Pediatric Injury: Modules to Manage Medical Stress
Phase: NA
Conditions: Post-Traumatic Stress Disorder in Children, Post-Traumatic Stress Disorder in Adolescence
Sponsor: University of Utah

St ati sti c al A n al y si s Pl a n  
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C O N FI D E N TI A L  
S T U D Y  P R O T O C O L & 
S T A TI S TI C A L A N A L Y SI S P L A N 
Pr ot oc ol Title  
Rec o ver y after Stress T o ol kit ( R E S E T) Trial  
Pr ot oc ol Date:  
3/ 1 / 2 0 2 3, V 6 
N C T N u m ber 
N C T 0 4 8 4 8 9 7 7 
S A P A ut h or:  
A n gela Press o n  
S A P Versi o n:  
1. 1  
S A P Date:  
9 /1 1 / 2 0 2 3 

St ati sti c al A n al y si s Pl a n  
P a g e 2 
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C O N FI D E N TI A L  
T A B L E O F C O N T E N T S 
1. 
P R E F A C E ............................................................................................................... 5  
2. 
P U R P O S E O F S A P ................................................................................................ 6  
2. 1  
S A P V E R SI O N HI S T O R Y ................................................................................... 6  
3. 
S T U D Y O B J E C TI V E S A N D E N D P OI N T S ........................................................ 7  
3. 1  
St u d y O bjecti ves .......................................................................................... 7  
3. 1. 1  Pri mar y O bjecti ve ............................................................................ 7  
3. 1. 2  Sec o n dar y O bjecti ves ....................................................................... 7  
3. 2  
St u d y E n d p oi nts ........................................................................................... 7  
3. 2. 1  Pri mar y E n d p oi nt ............................................................................. 7  
3. 2. 2  Sec o n dar y E n d p oi nts ....................................................................... 7  
3. 2. 3  E x pl orat or y O utc o mes ..................................................................... 7  
4. 
S T U D Y M E T H O D S .............................................................................................. 9  
4. 1  
O verall St u d y Desi g n a n d Pla n .................................................................... 9  
4. 2  
Selecti o n of St u d y P o p ulati o n ...................................................................... 9  
4. 3  
Met h o d of Treat me nt Assi g n me nt a n d Ra n d o mizati o n ............................... 9  
4. 4  
Treat me nt Mas ki n g ( Bli n di n g) .................................................................... 9  
5. 
S A M P L E SI Z E D E T E R MI N A TI O N ................................................................... 9  
6.  
A N A L Y SI S P O P U L A TI O N S A N D S T U D Y S U B J E C T S ................................ 1 0  
7.  
G E N E R A L I S S U E S F O R S T A TI S TI C A L A N A L Y SI S .................................. 1 3  
7. 1  
A nal ysis S oft ware ...................................................................................... 1 3  
7. 2  
Met h o ds f or Wit h dra wals, Missi n g Data, a n d O utliers ............................. 1 3  
7. 3  
M ultice nter St u dies .................................................................................... 1 4  
7. 4  
M ulti ple C o m paris o ns a n d M ulti plicit y ..................................................... 1 4  
7. 5  
Pla n ne d S u b gr o u ps, I nteracti o ns, a n d C o variates ...................................... 1 4  
8. 
S T U D Y S U B J E C T S ............................................................................................. 1 5  
8. 1  
Dis p ositi o n of S u bjects a n d Wit h dra wls .................................................... 1 5  
8. 2  
Pr ot oc ol De viati o ns .................................................................................... 1 5  
8. 3  
I ncl usi o n a n d E xcl usi o n Criteria ................................................................ 1 5 
9.  
D E M O G R A P HI C S A N D O T H E R B A S E LI N E C H A R A C T E RI S TI C S ........ 1 5  
9. 1  
De m o gra p hics ............................................................................................ 1 5  
9. 2  
Meas ure me nt of Treat me nt C o m plia nce .................................................... 1 6  
1 0. 
E F FI C A C Y A N A L Y S E S .................................................................................... 1 6  
1 0. 1  
A nal ysis of Pri mar y O utc o me .................................................................... 1 6  

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C O N FI D E N TI A L  
1 0. 2  
A nal ysis of Sec o n dar y O utc o mes .............................................................. 1 7  
1 0. 3  
A nal ysis of E x pl orat or y O utc o mes ............................................................ 1 8  
1 1.  
R E F E R E N C E S ..................................................................................................... 1 8  

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C O N FI D E N TI A L  
A B B R E VI A TI O N S 
A B B R E VI A TI O N 
D E FI NI TI O N 
D S M B  
Data a n d Safet y M o nit ori n g B oar d 
S A P  
Statistical A nal ysis Pla n 
I T T 
I nte nt-T o - Treat P o p ulati o n 
P P  
Per - Pr ot oc ol P o p ulati o n 
C S R 
Cli nical St u d y Re p ort 
P T S S  
P ost- Tra u matic Stress S y m pt o ms 
C B T 
C o g niti ve Be ha vi oral T hera p y 
C P S S 
C hil d P T S D Scale 

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C O N FI D E N TI A L  
1. 
P R E F A C E
T his S A P descri bes t he pla n ne d a nal ysis a n d re p orti n g f or t he Rec o ver y after Stress 
T o ol kit ( R E S E T) Trial.  
T he rea der of t his S A P is e nc o ura ge d t o als o rea d t he cli nical pr ot oc ol f or details o n t he 
c o n d uct of t his st u d y, a n d t he o perati o nal as pects of cli nical assess me nts a n d ti mi n g f or 
c o m pleti n g a patie nt i n t his st u d y.

