Testing the Effectiveness of a Graphic Novel Health Education Curriculum for Patients With Addiction
Phase: NA
Conditions: Alcohol Use, Drug Use
Sponsor: Treatment Research Institute

 
 
  
 
 
IRB-02 2.3.2017 
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Study Title: Testing the Effectiveness of a Graphic Novel Health Education Curriculum for Patients with 
Addiction 
NCT number: NCT02378181 
Document Date: 2/3/17 
 
 

 
 
  
 
 
IRB-02 2.3.2017 
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Treatment Research Institute—Institutional Review Board 
 
SUMMARY OF HUMAN SUBJECTS RESEARCH PROTOCOL 
 
Please address all applicable points to create a complete and succinct synopsis of the protocol. Use 
language, insofar as is possible, that can be understood by an external, non-scientist layperson, and 
provide meanings for all acronyms used. Form must be typewritten. 
 
 
(Maintain subheadings in body of text.) 
 
Title of project: Testing the Effectiveness of a Graphic Novel Health Education Curriculum for 
Patients with Addiction 
 
Funding Source and Funding Dates (Start and End Dates): Patient Centered Outcomes Research 
Institute (PCORI), 10/1/2014 – 6/30/2017 
 
Name, address, agency, and phone number of principal investigator: 
Adam C. Brooks, Ph.D., Senior Scientist 
Treatment Research Institute 
600 Public Ledger Building 
150 S Independence Mall West 
Philadelphia, PA, 19106 
215-399-0980 x 128 
 
1. Introduction and rationale for study 
 
This project addresses an important service gap in treatment for substance use disorders (SUDs). 
The U.S. has invested heavily in developing treatments for substance abuse resulting in a variety of 
replicable, empirically-supported treatments (ESTs). Unfortunately, most providers do not use these ESTs 
due to cost, complexity, and training burden, and therefore show very low rates of EST adoption. Poor 
treatment quality is reflected in patient dissatisfaction with SUD treatment, often leading to poor retention 
in treatment.  The most recently available Treatment Episode Data Set indicates that only a minority of 
clients complete intensive outpatient (39%) or outpatient (40%) treatment.  Many patients are leaving 
SUD treatment early because they do not perceive that their concomitant psychosocial needs are taken 
seriously or addressed quickly enough. Furthermore, ESTs with the strongest, most consistent evidence-
base are currently absent from the majority of outpatient treatment programs; for example, medication 
assisted treatment (MAT) approaches for alcohol use disorders have been established to be efficacious in 
reducing relapse, but their use is not widespread due to lack of awareness, patient reluctance to take 
medication, and misplaced concerns that these medications are addictive. 
Patients who drop out from treatment are perceiving a mismatch between what they perceive they 
need and what their treatment programs are providing.  This project aims to focus counselor and patient 
attention on the important healthcare and treatment decisions they need to make at the beginning of 
treatment, including raising patient awareness concerning previously ignored treatment options such as 
MAT. This study deploys a strategy to develop and evaluate a training-efficient, multimedia patient-
centered Health Education Toolkit to promote shared decision making between counselors and patients.   
 
 
 
 

 
 
  
 
 
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2. Specific aim(s)  
 
Aim 1: An existing evidence-based toolkit intervention will be adapted and redesigned by a patient and 
provider team into an engaging, narrative graphic novel curriculum useful in substance abuse counseling. 
The proven behavioral interventions will be augmented with health education material focused on MAT 
and HIV risk reduction. Together, these materials will comprise the Health Education Toolkit. The Health 
Education Toolkit (TK) will employ a shared decision making model to encourage 1) increased recovery 
engagement by patients, and 2) patient engagement in deciding whether to initiate and adhere to MAT. 
 
Aim 2: We will provide training and support to increase patient access to MAT for alcohol-related SUDs 
at a centrally located Federally Qualified Healthcare Center.  
 
Aim 3: We will assess the feasibility and acceptability of the HET Toolkit to estimate whether exposure 
to the Toolkit (TK) can reduce substance use and increase engagement with MAT.  We will conduct a 
three-month, randomized controlled trial of 50 patients with active alcohol SUDs enrolled in inpatient and 
outpatient treatment to obtain estimates of effect on the following exploratory hypotheses:  
 
Exploratory Hypothesis 1: Patients randomized to the TK will participate in shared decision making 
conversations with their counselors at higher rates than patients randomized to treatment-as-usual sessions 
(TAU). 
 
Exploratory Hypothesis 2: Patients randomized to the TK will report greater satisfaction and 
acceptability with their individual sessions than patients randomized to TAU. 
 
Exploratory Hypothesis 3:  Patients randomized to TK treatment sessions will demonstrate a) larger 
reductions in substance use (drug and alcohol) and b) increases in abstinence measured by urine-
confirmed, self-reported days using over the 3-month follow-up compared to patients randomized to 
TAU. 
 
Exploratory Hypothesis 4:  Patients assigned to the TK condition will demonstrate improved ASI 
Alcohol Severity Scores relative to patients assigned to TAU. 
 
Exploratory Hypothesis 5: Patients randomized to TK will attend more specialty substance abuse 
intervention and treatment sessions over the 3-month follow-up period than patients randomized to TAU.  
 
Exploratory Hypothesis 6: Patients randomized to TK will initiate MAT for alcohol dependence at 
greater rates than patients randomized to TAU. 
 
 
3. Endpoint(s) to be measured  
 
Patient variables that will be measured include client satisfaction, treatment integrity, drug and alcohol 
use and problems, intervention and treatment engagement, health and medical functioning, and 
psychosocial functioning.     
 
 
4. Number of subjects to be enrolled per year and in total. These numbers should incorporate 
numbers screened and consented to reach enrollment. 
 
We anticipate screening approximately 100 patients who are attending substance abuse treatment at 
two participating sites.  We expect approximately 50% of screened patients will meet eligibility 

 
 
  
 
 
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criteria and consent to take part in the study (about 50 patients).  Of those patients consented, we 
expect approximately 50 participants will be enrolled to participate in the study (n=25 per condition). 
 
