Efficacy of a Behavioral Intervention to Reduce Skin Cancer Risk Among Patients
Phase: NA
Conditions: Dermatology/Skin - Other, Health Behavior, Sunburn
Sponsor: Penn State University

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HRP-591 - Protocol for 
Human Subject Research 
 
Protocol Title: Efficacy of a Behavioral Intervention to Reduce Skin Cancer 
Risk Among Patients 
 
 
 
Principal Investigator: 
Kimberly Mallett 
320 Biobehavioral Health Building 
University Park, PA 16802 
814-865-5041 
kam54@psu.edu 
 
 
Version Date: 
January 23, 2018 
 
Clinicaltrials.gov Registration #: not applicable 
 
If you need help… 
University Park and other campuses: 
Office for Research Protections Human Research Protection Program 
The 330 Building, Suite 205 
University Park, PA 16802-7014 
Phone: 814-865-1775 
Fax: 814-863-8699 
Email: irb-orp@psu.edu 
College of Medicine and Hershey Medical Center: 
Human Subjects Protection Office 
90 Hope Drive, Mail Code A115, P.O. Box 855 
Hershey, PA 17033 
(Physical Office Location: Academic Support Building Room 1140) 
Phone: 717-531-5687 
Fax number: 717-531-3937 
Email: irb-hspo@psu.edu 
 
Instructions for using this protocol template: 
1. 
Add this completed protocol template to your study in CATS IRB (http://irb.psu.edu) in the “Basic 
Information” section. Links to Penn State’s protocol templates are available in the same location where 
they are uploaded and their use is required. 
2. 
This template is provided to help investigators prepare a protocol that includes the necessary 
information needed by the IRB determine whether a study meets all criteria for approval.  
3. 
There may be sections in this template that do not apply. If a section or question does not apply to the 
research study in question, provide the response “Not Applicable”. 
4. 
DO NOT TYPE IN THE GRAY BOXES.  All guidance language appears in gray boxes and these boxes 
MUST be deleted from the final version of the protocol prior to upload to CATS IRB. 
 
 

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Table of Contents 
1.0 
Objectives 
2.0 
Background 
3.0 
Inclusion and Exclusion Criteria 
4.0 
Recruitment Methods 
5.0 
Consent Process and Documentation 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
7.0 
Study Design and Procedures 
8.0 
Data and Specimen Banking For Future Undetermined Research 
9.0 
Statistical Plan 
10.0 
Confidentiality, Privacy and Data Management 
11.0 
Data and Safety Monitoring Plan 
12.0 
Risks 
13.0 
Potential Benefits to Subjects and Others 
14.0 
Sharing Results with Subjects 
15.0 
Economic Burden to Subjects 
16.0 
Number of Subjects 
17.0 
Resources Available 
18.0 
Other Approvals 
19.0 
Subject Stipend (Compensation) and/or Travel Reimbursements 
20.0 
Multi-Site Research 
21.0 
Adverse Event Reporting 
22.0 
Study Monitoring, Auditing and Inspecting 
23.0 
References 
24.0 
Appendix 
Statistical Analysis Plan 
 
1.0 Objectives 
1.1 
Study Objectives 
The purpose of this study is to extend previous research (R03 CA144435) and conduct a 
preliminary analysis of the effect of a brief dermatologist-delivered intervention (ABC 
intervention) on patients’ skin cancer related outcomes. The long-term goal with respect to the 
ABC intervention is to conduct a large-scale randomized controlled trial (RCT) with multiple 
clinics. Specific research aims of the study include: 
 
The first aim examines the efficacy of the Addressing Behavior Change (ABC) intervention 
versus treatment as usual (TAU) during a regular dermatological visit on patient reported 
number of UV protective behaviors (such as use of sunscreen) and UV risk behaviors (such as 
number of sunburns) using a longitudinal design (3 and 6 month).  
 
The second aim of the study will evaluate moderating factors, such as gender and history of 
skin cancer, and mediating factors, such as attitudes and self-efficacy, which impact the efficacy 

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of the intervention. The mediating and moderating variables may help to identify those 
individuals whom the intervention is more (or less) effective.  
 
 
1.2 
Primary Study Endpoints 
Whether or not the ABC intervention was efficacious when delivered by dermatologists during a 
routine office visit compared to treatment as usual, on a number of UV protective behaviors.  
 
1.3 
Secondary Study Endpoints 
Whether or not moderating factors such as gender, age, and history of skin cancer, and 
mediating factors, such as attitudes and self-efficacy, identify individuals for whom the ABC 
intervention is more or less effective.  
 
2.0 Background  
 
2.1 
Scientific Background and Gaps 
The diagnosis of melanoma (skin cancer) was estimated to have approximately 80,000 new 
cases in 2014, with over 10,000 persons dying from melanoma (American Academy of 
Dermatology, 2014). The main factor leading to skin cancer has been UV exposure (Veierod et 
al., 2003). Therefore, individuals can reduce their skin cancer risk (as well as its morbidity and 
mortality) by increasing sun protective behaviors (such as wearing sunscreen and protective 
clothing) and reducing both intentional and unintentional UV exposure.  
 
Deterrence through expert delivered education approaches has been the major method of 
attempting to change UV risk behaviors. Effective communication between doctors (MD) and 
patients has been shown to enhance a variety of outcomes, such as improved health, improved 
patient management of chronic illness, decreased symptoms, treatment compliance, and overall 
satisfaction with care.  
 
Using the ABC (Addressing Behavior Change) intervention to change UV risk behaviors is a 
strategy based on the principles of Motivational Interviewing (MI), which is a client centered 
approach originally developed in the addictive behaviors field with the intent of promoting and 
supporting behavior change through empathic communication. The ABC intervention 
emphasizes a collaborative relationship between health care providers and patients when 
addressing behavior change rather than MDs dictating change to a patient.  
 
While we have developed and tested the ABC intervention during routine office visits in our R03 
study, what is lacking is an examination of using the ABC intervention to address skin protective 
behaviors.  
  
 
2.2 
Previous Data 
This study is a continuation of a research program examining brief dermatologist-delivered 
intervention on patients’ skin cancer related outcomes. We had previously received a grant R03 
CA144435, which found that dermatologists were very motivated to deliver the ABC 
intervention, were able to quickly learn the skills associated with the intervention, were able to 
deliver the intervention with fidelity, and showed minimal deterioration in knowledge, skills, and 
motivation over a 6 month period. Based on those findings, we conducted a pilot study, 
collecting patient data following a dermatologist visit, and found that those patients who 
received the ABC intervention had much higher intentions to utilize sunscreen and rated the 
communication with their dermatologist much higher than control patients receiving TAU. These 
findings together suggest the promise of the ABC intervention, which supports the need of an 
evaluation of the effectiveness of the ABC intervention on patient outcomes such as UV risk and 
protective behaviors.  