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2. 
P U R P O S E O F S A P
T his S A P is i m p orta nt f or t he f oll o wi n g reas o ns: ( 1) t o e ns ure t hat data c ollecte d
i n t he st u d y are a de q uate t o a d dress t he st u d y h y p ot heses; ( 2) t o pre ve nt a d h oc
decisi o ns i n a nal yzi n g st u d y data; a n d ( 3) t o pr os pecti vel y i de ntif y a ti meli ne a n d
str uct ure f or c o m pleti o n of st u d y a nal yses. T he pla n ne d a nal yses i de ntifie d i n t his
S A P will be i ncl u de d i n f ut ure ma n uscri pts.  Als o, e x pl orat or y a nal yses n ot
necessaril y i de ntifie d i n t his S A P ma y be perf or me d t o s u p p ort t he cli nical
de vel o p me nt pr o gra m.  A n y p ost- h oc, or u n pla n ne d, a nal yses n ot i de ntifie d i n t his
S A P perf or me d will be clearl y i de ntifie d i n s u bse q ue nt versi o ns.
2. 1   
S A P V E R SI O N HI S T O R Y 
After a versi o n of a n a nal ysis pla n is a p pr o ve d f or use i n a st u d y (f or e xa m ple, b y 
a Data Safet y M o nit ori n g B oar d or st u d y Pri nci pal I n vesti gat or), a n y s u bse q ue nt 
c ha n ges t o t he S A P re q uire a s u bse q ue nt versi o n of t he S A P t o be release d.  Eac h 
s uc h s u bse q ue nt versi o n of t he S A P m ust e x plicitl y s u m marize all c ha n ges ma de 
i n eac h S A P re visi o n si nce t he i nitiall y a p pr o ve d versi o n.  T his secti o n of t he S A P 
c o ntai ns t hat s u m mar y.  All pre vi o us a p pr o ve d S A P versi o ns m ust be arc hi ve d 
a n d s h o ul d be easil y accessi ble f or re vie w if nee de d.

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C O N FI D E N TI A L  
3. 
S T U D Y O B J E C TI V E S A N D E N D P OI N T S
3. 1  St u d y O bjecti ves
3. 1. 1  
Pri m ary O bjective
T he pri mar y o bjecti ve is t o c o m pare t he effect of c o g niti ve be ha vi oral t hera p y
( C B T) deli vere d via tele healt h t o us ual care a m o n g c hil dre n wit h p ost-tra u matic
stress s y m pt o ms. We h y p ot hesize t hat C B T will decrease s y m pt o ms c o m pare d t o
us ual care.
3. 1. 2  
Sec o n d ary O bjectives
Sec o n dar y o bjecti ves are t o de m o nstrate t hat C B T deli vere d via tele healt h is
feasi ble a n d acce pta ble.
3. 2  
St u d y E n d p oi nts
3. 2. 1  
Pri m ary E n d p oi nt
T he pri mar y o utc o me is p ost-tra u matic stress s y m pt o ms ( P T S S) as meas ure d b y 
t he C hil d P T S D Scale ( C P S S) at a p pr o xi matel y 1 0 wee ks p ost ra n d o mizati o n. 
T he C P S S will be pr o vi de d b y b ot h pare nts a n d c hil dre n. C hil dre n ha ve a 
te n de nc y t o u n derre p ort t heir s y m pt o ms, a n d pare nts d o n’t al wa ys n otice t heir 
c hil dre n’s s y m pt o ms. As a res ult, t he pri mar y o utc o me of 1 0 wee k C P S S sc ore 
will be calc ulate d as t he s u m of t he ma xi m u m of eac h i n di vi d ual q uesti o n 
res p o nse acr oss pare nt/c hil d q uesti o n d ya ds. If eit her t he pare nt or c hil d is 
missi n g t he res p o nse f or a gi ve n q uesti o n, t he o nl y res p o nse a vaila ble will be 
utilize d. T here is a prece de nce f or t his a p pr oac h i n t he fiel d. 
3. 2. 2  
Sec o n d ary E n d p oi nts 
T he sec o n dar y o utc o me is C P S S at a p pr o xi matel y 6 m o nt hs p ost ra n d o mizati o n. 
3. 2. 3  
E x pl or at ory O utc o mes 
Ke y e x pl orat or y e n d p oi nts i ncl u de: P R O MI S- ps yc h ol o gical stress; P R O MI S- S F 
de pressi o n; S C A R E D ( meas ure of a n xiet y). 
We will als o l o o k at c hil d a n d pare nt re p ort C P S S at 1 0 wee ks a n d 6 m o nt hs p ost 
ra n d o mizati o n.  
T he f oll o wi n g ta bles i ncl u de all o utc o mes c ollecte d f or t he st u d y. N ote t hat o nl y 