Year 2: We anticipate we will screen and enroll 20 participants 
Year 3: We anticipate we will screen and enroll 30 participants 
 
We will also enroll 31 counselor participants.  Approximately 12 of these counselor participants will 
also be recruited for a focus group in Year 3. 
 
In Year 3 we will also recruit approximately 30 patients for focus groups in order to further determine 
the feasibility and acceptability of the Toolkit. 
 
5. Considerations of statistical power in relation to enrollment 
 
The purpose of this study is to determine the feasibility and acceptability of the Health Education Toolkit 
while collecting preliminary data is to establish effect sizes. These effect sizes will be used determine the 
sample size for a future fully powered clinical trial; therefore, statistical power is not relevant to this 
protocol. 
 
 
6. Explain procedures that will involve the subject 
 
We will work with 31 counselors from 1 inpatient and 2 outpatient substance abuse treatment site 
(note that one treatment site was able to enroll counselors but not clients prior to closing study 
recruitment). We will travel to the substance abuse treatment sites in order to present the study and recruit 
counselors. After presenting the study, we will obtain written informed consent for those counselors who 
are willing to participate in the study (the recruitment process for counselors is described in more detail in 
section 9 below). We then will randomly assign counselors to the toolkit (TK) or treatment-as-usual 
(TAU) group. Randomization will be within-sites, and ordered in matrices to ensure that the study 
conditions are evenly distributed within the treatment site. We will then screen and recruit clients who are 
attending individual treatment sessions with these counselors to participate in the study (recruitment 
process for clients is described in more detail in section 9 below). As part of their treatment experience, 
all patients who provide informed consent will continue to receive all other standard substance abuse 
treatment at the participating treatment sites.   
 
Intervention Procedures 
 
Health Education Toolkit (TK): Counselors in this condition will receive brief training in the use of the 
Health Education Toolkit and will run a 4 to 6-session, 4 to 6-week individual therapy series using the 
Toolkit. The toolkit will be developed by a project-specific Patient and Counselor Team (PACT) that will 
meet on a monthly basis in the first year of the study. The PACT will consist of approximately 10 patients 
and counselors who will work with the research team to compose characters, plot points, storyline, and 
content emphases for a four-volume graphic novel curriculum within the following working parameters: 
1) the curriculum will be in a narrative, fictionalized graphic novel format in four serial volumes 
appropriate for use in substance use treatment sessions over four to six weeks; 2) the curriculum will 
include learning supplements and talking points for counselors to use in running therapy sessions using 
the curriculum; 3) at least 50% of the content will focus on or highlight issues related to integrating the 
use of medication (psychiatric, relapse preventive) in recovery, including an introduction to Vivitrol; 4) 
other curriculum content will include, but not be limited to, psychoeducation on HIV risk and risk 
reduction strategies; 5) characters will demonstrate racial, ethnic, and socioeconomic diversity; and 6) 
each volume will contain at least three patient response exercises that can be used in the therapy session. 

 
 
  
 
 
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TK Workshop Training:  We will use our developed 3-hour training workshop which focuses on using the 
Toolkit. The workshop is divided between didactic information, demonstration, and brief skill practice via 
role-play. Counselors are given a brief introduction to the benefits of exposing their patients to the health 
and treatment option information in the TK, and the elements of the Toolkit are introduced. Counselors 
are shown how they can prepare each module, and are taken through the self-prep process for Module 1. 
Counselors briefly practice the Toolkit-specific skills of engaging in shared decision conversations 
surrounding the treatment options brought up by the curriculum, with a particular focus on engaging 
clients in their thought processes around the use of medication in treatment. TK counselors will be 
provided with Counselor Checklists and prompts to use them to stay on topic when conducting their 
therapy sessions.  Finally, TK counselors will be encouraged to follow-up on discussion topics brought up 
by their clients in sessions. 
Toolkit Condition:  The TK sessions will be conducted with a more focused agenda than typical 
individual treatment sessions. TK sessions will begin with a review of any assignments the patient 
completed since the last session. TK counselors will then lead the session in a reading and/or review of 
the graphic novel content slated for that session (typically one to two volumes will  be covered in each 
individual session so that the entire four-volume toolkit can be covered in about 4 to 6 weeks of 
individual sessions). The TK counselor will process the narrative content with the participant, and then 
move to application, which would typically cover opening up discussion topics regarding becoming more 
assertive and responsible for one’s recovery, and deciding what other supplemental treatment goals a 
patient might want to consider, or other services a patient might pursue.  In particular, TK counselors will 
look for opportunities to revisit the concepts laid out in that week’s module, and to engage clients in 
discussions regarding how to decide whether medication (psychiatric, relapse preventative) is right for 
them.  Each module includes corresponding interactive journaling content that patients can access in the 
graphic novel workbooks, which emphasizes important content and application points.  The Toolkit 
condition will consist of 4 to 6 individual therapy sessions, 1 conducted each week for a 4 to 6-week 
period.   
Toolkit Booster Trainings: In addition to the initial orientation training, TK counselors will receive three 
brief (~30 minute) booster trainings from a TRI expert TK trainer. These sessions will focus on concrete 
ways that the counselors can improve their use of the Health Education Toolkit.  These booster trainings 
will occur after the counselor has treated 1, 3, and 5 patients respectively.  The counselor’s checklists will 
be reviewed and in particular, the counselor will be provided booster training on using core homework 
assignments (Schedule Planning, Change Plans, and Shared Decision Making conversations).  
Treatment as Usual (TAU):  In the TAU condition, counselors will receive a control training of the 
same length and intensity on recovery topics that are covered in the Health Education Toolkit, but will not 
be immediately equipped with the Toolkit. They will then run 4 to 6 individual sessions throughout a 4 to 
6-week TAU span with each of their patients enrolled in the study.   
TAU Workshop Training: Our control training intervention compares to the TK training in that it presents 
new, didactic information; TAU counselors will be presented with discussion topic points on the areas 
covered by the Health Education Toolkit (medication facts, setting work and education goals, etc.). TAU 
counselors will attend a 3-hour workshop that introduces the talking points, and provides orientation on 
how to best to cover the talking points in therapy sessions. Counselors will be encouraged to study the 
talking points as they see fit to prepare to run a 4 to 6-session series over 4 to 6 weeks. Counselors will be 
given latitude to talk over these topics in any order they choose. 
TAU Condition: Counselors will lead a 4 to 6-session series on similar topics over a 4 to 6-week period, 
but without the Toolkit aids (graphic novel volumes).  
TAU Booster Trainings: In order to provide an attention control training that matches the amount of time 
that TK counselors will be trained, TAU counselors will also receive three brief (~30 minute) booster 
trainings from a TRI expert trainer. During these sessions, the counselor and trainer will discuss the 
counselor’s experience running individual sessions for this study.  

