Scalable Digital Delivery of Evidence-based Training for Addiction Professionals to Maximize Treatment Admission and Retention Rates of Opioid Use Disorder in Affected Families
Phase: NA
Conditions: Community Reinforcement And Family Training, Family Health, Substance-Related Disorders
Sponsor: We The Village, Inc.

Cover Page: Study Protocol
We The Village Counselor Training Study
NCT05875142
Document Date: 03.22.23
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Public Health Management Corporation
Human Subjects Research Protocol
INDEX
1 Protocol Background
6 Informed Consent
2 Participants
7 Study Data
3 Recruitment and Screening
8 Privacy and Confidentiality
4 Study Procedures
9 Risks and Benefits
5 Participant Payment
10 References
PROTOCOL OVERVIEW
Protocol Number
2202
Protocol Title
Scalable digital delivery of evidence-based training for addiction
professionals to maximize treatment admission and retention rates of
opioid use disorder in affected families: Phase I
Protocol Version
(mm/dd/yyyy)
3/22/2022
Principal Investigator
Jane Macky
PI’s Institution/Department
We the Village, Inc.
PI’s Email Address
jane@wethevillage.co
PI’s Phone Number
917.684.4267
Funder/Sponsor
NIH/NIDA
Funding Start Date
07/15/2022
Funding End Date
02/01/2023
Anticipated IRB Closure
Date
09/01/2023
1.
PROTOCOL BACKGROUND
1.1 Describe the scientific/scholarly rationale and background for your project. Describe the gaps
in current knowledge your project is intended to address.
Importance of the problem. There were nearly 100,000 overdose deaths in 2020, with 75% of the 93,331 related to
opioids.21 Many Americans suffer because of the loss of a family member to opioid use disorder (OUD), and the direct
and indirect costs of substance use disorders (SUDs) to society are estimated to be over $600 billion annually.22 Because
only 17% of people with OUD get medication assisted treatment (MAT) each year, the majority remain at heightened risk
for overdose, death, and other harmful personal and societal outcomes. Community Reinforcement and Family Training
(CRAFT) significantly improves treatment entry and retention of treatment-resistant individuals.2,24 It is delivered by
counselors to a family member or concerned significant other (CSO) motivated to help their loved one with an OUD
(Identified Persons, or IPs). It has strong empirical support, having been tested by multiple investigators in 10
well-controlled clinical trials,2-3,11-16,28,63 with consistently moderate to large effects on treatment entry (62-77%) vs
treatment controls (17-40%).11,26 In addition, two OUD-focused studies found that CRAFT improved retention in MAT such
that IPs were less likely to drop out of treatment compared to usual practices.2,28 Unfortunately, CRAFT is broadly
inaccessible to families because most counselors do not receive CRAFT training.
Approximately $70 million is spent annually to train SUD treatment providers17 and billions of dollars are spent to
develop and validate the efficacy of Empirically Supported Treatments (ESTs) like CRAFT, but these treatments are rarely
used in treatment programs. Moreover, when they are used, the quality of their implementation is usually poor. It is
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critical that we find effective ways to train counselors to implement CRAFT if we are to address the toll that OUDs are
taking on individuals, their families, and the American public.
Critical barrier to progress. Currently, CRAFT counselor training lacks scalability. Training workshops are held
in-person or through web-conferencing by Dr. R.J. Meyers, the developer of CRAFT, or by a few trainers approved by him.
Dr. Meyers has a post-workshop certification process that is user-friendly and allows counselors to securely upload digital
audiotapes to a server where they are manually coded by trained raters who generate written feedback on CRAFT
adherence and skill. During web-based coaching sessions, additional feedback and advice is provided. This process trains
counselors to proficiency in CRAFT and then certifies them; however, it is expensive, has limited scale, is largely
dependent on one person (Meyers), and has not been leveraged to take full advantage of a digital format. No
comprehensive digital CRAFT training and certification programs for counselors exist.
Research. Current methods for training counselors and disseminating ESTs, including CRAFT, rely on brief online or
in-person workshops. However, research shows this format is minimally effective in facilitating adoption and
implementation of ESTs.29 Counselors who receive post-workshop feedback and coaching on taped sessions with clients
show larger gains in proficiency and maintain them longer.7,31 Much of this well-controlled research has examined
in-person counselor training for motivational interviewing and cognitive behavior therapies.7,10,31-32 Because CRAFT uses a
motivational interviewing approach and is based in cognitive behavior therapy, it is very likely that the effectiveness of
these procedures generalizes to CRAFT training; however, no studies have specifically examined CRAFT counselor training
and very few controlled studies have evaluated scalable online training.