St ati sti c al A n al y si s Pl a n  
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C O N FI D E N TI A L  
t he o nes me nti o ne d a b o ve will be a nal yze d i n t he pri mar y ma n uscri pt f or t he 
pr oject. 
3. 2. 4 S A F E T Y O U T C O M E S 
Gi ve n t he nat ure of t he i nter ve nti o n we d o n ot a ntici pate a d verse e ve nts ( A Es). 
Seri o us A d verse E ve nt ( S A E): A seri o us a d verse e ve nt ( S A E) f or t his p o p ulati o n 
is a n a d verse e ve nt t hat: 
•
res ults i n deat h; or

St ati sti c al A n al y si s Pl a n  
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C O N FI D E N TI A L  
•
is life-t hreate ni n g (t he patie nt was, i n t he vie w of t he site i n vesti gat or, i n
i m me diate da n ger of deat h fr o m t he e ve nt as it occ urre d); or
•
re q uires i n patie nt h os pitalizati o n or pr ol o n gs a n e xisti n g h os pitalizati o n;
or
•
res ults i n persiste nt or si g nifica nt disa bilit y or i nca pacit y; or
•
a n y ot her e ve nt t hat, base d u p o n a p pr o priate me dical j u d g me nt, ma y
je o par dize t he s u bject’s healt h a n d ma y re q uire me dical or s ur gical
i nter ve nti o n t o pre ve nt o ne of t he ot her o utc o mes liste d i n t his defi niti o n.
S A Es are c ollecte d acc or di n g t o o ur sta n dar d data base f or m (see “ A E _f or m _ 5- 1-
2 3. d oc x” f or m rc _aesae).
4. 
S T U D Y M E T H O D S
4. 1  
O ver all St u d y Desi g n a n d Pl a n
R E S E T is a pr os pecti ve, ra n d o mize d, m ultice nter trial of pe diatric patie nts w h o
e x perie nce d a tra u matic i nj ur y a n d de vel o pe d p ost-tra u matic stress s y m pt o ms
( P T S S).  S u bjects were ra n d o mize d t o o ne of t w o st u d y gr o u ps t o recei ve eit her
( 1) 8 sessi o ns of c o g niti ve be ha vi oral t hera p y ( C B T) or ( 2) us ual care. T he mai n
researc h q uesti o n is w het her C B T re d uces P T S S s y m pt o ms relati ve t o us ual care
at 1 0 wee ks p ost ra n d o mizati o n.
4. 2  
Selecti o n of St u d y P o p ul ati o n 
Ca n di date c hil dre n are scree ne d at t he ti me of h os pitalizati o n f or tra u matic i nj ur y, 
a n d t he n a gai n at o ne m o nt h p ost disc har ge, wit h t he latter scree ni n g deter mi ne d 
w het her t he y ha d s ufficie nt P T S S t o q ualif y f or t he st u d y. T h ose w h o q ualifie d 
wit h s ufficie nt P T S S a n d c o nse nte d t o partici pate i n t he st u d y were ra n d o mize d t o 
C B T or us ual care. 
4. 3  
Met h o d of Tre at me nt Assi g n me nt a n d R a n d o miz ati o n 
Ra n d o mizati o n of c hil dre n eli gi ble after t he sec o n d scree n was c o n d ucte d usi n g 
per m ute d bl oc ks wit h e q ual all ocati o n t o eac h ar m stratifie d b y ce nter ( U U, U T, 
CI) a n d a ge gr o u p ( 8- 1 1 yrs, 1 2- 1 6 yrs). T he ra n d o mizati o n pr ot oc ol was
de vel o pe d b y t he statistical tea m a n d i m ple me nte d via R E D Ca p.
4. 4  
Tre at me nt M as ki n g ( Bli n di n g) 
Bli n di n g was n ot p ossi ble d ue t o t he nat ure of t his be ha vi oral t hera p y 
i nter ve nti o n. 
5. 
S A M P L E SI Z E D E T E R MI N A TI O N
G o al e nr oll me nt is 5 3 c hil dre n per gr o u p ( 1 0 6 t ot al).  T his will pr o vi de 8 0 % p o wer