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2.3 
Study Rationale 
To date, it is unclear how effective the ABC intervention will be on patients’ UV risk and 
protective behaviors. While we have found that dermatologists both like the ABC intervention 
and are able to deliver it with fidelity, and patients in a small pilot had higher intentions to utilize 
sunscreen and rated their dermatologist communications higher than TAU patients, it is unclear 
if the ABC dermatologist-delivered intervention will change patient behavior.  
 
3.0 Inclusion and Exclusion Criteria 
 
3.1 
Inclusion Criteria 
Patients must be:  
1) Fluent in English 
2) Mentally capable of giving consent and free of cognitive impairment (e.g., stroke, dementia, 
etc.) 
3) Age 21-65 years old  
4) A patient at Penn State Medical Center Dermatology Clinic in Hershey, PA or State College, 
PA, scheduled for a skin examination (either annual full body skin check or suspicious 
lesion) or scheduled for a Mohs surgical procedure.  
5) Patients may include anyone who meets inclusion criteria (including previous skin cancer 
patients, newly diagnosed skin cancer patients, non-skin cancer patients) 
 
Providers must:  
1) Provide skin examinations (either annual full body skin check or suspicious lesion) or Mohs 
surgical procedures directly to patients (rather than supervise residents)  
2) Treat patients that meet inclusion criteria for the study 
 
3.2 
Exclusion Criteria 
Patients will be excluded if they:  
 
1) Do not meet inclusion criteria as stated above 
2) Have psoriasis (as a recommended treatment of psoriasis is intentional UV exposure) 
3) Have had previous exposure to the ABC intervention during the R03 at Penn State Hershey 
Medical Center in 2010 or during data collection for this study during Spring 2016 
 
Providers will be excluded if they: 
1) Only supervise residents and do not provide skin exams directly to patients 
2) Do not treat patients that meet inclusion criteria for the study 
 
 
3.3 
Early Withdrawal of Subjects 
 
3.3.1 Criteria for removal from study 
The only reasons participants will be removed from the study is if they fail to give or withdraw 
consent for participation.  
 
3.3.2 Follow-up for withdrawn subjects 
N/A – withdrawn subjects are simply dropped from the participant pool, and no further contact 
will be made.  
 
 
4.0 Recruitment Methods 
 

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4.1 
Identification of subjects 
The first step in identifying potential patient participants will be to have the PSHMC Dermatology 
research nurse coordinator review appointment schedules at both sites (Hershey – intervention; 
State College – control) to see which patients are scheduled to receive skin checks (either 
annual full body skin check or suspicious lesion) or Mohs surgical procedures at upcoming 
appointments. The PSHMC Dermatology research coordinator at the clinics will either: 1) call 
potential patient participants and invite them to participate via the phone, or 2) send a letter to 
these patients approximately 2-4 weeks prior to their scheduled appointment, explaining the 
research and inviting them to call the research team to obtain more information or to email/call 
the PSHMC research team within approximately 2 weeks if they are not interested in learning 
more about the study.  
 
Providers interested in participating at Penn State Hershey Medical Center (PSHMC) and State 
College will be randomly selected from the departments (up to n=10 per site).  
 
4.2 
Recruitment process 
 
Recruitment of Patients:  
1) The PSHMC Dermatology research nurse coordinator will either: 1) call potential participants 
and invite them to participate via the phone, or 2) send a pre-notification letter to these 
patients approximately 2-4 weeks prior to their scheduled appointment, explaining the 
research and inviting them to call the research team to obtain more information or call/email 
within approximately 2 weeks if they are not interested in learning more about the study.  
2) For those receiving the pre-notification letter, after approximately 2 weeks, the patients who 
did not indicate disinterest in the study or contact PSHMC for more information, will be 
called by a PSHMC research assistant and will be formally invited to participate in the study. 
For both individuals who contact the research team directly and those who are contacted 
due to not declining, will follow the same procedures: If they are interested, the research 
assistant will obtain verbal consent to screen patients to see if they qualify for the study 
based on the inclusion/exclusion criteria. If they are eligible, they will then be formally 
invited. Potential participants interested in the study will be asked to arrive 25 minutes early 
for their appointment so that the consent form may be reviewed with them in its entirety and 
signed informed consent can be obtained in a private area of the clinic prior to the 
completion of the brief baseline survey. A log will be kept of all de-identified patients 
contacted via phone who declined participation, with the reasons for declining participation 
as well as those who decline to participate when approached in the clinic (example: adult 
male #1 refused study due to time commitment).  
3) For those who are called and invited to participate over the phone by a PSHMC research 
assistant, the research assistant will explain the study, and if the patient is interested, the 
research assistant will obtain verbal consent to screen patients to see if they qualify for the 
study based on the inclusion/exclusion criteria. If they are eligible, they will then be formally 
invited. Potential participants interested in the study will be asked to arrive 25 minutes early 
for their appointment so that the consent form may be reviewed with them in its entirety and 
signed informed consent can be obtained in a private area of the clinic prior to the 
completion of the brief baseline survey. A log will be kept of all de-identified patients 
contacted via phone who declined participation, with reasons for declining participation as 
well as those who decline to participate when approached in the clinic (example: adult male 
#1 refused study due to time commitment).  
 