 
 
  
 
 
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Participant Baseline Procedures 
Patients and counselors will be recruited following the procedures outlined in section 9 below. 
Following informed consent (described below in item 9), a Research Assistant will complete an 
assessment battery with participating counselors. As a part of this assessment, counselors will be paid $25 
in cash for completing the Baseline Interview. Participating clients in the recruited counselor’s caseload 
will also provide informed consent, and will complete a baseline assessment including a self-report of 
drug use, urine screen, and other measures. Patient participants will be paid $40 in cash for completing 
the Baseline Interview.  Additionally, participants will receive an additional $10 in cash for providing 
three verified collateral contact they provide on the Locator Form. Research staff will attempt to contact 
each collateral provided on the Locator Form, and a collateral contact will be considered verified if 
research staff are able to establish contact with the person. 
 
Participant Follow-up Procedures 
We will complete a 6-month follow-up assessment with counselor participants. This assessment 
will take place at the counselor’s treatment site. We will also complete follow-up assessment interviews 
with patient participants at 6 weeks, and 3 months after intake. (Note: We also completed a 6-month 
assessment interview with 2 participants due to a miscommunication with staff following the funder’s 
decision to end recruitment and close out the randomized trial). We will use patient-provided information 
on the Locator form to contact participants.  Research staff will use participant tracking software to 
ensure that they are alerted when call windows open at each assessment point (6 weeks and 3 months).  
Research staff will call participants at the times and numbers indicated on their Locator Form as the best 
time to reach them.  For participants who are more difficult to reach, call times and call numbers will be 
alternated.  Participants will also be mailed reminder notices informing them of an upcoming interview, 
as well as thank you notes for completing interviews.  Research staff will also attempt to contact 
participants via any other mechanisms that the participant consented to on the Locator (e.g. email, 
Facebook, home address).  For participants who are unreachable, messages will be left at all contacts that 
the participant consented to on the Locator Form, and postcards will be sent to contacts that we cannot 
reach on the phone.  Should contact persons indicate that they have lost track of the participant, research 
staff will search for the patient using available public search mechanisms (www.whitepages.com, etc.).  
When participants are reached by telephone, research staff will schedule the date and time of the 
interview, and will update the Locator Form in case the patient’s contact information has changed. 
In addition to contacting patient participants to complete their scheduled assessments, we also 
contacted four participants between the 3-month and 6-month assessments (at approximately 4.5 months) 
to verify their contact information prior to receiving notice from our funder to end recruitment and close 
out the randomized trial. Participants that we are able to establish contact with and who verify or update 
the information on their Locator Form will receive either a $5 gift card to a retailer in the community via 
mail, or $5 cash in person at a time and location convenient to both the participant and RA (e.g. the 
participant’s treatment program where RAs will travel to frequently).    
 
Confidentiality.  We have devised IRB-approved procedures to safeguard patient confidentiality 
while attempting to locate participants.  Research assistants will call participants from either a study 
provided cell phone or from TRI’s office phone.  TRI’s calling system blocks the name “Treatment 
Research Institute” off of its listing, preventing the incoming phone from accessing TRI’s name.  If a 
participant registers more significant confidentiality concerns, research staff will call from blocked cell 
phone numbers that do not display the return number.  When messages are left for the participant on 
recording devices or with collaterals, research staff members report that they are trying to reach the 
participant to complete a “health care survey” that the participant volunteered for.  Additional protections 
for patient follow-up can be found in the Human Subjects Protections section (item 11). 
  Follow-up assessments will take place in-person, generally at the participant’s treatment site. If 
patient participants have been discharged from their respective treatment site,  follow-up assessments will 
be done in person either at another mutually agreed upon location, such as the Public Health Management 

 
 
  
 
 
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Corporation (PHMC)’s Care Clinic (a Federally Qualified Health Center), or at one of The Wedge’s 
substance abuse treatment program sites.  If the participant is not able to travel to any of these sites or 
their treatment site, then we will meet them in a safe, neutral location such as a restaurant or public 
library.  The assessment battery will be similar to that collected at Baseline (see Participant Measures 
below), and we will collect a urine sample.  Participants will be provided with a payment of $40 in cash 
for the 6-week and 3-month assessments.  The two participants mentioned above received $50 in cash for 
the 6-month assessment. If a participant is incarcerated at any follow-up point research staff will not 
attempt to contact the participant while incarcerated. 
 
