Intervention to Change Attributions That Are Negative (ICAN): a New Approach to Reducing Anger and Aggression After Brain Injury
Phase: NA
Conditions: Trauma, Brain, Brain Injuries, Traumatic Brain Injury, Brain Injuries, Traumatic, Brain, Trauma
Sponsor: Indiana University

 
 
 
 
 
 
Intervention to Change Attributions that are Negative (ICAN): a New Approach to 
Reducing Anger and Aggression after Brain Injury 
 
Study Protocol and Statistical Analyses Plan 
 
Clinicaltrials.gov #: NCT03648476    
Unique Protocol ID: 1806829789    
Secondary IDs: 1R21HD094232-01 
 
April 19,2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

STUDY PROTOCOL 
      
Study Design. We will conduct a small, randomized waitlist controlled trial of the ICAN intervention to examine 
feasibility and acceptability (Aim 1); effect size estimates on perspective taking and hostile attributions (Aim 2); 
and anger and aggression (Aim 3) in participants with TBI. 
 
     
Inclusion/Exclusion Criteria.  
Inclusion Criteria  
• 
History of complicated mild to severe TBI (injury due to an external physical force), with injury severity 
being defined either by1 Glasgow Coma Score at time of injury (≤12), or post-traumatic amnesia (≥1 
day), or loss of consciousness (≥30 minutes), or positive head CT scan consistent with TBI.  
• 
At least 18 years of age or older;  
• 
≥1 year post-injury;  
• 
Have adequate vision, hearing, and speech/ language skills to participate in assessments and group 
therapy (determined based on interaction with the participant at screening) 
• 
Have adequate reading comprehension (due to the primary assessment involving written scenarios)  
• 
Have abnormal scores on one or more of the below measures of negative attributions or perspective 
taking (determined at T0 screening): 
o Epps Intent: >4.8, or 
o Epps Hostility: >4.2, or 
o Epps composite score: >-0.2, or 
o AIHQ Intent: >3.3, or 
o IRI Perspective Taking: < 14.5 for men and < 15.5 for women   
• 
Have above average aggression (>49 at telephone prescreening; >55 at T0 screening) on one of the 
Buss Perry Subscales. 
• 
No anticipated medication changes for emotions/ behavior during length of study participation; medica-
tions for emotions/ behavior must be stable within last 30 days prior to consent at T0 (Screening)  
• 
Have reliable mode of transportation  
Exclusion criteria:  
• 
Pre-morbid neurological disorders that could affect mood and cognition (e.g. stroke); does not in-
clude controlled seizures  
• 
Progressive central nervous system disorders (e.g. dementia, Parkinson’s)  
• 
Developmental disability (e.g., autism, developmental delay); 
• 
Major psychiatric disorders (e.g. schizophrenia, Borderline Personality Disorder);  
• 
Severe Depression and/or perceived risk to self or others (mental health resources will be provided 
and if suicide risk, approved suicide protocol will be utilized);  
• 
Currently receiving active behavioral therapy for anger.   
• 
On drug research study for irritability, anger, aggression  
 
Note: Participants will not be excluded if they do not have caregiver.  
 
Sample Size Calculation. Forty participants (20 per group) will be enrolled to allow for 20% dropout. Thirty-
two participants (16 per group) are expected to finish the study. For Aim 1, feasibility and satisfaction percent-
ages of 80%, a sample size of 30 will allow these proportions to be estimated to within 13% using one-sided 
95% confidence intervals. For between group effect sizes for Aims 2 and 3, a sample size of 21 per group will 
detect an effect size of 0.9 standard deviations with 80% power using a two-sided t-test at a .05 level of signifi-
cance. An ANCOVA model with pre/post correlation of 0.5 can reduce the sample size needed by 25% or to 16 
per group. For within group effect sizes for Aims 2 and 3, 16 subjects will provide 80% power to detect a differ-
ence in means of .78 standard deviations using a two-sided paired t-test at the .05 level of significance. 
  