St ati sti c al A n al y si s Pl a n  
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C O N FI D E N TI A L  
at a 0. 0 5 si g nific a nce t o detect a n effect size of 0. 5. 
T he f oll o wi n g ta ble i n dicates sa m ple sizes per gr o u p a n d t otal sa m ple size f or o ur 2 ar m 
st u d y u n der differe nt c o m bi nati o ns of c orrelati o n a n d effect size. Wit h a c orrelati o n 
bet wee n baseli ne a n d f oll o w- u p C P S S meas ure me nts of 0. 5 5, a n d a n e x pecte d lar ge 
effect size of 0. 5, we w o ul d ha ve 8 0 % p o wer at a 0. 0 5 si g nifica nce le vel t o detect t his 
differe nce wit h 4 5 s u bjects per gr o u p ( 9 0 t otal). E x pecti n g a l oss- t o-f oll o w- u p ( L T F) rate 
of 1 5 %, we w o ul d nee d t o e nr oll 5 3 s u bjects/ gr o u p or 1 0 6 t otal.  T hese calc ulati o ns are 
base d o n a n A N C O V A m o del, a n d were c o n d ucte d i n P A S S v 1 6. 0. 6. 
T a bl e 3. S a m pl e siz e c alc ul ati o ns f or diff er e nt c o m bi n ati o ns of wit hi n s u bj ect 
c orr el ati o ns a n d eff ect siz es. 
S a m pl e Siz e 
S a m pl e Siz e 
A dj ust e d f or L T F 
C orr el ati o n  
Eff ect 
Siz e 
A dj ust e d 
S D  
N/ Gr o u p  T ot al N 
N/ Gr o u p  
T ot al N 
N o n e  
0. 3 5  
1. 0 0  
1 3 0  
2 6 0  
1 5 3  
3 0 6  
0. 4  
0. 3 5  
0. 9 2  
1 1 0  
2 2 0  
1 2 9  
2 5 8  
0. 5 5  
0. 3 5  
0. 8 4  
9 0  
1 8 0  
1 0 6  
2 1 2  
N o n e  
0. 5 0  
1. 0 0  
6 4  
1 2 8  
7 5  
1 5 0  
0. 4  
0. 5 0  
0. 9 2  
5 3  
1 0 6  
6 2  
1 2 4  
0. 5 5  
0. 5 0  
0. 8 4  
4 5  
9 0  
5 3  
1 0 6  
6.  
A N A L Y SI S P O P U L A TI O N S A N D S T U D Y S U B J E C T S
6. 1 A N A L Y SI S P O P U L A TI O N S 
T he f oll o wi n g a nal ysis p o p ulati o ns are pla n ne d f or t he st u dies: 
•
I nte nt-t o- Tre at P o p ul ati o n (I T T): T he I T T p o p ulati o n i ncl u des all
patie nts w h o are ra n d o mize d. All ra n d o mize d s u bjects are i ncl u de d a n d
a nal yze d acc or di n g t o t heir ra n d o mizati o n assi g n me nt. T he I T T
p o p ulati o n will be use d f or t he pri mar y a nal ysis.
•
Per - Pr ot oc ol Effic ac y ( P P): T he P P p o p ulati o n i ncl u des all patie nts i n
t he Efficac y P o p ulati o n w h o recei ve d t he t hera p y t hat t he y were
ra n d o mize d t o a n d t he n c o m plete d t he C P S S at a p pr o xi matel y 1 0 wee ks
p ost ra n d o mizati o n. F or t he C B T ar m we re q uire at least 4 of t he 8 t hera p y
sessi o n(s) t o q ualif y.
6. 2 S T U D Y S U B J E C T S 
P ote ntial partici pa nts are i de ntifie d b y i nitial E H R re vie w cl ose t o t he ti me of i nj ur y. 
Fr o m t here, selecte d i ncl usi o n a n d e xcl usi o n criteria are f urt her e val uate d via E H R i n a 
preli mi nar y fas hi o n (see bel o w u n der “ Baseli ne Scree ni n g”). T h ose meeti n g criteria 
base d o n i nitial E H R re vie w are c o ntacte d w he n p ossi ble i n a n atte m pt t o f ull y e val uate 

St ati sti c al A n al y si s Pl a n  
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C O N FI D E N TI A L  
eli gi bilit y. O nce eli gi bilit y is c o nfir me d a n d fa milies a gree, t he y are as ke d t o c o m plete 
baseli ne s ur ve ys o ne wee k p ost i nj ur y, i ncl u di n g t he C hil d P T S D S y m pt o m Scale 
( C P S S), see Fi g ure 1a bel o w.  
Re gar dless of o ne wee k C P S S sc ore, fa milies w h o are eli gi ble at t he baseli ne scree ni n g 
a n d c o m plete o ne wee k s ur ve ys are c o ntacte d at o ne m o nt h after i nj ur y t o a gai n c o m plete 
t he C P S S. T h ose wit h c o m bi ne d pare nt/c hil d C P S S ≥ 1 1 at o ne m o nt h after i nj ur y are 
c o nsi dere d f or partici pati o n i n t he mai n trial. After eli gi bilit y c o nfir mati o n, pare nts a n d 
c hil dre n are a p pr oac he d f or c o nse nt/asse nt a n d ra n d o mizati o n ( Fi g ure 1 b). 
Fi g ure 1a- b. Recr uit me nt a n d ra n d o mizati o n of partici pa nts. 

