behavior Analysis, 30, 313-325.
doi:10.1901/jaba.1997.30-313
Iwata, B. A., Dorsey M. F., Slifer K. J., Bauman, K. E., & Richman, G. S. (1982/1994).
Toward a functional analysis of self-injury. Journal of Applied Behavior Analysis, 27,
197ˆ209.
Mudford, O. C., Zeleny, J. R., Fisher, W. W., Klum, M. E., & Owen, T. M. (2011). Calibration
of observational measurement of rate of responding. Journal of Applied Behavior Analysis, 
44, 571ˆ586.
National Institutes of Health. (1989). Treatment of destructive behaviors in persons with
developmental disabilities conference.
Nunnally, J. C. (1978). Psychometric theory. New York, NY: McGraw-Hill.
Tiger, J. H., Hanley, G. P., & Bruzek, J. (2008). Functional communication training: A review
and practical guide. Behavior Analysis in Practice, 1,16-23.
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S E C TI O N III
S U B MI S SI O N D E A D LI N E
A. F ull B o ar d R e vi e w:  
T h e I R B m e et s m o nt hl y, o n t h e f o urt h T u e s d a y of t h e m o nt h. N o m or e t h a n 1 5
a p pli c ati o n s (i. e., i niti al r e vi e w of a n e w st u d y, r e-r e vi e w of a t a bl e d st u d y) will b e
r e vi e w e d at e a c h m e eti n g. All r e vi e w s ar e p erf or m e d o n a fir st- c o m e fir st- s er v e d b a si s.
T h e I R B m e eti n g s c h e d ul e a n d d e a dli n e d at e s c a n b e f o u n d o n t h e I R B w e b sit e at 
w w w. u n m c. e d u/ir b .
B. E x p e dit e d R e vi e w  
A p pli c ati o n s t h at q u alif y f or e x p e dit e d r e vi e w h a v e n o s u b mi s si o n d e a dli n e a n d c a n b e
r e vi e w e d i n d e p e n d e nt of t h e I R B m e eti n g s c h e d ul e. Pl e a s e c all t h e Offi c e of R e g ul at or y
Aff air s f or a s si st a n c e i n d et er mi ni n g if y o ur st u d y m e et s t h e r e q uir e m e nt s f or
e x p e dit e d r e vi e w.
S U B MI S SI O N C H E C K LI S T
C h e c k all t h at a p pl y.  
S u bj e ct r e cr uit m e nt m at eri al 
P erf or m a n c e sit e a p pr o v al f or all n o n- U N M C, T N M C, U N O a n d C H & M C sit e s 
C o p y of all q u e sti o n n air e s, s ur v e y s, a s s e s s m e nt t o ol s, a n d ot h er r el e v a nt m at eri al s 
D et ail e d pr ot o c ol 
Gr a nt A p pli c ati o n 
I R B R e vi e w F e e F or m f or all c o m m er ci all y s p o n s or e d r e s e ar c h pr oj e ct s. 
U N M C Di s cl o s ur e of P ot e nti al C o nfli ct of I nt er e st F or m f or t h e Pri n ci p al I n v e sti g at or if a
fi n a n ci al i nt er e st h a s b e e n d e cl ar e d i n S e cti o n I. 1 0. 
U N M C Di s cl o s ur e of P ot e nti al C o nfli ct of I nt er e st F or m f or a n y r e s p o n si bl e p er s o n n el wit h a
fi n a n ci al i nt er e st d e cl ar e d i n S e cti o n I. 1 0. 
Ot h er 
♦ N o att a c h m e nt s
A D DI TI O N A L R E VI E W R E Q UI R E M E N T S
Fi n al I R B a p pr o v al a n d r el e a s e of st u di e s i s c o nti n g e nt u p o n a p pr o v al b y t h e
f oll o wi n g U N M C c o m mitt e e s or d e p art m e nt s. C h e c k t h e a p pr o pri at e b o x e s:  
U N M C E p pl e y C a n c er C e nt er S ci e ntifi c R e vi e w C o m mitt e e ( S R C):  R e vi e w b y t h e S R C
i s r e q uir e d f or all pr ot o c ol s i n v ol vi n g c a n c er p ati e nt s. 
S p o n s or e d Pr o gr a m s A d mi ni str ati o n ( S P A)/ Offi c e of R e g ul at or y Aff air s:  F or
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c o m m er ci al s p o n s or e d st u di e s, t h e c o n s e nt f or m a n d c o ntr a ct will b e c o m p ar e d f or
c o n si st e n c y. Fi n al I R B a p pr o v al a n d r el e a s e i s c o nti n g e nt u p o n c o m pl eti o n of a si g n e d
c o ntr a ct f or all c o m m er ci all y s p o n s or e d r e s e ar c h. 
C o nfli ct of I nt er e st C o m mitt e e ( C OI C)  All r e s p o n si bl e p er s o n n el li st e d i n I. 3 A- E of t h e I R B
a p pli c ati o n (i. e., PI, S e c o n d ar y I n v e sti g at or, P arti ci p ati n g P er s o n n el, a n d C o or di n at or( s))
m u st di s cl o s e a n y  fi n a n ci al i nt er e st i n t h e r e s e ar c h ( s e e S e cti o n I. 1 0 of t hi s a p pli c ati o n).