Expanding Patient Access to MAT 
Few community treatment programs (including some that will serve as research sites for this 
study) offer MAT as a treatment option for patients. As part of this project, we will work with the Public 
Health Management Corporation’s (PHMC) Care Clinic to offer MAT for alcohol SUDs.  PHMC is a 
regional public health institute that serves close to 200,000 patients annually and includes more than 250 
programs in 70 locations, one of which is the Care Clinic, a Federally Qualified Health Center (FQHC) 
where study patients may be referred. The medical staff at the Care Clinic will establish a routine protocol 
for treating patients with Vivitrol.  Staff at the Care Clinic will evaluate patients for suitability following 
standard medical guidelines, and dispense Vivitrol to study participants as well as non-study patients 
provided the patient is suitable, medically eligible, and is covered by their insurance.  Behavioral health 
staff will interview prospective patients to determine whether they are suitable for Vivitrol MAT, and 
medical staff will oversee their medical treatment. It is important to note that this protocol at the Care 
Clinic will not be considered research, or part of the present research project. The purpose of our research 
is to determine whether patients exposed to the Health Education Toolkit in a SUD treatment setting 
become more likely to seek out and initiate MAT for alcohol SUDs. No patient will be assigned to 
Vivitrol, or asked to take it as part of this protocol. With a patient participant’s permission, our team will 
be given a release to confirm when study participants are evaluated for and initiated on Vivitrol, but this 
permission is at the patient’s discretion and not mandatory to participate in the current research project. 
 
Focus Groups 
 
We will conduct a series of focus groups to obtain feedback from counselors and patients about the 
Toolkit.  The feedback from these focus groups will be used to inform feasibility and acceptability and 
further refine the Toolkit materials.  Specifically, we will be seeking feedback on usefulness, perceived 
helpfulness, and opinions on ways to improve the curriculum. 
 
We will hold 2 to 3 focus groups with 5 to 10 patients each and 2 focus groups with 5 to 7 counselors 
each.  We will ask counselors assigned to the Toolkit condition who have used the Toolkit with clients to 
participate in a counselor focus group.  We will also ask counselors to refer clients with whom they have 
used the Toolkit.  As we will be looking for feedback on all of the graphic novel books, we will ask 
counselors to make referrals based on the various books those clients received.  Though we expect that 
some of these clients may already be enrolled in the study, we anticipate that many will be new clients 
(not previously enrolled in the clinical trial) in order to represent the full curriculum. 
 
Each focus group will last two hours, and refreshments will be provided.  Participants will be reimbursed 
$50 for their time for each focus group.  Recruitment and consent procedures are outlined in detail in 
section 9. 
 
 
 
 

 
 
  
 
 
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7. Identify the sources of research material obtained from individually identifiable living human 
subjects in the form of specimens, records, or data. 
 
Patient Screening Instruments 
Alcohol Use Disorders Identification Test (AUDIT). The AUDIT (Babor et al., 2007) was developed by 
the World Health Organization to serve as a brief screening instrument and includes questions on 
frequency and alcohol problems and dependence (Allen et al., 1997, Reinert & Allen, 2002, Saunders et 
al., 1993).  
DSM-V SUD Diagnosis: MINI Plus 5.0. The MINI is a short structured diagnostic interview developed in 
the United States and Europe for DSM-IV and ICD-10 psychiatric disorders (Sheehan et al., 1998). The 
MINI has become the structured psychiatric interview of choice for psychiatric evaluation and outcome 
tracking in clinical psychopharmacology trials and epidemiological studies. We will modify the MINI to 
meet DSM-V criteria for SUD.  In DSM-V, the 7 DSM-IV items for dependence and 4 items for abuse 
have been merged into a single entity of 11 items called a “Substance Use Disorder” but with the 
following two changes - the abuse item of recurrent legal problems will be removed and an item for 
craving or strong desire to use will be added (American Psychiatric Association, 2013).  A diagnosis of 
SUD requires 2 or more of the 11 items, and SUDs have three levels of severity: 2-3 items = mild, 4-5 = 
moderate, and 6+ = severe; any diagnosis of SUD results in study eligibility.  We also included two pre-
screening questions to assess for past 60 day alcohol use. 
Patient Outcomes  
Quick Drinking Screen and ASI Drug Grid:  This instrument contains items from two established 
instruments: the Quick Drinking Screen (QDS), and the Addiction Severity Index (ASI).  The QDS is a 
six question screener that estimates the frequency and quantity of drinking. Two comparison studies 
found high levels of agreement between the QDS and the Timeline Followback, the “gold standard” in 
drinking measurement (Roy et al. 2008, Sobell et al, 2003).  We also included the Follow-up Assessment 
Drug Grid and overall drug use questions from the ASI (see below) in order to assess for both alcohol use 
and other substance use. Administered at 6 weeks only. 
Urine testing:  Urine drug testing will be done using kits that test for cocaine, opiates, amphetamines, 
methamphetamines, benzodiazepines, cannabis, barbiturates, and PCP. These will be purchased from 
ACON International. These kits provide a rapid (5-minute) on-site urine test.  Administered at BL, 6 
weeks, 3 months, 6 months. 
Non-Study Medical and Other Services (NSMOS):  This questionnaire was adapted from the Treatment 
Services Review (McLellan et al., 1992) for patients in medical settings.  The NSMOS counts substance 
abuse treatment, medical services, visits to medical offices, hospitalizations, and emergency room visits 
received that were not a part of the assigned treatment.  Administered at BL, 6 weeks, 3 months, 6 months. 
PHMC Utilization Review: PHMC Care Clinic will maintain records on patients from the study who are 
referred for Vivitrol evaluation.  By prior patient consent, the Care Clinic will release records on whether 
a study patient attended an appointment for a Vivitrol evaluation, the determination of appropriateness for 
Vivitrol, and whether the patient actually received the initial dose and subsequent doses (if any) of 
medication. 
HIV Risk Assessment (HIV-RA): The HIV Risk Assessment provides a brief self-report measure of HIV 
testing history and sexual risk and uses the preceding three months as the time interval of interest.  The 
HIV-RA was developed Lisa Bond, PhD, and David Metzger, PhD, experts in the field of HIV risk 
behaviors. Administered at BL, 6 weeks, 3 months, 6 months. 
Addiction Severity Index-6th Edition Modified Version (ASI6-Modified): The ASI is a multi-dimensional 
interview used to measure the substance use, health, and social problems of those with alcohol and other 
drug problems, both at admission to treatment and subsequently at follow-up contacts (McLellan et al., 
1992; McLellan et al., 1980).  We are using an abbreviated version of the ASI-6 that eliminates many of 