Recruitment. The Rehabilitation Hospital of Indiana (RHI), an affiliate of Indiana University (where the PI and 
Co-I’s have offices), will be a primary source of recruitment (see Hammond LOS). IU/RHI is one of 16 nation-
ally recognized Traumatic Brain Injury Model Systems (TBIMS) sites in the United States, making it a strong 
site for recruitment of this population. On average, RHI admits around 120 individuals with TBI annually; >1,000 

individuals with TBI are seen in the RHI outpatient clinics. We will use 1) past RHI inpatients, 2) RHI Outpatient 
Clinic, 3) RHI Research Registry (n=295), and 4) IU/RHI TBIMS Database (>230 enrolled to date). We will re-
cruit through letters sent by physicians to their patients, pre-clinic chart screening, clinician discussions with 
patients, flyers posted in RHI, recruitment videos shown around the facility, researchmatch.com and through 
The Rehabilitation Hospital of Indiana's Facebook page. Flyers will be distributed at TBI support groups and 
the Brain Injury Association of Indiana.  RHI patient letters will be followed with a phone call to confirm receipt 
of the letter and inquire about interest in the study.  See Pre-screen below.  
      
Outcome Measures. 
Perspective Taking and Empathic Concern. The Interpersonal Reactivity Index (IRI),2,3 is a subjective question-
naire that measures perspective-taking, empathic concern, fantasy, and personal distress. Participants use a 
scale to rate how well statements describe them. Only ques-
tions from the perspective-taking and empathic concern sub-
tests will be administered. The IRI has good test-retest relia-
bility and internal reliability.2,3 It was used in the PI’s previous 
studies on attributions. To determine the subjects’ global 
sense of change in his/ her perspective taking and empathy, 
the Patient Global Impression of Change (PGIC) regarding 
these outcomes will be administered. To determine global be-
havioral changes in perspective taking and empathy as per-
ceived by others, the Caregiver Global Impression of Change 
(CaGIC)4,5 will be administered to participant caregivers. Us-
ing a 7-point Likert scale, caregivers will be asked to rate the 
degree of change (1=no change; 7=a great deal better) in the 
participant’s perspective taking and empathy. The PGIC and CaGIC for perspective taking and empathy are 
considered secondary outcome measures for the study.  
 
 Attributions of hostility, intent, blame and anger responses to hypothetical scenarios.  
Epps Scenarios are 21 brief and standardized hypothetical scenarios, portraying benign, ambiguous, 
and hostile behaviors.6 Scenarios have a 7th grade reading level and were sensitive enough to detect hostility 
bias in our previous studies.7 On a 9-point scale, participants will first rate how angry they would be if the sce-
nario happened to them, then how hostile, how intentional, and how much to blame they think the character’s 
behavior was. They will then be asked, “what would you do about it?”.  Participants’ responses will be audio 
recorded to assure we accurately capture their responses.  Participants will be alerted before the audio record-
ing begins.  
 
Ambiguous Intentions Hostility Questionnaire:    This questionnaire consists of 15 written vignettes describing 
actions/ situations that were intentional (5), ambiguous (5) and accidental (5).   After participants read each 
vignette and imagine the scenario happening to her or him, they are asked five questions: 1) why the other per-
son (or persons) acted that way toward you (open-ended response later rated by two independent raters; score 
indicates ‘‘hostility  bias’’); 2) Whether the other person (or persons) performed the action on purpose (1 ‘‘defi-
nitely no’’ to 6 ‘‘definitely yes’’) using a Likert Scale (Intent score); 3)  how angry it would make them feel (1 
‘‘not at all angry’’ to 5 ‘‘very angry’’) using a Likert scale (anger score); 4) how much they would blame the 
other person (or persons) (1 ‘‘not at all’’ to 5 ‘‘very much’’) using a Likert scale (blame score); and 5) how she 
or he would respond to the situation, (open-ended response). 
 