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C O N FI D E N TI A L  

St ati sti c al A n al y si s Pl a n  
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C O N FI D E N TI A L  
7.  
G E N E R A L I S S U E S F O R S T A TI S TI C A L A N A L Y SI S
7. 1  
A n al ysis S oft w are
All a nal ysis will be perf or me d usi n g S A S ®  S oft ware versi o n 9. 4 or later w he ne ver
p ossi ble.  Ot her s oft ware pac ka ges, i ncl u di n g R, S T A T A a n d Stat Xact ®, ma y be
use d f or partic ular s pecialize d pr oce d ures.
7. 2  
Met h o ds f or Wit h dr a w als, Missi n g D at a, a n d O utliers
We d o n ot e x pect a n iss ue wit h l oss t o f oll o w u p i n o ur st u d y. Si nce C P S S is
defi ne d as t he ma xi m u m of t he c hil d a n d pare nt sc ores, t he n i n t he e ve nt t hat o ne
of eit her a c hil d or pare nt sc ore is missi n g, t he ot her will be use d. T his aff or ds
s o me pr otecti o n fr o m missi n g ness f or o ur pri mar y o utc o me. H o we ver, we d o
e x pect t hat t here will be o utliers i n ter ms of w he n t he C P S S was c ollecte d. Gi ve n
t hat t his is a s maller st u d y, we pla n t o i ncl u de all a vaila ble meas ure me nts. We
will s u m marize t he e xte nt of misti me d meas ures i n o ur st u d y a n d c hec k f or
differe nces b y treat me nt ar m.
MI will be i m ple me nte d f or o ur I T T a nal ysis if t here is n ota ble missi n g ness i n 1 0
wee k C P S S or a n i m bala nce i n missi n g ness bet wee n treat me nt ar ms. 1 MI  is
partic ularl y usef ul if t here are a u xiliar y varia bles t hat are hi g hl y c orrelate d wit h
b ot h t he st u d y o utc o mes a n d ris k of missi n g ness. We will i ncl u de t he f oll o wi n g
a u xiliar y varia bles: c hil d a n d pare nt meas ures ( Ta bles 1- 2) a n d patie nt
de m o gra p hic fact ors ( Ta ble 3).
I n t he e ve nt t hat MI is use d, we will ge nerate 2 0 i m p ute d data sets w hic h c o ntai n
i m p ute d val ues of t he pri mar y C P S S o utc o me (if R is use d, we will use t he mice
pac ka ge). T he i m p utati o n m o del will i ncl u de t he o utc o mes a n d all pre dict or
varia bles i ncl u di n g t he ra n d o mize d treat me nt assi g n me nt, a u xiliar y varia bles a n d
t he baseli ne le vel of C P S S.
We pla n t o i ncl u de all C P S S p ost t hera p y f oll o w- u p meas ures, re gar dless of
ti mi n g. At t he ti me of writi n g ( 3/ 3 1/ 2 3) we ha ve 4 s u bjects pri or t o 1 0 wee ks ( 5 9-
6 5 da ys) i n t he C B T ar m ( n o ne i n us ual care) a n d 8 s u bjects after ( 7 8- 9 6 da ys) i n
t he C B T ar m a n d 1 s u bject after ( 1 0 5 da ys) i n t he c o ntr ol ar m d ue t o a n iss ue wit h
R E D Ca p pr o gra m mi n g t hat se nt t he p ost-t hera p y assess me nt at t he fi nis h of
t hera p y i nstea d of 1 0 wee ks. T he R E D Ca p iss ue was c orrecte d. Si nce m ore
s u bjects c o me after t he wi n d o w i n t he C B T ar m t his i ntr o d uces a n
a ntic o nser vati ve bias. We will ha n dle t his i n t w o wa ys: a dj usti n g f or ti me si nce
ra n d o mizati o n as a c o nti n u o us varia ble i n o ur a nal ysis ( pri mar y strate g y) a n d
dr o p pi n g t hese ki ds fr o m o ur a nal ysis (sec o n dar y strate g y). T he d o w nsi de t o o ur
pri mar y strate g y is t hat it ass u mes t hat rec o ver y is c o nsiste nt o ver ti me. I n realit y,
it’s li kel y t hat m ore rec o ver y ha p pe ns earlier, s o t hat t his w o ul d be a c o nser vati ve
a p pr oac h ( b ut if m ore rec o ver y ha p pe ne d later, t he n t his w o ul d p ote ntiall y be
a ntic o nser vati ve). A n ot her d o w nsi de is t hat re vie wers will ha ve a diffic ult ti me
u n dersta n di n g o ur rati o nale – b ut it is defe nsi ble a n d p ote ntiall y ta kes a n