 
 
  
 
 
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the items that do not contribute to our primary hypotheses and takes approximately 20 minutes to 
complete.  We will use only the ASI domains for medical, drug use, alcohol use, and psychological status 
for covariate analysis.  The ASI-6 produces Recent Status Scores in each of these four areas, which have 
demonstrated high levels of inter-rater, test-retest, and concurrent reliability (Cacciola et al., 2011). Our 
modified version also includes items from the QDS (see above) in order to obtain consistent and reliable 
estimates of alcohol use. Administered at BL, 3 months, and 6 months. 
EQ-5D-5L: The EQ-5D™, a trade mark of the EuroQol Group, is a standardized measure of health 
outcomes. It takes only a few minutes to complete, and it provides a simple descriptive profile and a 
single index value for health status. Administered at BL, 6 weeks, 3 months, 6 months. 
Client Shared Decision Making Questionnaire: The Shared Decision Making Questionnaire (SDM-Q 
client version; Kriston et al., 2010) is a validated 9-item questionnaire that measures the process of shared 
decision making between clinicians and patients. We adapted this measure to apply to substance abuse 
treatment decision making. This version of the questionnaire measures shared decision making from the 
patient’s perspective. Administered at BL, 6 weeks, 3 months, 6 months. 
Client Satisfaction Questionnaire: The Client Satisfaction Questionnaire was developed for this study and 
assesses the extent to which participants perceived the intervention to be helpful and useful. It contains 
both closed- and open-ended questions in order to obtain information that will help us further refine the 
intervention for dissemination. Administered at 3 months only. 
Client Fidelity Checklist: The Client Fidelity Checklist will indicate the content areas that were covered 
in group and individual treatment during the intervention period and across the follow-up period, and it 
will detect any between-condition contamination. In particular, the checklist will confirm whether patients 
have been exposed to any treatment content delivered in a graphic novel format. Administered at 6 weeks, 
3 months, 6 months. 
 
Counselor Measures 
Counselor Background Form (CBF): The CBF was developed for this study and assesses the 
demographics and work/training histories of each participating counselor. Additionally, for this study, we 
have added questions on counselor’s experience with medication assisted treatment. Administered at 
baseline only. 
Counselor Satisfaction Form: The Counselor Satisfaction Form was developed for this study and assesses 
the extent to which counselor participants perceived the intervention to be helpful and useful. It contains 
both closed- and open-ended questions in order to obtain information that will help us further refine the 
intervention for dissemination. Administered at 6 months only. 
Counselor Shared Decision Making Questionnaire (SDM-Q): The Shared Decision Making Questionnaire 
(SDM-Q counselor version; Simon et al., 2006) is a validated 9-item questionnaire that measures the 
process of shared decision making between clinicians and patients. We adapted this measure to apply to 
substance abuse treatment decision making. This version of the questionnaire measures shared decision 
making from the clinician’s perspective. Administered at baseline and 6-months. 
Counselor Evidence-Based Practices Questionnaire: The Evidence-Based Practices Questionnaire 
(Abraham et al., 2009).  measures counselors’ attitudes and familiarity with a range of evidence-based 
practices, such as MAT, CBT, and MET. Administered at baseline and 6 months. 
Counselor Fidelity Checklist: The Counselor Fidelity Checklist will indicate the content areas that were 
covered in treatment during the intervention period. It will measure counselors’ adherence to their 
assigned intervention, and it will help detect any between-condition contamination. Ongoing; completed 
after each study treatment session. 
 
 

 
 
  
 
 
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8. Describe characteristics of the subject population, such as their anticipated number, age ranges, 
sex, ethnic background, and health status. The study should employ a study design with gender 
and race representation appropriate to the purpose of the research. Strong justification must be 
provided for exclusion of broad population groups. Identify the criteria for inclusion or 
exclusion. Explain the rationale for the use of vulnerable populations as research subjects (i.e., 
prisoners, pregnant women, disabled persons, drug users, children). 
 
Research participants will be patients currently receiving treatment at one of our participating 
inpatient or outpatient substance abuse treatment sites. We expect that 350 participants will enroll in the 
study. We will not exclude any potential participant based on race or gender, and members of gender and 
minority groups, the elderly, and disabled will be included in the research in the same proportion as they 
are represented in the populations of patients served at the participating treatment sites. We anticipate that 
the demographic characteristics associated with the client participants will be similar to the characteristics 
of the clients we have recruited in the Philadelphia area in the past; clients are, on average, 30% female, 
36% Black, 51% White, 13% other minorities, and 15% Hispanic. Elderly subjects and those with 
medical problems will be included in the research as long as they are able to give competent, informed 
consent and understand the content of the research instruments. Participants with disabilities will be 
accommodated. We will monitor gender and minority representation to ensure that it is representative of 
the target population, and we will over-sample any gender and racial groups that are significantly under-
represented. 
 
 
9. Describe plans for recruitment of subjects, including advertisement and posters and the consent 
procedures to be followed, including the circumstances under which consent will be sought and 
obtained, who will seek it, the nature of the information to be provided to prospective subjects 
and the methods of documenting consent. 
 
Counselor Recruitment 
We will travel to the inpatient and outpatient substance abuse treatment sites in order to present the 
study and recruit counselor participants. After presenting the study, interested counselors can schedule a 
time with research staff to consent into the study. At this scheduled time, research staff will obtain written 
informed consent and will then administer an assessment battery as part of the Baseline Interview.   
Research staff will only work with treatment sites whose administrators agree that they will not impose 
any negative consequences on counselors who choose not to participate in the study. We then will 
randomly assign counselors to the toolkit (TK) or treatment-as-usual (TAU) group, and counselor 
participants will schedule a time to complete the initial training on their assigned condition. Counselors 
will be paid $25 for measures completed at the Baseline Interview, $75 for the initial training, $25 for 
each of the 3 booster trainings, $20 for each set of 5 fidelity checklists up to $200, and $25 for measures 
completed 6-months post Baseline Interview. Counselors can earn up to $400 throughout the course of 
the study.  
 