 General Anger and Aggression:  Changes in anger and aggression will be evaluated with several different 
measures.  General anger will be measured with the Anger-Affect Scale from the NIH Toolbox Emotion Battery 
(also known as the Patient Reported Outcomes Measurement Information System; PROMIS) Anger Short 
Form), and will be a secondary outcome measure.8 This 5 item subjective questionnaire requires participants 
to indicate the frequency with which they have been bothered by anger symptoms in the past week using a 5 
point Likert scale. Scores are converted to standard scores, and can be used to classify anger severity. Devel-
oped as part of NIH’s initiatives for better outcomes measurement, this tool has good validity and reliability.8 
Aggression will be measured with the Buss-Perry Aggression Questionnaire (AQ) and the AQ will be the pri-
mary outcome measure.9 The AQ is a standardized measure comprised of 34 statements to assess anger, 
hostile thoughts, and physical and verbal aggression. Participants rate statements using a 5-point scale.  Raw 
Table 1                            
Outcome Measure 
Aim 
IRI Perspective Taking  2 
**PGIC and CaGIC perspective taking & 
empathy 
2 
Intent and Hostile attributions to scenarios  2 
Anger Ratings to scenarios  3 
**PROMIS Anger-SF  3 
*Aggression Questionnaire 
3 
**PGIC and CaGIC aggression 
3 
CSQ-8  1 
*Primary Outcome; **Secondary Outcome 
 

and scaled scores (adjusted by age and gender) are provided for aggression subcomponents and total aggres-
sion. Total aggression will be used for our analyses. The AQ is a widely used and accepted aggression meas-
ure, including for TBI studies.10-14  It has good test-retest reliability (.72-.80), and good internal consistency 
(.76-.94).9  To determine the subjects’ global sense of change in anger and aggression, the Patient Global Im-
pression of Change (PGIC) regarding these outcomes will be administered. To determine global behavioral 
changes in anger and aggression as perceived by others, the Caregiver Global Impression of Change 
(CaGIC)4,5 will be administered to participant caregivers. Using a 7-point Likert scale, caregivers will be asked 
to rate the degree of change (1=no change; 7=a great deal better) in the participant’s anger and aggression. 
The PGIC and CaGIC are considered secondary outcome measures.  
 
Emotion Regulation: The Difficulty with Emotion Regulation Scale (DERS)61 is a 5-point Likert scale that partici-
pants use to rate the frequency they utilize self-regulation behaviors in response to general emotional distress. 
There are 6 subscales: Lack of Emotional Awareness, Lack of Emotional Clarity, Difficulties Controlling Impul-
sive Behaviors When Distressed, Difficulties Engaging in Goal-Directed Behavior When Distressed, Non-ac-
ceptance of Negative Emotional Responses, and Limited Access to Effective Emotion Regulation Strategies. 
Items are summed to provide a Total Emotion Dysregulation score. The DERS has high internal consistency, 
test-retest reliability, and good construct validity.61 Importantly, because this measure assesses difficulties reg-
ulating all types of emotions, it captures different information than that provided by measures specific to anxi-
ety, anger, or depression which can miss more general, yet common, self-regulation problems.  
 
Social Inference/Theory of Mind: The Awareness of Social Inference Test (TASIT)15 uses short one minute 
video vignettes to assess emotion and social inferences.  There are three subtests that comprise the TASIT: 
Emotional Evaluation Test (EET); the Social Inference-Minimal (SI-M); and Social Inference-Enriched (SI-E). In 
the EET subtest, actors portray six different emotions with dynamic facial movements, tone of voice, postures 
and gestures through short vignettes.  These emotions include happy, sad, angry, disgust, fearful, surprised 
and neutral.  In the SI-M test, actors depict social exchanges that are either sincere (text and context are con-
sistent) or sarcastic (text and context are inconsistent).  In the SI-E test, the actors perform social skits that de-
pict either sarcasm or lies.  Participants must make inferences about what the characters are thinking or believ-
ing and their intentions. We will use data from the EET, SI-M, and SI-E subtests for our analyses (3 variables). 
The TASIT was tested for construct validity and was determined to be able to distinguish the social perceptual 
abilities of persons with and without brain injury on overall performance.15 
 
Depression: Patient Health Questionnaire 9 (PHQ-9):64 This self-report depression assessment uses a 3-point 
Likert scale (maximum score 27), with established validity and reliability, including in the TBI population.64,65 
Participants rate the frequency of specified problems during the past 2 weeks.  
 
Anxiety: Generalized Anxiety Disorder Assessment (GAD-7)16 is a self-report 7-item questionnaire that as-
sesses frequency of seven anxiety symptoms linked to the DSM-IV criteria for GAD. 
 