4) In the first cohort in Spring 2016, we enrolled 27 participants who qualified after completing 
the screening. For the second cohort in Spring 2017, we plan to enroll an additional sample 
of 200 (100 per site). Based on the response rate of the first cohort in Spring 2016, we will 
invite up to 770 participants in Spring 2017. Once the target enrollment of 200 total (about 
100 per site) is obtained, we will discontinue recruiting. The study will be split into 2 cohorts 

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– one taking place in Spring 2016 (n=27) and the other taking place in Spring 2017 (target 
n=200).   
5) Participants who are interested and who qualify to participate will either: 1) be asked on the 
phone for their email address in order to send a copy of the consent form and reminder to 
arrive at their scheduled appointment 25 minutes prior to their scheduled time, or 2) receive 
a copy of the informed consent and a letter by mail reminding them to arrive at their 
scheduled appointment 25 minutes before their scheduled time  to perform the written 
informed consent process  and to complete the baseline survey. Participants will also be 
called 1-3 days before their scheduled appointment to remind them to arrive 25 minutes 
early (see reminder phone script).  
6) 1-month and 3-month follow-up surveys will be conducted online to reduce burden and allow 
participants to complete them from home. Participants can request mailed, paper-based 
surveys if they do not want to complete the online version of the survey. Paper-based cover 
letter and surveys will be mailed to participants’ homes along with prepaid return envelopes. 
Both the online version of the follow-up surveys as well as the hardcopy surveys (which will 
include identical questions/prompts as the REDCap survey), will include the text at the 
beginning of the survey that states “By completing the following survey you are agreeing to 
take part in this research study. If you have any questions about the survey or your 
participation, please contact project coordinator, Sarah Ackerman, at 814-865-4222 or 
sdf5013@psu.edu”. Participants will receive an invitation email, up to 5 reminder emails, 
and up to 3 reminder phone call attempts to complete each survey. During the baseline 
survey, participants will also be asked if they would like to receive SMS text message 
reminders to participate in the follow-up surveys. If participants opt into receiving SMS text 
message reminders, they will receive 2 text message reminders for each survey along with 
all other contact methods.  
Subjects will be informed in the consent process: 
“You should be aware that it is illegal in the Commonwealth of Pennsylvania to text while 
driving.  It is also dangerous to pay attention to your cellular phone while driving, walking, or 
doing any activity that requires your attention. You should continue to exercise good judgment 
on this while participating in this study.” 
 
Please note: Mailed hardcopy surveys/letters will only be offered to individuals who indicate 
that they do not have access to the internet, not as an option for all participants. With the 
timeframe between the 1-month survey and the 3-month survey being shorter, we do not 
want there to be any overlap of surveys if participants are slow to mail back their responses.  
 
Recruitment of Physician Interventionists: 
1) The dermatologists from the intervention site will undergo 1 session of training to deliver the 
ABC intervention, following the same protocol developed and used in the R03 study. A 
weekly scheduled journal club meeting will be cancelled and this training will take the place 
of it in the evening (instead of morning) and will require no additional time commitment from 
the dermatologists to participate in the training or study.  
a. The first component of training will involve learning to deliver each of the 6 
components of the intervention. Patient interactions will be demonstrated by the 
study staff. 
b. The second component will involve role plays. The physicians will practice 
implementing the intervention on research assistants who will pose as mock patients.  
c. The third component will involve supervision and feedback. Drs. Mallett and Turrisi 
will observe the physicians while they deliver the ABC intervention to patients. They 
will then provide feedback privately.  
i. For Spring 2017, a training booster will take place. This will include 
component C (supervision) in order to ensure there is consistency in 
intervention delivery.  
2) Up to 10 providers from the intervention site and up to 10 providers from the control site will 
be randomly selected to participate. If they agree, intervention dermatologists will give 

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verbal consent after reviewing the Summary Explanation of Research provided by a 
member of the research team during the scheduled Dermatology Department meeting, and 
control site dermatologists will give verbal consent prior to the recruitment of patients.  
3) The dermatologists at the control site will deliver treatment as usual (TAU) to their patients, 
and will not undergo the training and supervision.  
 
4.3 
Recruitment materials 
See details of procedure in section 4.2 
 
1) Options Pre-Note Initial Recruitment Letter 
2) Options Phone Script Baseline Invite 
3) Options Reminder Email for Baseline Participation 
4) Options Phone Script for Baseline Survey 
5) Options Reminder Letter for Baseline Participation 
6) Options Phone Reminder Script for Baseline Survey 
7) Options 1 Month Followup Survey Email Mail Invite 
8) Options 1 Month Followup Survey Reminder Email 
9) Options 3 Month Followup Survey Email Mail Invite 
10) Options 3 Month Followup Survey Reminder Email 
11) Options Followup Reminder Call Script 
12) Options Followup Survey Text Message Reminder 
13) Options Thank You Letter for Study 
14) Options Collateral Contact Call Script 
15) Options Collateral Contact Email Mailed Letter 
 
 
4.4 
Eligibility/screening of subjects 
Patients will be pre-screened following the inclusion and exclusion criteria listed in sections 3.1 
and 3.2 of this protocol by the PSHMC Dermatology Research Nurse Coordinator who has 
clinical access to this patient population. Subjects will then give verbal consent to be screened 
over the phone for eligibility for this research study for items not able to be determined from 
clinical access.  
 
 
5.0 Consent Process and Documentation  
5.1 
Consent Process  
5.1.1 Obtaining Informed Consent 
 
5.1.1.1 
Timing and Location of Consent 
If a patient expresses interest in participating when they are called to be invited over 
the phone (or when they contact us), they will be verbally consented to be screened 
for the research study (see phone scripts for consenting language).  
 
Research assistants will then approach participants to obtain informed  consent 
when they arrive in the dermatology clinics at PSHMC and State College after they 
check in for their appointment. The research assistant will escort the patient to a 
private area where the informed consent process will take place. The consent form 
will be read and reviewed in its entirety, all questions will be answered prior to the 
subject signing for participation. If patients agree to participate, they will then sign 
the informed consent form and provided a copy.  
 
Additionally, at the beginning of every online survey (as well as paper-based 
copies), it will include the text that states “By completing the following survey you 
are agreeing to take part in this research study. If you have any questions about the 

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survey or your participation, please contact project coordinator, Sarah Ackerman, at 
814-865-4222 or sdf5013@psu.edu”. 
 
For participating physicians: Those physicians who agree to participate in the 
research will give verbal consent after reviewing the Summary Explanation of 
Research provided by a member of the research team during the scheduled training 
(intervention) or prior to patients being recruited (control).  
 
5.1.1.2 
Coercion or Undue Influence during Consent 
Study procedures will be fully explained, all critical study information will be 
disclosed, voluntariness will be emphasized as well as the fact that no care will be 
denied regardless of the subject’s decision. Subjects will be told they do not have to 
participate in the research. They will be told that whether or not they agree to 
participate in the study, their current or future care at the PSHMC will not be 
affected by their decision. 
 
For physician subjects, they will be told they do not have to take part in the research 
and that their educational and employment status will not be affected in any way by 
their decision. 
 