Most internet training studies have had small sample sizes,33 no control group,33-37 and/or relied on knowledge-based and
self-report measures 33,35-36,38-39 that do not necessarily reflect actual change in counselor behavior.7,30 Of the three studies
that used the preferred method of direct observation of counselor proficiency, two had no control comparison but found
pre to post training improvements after an online tutorial followed by live remote observation with feedback and
coaching.34,35 The third study found improvements in Motivational Interviewing proficiency for counselors receiving
feedback on taped sessions or live supervision of sessions at 8 and 20 weeks post-workshop and these improvements
were greater than for a workshop alone group.41 We found no randomized controlled trials of counselor web-based
training that examined CRAFT.
Contributions. The development and rigorous testing of a scalable CRAFT counselor training product will contribute
to scientific knowledge because:
1. Replication and generalization of the previous counselor training research is needed. Research on web-based
counselor training is limited, and no studies have examined training in CRAFT.
2. Most studies have not examined the feasibility and necessity of training counselors to proficiency. This project will be
the first to explore the effect of different levels of training on family outcomes.
3. Web-based training programs have not fully explored the potential of the digital format to leverage automation in
training staff efficiently. It is possible that fully digitized self-study materials could allow some counselors to
significantly improve their proficiency or even prepare to achieve certification.
4. Additional studies would better establish methods for maintaining EST skills. Few web-based training trials have
examined skills maintenance past the end of the most intensive training group.
1.2 List the primary and secondary aims, research questions, and hypotheses.
The goal of this project is to develop and evaluate the technical feasibility and commercial viability of a scalable
digital counselor training program for CRAFT. This Phase I project will develop an enhanced training model for CRAFT
and digitize it to maximize scalability. In this project, we will:
Aim 1: Produce the digital counselor training prototype and coaching process, tailored to OUD - with stakeholder input.
Aim 2: Conduct a pilot study of 3 levels of digital training (Level 1 – Digital tutorial only [T]; Level 2 – Tutorial & digital
training materials for self-study [TM]; Level 3 – Tutorial, digital materials, feedback and coaching [TMC]) to
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establish feasibility, acceptability, and examine the effects of training on CRAFT knowledge, fidelity, and treatment
entry and retention.
1.
Primary Hypothesis
1.1.
At 12 weeks (after study start), participants assigned to the TMC condition will demonstrate the highest
CRAFT procedure fidelity (measured in audiotaped sessions with a standardized patient) followed by TM
and then T.
Rationale: Direct observation measuring content of CRAFT delivered in treatment sessions is our primary
outcome as this provides the best assessment of counselor adherence and skill and is consistent with
previous studies.7,10,41 Our hypothesis that TMC will produce greater use of CRAFT than T (or TM) is based
on the results from previous trials comparing a workshop only to workshops plus feedback and
coaching.7,10,41
2.
Secondary Hypotheses
2.1.
Participants assigned to the TMC condition will demonstrate the highest CRAFT knowledge followed by
TM and then T, in their 12-week knowledge test.
Rationale: Results from previous controlled trials have shown no differences in counselor knowledge pre-
to post-workshop, but increases have been seen when fact sheets and supervision are added after the
workshop.39,57-58
2.2.
Participants will rate the programs satisfactory, useful and usable with similarly positive scores (3 on a 5
point scale or above) at each follow-up assessment point.
Rationale: Research shows (and with our own CRAFT Family product) that all programs are rated similarly
satisfactory and useful.39
2.3.
Participants in all conditions will perceive increased implementation potential over time (pre-tutorial,
post-tutorial, 12 week follow up), but at 12 weeks implementation potential will be lower for TMC
compared to TM and T.
Rationale: In a CBT (Cognitive Behavioral Therapy) web-based training study implementation potential of
three training programs increased over time, but a condition involving expert supervision was seen as
more difficult to implement.39
2.4.
Participants assigned to the TMC condition will assign the highest monetary value to the tutorial, digital
training and certification components, followed by TM and then T participants, in their 12-week
follow-up surveys.