Alexithymia: The Toronto Alexithymia Scale-20 (TAS-20) 21 is the most widely used self-report questionnaire to 
measure alexithymia (52-60=moderate alexithymia; ≥61=high alexithymia), and has good test-retest reliabil-
ity.21 The TAS-20 is comprised of 3 factors: 1) ability to identify emotions (e.g., I am often confused about what 
emotion I am feeling); 2) ability to describe emotions (e.g., It is difficult for me to find the right words for my 
feelings); and 3) externally-oriented thinking (e.g., I prefer to just let things happen rather than understand why 
they turned out that way).  
 
Satisfaction: We will use the Client Satisfaction Questionnaire (CSQ-8)17 which is an 8 item instrument with a 
4-point Likert scale that participants use to answer questions about perceived satisfaction with the program 
(e.g., To what extent has our program met your needs?; Have the services you received helped you to deal  
more effectively with your problems?  In an overall, general sense, how satisfied are you with the service you 
have received?). Scores are summed (8-32) with higher scores indicating greater satisfaction. Normed scores 
based on 8000 clients are available. The test has good reliability and validity.17  
 
Post-Treatment Qualitative Interview: After participants receive the ICAN treatment (Time 2 for ICAN Subjects 
and Time 3 for WLC subjects), the unblinded RA will Interview the subjects with the following questions. A) 
Have you noticed any changes in yourself since going through the group therapy? (yes/no); B) What changes 

have you noticed (if any)?; and c) What parts of the therapy do you think were the most helpful? 
 
Subsidiary Measures 
Discourse Comprehension Test (DCT): Test of reading comprehension for explicit and implicit main idea and 
details of short passages.  There are two versions of the test.  One version examines reading comprehension 
for information the participants read themselves (self-read).  The other version tests auditory comprehension.  
Participants must demonstrate sufficient comprehension in one version or the other (6/8 questions correct or 
75% correct).  For the auditory version, subjects will listen to the story once, and then answer the 8 yes or no 
questions.  For the self-read version, participants will read the story on his/ her own and this will be followed by 
eight written yes/no questions, based on the stated (4) and implied (4) information within the story. When the 
subjects are answering the questions, they may refer back to the text for information, so that the test will truly 
assess comprehension and not memory skills.  Responses are recorded in terms of number of items correct 
for stated versus implied main ideas and details.  Participants will need to achieve 75% accuracy in either the 
self-read or auditory version.   
 
Cognition/ Executive Functioning:  We will assess executive functioning skills for attention, dis-inhibition and 
verbal fluency. The following tests were chosen based on findings from our preliminary study. Color-word inter-
ference (Stroop): Attention and dis-inhibition will be assessed with a commonly used color-word interference 
test that assesses skills such as basic color naming; word reading; and names of colors written in different 
color ink (participants must name the color of the ink, not read the words).  Verbal Fluency: assesses word as-
sociation fluency; we will examine letter fluency and category fluency. This test measures a person's ability to 
make verbal associations to letters and categories.  Responses for verbal fluency will be audio recorded for 
data integrity.  
 
Neurobehavioral Functioning: We will evaluate how participants’ caregivers perceive the neurobehavioral func-
tioning of our participants with TBI with the Frontal Systems Behavior Scale (FrSBe).18,19 It is a 46-item subjec-
tive questionnaire that measures apathy, dis-inhibition, and executive dysfunction with a 5-point Likert scale. 
The FrSBe has good reliability and validity18,19 and has been used in variety of clinical populations, including 
brain injury and Alzheimer’s disease.20 
 
 
 
Table 1a. ICAN MEASURES AND TIMELINE (Subjects with TBI) 
 
T0 
(screen) 
T1 
T2 
T3  
(WLC only) 
Consent/ HIPPA* 
X 
 
 
 
Demographics*; TBI History*; 
medication infor and therapy 
status* 
X (inc) 
 
 
 
Med and therapy status update 
only* 
 
X 
X 
WLC only 
Discourse Comprehension Test*  X (inc) 
 
 
 
Epps stories (attributions and 
anger to hypothetical scenarios) 
X (inc) 
 