5.1.2 Waiver or alteration of the informed consent requirement 
We are requesting a waiver of informed consent so that the Hershey coordinator/team 
can review clinic schedules for recruitment purposes. This waiver will minimize the 
possibility of subjects being contacted who do not qualify for the research based on 
information available in their medical record.  
 
5.2 
Consent Documentation 
 
5.2.1 Written Documentation of Consent 
 
Written informed consent will be obtained from all participants in a private area of the 
clinic prior to their scheduled appointment. The consent form will be read and reviewed 
in its entirety with the subject, all questions will be answered prior to the potential subject 
signing for participation. Both the subject and the investigator obtaining informed 
consent will sign, date and time the consent document. 
 
The participant will receive a signed/dated copy of the consent documentation for their 
records. 
 
A copy of the signed consent form will not be added to the subject’s medical record.  
 
5.2.2 Waiver of Documentation of Consent 
Verbal consent will be obtained to screen potential participants for eligibility. This waiver 
will minimize the possibility of subjects being approached in the clinic who do not qualify 
for the research based on information available in their medical record or able to be 
screened for via the telephone.  
 
5.3 
Consent – Other Considerations  
 
5.3.1 Non-English Speaking Subjects 
Not Applicable – Participants will not be non-English speaking 
 
5.3.2 Cognitively Impaired Adults 
 

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5.3.2.1 Capability of Providing Consent 
Not Applicable – Participants will not be cognitively impaired 
 
5.3.2.2 
Adults Unable To Consent 
Not Applicable 
 
5.3.2.3 Assent 
Not Applicable 
 
5.3.3 Subjects who are not yet adults (infants, children, teenagers)  
 
5.3.3.1 
Parental Permission 
Not Applicable – Inclusions criteria states that participants must be at least 21 years 
of age.  
 
5.3.3.2 Assent 
Not Applicable 
 
 
6.0 HIPAA Research Authorization and/or Waiver or Alteration of 
Authorization 
 
6.1 
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures 
of PHI 
 
Check all that apply: 
 
Authorization will be obtained and documented as part of the consent process. 
 
Partial waiver is requested for recruitment purposes only (Check this box if patients’ 
medical records will be accessed to determine eligibility before consent/authorization 
has been obtained) 
 
Full waiver is requested for entire research study (e.g., medical record review studies)  
 
Alteration is requested to waive requirement for written documentation of authorization 
 
6.2 
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
6.2.1 Access, use or disclosure of PHI representing no more than a minimal risk to the 
privacy of the individual 
 
6.2.1.1 Plan to protect PHI from improper use or disclosure 
Information is included in Section 10 of this protocol.  
 
6.2.1.2 Plan to destroy identifiers or a justification for retaining identifiers  
The patient permission for the use, storage, and sharing of their health information 
will expire upon completion of the research study. At that time, the identifying 
research information will be destroyed.  
 
6.2.2 Explanation for why the research could not be practicably be conducted without 
access to and use of PHI 
We will be conducting the study in dermatology clinics and will be contacting participants 
via mail, email, and/or phone for recruitment purposes. We will need the names of 
participants in order to know who was deemed eligible by clinic nurses, and as age is an 
inclusion criteria, we will need access to age. However, until the patients agree to 
participate in the study via the phone screening or contact PSU researchers directly, the 

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PSHMC Dermatology Research Nurse Coordinator/Hershey team will be the only ones 
with access to this information.  
 
6.2.3 Explanation for why the research could not practicably be conducted without the 
waiver or alteration of authorization 
The waiver of authorization is required to screen for eligibility. 
 
6.3 
Waiver or alteration of authorization statements of agreement 
Not Applicable 
 
7.0 Study Design and Procedures 
 
7.1 
Study Design  
This study will use a longitudinal design to compare the effect of the ABC intervention on the 
intervention group versus the control group receiving TAU. Participants will not be randomized 
to a group. Instead, patients who meet eligibility criteria at PSHMC will be invited to participate 
at the intervention site, and current patients who meet eligibility criteria at the clinic in State 
College will be invited to participate at the control site.  
 
 
7.2 
Study Procedures 
Subjects will be recruited from two sites: 1) Penn State Hershey Medical Center Clinic in 
Hershey (PSHMC), which will serve as the intervention site where patient participants will 
receive the ABC interventions, and 2) Penn State Medical Group in State College (State 
College), which will serve as the control site where patient participants will receive TAU.  
 
1) Participation will begin when participants are screened for eligibility over the phone.  
2) Participation will continue for subjects when they arrive at either PSHMC or State College for 
an appointment with a participating physician that will include a skin check (either annual full 
body skin check or suspicious lesion) or Mohs surgical procedure (please see the 
recruitment section for a step-by-step process of how eligible participants will be obtained).  
A skin check involves the physician checking the patients’ skin for any growth or mark that 
could potentially become cancerous. Patients at the control site will be receiving TAU for 
their skin check; patients at the intervention site will receive a normal skin-check, combined 
with the ABC-intervention (see uploaded information sheet). The audio recordings which will 
be done at both the control and intervention sites for all participants will be used to compare 
the information patients receive from their doctor during the course of a skin check.  
3) Participants will be asked to arrive 25 minutes prior to their appointment so the informed 
consent process may take place prior to any study related procedures being conducted. 
After they check in, they will be greeted by a research assistant in the waiting room and 
directed to a private area within the clinic. The research assistant will be accessible while 
the participant completes the survey to answer questions that may arise. The baseline 
survey will assess demographic information, history of skin cancer, UV risk behaviors, 
perceived risk of skin cancer, dermatologist communication, attitudes about sun protection 
behavior, self-efficacy about sun protective behaviors, etc. (Please refer to Measures 
document for full questionnaire).  
4) As part of the surveys, participants will be asked to provide the contact information of a 
friend or relative that we could contact in the event that we are unable to locate the 
individual for the 1-month and 3-month follow-up surveys. Phone and email/letter scripts are 
included in the recruitment documents. We will attempt to call the “collateral contact” up to 2 
times, and then will send a letter or email if we cannot reach them by phone. Participants will 
be reminded of the following when they log on to the survey: “By completing the following 
survey you are agreeing to take part in this research study. If you have any questions about 