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a ntic o nser vati ve bias a n d ma kes it c o nser vati ve. T he d o w nsi de t o t he sec o n dar y 
strate g y is a l oss of p o wer. 
7. 3  
M ultice nter St u dies 
Si nce ra n d o mizati o n was stratifie d b y ce nter we will acc o u nt f or ce nter i n o ur 
a nal yses as a c o variate or stratificati o n varia ble (t he sa me a p plies f or a ge gr o u p). 
7. 4  
M ulti ple C o m p aris o ns a n d M ulti plicit y 
As t here is a si n gle pri mar y e n d p oi nt f or t his st u d y ( 1 0 wee k C P S S), a dj ust me nt 
f or m ulti ple c o m paris o ns will n ot be re q uire d f or t he pri mar y a nal ysis. Si milarl y, 
m ulti ple c o m paris o n a dj ust me nt is n ot re q uire d f or t he mai n sec o n dar y e n d p oi nt 
as a si n gle mai n sec o n dar y c o m paris o n of C P S S at 6 m o nt hs has bee n defi ne d.  
All ot her a nal yses will be c o nsi dere d e x pl orat or y. He nce, a nal yses of a d diti o nal 
e n d p oi nts will be perf or me d o n a c o m paris o n- wise basis u nless t he writi n g 
c o m mittees f or s pecific ma n uscri pts defi ne m ulti ple c o m paris o n a dj ust me nts 
d uri n g t he p u blicati o ns pr ocess.  Re p orts fr o m t his trial s h o ul d, w he ne ver 
a p pr o priate, n ote t he nat ure of e n d p oi nts re p orte d ( pri mar y vs. sec o n dar y vs. 
e x pl orat or y) as well as rele va nt m ulti plicities of c o m paris o ns. 
7. 5  
Pl a n ne d S u b gr o u ps, I nter acti o ns, a n d C o v ari ates 
Ra n d o mizati o n was stratifie d b y ce nter a n d a ge gr o u p, a n d t h us ce nter a n d a ge 
gr o u p will be i ncl u de d as c o variates i n o ur a nal yses as me nti o ne d a b o ve.  
Pla n ne d s u b gr o u p a nal yses i ncl u de se x, a ge gr o u p, a n d i nj ur y se verit y. 
C ut off f or e nr oll me nt was 1 1 +, b ut we will c o n d uct a n e x pl orat or y a nal ysis usi n g 
1 5 +. 
F ut ure p u blicati o ns will e x pl ore t he f oll o wi n g q uesti o ns: 
E x pl orat or y q uesti o ns i ncl u de w het her c hil dre n’s pre-i nj ur y ps yc h ol o gical healt h 
(a n xiet y a n d de pressi o n) a n d pare nt P T S S s y m pt o ms at ti me of i nj ur y will m o dif y 
t he treat me nt effect. T h us, we will pla n t o e xa mi ne t hese q uesti o ns t hr o u g h 
i nteracti o ns.   
A n ot her e x pl orat or y researc h q uesti o n is t he relati o ns hi p bet wee n P T S S 
s y m pt o ms a n d c hil dre n’s a n d care gi vers’ pre-i nj ur y ps yc h ol o gical a dj ust me nt a n d 

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fa mil y f u ncti o n. T his q uesti o n will be e val uate d b y e xa mi ni n g t hese varia bles i n 
e x pl orat or y m o dels.  
8. 
S T U D Y S U B J E C T S
8. 1  
Dis p ositi o n of S u bjects a n d Wit h dr a wls
All s u bjects w h o pr o vi de i nf or me d c o nse nt will be acc o u nte d f or i n t his st u d y.
T he fre q ue nc y a n d perce nt of s u bjects i n eac h p o p ulati o n, st u d y wit h dra wls,
s u b gr o u ps, a n d maj or pr ot oc ol de viati o ns will als o be prese nte d.
8. 2  
Pr ot oc ol De vi ati o ns
We will s u m marize t he n u m ber a n d % of s u bjects o verall a n d b y ce nter wit h
mi n or a n d maj or pr ot oc ol de viati o ns. See “ Rec o ver y After Stress T o ol kit - Re Se T
_ R E D Ca p. p df” f or m “rc _ pr ot oc ol _ de viati o n” f or a list of de viati o ns.
8. 3  
I ncl usi o n a n d E xcl usi o n Criteri a
T he n u m ber a n d perce nt will  be prese nte d f or s u bjects meeti n g eac h I ncl usi o n a n d
E xcl usi o n Criteria.  Ge nerall y, it is e x pecte d t hat t he o verall perce nta ge will be
1 0 0 % f or i ncl usi o n a n d e xcl usi o n criteria, e xce pt w he n wai vers are gra nte d or
w he n data re vie w i n dicates t hat i ncl usi o n or e xcl usi o n criteria ha ve bee n vi olate d.
9.  D E M O G R A P HI C S A N D O T H E R B A S E LI N E C H A R A C T E RI S TI C S
9. 1  
De m o gr a p hics 
T a bl e 3: D e m o gr a p hics  
C hil d  
S ex  
A g e  
R ac e/ et h nicit y 
Gr a d e i n sc h o ol 
If s u m m er – l ast c o m pl et e d gr a d e 
C o - m or bi diti es ( A D H D, a nxi et y, 
d e pr essi o n, l e ar ni n g pr o bl e ms) 
D o es y o ur c hil d h a v e a n y ill n ess t h at 
n e e ds l ots of d oct or visits s uc h as ast h m a 
or di a b et es ? 
H as y o ur c hil d b e e n h os pit aliz e d i n t h e 
p ast y e ar ? 
R e q uir es tr e at m e nt – y es/ n o  
Y es/ n o  
F a mil y 
N u m b er of a d ults i n t h e h o m e 
B ott o m l e v el is 1 = if gr e at er t h a n 1 – Is 
t h er e a s ec o n d p ar e nt i n t h e h o m e ? 