Rationale: The pilot study of our CRAFT Family product showed participants assigned to the CRAFT
private coaching condition valued all components of the program substantially higher than those who
received less coaching in the group condition, or digital only (no coaching) condition.
2.5.
Participants assigned to the TMC condition will report that more IPs have entered treatment compared
to TM and T at 12-weeks (after study start) follow-up surveys.
Rationale: This hypothesis is based on the results from previous trials examining counselor fidelity 7,10,41
and studies showing that CBT fidelity enhances treatment outcome.59-60 We consider this hypothesis
exploratory because the 6 month timeline will not be sufficient to adequately test for differences in
treatment entry, as there would not be much time after all counselors completed training for them to
complete CRAFT with CSOs.
1.3 List the primary and secondary outcomes.
The primary outcome variable is the participant’s demonstration of procedure fidelity, measured in audiotaped sessions
with a standardized patient.
Secondary outcome variables include participant’s CRAFT knowledge; participant’s satisfaction with the program
(website content and delivery); participant’s perceived implementation potential; participant’s monetary valuation of the
program; and participant’s report of IPs entering treatment via CSO report.
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2.
PARTICIPANTS
2.1 Describe the general characteristics of the intended primary participant populations,
including age range, gender, sexual orientation, racial/ethnic background, socioeconomic status,
health status, criminal history, and any other characteristics relevant to the study.
Aim 1 - Qualitative Review:
We will sample individuals from 4 groups (n=3/group) with a group of: 1) subject matter advisory board (SMAB)
members representing customer perspectives (state-level counselor training decision-makers, payors, SUD program
administrators), 2) CRAFT trainers and expert supervisors, expanding beyond our immediate network: 3) counselors, and
4) addiction program leaders (Addiction Administrators). Participants will include individuals identified as subject matter
experts in the addiction industry and represent different customer audiences. Participants must be older than 19 years
(given the profile of addiction professionals we expect no participants will be excluded on this basis).
Gender Representation: We anticipate that about 66% of our research participants will be women. We will monitor
gender balance of the counselors at the participating clinics and make extra effort to recruit men (e.g., directly
conducting outreach to them through addiction treatment providers and emphasizing the benefits of participation) if
they appear to be appreciably under-represented.
Racial/Ethnic Representation: Given the Phase I timeline and the early stage and budget we do not anticipate
conducting extensive explicit efforts.
Socioeconomic status: Because we will be sampling from counselors, counselor training decision makers, payers and
administrators we would expect a wide range of income - from around $30,000 to $200,000.
Aim 2 - Training Intervention:
The target population is United States based addiction professionals and counselors working with concerned
significant others (CSOs), as well as the family members and friends of identified persons (IPs) with an opioid use
disorder (OUD). Participants must be older than 19 years old, and given the profile of the current counselor working in
the addiction profession, we expect that none will be excluded on this basis. Participants will be recruited and enrolled
using phone outreach and online methods, including WTV developed relationships with SUD treatment providers,
SAMHSA listed treatment providers and professional listservs, as well as the WTV website, Google, Facebook, and
Instagram. Our recruitment strategy drawing from those employed at SUD treatment providers and related listservs gives
us a high chance of reaching many counselors. This will produce a sample that is representative of this group but not
representative of all counselors working with CSOs. CSOs may seek private counseling outside of the addiction services
providers when someone they love has an OUD. We will make efforts to target this broader counselor audience by
recruiting through more general counseling listservs. The sample will be limited to participants who have internet access
and are willing to receive training from web-based sites.
Gender Representation: Based on population estimates64 for substance abuse counselors in the United States, we
anticipate that 50 – 60% of our research participants will be women. We will monitor gender balance of the counselors
at the participating clinics and make extra effort to recruit men (e.g., directly conducting outreach to them through
addiction treatment providers and emphasizing the benefits of participation) if they appear to be appreciably
under-represented.
Racial/Ethnic Representation: Given the Phase I timeline, and budget we do not expect to conduct extensive explicit
efforts to recruit for racial/ethnic representation beyond reaching out to specific minority represented list-serves such
as the Association of Black Social Workers. Given the small sample size for this early stage pilot and feasibility study we
do not anticipate having enough racial/ethnic minorities in any group to allow demographic analysis. Regardless, we
expect to have some racial/ethnic minority representation among our participants.