Page 11 of 20 
the survey or your participation, please contact project coordinator, Sarah Ackerman, at 
814-865-4222 or sdf5013@psu.edu”. 
5) The patient will then proceed to their appointment with a dermatologist. At the intervention 
site, the provider who has been trained to deliver the ABC intervention will do so during the 
skin exam. During the appointment at the intervention site, providers will provide their 
patients with a handout (as a small card and/or magnet) which summarizes what they 
discussed during the appointment regarding sun protection (CURE Method Tips – see 
uploaded document). At the control site, patients will receive TAU, with no ABC intervention. 
All patient participant appointments are to be audio recorded and by consenting to the study, 
patients are consenting to be audio recorded. A research assistant will accompany the 
patient into the exam room to audio record the visit. Only providers who have taken the 
appropriate training will have patients identified to participate in this study (intervention). 
Providers at both the intervention and control sites will be consented prior to any audio 
recordings being done, as explained in section 5.1.1. Research assistants will later listen to 
and code the data to determine if the components of the ABC intervention were delivered 
with fidelity. Control sessions will be recorded and coded using the same criteria to 
document those patients who did not receive elements of the ABC intervention. The 
recordings will be coded with the patient’s study number and will be destroyed per PSHMC 
IT Security Group policy as soon as data is coded from their analysis. The participant and 
the provider will be reminded prior to the recording to not use names or other identifying 
information during the recording. 
6) At 1-months and 3-months following this appointment, the first (1 month) and second (3 
months) follow-up surveys will be sent out, via email to complete online to allow participants 
to complete at home. Participants can request mailed, paper-based surveys if they do not 
want to complete the online version of the survey. A cover letter and paper-based surveys 
will be mailed to participants’ homes along with prepaid return envelopes. In an email, 
participants will be instructed to complete the survey online (or, if the participant requested a 
mailed paper-based survey, they will be instructed via mailed letter to mail back the paper-
based survey to the investigator’s office in the enclosed pre-paid envelopes). The 1-month 
and 3-month follow-up surveys will be almost identical to the baseline survey (minus the 
screening items, background item, and physician communication item, as indicated in the 
measures document), and each should take about 5-10 minutes to complete. Participants 
will receive a $25 Walmart gift card, Target gift card, or Amazon electronic gift card for 
completing each survey, totaling $75 if they complete all 3 surveys. Participants will be paid 
for the baseline survey after completion of the visit, and the two follow-up surveys will be 
paid at the end of the study (that is, after the 3-month follow-up survey). If they do not 
complete all surveys they will be compensated for the ones they do complete. Participants 
will be asked during the screening call which payment option they would like, so that we can 
have the appropriate option in clinic, and if they do not complete one of the follow-up 
surveys, we will have their payment option on file.  
 
Note: Dermatologists from the intervention site will undergo 1 session of training to deliver the 
ABC intervention. This will take place during the rescheduled weekly journal club meeting, 
which will take place in the evening and will require no additional time. 1) The first component of 
training will involve learning to deliver each of the 6 components of the intervention. Patient 
interactions will be demonstrated by the study staff. 2) The second component will involve role 
plays. The physicians will practice implementing the intervention on research assistants who will 
pose as mock patients. 3) The third component will involve supervision and feedback. Drs. 
Mallett and Turrisi will observe the physicians while they deliver the ABC intervention to 
patients. They will then provide feedback privately. Up to 10 providers from the departments of 
dermatology at each site will be selected to perform the skin exams, based on their availability.  
 
Physicians at the control site will deliver TAU to their patients, and will not undergo the training 
and supervision.  
 

Page 12 of 20 
7.3 
Duration of Participation 
Patient participants will be involved in the study for up to 4 months. The baseline visit in clinic 
will take approximately 25 minutes longer than their scheduled appointment, which lasts on 
average 15 minutes (they are asked to arrive 25 minutes early to complete the consent and 
baseline survey). Each post- survey will take 5-10 minutes to complete. Participants will 
complete a baseline assessment, and subsequent 1-month and 3-month post-surveys.  
 
Their participation will last up to 60 minutes (inclusive of their scheduled dermatologist 
appointment) over a 4 month period.  
 
Dermatologists at the intervention site will be involved from the beginning of their training 
through the end of baseline data collection, approximately 8-10 weeks (April-May 2016 & 2017). 
Dermatologists at the control site will be involved only during baseline data collection, 
approximately 8-10 weeks (April-May 2016 & 2017).  
 
 
8.0 Data and Specimen Banking For Future Undetermined Research 
 
 
8.1 
Data and/or specimens being stored  
Not Applicable 
 
8.2 
Location of storage 
 
Not Applicable 
 
8.3 
Duration of storage 
Not Applicable 
8.4 
Access to data and/or specimens 
Not Applicable 
 
8.5 
Procedures to release data or specimens 
 
Not Applicable 
 
8.6 
Process for returning results 
 
Not Applicable  
 
9.0 Statistical Plan 
 
9.1 
Sample size determination 
874 is the maximum number of patient participants to be enrolled.  
The number of participants that will be contacted (874) is much larger than the number we 
intend to enroll (227). Based on the response rate of the first cohort in Spring 2016, we are 
confident that the recruitment process explained above will yield the required number of 
participants within the proposed period.  
 
27 participants were enrolled during the first cohort in 2016.   
 
 
9.2 
Statistical methods 
We will utilize a number of statistical methods. For example, basic t-tests and regression will be 
used for preliminary analyses. The majority of the analyses will center on two types: 1) 
moderated multiple linear regression (SEM models) for Aim 2 and 2) Mixed ANOVA for Aims 1 
and 2.  
 

Page 13 of 20 
 
10.0 Confidentiality, Privacy and Data Management  
 
10.1 
Confidentiality 
The collected research data will be kept completely confidential. All hard copies of completed 
questionnaires will be labeled with a code number only (PIN) and stored in locked filing cabinets in 
locked offices. Survey responses will be entered into a secure research database: REDCap (Research 
Electronic Data Capture) is a secure, web-based application designed to support data capture for research 
studies. REDCap is maintained by the REDCap Consortium which is comprised of over 600 institutional 
partners including Penn State University, on a password protected computer in a locked office and/or the 
PRO Health Lab’s departmental Penn State PASS drive, only accessible by the team members listed 
on this application.  
We have taken the following steps to protect individuals’ identities as research participants: 1) PSU 
research team will not have access to potential participants until they are pre-screened by Hershey staff 
and agree to participate or contact us directly via phone or email, and only the PSHMC Dermatology 
research nurse coordinator and Hershey team, who has access to this population, will be involved in 
the initial recruitment; 2) Responses to surveys will be identified only by a unique personal identifier 
(PIN), which is a number randomly generated for each participant in this study; 3) Hershey will keep a 
master list of names, addresses, phone numbers, and PINs so that they can mail recruitment letters, 
and PSU will create a master list based on the participants who agree to participate when pre-screened 
(and verbally consented) over the phone or contact us directly, to send reminder letters, 1-month and 3-
month follow-up surveys and compensation. The master list of consented participants will be stored 
separately from the survey responses on a password protected computer in a locked office and/or the 
PRO Health Lab’s departmental Penn State PASS drive, only accessible by the team members listed 
on this application; and all audio recordings will be destroyed once they are scored and coded.  
 