Client Recruitment 
Immediately after a counselor completes training (either TK or TAU), we will work with the 
counselor to schedule a date within the next two weeks to present the study to patients who are on his or 
her caseload. On the scheduled day, research staff will travel to the treatment site and will present the 
study to those patients who attend individual therapy sessions with the counselor. Patients who are 
interested in the study will be asked to complete a brief verbal screening consent.  We will administer the 
AUDIT; patients who score a 16 or above (criteria for moderate to severe alcohol use disorder) will 
receive further screening. We will then administer the MINI (modified for DSM-V criteria). Patients must 
meet criteria for current alcohol SUD (i.e., positively endorse at least 2 of the 11 items on the MINI) and 
have experienced 6 days of alcohol use in the past 60 days in order to be eligible. To maximize 

 
 
  
 
 
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generalizability and practical relevance of our findings, only patients who are unable to provide valid 
informed consent will be excluded. We expect to recruit 50 patients.  
Inclusion and Exclusion Criteria 
Inclusion Criteria: (a) patient is on the caseload of a participating counselor, (b) patient is 18 years or 
older, (c) a screening score of at least 16 on the AUDIT, (d) patient meets criteria for a substance use 
disorder as defined by DSM-V assessed via the MINI Plus 5.0, (i.e., endorsement of at least 2 of the 11 
items on the MINI), (e) the patient has enrolled in the treatment program within 4 weeks prior to the date 
of consent and (f) patient reports 6 days of alcohol use in the past 60 days.  Each participant must meet all 
the inclusion criteria in order to be enrolled in the study.  
Exclusion Criteria: (a) the patient reports plans to leave the Philadelphia greater metropolitan area within 
the next 6 months; (b) the patient is not English-speaking; (c) the patient is mandated to attend inpatient 
treatment (i.e. considered a prisoner), or (d) if the patient is unable to provide valid informed consent by 
correctly describing the key components of consent to the RA.  
 
Research staff will work with participating counselors to identify patients on their caseload who 
have enrolled in treatment within the past 4 weeks. Patients who are identified as potential study 
participants will be asked to complete a screening consent with an RA. We are requesting a waiver of 
written documentation of consent for the screening process. According to 45 CFR 46.117(c), written 
documentation may be waived if “the only record linking the subject and the research would be the 
consent document and the principal risk would be potential harm resulting from breach of 
confidentiality.” For patients who are found ineligible through the screening process, the screening 
consent form would be the only written document linking the patient to the research, thus a requirement 
for written consent would paradoxically be the only real danger to loss of privacy and confidentiality for 
participants who agree to be screened. We will provide an information sheet (i.e. a screening consent) to 
patients prior to screening that contains informed consent information, and we will obtain verbal consent 
that the patient is willing to participate in the screening. For patients who consent to screening, the RA 
will administer the AUDIT, MINI, and 8-week TLFB to determine if they meet inclusion criteria. Patients 
who meet the inclusion criteria and are interested in participating will be asked to provide written 
informed consent. Study research assistants (RAs) will fully explain the study procedures to eligible 
patients, and will obtain informed consent from those interested in participating. 
During the informed consent process, patients will be fully informed of the procedures, the nature 
of the study conditions, inclusion and exclusion criteria for the study, and the compensation associated 
with participating in the study. They will be informed that all research data collected in the study will be 
kept strictly confidential and that we have applied for or obtained an NIH Confidentiality Certificate that 
will shield the research data from a subpoena or court order. The only exceptions to confidentiality 
(clearly specified in the consent form) will pertain to information related to medical emergencies, 
disclosure of current child/elder/dependent abuse or neglect, or imminent risk of death or serious injury to 
the participant or others. Finally, these individuals will be informed of all known potential risks and 
benefits of participation, their right to refuse or revoke consent at any time, and the names and phone 
numbers of responsible individuals they may contact for additional information or to register complaints 
about study procedures. They will also be asked to complete a brief consent quiz to ensure their 
understanding of the study requirements, the risk and benefits, and their human subject protections. All 
items answered incorrectly will be reviewed with the participant to ensure adequate understanding. This 
process will continue until participants demonstrate at least a 95% understanding of the essential elements 
of the informed consent document. Potential participants will then be asked if they have any questions 
and will be asked to sign the informed consent form to document their agreement to participate. They will 
receive a duplicate copy of the consent form for their records. The original signed consent form will be 
kept in a locked filing cabinet only accessible to staff working on this study. 
 
 

 
 
  
 
 
IRB-02 2.3.2017 
12 
Focus Groups 
 
We will recruit Counselor focus group participants from already enrolled counselors assigned to 
the Toolkit condition.  Counselors must have used the Toolkit with at least one of their clients in order to 
be eligible for the focus group.  We will recruit Client focus group participants from counselor referral.  
We will ask counselors who meet the criteria for our focus group to refer clients who received at least part 
of the Health Education Toolkit as a part of their care.  Clients must have received at least part of the 
Health Education Toolkit as a part of the care in order to be eligible for the focus group.  A member of the 
TRI research team will speak individually with each prospective focus group participant and explain the 
procedures of the focus group (types of people participating, activities the group will engage in, and the 
fact that the group will be audio-recorded).  Counselors and clients willing to participate will be 
scheduled for the appropriate group. 
We are requesting a waiver to document informed consent for individuals participating in the focus 
groups according to 45 CFR 46.117(C)(2) which states documentation may be waived if “the research 
presents no more than minimal risk of harm to subjects and involves no procedures for which written 
consent is normally required outside of the research context.”  At the beginning of each focus group 
meeting, TRI staff will provide a copy of the Focus Group Information Sheet to all participants and will 
fully explain the focus group procedures.  Participants will be asked to provide verbal informed consent to 
participate, and will be told that they can stop participation at any time by leaving the focus group room.   
  