D at a a n d A d mi ni str ati v e P er s o n n el ar e e x e m pt. T h e C OI C will r e vi e w a n y fi n a n ci al i nt er e st
w hi c h i s cl a s sifi e d a s si g nifi c a nt . 
I n v e sti g ati o n al D e vi c e R e vi e w C o m mitt e e (I D R C): R e vi e w b y t h e I D R C i s r e q uir e d f or all
pr ot o c ol s i n v ol vi n g t h e u s e of i n v e sti g ati o n al or m ar k et e d d e vi c e s. 
♦ N o A d diti o n al R e vi e w s R e q uir e d
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ADDENDUM L
Waiver or Alteration of Child Assent
Title of Protocol
Treatment of severe destructive behavior: A randomized clinical trial of functional
communication training versus wait-list control
Principal Investigator
Fisher, Wayne W - MMI Ctr for Autism Spec Disord - 402-559-8863 -
wfisher@unmc.edu
Waiver or Alteration of Child Assent  
1. Is waiver or alteration of assent being requested because the children lack capacity
to provide assent. [45 CFR 46.408(a) and 21 CFR 50.55(c)(1)]?
Yes
2. Is waiver or alteration of assent being requested because there is direct benefit to
the children which is only available in the context of the research. [45 CFR 46.408(a)
and 21CFR 50.55(c)(2)]? 
No
3. Is waiver or alteration of assent being requested because obtaining assent is
impracticable, the research is no more than minimal risk and the rights and welfare of
the subject will not be adversely affected. [45 CFR 116(d) and 21 CFR 50.55(d)]? 
No
A. Children that Lack Capacity to Provide Assent  
Explain why the capability of some or all of the children is so limited that they cannot
assent to participate in research. [45 CFR 46.408(a) and 21 CFR 50.55(c)(1)]
All children will be currently enrolled in the Severe Behavior Disorders clinic at the
Munroe-Meyer Institute or on the wait list. Many of the children who attend these clinics
have cognitive impairments and participants for this study will have limited communication
skills. Thus, the children in the current study will lack the capacity to assent to participation.
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ADDENDUM Y
Research Involving Adults as Subjects Participating in a Pediatric Trial
Title of Protocol
Treatment of severe destructive behavior: A randomized clinical trial of functional
communication training versus wait-list control
Principal Investigator
Fisher, Wayne W - MMI Ctr for Autism Spec Disord - 402-559-8863 -
wfisher@unmc.edu
Waiver of Alteration of Informed Consent  
Is a waiver of alteration of consent requested?
No
1. Capacity to Consent  
a. At the time of initial consent, will all subjects have the capacity to give informed
consent?
Yes
b. Is there a reasonable likelihood that some subjects may lose the capacity to
continue to provide informed consent during the course of the study?
No
2. Process of Informed Consent for Competent Adult Subjects  
a. When will the prospective subject be approached relative to their actual participation
in the study?
The caregivers of the children participants will approached several weeks prior to their
actual participation in the study.
b. What is the location where informed consent will be obtained, and how will the
environment be conducive to discussion and thoughtful consideration?
Informed consent will be obtained in a private conference room, allowing the
parents/guardians to reflect on their participation in the study while in a quiet environment.
c. Who will be involved in the process of consent and what are their responsibilities?
Secondary investigators (Dr. Piazza or Dr. Greer) or participating personnel (Ashley
Niebauer, Daniel Mitteer, Valdeep Saini, Katherine Lichtblau, Patrick Romani, Todd Owen
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or Andresa De Souza) will provide the parents/guardians with an overview of the study and
the consent process. These investigators will ask questions to ensure that the caregivers
understand the documents presented to them and will refer any of their concerns to the
primary investigator, Dr. Wayne Fisher.
d. How much time will be allotted to the process of consent?
Parents/guardians will be allowed as much time as they would like to review the information
that we willprovide and will be encouraged to take the information home to
make their decisions.
e. How will the process of consent be structured for subjects who are likely to be more
vulnerable to coercion or undue influence?
We will provide the option for parents to include family, friends, an advocate, or other
confidants. Investigators will question the parents or guardians about each section of the
consent form to ensure they understand.
f. Will non-English speaking subjects be enrolled in this research?
Yes
Explain how will you ensure that the language used in the consent process and
consent form is understandable to the subjects.
While most caregivers whose children attend our clinic are English-speaking, a UNMC
interpreter will be provided during all interactions between research personnel and
non-English speaking caregivers. The research personnel will use the same level of detail
with non-English speaking caregivers via the translator as they would with English speaking
caregivers who are consented.
g. How will it be determined that the subject understood the information presented?
Parents/guardians will be asked questions about each section of the consent form to ensure
all elements are understood. Parents/guardians also will be encouraged to ask any
questions they may have throughout the process.
h. Will there be a formal process of on-going re-consent (over and above re-consent
associated with changes in protocol)?
No
3. Consent and Assent Forms  
Indicate the type of consent forms and/or study information sheets to be used in this
research:
Version 13 - PROTOCOL # 363-15-FB
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