Considering that participants will be sent a link and PIN number to access the 1-month, and 3-month 
follow-up surveys, they can complete it in any location they wish (e.g., home). The level of privacy they 
receive is limited to the location they choose to complete it at.  
 
10.1.1 Identifiers associated with data and/or specimens 
The data is de-identified as we use a PIN number to identify the data. Any identifiable 
information is used only to invite participants for follow-up surveys (and is marked as an 
identifier within REDCap) and to compensate them for participating in the study, and is stored in 
a file separate from the survey data.  
 
10.1.1.1 Use of Codes, Master List 
A master list containing a code number (PIN) and participants’ identity will be stored 
in a separate password protected computer file within the REDCap database, only 
accessible by the study staff listed on this document. The overall list of ALL 
participants invited to the study will be maintained by the Hershey team; the Penn 
State team will keep a separate list as participants complete phone screening. This 
file will be kept separate from any collected data. The list will be saved on a 
password protected computer in a locked office and/or the PRO Health Lab’s 
departmental Penn State PASS drive, only accessible by the team members listed 
on this application 
 
10.1.2 Storage of Data and/or Specimens 
 
All data will be stored in the REDCap database on locked, password protected computers in the 
PSHMC Dermatology Research office and PRO Health Lab (320 BBH) and/or on the PRO 
Health Lab’s departmental Penn State PASS drive, only accessible by the team members listed 

Page 14 of 20 
on this application. The data files may also be stored on a Penn State Project Box account 
accessible only by the individuals listed on this document. All data files will be void of any 
participant information, and data will be organized by randomly assigned ID numbers.  
 
This study has been issued a Certificate of Confidentiality. Researchers will not disclose or 
provide any identifiable information without the subject’s prior consent or where permitted 
according to NIH’s Policy on Issuing Certificates of Confidentiality.  
 
10.1.3 Access to Data and/or Specimens 
Only the study staff listed on this application will have access to the list.  
 
10.1.4 Transferring Data and/or Specimens 
Data will be physically transported from the Penn State Hershey Medical Center clinic sites to 
PSU at University Park. Signed informed consents, baseline surveys, and audio recordings will 
be transported via vehicle from Penn State Hershey Medical Center clinic sites to PSU at 
University Park. The items will be transported in a locked file box in a locked car trunk.   
                                                                                                                                                                     
10.2 
Privacy 
All data and other information in this study will be maintained confidentially, and will be identified 
only by a unique personal identifier (PIN), which is a number randomly generated for each 
participant. Data will be entered into an electronic, password protected file, only accessible by 
the study staff listed on this document. Considering that participants will be sent a link and PIN 
number to access the 1-month and 3-month follow-up surveys, they can complete it in any 
location they wish (e.g., home). The level of privacy they receive is limited to the location they 
choose to complete it.  
 
  
 
 
11.0 Data and Safety Monitoring Plan 
 
 
11.1 
Periodic evaluation of data 
Not Applicable 
 
11.2 
Data that are reviewed 
Not Applicable 
 
11.3 
Method of collection of safety information 
Not Applicable 
 
11.4 
Frequency of data collection 
Not applicable 
 
11.5 
Individual’s reviewing the data 
Not Applicable 
 
11.6 
Frequency of review of cumulative data 
Not Applicable 
 
11.7 
Statistical tests 
Not Applicable 
 
11.8 
Suspension of research 
Not Applicable 
 

Page 15 of 20 
12.0 Risks 
Psychological risks posed by the research are primarily related to the sensitivity of some of the 
measures. Items include thoughts, feelings, and personal difficulties that may be private, and personal 
behavior such as thinking about their likelihood of developing skin cancer. These questions may make 
participants uncomfortable, or be perceived as an intrusion on their privacy. Although it is our 
responsibility to point out the potential for these risks, we must emphasize that we have not observed 
any indications of these risks materializing in any of our previous research using the same procedures 
we will employ in this study. Participants will be assured of their voluntary participation in the study, 
their choice to answer or not answer any question, and of our protocol for maintaining confidentiality.  
 
We have taken steps to protect participants against potential risks posed by their participation in this 
research. Psychological risks of invasion of privacy or increased awareness or concern about one’s 
behavior as a result of completing the assessments will be addressed as a risk in the consent form. 
Participants are encouraged to contact the investigators at any time to discuss any concerns they might 
have. Drs. Mallett (PI) and Turrisi (Co-Investigator) are qualified to provide referrals and address 
concerns related to psychological distress arising through participation.  
 
Additionally, we have a Certificate of Confidentiality from NIH.  
 
 
13.0 Potential Benefits to Subjects and Others 
 
13.1 
Potential Benefits to Subjects 
Through completing this questionnaire, participants may become more aware of their skin protective 
behaviors and risk factors, which may prompt some behavior change. However, there may be no direct 
benefit to participants.  
 
13.2 
Potential Benefits to Others 
The knowledge to be gained from this study is of great importance and will benefit others and society 
as a whole. Findings will help to improve physician-patient communication, to increase the use of sun-
protective behaviors, and therefore reduce the chance of developing skin cancer among patients.  
 
 
14.0 Sharing Results with Subjects 
Not Applicable 
 
15.0 Economic Burden to Subjects 
 
15.1 
Costs  
The participant will not bear any costs.  
 
15.2 
Compensation for research-related injury 
Not Applicable – the research does not involve more than minimal risk to subjects.  
 
 
16.0 Number of Subjects 
 
The total maximum number of participants to be enrolled is 894.  
The number of patient participants that will be contacted (up to 874) is much larger than the number we 
intend to enroll (227 – including both Cohort 1 and Cohort 2)  (27 enrolled in Cohort 1 between 
Intervention and Control; 200 intended to enroll in Cohort 2 – 100 intervention, and 100 control). Based 
on the response rate of the first cohort in Spring 2016, we anticipate a 26% overall response rate, 
resulting in 200 individuals (for cohort 2) who agree to participate. However, due to uncertainty on the 

Page 16 of 20 
overall response rate, participants will be invited in chunks and once we hit our target enrollment, we 
will stop recruiting.  Additionally, we will enroll up to 20 providers (up to 10 from the control site and up 
to 10 from the intervention site).  
 