X 
WLC only 
AIHQ Scenarios 
X (inc) 
X** 
X 
WLC only 
IRI Perspective Taking and Em-
pathic Concern*   
X (inc) 
X** 
X 
WLC only 
Buss Perry Aggression*  
X (inc) 
 
X 
WLC only 
NIH Toolbox Anger Affect*   
 
X 
X 
WLC only 
TASIT (theory of mind)  
 
X 
X 
WLC only 
PHQ9 (Depression)* 
X (inc) 
 
X 
WLC only 
GAD7 (anxiety)* 
 
X 
X 
WLC only 
TAS-20 (alexithymia)* 
 
X 
X 
WLC only 
DERS (emotion regulation)* 
 
X 
X 
WLC only 
COWAT verbal fluency (cog f)* 
X 
 
 
 
Color word interference 
(Stroop)  (cog f) 
X 
 
 
 

Patient Global Impression of 
Change in Anger and Aggres-
sion*  
 
 
X 
WLC only 
Patient Global Impression of 
Change in Empathy/ Perspective 
Taking* 
 
 
X 
WLC only 
Client Satisfaction Question-
naire 8 (CSQ-8)* 
 
 
ICAN 
only 
WLC only 
Post-Treatment Qualitative In-
terview* 
 
 
ICAN 
only 
WLC only 
RA opinion of group allocation  
 
 
X 
 
 
* May be administered via phone, mail, REDCap survey, video conference call and/or in person; ** These measures will be 
collected at T1, if participants did not complete them at prior T0 due to protocol change.  
 
 
 
Table 1 b.  ICAN MEASURES AND TIMELINE Caregivers 
 
T1 
T2 
T3 
FrsBE* 
X 
 
 
IRI PT and EC  (per-
spective taking and 
empathy (Aim 1)* 
X 
X 
WLC only 
CaGIC Aggression & 
Empathy/ Perspective 
Taking* 
 
X 
WLC only 
 
     
 
Intervention (Intervention to Change Attributions that are Negative; ICAN). In a group therapy format (approxi-
mately 5 subjects per group), ICAN will train perspective taking through role-playing and perspective-position-
ing exercises.  
Each of the 6 sessions will include the core exercises outlined in Table 2. See publication for more detail.21 
     
A) Role Play Video Scenario 
Participants will watch video scenarios depicting situations in which a character’s motives are ambiguous (e.g., 
some-one bumped into you). After watching the scenario, participants will be asked to generate possible mo-
tives. In other words, produce as many potential explanations for the behavior22 After generating possible mo-
tives, they will be asked to role-play the scenario assuming a positive interpretation of the motive for the ob-
served behavior.  After the role-play, participants will be asked questions to process the experience and how 
the role play changed how they felt about the person’s actions.  
 
B) Perspective-Positioning Personal Experiences 
Participants will be asked to produce personal examples of situations in which someone’s behaviors led to an 
unpleasant outcome for the participant, and possibly perceived by the participant as purposeful.  After introduc-
ing this scenario to the group, the participant will take part in a Perspective-positioning exercise in which partic-
ipants will sit in one chair representing self-perspective (Chair A) to explore his/ her own thoughts and feelings 
surrounding the situation, and then move to a different Chair (Chair B) to experience the other person’s per-
spective, eliciting their thoughts and feelings. After the Perspective-positioning activity, participants will be 
asked questions to help them process the experience and how it felt to “be” the other person and what they 
learned about the other person’s feelings and motives for their actions, and how that in turn changed how they 
felt about the situation and the person’s actions.  
 
Procedures. This is a randomized waitlist controlled trial. We will recruit waves of approximately 6-10 partici-
pants, resulting in the need for 4-7 waves, depending on how large each wave is (N=40). For each wave, par-
ticipants will be screened for eligibility. Once approximately 6-10 eligible participants have been identified, they 
will be invited to come back for baseline testing (Time 1). Once they complete Time 1 testing, they will be ran-
domized to the ICAN group (n=3-5 / wave) or the WLC group (n=3-5/ wave).  See Figure 2 for design and Ta-
bles 1 a and b schedule of events. Each Time 0-4 visit may be split up over multiple sessions in order to keep 

testing time reasonable and limiting in-person interactions as a safety precaution due to the COVID-19 pan-
demic. 
 