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N u m b er of c hil dr e n i n t h e h o m e i ncl u di n g 
t h e i nj ur e d c hil d 
B ott o m l e v el is 1 
R es p o n d e nt r el ati o ns hi p t o c hil d 
List – m ot h er, f at h er, gr a n d m ot h er, 
gr a n df at h er, a u nt, u ncl e, ot h er r el ati v e, 
n o n -r el ati v e g u ar di a n or f ost er p ar e nt 
F a mil y i nc o m e 
Sli d er b ar ? 
R es p o n d e nt e d uc ati o n 
Gr a d e sc h o ol, hi g h sc h o ol, s o m e c oll e g e, 
c oll e g e or gr e at er 
I ns ur a nc e 
N o n e, M e dic ai d/ C HI P, Pri v at e, Milit ar y 
M arit al st at us 
M arri e d, p art n er e d, n e v er m arri e d, 
di v orc e d  
R es p o n d e nt r ac e/ et h nicit y 
9. 2  
Me as ure me nt of Tre at me nt C o m pli a nce 
T he C B T ar m c o nsists of 8 t hera p y sessi o ns, a n d we will s u m marize t he 
distri b uti o n of sessi o ns c o m plete d as n ( %).  
1 0. 
E F FI C A C Y A N A L Y S E S
1 0. 1  
A n al ysis of Pri m ar y O utc o me
T he pri mar y a nal ysis will test t he n ull h y p ot hesis:
H 0:  T here is n o differe nce i n mea n 1 0 wee k C P S S sc ore bet wee n t he C B T 
a n d us ual care ar ms. 
T he alter nati ve h y p ot hesis is: 
H 1:  T here is a differe nce i n mea n 1 0 wee k C P S S sc ore bet wee n t he C B T a n d 
us ual care ar ms. 
Rejecti n g t he alter nati ve h y p ot hesis i n t he I T T p o p ulati o n, al o n g wit h a p ositi ve 
i m pr o ve me nt i n 1 0 wee k C P S S f or C B T relati ve t o t he us ual care ar m, will be 
c o nsi dere d t o be a s uccessf ul de m o nstrati o n of efficac y. 
T he m o del use d t o c o m plete t he pri mar y a nal ysis is a ge neralize d li near 
re gressi o n m o del wit h a n o utc o me of 1 0 wee k C P S S sc ore a n d pre dict ors t hat 
i ncl u de a n i n dicat or f or treat me nt gr o u p, baseli ne ( o ne m o nt h) C P S S sc ore, ti me 
si nce ra n d o mizati o n, site a n d a ge gr o u p. T he c oefficie nt f or treat me nt gr o u p will 
a ns wer o ur pri mar y efficac y q uesti o n re gar di n g w het her 1 0 wee k C P S S sc ore 
differs bet wee n C B T vers us us ual care ar ms. A dj ust me nt f or t he baseli ne C P S S 
sc ore pr o vi des t he str uct ure of a n a nal ysis of c o varia nce ( A N C O V A) t o i m pr o ve 