 
17.0 Resources Available 
 
17.1 
Facilities and locations 
1) PRO Health Lab, University Park, PA – Project preparation including grant writing and 
submission, IRB document preparation, mailing of recruitment materials, initial telephone 
contact, participant compensation preparation, and data analysis and report writing will take 
place on the University Park campus. The office space that will be utilized is located in the 
Prevention Research Center’s PRO Health Lab (320 Biobehavioral Health Building), 
consisting of a suite of 7 offices, a data coding room, and a large conference meeting area. 
It has 13 workstations, networked computers and fully functioning office equipment (e.g., fax 
and copy machines, networked printers). It also contains 8 iMac desktops with 4.0GB RAM, 
along with 4 Dell PCs with sufficient storage and memory for most analytic functions. The 
lab also contains 2-laser jet and 4-color jet networked printers, as well as networked access 
to a large format plotter that can print outstanding presentation-quality posters.  
2) Penn State Hershey Medical Center (PSHMC) – Our intervention site will be Penn State 
Hershey’s Department of Dermatology, located at University Physician’s Center, 500 
University Drive, UPC I, Suite 100, Hershey, PA 17033 
3) Penn State Medical Group State College (State College) – Our control site will be Penn 
State Hershey Medical Group Colonnade and Endoscopy Center, located at 32 Colonnade 
Way, State College, PA 16803 
 
17.2 
Feasibility of recruiting the required number of subjects 
We have access to all dermatology patients at both the intervention and control sites. We have 
secured agreement to use both clinics. Out of all of the dermatology patients, we will only be 
recruiting a portion.  
 
17.3 
PI Time devoted to conducting the research 
Given the current research load and the quality and size of the research support team, there is 
no doubt the PI will have sufficient time to conduct the proposed research.  
 
17.4 
Availability of medical or psychological resources 
Participants are encouraged to contact the investigators at any time to discuss any concerns 
they might have. Drs. Mallett (PI) and Turrisi (Co-Investigator) are qualified to provide referrals 
and address concerns related to psychological distress arising through participation.  
 
 
17.5 
Process for informing Study Team 
All members of the research staff will be sufficiently trained in study procedures, protocol, and 
timeline. They will be reminded of confidentiality procedures. Each staff member will receive a 
copy of the original grant proposal and the approved IRB application. We will walk through 
procedures in person. Study staff who will be on site at the clinics for consenting participants, 
administering surveys, and audio recording participants, will be trained on the proper 
procedures.   
 
18.0 Other Approvals 
 
This project is funded by the National Cancer Institute/National Institutes of Health, and we have a 
Certificate of Confidentiality as well.  
 

Page 17 of 20 
19.0 Subject Stipend (Compensation) and/or Travel Reimbursements 
 
All patient participants will be compensated for their participation in the study. Patients will receive $25 for 
completing each of the 3 surveys (baseline, 1-month, and 3-month follow-up). The compensation for the 
baseline survey will be dispersed at the clinic after completing the baseline survey. The compensation for the 
two follow-up surveys will be dispersed at the end of the study (that is, after the 3-month follow-up). 
Participants may choose to receive either a Walmart gift card, a Target gift card, or an Amazon electronic gift 
card. The total possible compensation is $75. If a participant does not complete the study in its entirety (that is, 
they completed some but not all of the surveys), they will be paid for the surveys that they completed.  
 
 
20.0 Multi-Site Research 
20.1 
Communication Plans 
Not Applicable 
20.2 
Data Submission and Security Plan 
Not Applicable 
20.3 
Subject Enrollment 
Not Applicable 
20.4 
Reporting of Adverse Events and New Information 
Not Applicable 
20.5 
Audit and Monitoring Plans 
Not Applicable 
 
21.0 Adverse Event Reporting 
 
21.1 
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB 
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) 
experienced by a subject or other individual, which in the opinion of the investigator is determined to be 
(1) unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures. 
 
21.2 
Auditing and Inspecting 
The investigator will permit study-related monitoring, audits, and inspections by the Penn State quality 
assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related 
documents (e.g., source documents, regulatory documents, data collection instruments, study data 
etc.).  The investigator will ensure the capability for inspections of applicable study-related facilities 
(e.g., pharmacy, diagnostic laboratory, etc.). 
 
22.0 Study Monitoring, Auditing and Inspecting 
 
22.1 
Auditing and Inspecting 
The investigator will permit study-related monitoring, audits, and inspections by the Penn State quality 
assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related 
documents (e.g., source documents, regulatory documents, data collection instruments, study data 
etc.).  The investigator will ensure the capability for inspections of applicable study-related facilities 
(e.g., pharmacy, diagnostic laboratory, etc.). 

Page 18 of 20 
22.2 
 
 
23.0 References 
1. American Academy of Dermatology (2014). Skin cancer stats and facts. Retrieved September 25, 
2014 from https://www.aad.org/media-resources/stats-and-facts/conditions/skin-cancer  
2. Veierod, M. B., Weiderpass, E., Thorn, M., Hansson, J., Lund, E., Armstrong, B., & Adami, H. O. 
(2003). A prospective study of pigmentation, sun exposure, and risk of cutaneous malignant 
melanoma in women. J Natl Cancer Inst, 95(20), 1530-1538. 
3. Mallett, K. A., Ackerman, S., Turrisi, R., & Robinson, J. (2015). Rates of sunburn among 
dermatology patients. JAMA Dermatology, 151(2), 231-232.  
4. Mallett, K. A., Turrisi, R., Guttman, K., Read, A., Billingsley, E., & Robinson, J. (2011). Assessing 
dermatologists’ ability to deliver a novel intervention to improve patients’ use of sun protection: The 
ABC method of physician-patient communication. Arch of Dermatol, 147(12), 1451-1453.  
5. Kristjansson, S., Ullen, H., & Helgason, A. R. (2004). The importance of assessing the readiness to 
change sun-protection behaviours: a population-based study. Eur J Cancer, 40(18), 2773-2780. 
6. Turrisi, R., Hillhouse, J., Gebert, C., & Grimes, J. (1999). Examination of cognitive variables 
relevant to sunscreen use. Journal of Behavioral Medicine, 22(5), 493-509. 
7. Mallett, K. A., Turrisi, R., Billingsley, E., Comer, C. D., Read, A., Varvil-Weld, L., Gaber, R., Favero, 
S., Guttman, K., & Robinson, J. K. (2012).  Enhancing patients’ satisfaction and sun-protective 
behaviors using the ABC method of physician-patient communication. Archives of Dermatology, 
148(9), 1087-1089 
 