           
The specified weeks outlined for testing and treatment in this protocol are approximate. While specified timing is 
ideal, many unforeseen and uncontrollable factors will influence the ability to strictly adhere to this timeline.  Thus the 
specified windows for assessment and treatment will fluctuate.    Most important to the study integrity is that Time 2 
testing for both subject groups occur within an approximately 2-3 week time period (and within approximately 1-2 
weeks of ICAN subjects completing treatment). Time 3 testing for WLC should be within approximately 2 weeks of 
completing treatment. When applicable, video conference call via HIPAA-compliant Zoom Health may be used for test-
ing/data collection. Video will not be recorded when this happens. 
  
Prescreening (telephone script). Some people with TBI (RHI patients/ or former patients) will receive a patient 
recruitment letter.  These letters will be followed by a phone call (see Telephone script) to confirm receipt of the 
letter and inquire about their interest in the study.  Others may call us after receiving one of our recruitment 
materials.  We will use the telephone script to provide them with more detail about the study. The Telephone 
script will also serve as a Pre-screener to determine if subjects meet initial inclusion criteria in order to reduce 
any unnecessary burden of coming in to RHI if we can determine early on, that they will not meet inclusion cri-
teria. One of those criteria is “above average aggression” based on a standardized test.  If after hearing the 
description of the study, participants are still interested, they will be administered an aggression questionnaire 
over the phone along with some inclusion / exclusion questions. 
 
Screening/ enrollment (T0). Participants who indicate 
an interest in the study and provide informed consent will be 
screened for meeting inclusion criteria (described above). 
Screening may be discontinued at any point in the visit if ineli-
gibility is determined before the visit is over. Order of assess-
ments may vary depending on in-person versus remote ad-
ministration (e.g., over the phone, video conference call) as 
well as eligibility criteria met at any given point throughout 
screening. 
• 
Injury criteria will be determined with a demographic 
and injury interview (later verified via medical report), which also includes a Substance abuse survey.  
• 
Reading comprehension (inclusion): Following procedures from our past two studies23,24, we will use 
the Discourse Comprehension Test (DCT)25 to determine adequate comprehension. If this criterion is 
not met, screening will discontinue.  
• 
Aggression (inclusion): Participants will also have to score higher than average on one of the Buss 
Perry Aggression Questionnaire subscales.  If this criterion is not met, screening will discontinue. 
• 
Depression (inclusion): Severe Depression and/or perceived risk to self or others will be evaluated. If 
the participant is severely depressed or a perceived risk to self or others, the participant will be pro-
vided with Mental health resources, and if suicide risk, approved suicide protocol will be utilized. Addi-
tionally, this person will be excluded, and screening will discontinue.     
• 
Negative attribution and perspective taking (inclusion): Participants will be presented with two different 
attribution measures (Epps scenarios or AIHQ) and a perspective taking measure (IRI respective tak-
ing). Since the intervention trains perspective taking for negative attribution styles, participants must 
have abnormal attribution or perspective taking scores on one of these measures.  
• 
Other measures administered at the screening visit (not inclusion criteria), are indicated in Table 1 a 
(Screen T0) and include COWAT and Stroop Color word interference.   
 
**Past screen failures and re-screening: Several new inclusion criteria have been added since the study 
start, and it is possible the changes may have altered the eligibility of earlier screened subjects. Subjects who 
initially failed screening will be allowed to be re-screened.  Formerly excluded subjects will be contacted to see 
if they are interested in being screened again.   If they are interested in being screened again, they will be re-
consented (explaining they have previously been screened and failed and are now being re-tested) and re-ad-
ministered all assessments as outlined in the protocol with the exception of subjects who have screen failed 
within 8 weeks from the new inclusion criteria. 
Fig 2.  Study Design R=Randomization; T=Time; WLC = Waitlist Control 

  
Assessment Visits T1, T2, and T3.  Assessments as outlined in Tables 1 a and b (except for the CSQ8 and the 
Post-Treatment Qualitative Interview; see below) will be conducted by the blinded RA. For T2, the RA will be 
blinded to group assignment. Because T3 is only WLCs, the RA will no longer be blinded to group assignment 
at that point. At the end of T2, the blinded RA will complete a survey on their belief regarding group allocation. 
 