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statistical p o wer.2 Ti me si nce ra n d o mizati o n will be i ncl u de d as a c o nti n u o us 
varia ble t o c o ntr ol f or a tec h nical re dca p iss ue (see Secti o n 7. 2 ). Sit e a n d a ge 
gr o u p are i ncl u de d si nce t he y were stratificati o n varia bles use d i n t he 
ra n d o mizati o n pr ot oc ol.  
Re gressi o n dia g n ostics will i ncl u de pl otti n g resi d uals vs fitte d val ues t o assess 
li nearit y, t he s q uare r o ot of t he sta n dar dize d resi d uals vs fitte d val ues (ie “ Scale-
L ocati o n) t o assess varia nce h o m o ge neit y, q q pl ot t o assess n or malit y, a n d 
sta n dar dize d resi d ual vs le vera ge t o assess f or o utliers. T he c h oice of o utc o me 
m o del will de pe n d o n t he distri b uti o n of t he C P S S sc ore, w hic h will be vis ualize d 
usi n g a hist o gra m a n d de nsit y c ur ves stratifie d b y treat me nt ar m. Pr o vi de d t he 
C P S S sc ore distri b uti o n is s ufficie ntl y s y m metric, we will use a n or mal o utc o me 
m o del. If t he re gressi o n ass u m pti o ns are n ot reas o na bl y met, we will c o nsi der 
alter nati ve m o dels s uc h as ga m ma or l o g n or mal, or a t o bit m o del if t here are 
n ota ble fl o or a n d/ or ceili n g effects. 3 
As a se nsiti vit y a nal ysis, we will re peat t he a b o ve m o del e xcl u di n g ti me si nce 
baseli ne, a n d als o e xcl u di n g t he C B T s u bjects t hat ha d a C P S S sc ore c ollecte d 
after 1 2 + wee ks.  
If t here is a n iss ue wit h treat me nt a d here nce, we will use a n i nstr u me ntal varia bles 
a p pr oac h t o esti mate treat me nt effects u n der differe nt treat me nt d oses. T he 
a d va nta ge of t his a p pr oac h o ver a per- pr ot oc ol a nal ysis is t hat it e na bles us t o 
a nal yze patie nts acc or di n g t o t heir ra n d o mize d assi g n me nt.  
We will als o e xa mi ne t he efficac y of C B T treat me nt i n s u b gr o u ps c o nsisti n g of 
se x, a ge gr o u p a n d i nj ur y se verit y b y i ncl u di n g i nteracti o ns bet wee n t he i n dicat or 
f or C B T vers us us ual care a n d se x, a ge gr o u p a n d i nj ur y se verit y ( w here eac h 
i nteracti o n will be assesse d i n a se parate m o del). Eac h i nteracti o n m o del will 
a ns wer t he q uesti o n of w het her t he efficac y of C B T treat me nt differs b y t he 
s u b gr o u p, a n d it will als o pr o vi de t he efficac y esti mates wit hi n eac h s u b gr o u p 
le vel. 
1 0. 2  
A n al ysis of Sec o n d ar y O utc o mes 
F or a nal ysis of t he 6 m o nt h C P S S ti me p oi nt, w hic h will assess persiste nce of t he 
treat me nt effect bet wee n t he C B T a n d us ual care gr o u ps, we will use restricte d 
ma xi m u m li keli h o o d esti mati o n 4 u n der a ge neralize d li near mi xe d m o del. We will 
a gai n a dj ust f or t he sa me varia bles as descri be d a b o ve f or t he mai n efficac y 
a nal ysis, e xce pt t hat ti me will be c o de d as bi nar y ( 1 0 wee ks vs 6 m o nt hs). T he 
pri mar y efficac y e val uati o n will be perf or me d usi n g a n i nteracti o n bet wee n t he 
C B T vers us us ual care gr o u p i n dicat or a n d ti me. We will a dj ust f or 1 m o nt h 
baseli ne C P S S i n t his a nal ysis.  

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1 0. 3  
A n al ysis of E x pl or at or y O utc o mes 
Si milar a nal ysis a p pr oac hes will be use d f or t he se parate c hil d a n d pare nt C P S S 
sc ores, a n d t he ot her e x pl orat or y o utc o mes descri be d pre vi o usl y. As t he n o n-
C P S S e x pl orat or y o utc o mes are n ot assesse d at t he 1 m o nt h ti me p oi nt, b ut t he y 
are a vaila ble at 1 wee k after i nj ur y, we will use t his 1 wee k ti me p oi nt as o ur 
baseli ne meas ure.  
As a n e x pl orat or y a nal ysis, we will re peat t he pri mar y a n d sec o n dar y a nal ys es 
wit hi n t he s u b gr o u p of ki ds w h o ha ve a C P S S sc ore of 1 5 +. 
1 1.  R E F E R E N C E S
1. Ja k o bse n J C, Gl u u d C, Wettersle v J, Wi n kel P. W he n a n d h o w s h o ul d m ulti ple
i m p utati o n be use d f or ha n dli n g missi n g data i n ra n d o mise d cli nical trials - a practical
g ui de wit h fl o wc harts. B M C Me d Res Met h o d ol.  2 0 1 7 Dec 6; 1 7( 1): 1 6 2.
2. Fitz ma urice G, Laire d N, Ware J. A n alyzi n g res p o nse pr ofiles. A p plie d l o n git u di n al
a n alysis, m o deli n g t he me a n.  Ne w Y or k: Wile y; 2 0 0 4.
3. B o ult o n, Aar o n J a n d Willif or d, A n ne ( 2 0 1 8). " A nal yzi n g S ke we d C o nti n u o us
O utc o mes Wit h Ma n y Zer os: A T ut orial f or S ocial W or k a n d Y o ut h Pre ve nti o n
Scie nce Researc hers". J o ur n al of t he S ociety f or S oci al W ork & Rese arc h . 9 ( 4): 7 2 1-
7 4 0.
4.  Har ville D A. Ma xi m u m Li keli h o o d A p pr oac hes t o Varia nce C o m p o ne nt Esti mati o n
a n d t o Relate d Pr o ble ms. J o ur n al of t he A meric a n St atistic al Ass oci ati o n.
1 9 7 7; 7 2( 3 5 8): 3 2 0- 3 3 8.