 
 
10. Discuss whether risks to the subject are ‘minimal’ or ‘greater than minimal.’ List the major 
risks of subject participation. Describe any possible benefits of subject participation. Are the 
risks to subjects reasonable in relation to the anticipated benefits to subjects and in relation to 
the importance of the knowledge that may reasonably be expected to result? 
 
The risks to subjects enrolled in this study are minimal. There are three anticipated potential risks 
associated for both counselor and patient participants enrolled in this study.  
1. Perception of coercion: It is possible that some participants may feel coerced to participate in the 
research study. Our previous studies with similar populations indicate that this is a rare event. 
2. Discomfort answering research questions and/or providing biological data: Participants may 
experience mild and transitory psychological discomfort from completing research measures that deal 
with emotionally laden material or from providing urine samples. The probability of these risks and 
the magnitude of the anticipated harm are likely to be small. These events have not been encountered 
in any of our previous studies using similar assessments. 
3. Harm from Breach of Confidentiality: Participants are at risk for harm as a result of being identified 
as a study participant or as someone with an alcohol or drug problem. The likelihood of this occurring 
is small and was not encountered in our previous studies. 
 
Benefits to participants: Participants in this study may benefit from receiving an intervention which is 
designed to educate patients about their treatment options and encourage self-efficacy to access treatment 
modalities that best address patients’ needs, including alcohol-related MAT. This project will also yield 
considerable information on behavioral changes associated with the Health Education Toolkit 
intervention. 
 
Importance of Knowledge to be Gained:  The aim of this project is to test the impact of a Health 
Education Toolkit in increasing patient knowledge, increasing treatment modalities accessed, and 
reducing substance use. The Toolkit series will be designed to communicate pertinent health information 
to SUD patients in a format that is engaging and easily understood. If this Health Education Toolkit 
proves to be effective, patients will demonstrate detectable reductions in substance use, higher 

 
 
  
 
 
IRB-02 2.3.2017 
13 
engagement rates with supplemental treatments including MAT, and increased knowledge about 
treatment options. 
 
The risks associated with participating in this study are reasonable given the benefits and importance of 
knowledge to be gained.  
 
 
11. Describe the procedures for protecting against or minimizing any potential risks, including 
physical, psychological, legal and confidentiality risks, and assess their likely effectiveness. 
Where appropriate, discuss provisions for insuring necessary medical or professional 
intervention in the event of adverse events to the subjects and for monitoring the data collected 
to insure the safety of subjects. Also, where appropriate, describe alternative treatment and 
procedures that might be advantageous to the subjects. 
 
1. Perception of coercion: Research staff will be trained to describe the study to eligible counselors and 
patients, including the risks and benefits, prior to offering an invitation to participate in the study. 
Research staff will clearly state that the counselor’s decision to participate is voluntary and will not 
affect their employment at the site. Similarly, we will state that a patient’s decision to participate is 
voluntary and that it will not impact the services they receive at their treatment site. Patients will be 
told that treatment site staff have no vested interest in their participation and will receive no benefit if 
they choose to participate. All potential participants will be told that if they feel any pressure to 
participate from any treatment site staff, they can voice this concern to the PI or other TRI research 
staff, and the PI will discuss this matter with the site’s director and/or other appropriate individuals. 
2. Discomfort answering research questions and/or providing biological data: Individuals enrolled in any 
study may experience mild and transitory emotional discomfort when answering the questions posed in 
interviews and on questionnaires, or providing a urine sample. All participants will be informed about 
these possible risks before signing the consent form. In order to minimize discomfort with providing a 
urine sample, the sample will not be collected under observation. The research staff will complete a 
training regarding monitoring and addressing emotional distress among research participants, as well 
as an additional training on the urine collection process which will include suggestions for decreasing 
participant discomfort. Participants will be told that they can choose not to respond to a question that 
they find upsetting and can withdraw from participation at any time without negative consequence. 
3. Harm from Breach of Confidentiality: Data collected in the study will be kept strictly confidential and 
will not be shared with anyone outside of the research team. The only exceptions to confidentiality, 
which will be clearly specified in the consent form, will be for information related to medical 
emergencies, current child abuse or neglect, or imminent risk of death or serious injury to the 
participant or others. All research materials will be coded with a research number and will contain no 
other identifying information. Information collected on paper (e.g., consent forms, HIPAA forms, 
Locator Forms) will be stored in locked filing cabinets at TRI, and computer spreadsheets will be 
saved in password-protected files. Participants will be assigned a study identification number which 
will be affixed to all collected data. Linkage between participant identity and identification numbers 
will be stored in a password protected electronic file available only to the PI and designated research 
staff. All research instruments will be computerized for this study, and the data will be entered via the 
Web into a secure server located at the University of Pennsylvania’s Data Management Unit. All 
computers have security codes and password protections to prevent unauthorized access. Efforts to 
contact participants for telephone check-ins or follow-up appointments will make no mention of the 
study until it is established that the participant has been reached. Access to participants’ telephone 
numbers, addresses, and other contact information will be limited only to research staff members who 
need to contact a participant for study purposes.  
 

 
 
  
 
 
IRB-02 2.3.2017 
14 
Digital audio recordings of the focus groups will be coded/saved with the date of the session and an 
identification code; no personal identifying information will be placed in the filename or intentionally 
dictated into the audio recording.  Research staff who are responsible for transcribing the interview 
content will also be responsible for ensuring that identifying information does not appear in the 
transcript.  Once the transcript is completed and checked for accuracy, the audio recording will be 
erased from the computer.  
 
Should any breaches of participant confidentiality occur, they will be reported to the relevant IRB, 
DSMB, and PCORI officials. 
 