Randomization and Stratification. Participants will be randomized to group after T1 testing by the study statisti-
cian using a random number generator. Randomization will be blocked and stratified by gender due to ex-
pected gender differences in hostility bias. For each treatment wave, ~6-10 participants will be randomly as-
signed to ICAN or WLC.  Once ~6-10 eligible participants have been identified and completed Time 1 testing, 
the statistician will assign treatment allocation to ICAN or WLC.  An unblinded RA will notify the subject of their 
group allocation.  This method will allow blinded Research assistants to remain blinded to group assignment. 
After the 4-7 waves, 20 participants will have been randomized to ICAN and 20 to WLC (n=40). 
  
 
Intervention Procedures and Treatment Fidelity.  Participants randomized to ICAN will start treatment after 
Time1. For WLC participants, their treatment will be delayed until after Time 2 data collection. ICAN will be de-
livered over six sessions each lasting approximately 2 hours, once a week in a group setting (n=~5 partici-
pants/ group), for 6 weeks by 1-2 clinical facilitators. Participants will be given a notebook with information and 
exercises. Treatment Fidelity. Steps from an adapted Treatment Fidelity Checklist (NIH Behavior Change 
Consortium working group on treatment fidelity;26) will be used to ensure fidelity of Theory, Provider Training, 
Treatment Implementation, Treatment receipt, and Treatment Enactment. Specific to Training: Facilitators will 
have a minimum of 2 years of brain injury experience and clinical experience. Facilitators will be trained by the 
PI and study consultant, Dr. Winegardner (ICAN creator; see LOS), which will involve reviewing a treatment 
manual and role-play of the ICAN exercises. The treatment manual will consist of a power point presentation 
outlining treatment procedures and activities, which will also be used to guide the treatment sessions with the 
subjects. Delivery. For all sessions, the power point presentation outlining treatment procedures and activities 
will be followed and an implementation checklist will be completed.  
 
Satisfaction Survey (CSQ8): To encourage honest feedback and ensure blinding of RA’s, an unblinded RA will 
be responsible for collecting data on the CSQ-8 within approximately 1-2 weeks of completing the intervention 
(proximal to Time 2 for ICAN subjects and Time 3 for WLC subjects). In the case of withdrawal from treatment, 
the CSQ-8 may be conducted upon withdraw from treatment, if the participant is agreeable. If participants with-
draw, reasons for withdraw will attempt to be collected. At the end of the CSQ-8, the participant is presented 
with an optional comments section regarding their feedback and thoughts about what they liked/ did not like 
about the program. 
 
Post-Treatment Qualitative Interview:  To encourage honest feedback and ensure blinding of RA’s, an un-
blinded RA will be responsible for administering the post-treatment Interview with the participant over the 
phone, via mail, email or in person within 1-2 weeks of completing treatment (proximal to Time 2 for ICAN sub-
jects and Time 3 for WLC subjects). 
      
 
Statistical Analysis Plan.   
Primary Analyses. For Aim 1, the proportion of participants who complete at least 5 out of 6 sessions, and the 
proportion of participants who have satisfaction ratings that are average or higher on the standardized CSQ-8 
will be calculated. For between group comparisons for Aims 2 and Aim 3, the primary analysis will be ANCOVA 
models with T2 measures as the outcomes, treatment group as the explanatory variable, and covariates of 
wave and T1 outcomes (except CaGIC which will not have T1 data since it is only collected at T2). Effect sizes 
(ω2) will be calculated.  
Secondary Analyses. WLC control outcomes at T2 will be compared to T1 for the ICAN and WLC group. If 
there are no significant differences, secondary analyses combining the data from the two treatment groups (as-
sessments before and after intervention) will include ANCOVA, paired t-tests, and estimating effect sizes.   
Missing Data. We will compare all baseline variables between subjects who drop out of the study to those who 
don’t using two-sample t tests, chi-square tests or their non-parametric equivalents as appropriate. Also, we 
will collect as much information regarding reasons for missing data as possible. If we find that the missing data 
appear to be not at random, this important information will be used in designing the larger trial. Because of the 
small sample size, we will not attempt to model the missing data mechanism in this study. 

 
 
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