 
24.0 Appendix 
 
 
 
 

Page 19 of 20 
25.0 Statistical Analysis Plan 
25.1 Power/Sample Sizes 
The sample sizes were chosen based on statistical, analytic, and theoretical considerations. For 
comparisons of the ABC vs. TAU controls on our outcome variables for Aim 1 (e.g., sun 
protection behaviors), our N should be able to detect effect sizes that correspond to small effects, 
Cohen’s d = .2 or eta squares of 2%. The effect sizes are based on our pilot study examining 
patients’ sunscreen use intentions following exposure to the ABC intervention (see preliminary 
studies section) and our studies examining group differences using motivational enhanced 
interventions to reduce tanning intentions and behaviors. Using power estimation procedures 
described in Cohen, the sample sizes should yield power of greater than 0.90 for the contrasts of 
interest. A second analysis that we will pursue will be moderated multiple linear regression or 
SEM models for Aim 2. Turrisi has special expertise in such analyses, where we test for 
effectiveness of the intervention as a function of a moderator variable at baseline (e.g., gender). 
With every moderator, our sample sizes for each group are reduced by approximately 50%. With 
our target N = 300 (at baseline), we will have sufficient samples to explore the potential of 2 
moderators simultaneously and still have sample sizes that approximate n = 37 per group. Such 
Ns will also permit us to detect partial r2 sizes in the .04-.06 range and will have power of .70 or 
greater for the contrasts of interest. 
25.2 General Analytic Issues 
Missing Data. We will first test if the data are missing at random by forming a dummy variable 
that indicates the presence or absence of missing data on a variable. If the data are missing at 
random, the correlations with other variables should be trivial. We will use the EM method as 
implemented in SOLAS or FIML in Amos to impute missing data. If the data are not missing at 
random, then we will include dummy variables that explicitly model the nature of the missing 
data. 
Outlier Analysis and Response Distributions. Throughout all of our statistical analyses, we will 
be sensitive to the potential influence of outlier cases and possible biases due to ill-behaved (i.e., 
nonnormal) distributions. Where necessary, we will use robust analytic techniques. 
Measurement Error. Many of our variables will be subject to some measurement error that, in 
turn, can bias our parameter estimates. Where possible, we will pursue analytic strategies that 
permit us to incorporate an error theory into our parameter estimation methods (structural 
equation modeling). When multiple indicators of an underlying latent variable are present, the 
incorporation of an error theory is straightforward. When an error theory cannot be empirically 
operationalized, we will take care to interpret our data in light of the potential bias that may be 
present. 
Multiple Tests and Evaluation of Study Aims. Some of our analyses will have multiple DVs. We 
will be sensitive to inflated experiment-wise error and control it with the multivariate F statistic 
based on Pillais criterion in our MANOVAs or with modified Bonferroni methods based on 
recommendations of Jaccard, Turrisi, and Kirk. 
25.3 Aim 1: Evaluate efficacy of the ABC intervention 
Dr. Turrisi (Co-I) will conduct all outcome analyses in order to avoid any bias. First a 2 (Group: 
ABC vs. Controls) x 3 (Time: baseline, 3 & 6 mo. follow-up) Mixed ANOVA will be conducted 
to test the intervention on a given outcome variable (e.g., use of sun protection). First, we expect 
to observe a main effect of Group with the highest reports of sun protection (and lowest reports 
of UV risk behaviors) occurring in our ABC condition. Second, we anticipate observing a Group 
x Time interaction with no differences between the groups at baseline but differences (lower risk 
in the ABC group) at each of the follow-ups. He will also assess the scientific and clinical 
significance of the effects utilizing the magnitude estimation approach described by Jaccard. 
Specifically, statistical significance refers to the case when the null hypothesis is rejected, 
whereas magnitude estimation approaches emphasize the size of the effect. To utilize magnitude 

Page 20 of 20 
estimation approaches, the researcher must specify an a priori effect size that differentiates a 
trivial effect from a meaningful effect. If the effect size observed is less than the criterion for 
meaningfulness, then the result is deemed nonsignificant, even if the null is rejected. We will use 
Cohen’s d statistic to assess clinical significance of the main effects and interactions. We will 
define an effect as clinically and statistically significant to the extent that the d is greater than or 
equal to .20. 
25.4 Aim 2: Evaluate moderators and mediators 
We will also undertake a set of analyses that identify individual differences in intervention 
efficacy to examine for whom the intervention is more or less effective. Where the moderator 
variable is qualitative (e.g., gender), it will be included as another factor into the Mixed ANOVA 
described earlier. For example, a 2 x 3 x 2 (group x time x patient gender) on sun protection may 
be used to evaluate gender of the patient as a moderator. First, we will explore whether our effect 
of Group, where the lowest reports of UV risk behaviors occurring in our ABC condition, differs 
by the gender of the patient (a group x gender interaction). Second, we will explore whether our 
Group x Time interaction differs by gender (e.g., a significant group x time x gender interaction). 
These analyses will be repeated for each of the qualitative moderator variables and evaluated for 
clinical significance. For quantitative (ordinal or interval) moderator variables (e.g., age), we will 
calculate product terms between the moderator and group and then analyze the data using 
moderated regression following the logic in Jaccard & Turrisi. For mediation, we will use the 
joint significance test, which Monte Carlo simulations have shown has the most power and 
lowest Type I error rates relative to other approaches. We will evaluate model fit using global fit 
indices (e.g.,CFI, RMSEA), and more focused indices that suggest specific areas of poor fit 
(modification indices). We will use bootstrapping where necessary to account for non-normal 
variable distributions. Using Amos 20.0, if both the a and b paths are significant at the .05 level 
there is evidence for mediation. The mediated effect is the product of a and b and provides an 
estimate of the strength of the mediated effect. When there is evidence of mediation, 95% 
confidence intervals using the bootstrap procedures in Amos can be calculated to provide a range 
of estimates for the mediated effect. If the confidence intervals do not contain zero there is 
evidence of statistically significant mediation. Figure 1.