 
12. Describe procedures for reporting Serious Adverse Events (SAEs) and Adverse Events (AEs), 
and Unanticipated Problems.  Include the definition of SAEs and AEs.   
 
Serious Adverse Events (SAEs) for client participants will be defined as death; a life threatening 
event such as drug overdose, suicide attempt, or inpatient hospitalization (including substance abuse or 
psychiatric hospitalizations) due to drug/alcohol overdose, suicidal behavior, or psychiatric distress; or an 
event that extends an existing hospitalization as defined above. Childbirth, pre-planned elective 
procedures, and unrelated medical events that require hospitalization will not be considered SAEs. No 
SAEs are expected as a result of the study procedures or intervention. Client participants in this study are 
individuals attending therapy in substance abuse treatment, and are thus, as a population, at risk for 
relapse to substance use or clinical worsening. Although we do not believe the study procedures or 
intervention places clients at increased risk for clinical worsening, we will review and report events of 
clinical worsening that lead to a substance abuse or psychiatric hospitalization. These events are not 
anticipated to occur more often than the baseline rate in this population. 
We do not expect and we will not report any Serious Adverse Events for counselor participants, as 
participating in this study would put them at no related risk for medical or psychiatric distress. 
Adverse Events (AEs) for clients will be defined as: report of coercion to participate in the study; 
significant discomfort from answering research questions or providing urine samples such that the 
participant decides to stop their participation; risk of harm resulting from a breach of confidentiality; or 
suicidal thoughts. For client participants, we will also report significant returns to drug/alcohol use 
defined as a 50% or higher increase of drug/alcohol use compared to baseline, and significant increases in 
psychiatric symptoms compared to baseline. Clinically insignificant events are not considered AE’s. 
Examples of clinically insignificant events include mild viral illness (e.g., colds, flu, and runny nose), 
common headaches, minor scratches, and mild symptoms or problems associated with medical conditions 
not related to drug use (e.g., back pain). Clients in  substance abuse treatment often enter treatment with 
various medical and/or psychological problems which may continue during the course of treatment, and 
new problems often develop. As per the definition of AEs, only significant worsening of baseline 
psychiatric or drug/alcohol abuse status or new problems will be reported as AEs. 
Adverse Events (AEs) for counselors will be defined as report of coercion to participate in the study; 
or significant discomfort from answering research questions such that the participant decides to stop their 
participation. 
In prior research, the AEs listed above have been known to occur. However, due to the protections we 
have put in place we do not anticipate a report of coercion to participate in the study, significant 
discomfort from answering research questions or providing urine samples, or harm resulting from a 
breach of confidentiality to occur. Substance abuse and psychiatric disorders are often chronic relapsing 
diseases, and therefore we anticipate a small percentage of clients will report an increase in drug/alcohol 
use or psychiatric symptoms during their participation in the study. However, as stated above we will 
only report these if they are a significant increase from baseline. 
All adverse and serious adverse events occurring during the study are documented on a form, 
reviewed and signed by the PI or Co-I and reported to TRI and other applicable IRBs. All non-fatal 

 
 
  
 
 
IRB-02 2.3.2017 
15 
adverse events that meet the above definition of “Severe” are reported to the IRBs within 48 hours of our 
awareness of the event. Fatal SAEs are reported to the IRBs and relevant PCORI Office within 24 hours 
of our awareness of the event. A summary of all SAEs and AEs that occurred during the previous year 
will be including the annual progress report to the relevant IRBs. 
 
 
13. If this study is a chart review, indicate the time frame of data to be collected (from when to 
when). Also, will the data be collected anonymously (meaning that only aggregate data will be 
collected, and there will be no names or codes maintained to match the data with the original 
files)? 
 
Not Applicable 
 
14. Children, defined as individuals under the age of 21, must be considered for potential 
enrollment in every study as subjects unless there are scientific or ethical reasons for excluding 
them. See below for the permissible exclusionary circumstances listed in the NIH Policy. If no 
exclusion applies: 1) discuss your plan for the inclusion of children; 2) justify the age range of 
children to be enrolled; 3) indicate the expertise of the research team with regard to children; 4) 
describe the facilities for the children; 5) indicate the number of children to be enrolled to give 
sufficient power for meaningful analysis; 6) describe how the assent process for children 7 to 17 
years of age will be carried out. 
 
Justify your exclusion based on one of the exclusionary circumstances listed: 
 
 
The research topic is irrelevant for children 
 
Children are barred by law from participation because of the risk 
 
Study is redundant; knowledge is being obtained in another study or is already available 
 
Separate age-specific children study is preferable 
 
Rarity of disorder makes inclusion of children extremely difficult 
 
The limited number of available children are already enrolled in a nation-wide pediatric 
disease network 
 
Study design precludes direct applicability to children 
 
Insufficient adult data to judge potential risk for children 
 
Study design is a follow-up of an adult study 
 
As the NIH definition of children includes all persons less than 21 years old, we will include children 
between the ages of 18 and 21 in this investigation. Based on previous enrollment in studies in the 
Philadelphia treatment system, we expect that 5-8% of our clients will be between the ages of 18-21. We 
will exclude potential participants who report that they are younger than the age of 18. 
 
15. This study involves research to be performed at: 
 
The specific sites are listed below. Each participating site will sign a site letter of agreement.  We will 
also work with PHMC’s Care Clinic as described above. The PI and Study Coordinator will be 
responsible for obtaining FWA’s at all sites prior to any data collection. 
 
 
Program 
City/State 
1 
Wedge Medical Center 
Philadelphia, PA 
3 
PHMC Care Clinic 
Philadelphia, PA 
4 
Presbyterian Medical Center 
Bensalem, PA 

 
 
  
 
 
IRB-02 2.3.2017 
16 
5 
Kirkbride 
Philadelphia, PA 
 
Reminder:  It is Principal Investigator’s responsibility to obtain copies of FWAs for each 
performance site. 
 
 
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