Socio-economic Representation: Given our recruitment of addiction professionals, we anticipate a relatively consistent
socioeconomic range for the participants. We expect that within the sample there will be a few counselors with a higher
socio-economic level, however, because some may be working in private practice or be physicians. We anticipate most
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participants will fall within a middle to low socioeconomic status as the median salary of an addictions counselor is
$48,520 per year, or $23.33 per hour, according to the US Bureau of Labor Statistics.
2.2 Select all populations, settings, or records that will be involved in the research. Complete the
corresponding appendix for each selection.
☐People who use substances, substance use treatment sites, and/or substance use records (Appendix J)
☐Students, school settings, and/or student education records (Appendix L)
For protocols that meet the criteria for exempt research, skip to Section 4.
2.3 Select all intended primary participant populations. Complete the corresponding appendix
for each selection.
☐Pregnant women (Appendix G)
☐Prisoners (Appendix H)
☐Children (Appendix I)
☐People with limited decision-making capacity (Appendix K)
2.4 List the study inclusion criteria.
Aim 1 - Qualitative Review: We will sample individuals from 4 groups (n=3/group) including:
●
Members of WTV’s Subject Matter Advisory Board (SMAB)
●
CRAFT trainers or experts
●
Counselors working in addictions, or
●
Addiction program leaders (Addiction Administrators)
These individuals must be
1.
19 years or older
2.
Able and willing to participate in audio recorded focus groups and individual interviews
3.
Demonstrates complete understanding of the requirements for participation in the study by reading and signing
the consent form
Aim 2 - Training Intervention: We aim to enroll 45 participants, meeting the following criteria.
1.
Is over 19
2.
Lives in the US
3.
Working in a counselor-related profession
4.
Has not been trained in CRAFT
5.
Could provides at least 45 minute individual counselor sessions to at least one CSO (CSO)
6.
Counseling work involves clients affected by OUDs, or might if they learned CRAFT
7.
Is able and willing to submit the required session audiotapes and participate in the tutorial and training and
intervention activities over the course of the 12-week study
8.
Reports having access to a computer and smartphone with internet access, email, and word processing capability
9.
Demonstrates complete understanding of the requirements for participation in the study by reading and signing
the consent form
10. Provides valid locator information to allow research and CRAFT training staff to contact them to schedule
study-related appointments
11. Completes the first assessment mock session with our standardized patient (SP) and pre-tutorial surveys
2.5 List the study exclusion criteria.
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Aim 1 - Qualitative Review: Participants from the four groups will be excluded based on the following criteria:
1.
Does not agree to participate
2.
Does not attend focus group
3.
Is not English-speaking
Aim 2 - Training Intervention:
1.
Does not agree to participate
2.
Does not complete the baseline assessment requirements
3.
Is not English-speaking
4.
Participated in the Qualitative Review study
2.6 Provide justification for the exclusion of broad population groups.
For this study we are excluding people under 19 years of age, and there is no upper age limit. The study design excludes
anyone under 19 years old. The primary hypothesis for the study is to help professionals increase treatment utilization
among IPs by counseling CSOs in CRAFT. Because the participants in this study are working counselors and addiction
professionals, it is not anticipated that any will be children or adolescents.
3
RECRUITMENT AND SCREENING
3.1 Identify the expected number of individuals screened and the expected number of individuals
consented/enrolled to reach your target sample size. If multi-site, break the total down per study
site. If multi-year, break the total down per study year.
Aim 1 - Qualitative Review: We will sample individuals from 4 groups (n=3/group) for a total of 12 participants. Our first
two target groups are already identified via our already committed SMAB, close ties to the CRAFT trained counseling
community, our status in the addiction professional networks, and access through professional listservs. We therefore
anticipate filling our focus groups expediently with a 1 in 2, or 1 in 3, chance of targeted participants being eligible after
screening and accepting the invitation to participate. As such, we expect to screen no more than about 40 individuals to
reach our target sample of 12.
Aim 2 - Training Intervention: We will enroll 15 participants per study arm, resulting in enrollment of a total of 45
participants in the study period (6-months). Our previous family training pilot study (also with a total of 45 participants
in the same project timeline) experienced a large drop off during recruitment. Although 1275 individuals began the
screening process in that previous study, only 129 completed a consent form online, and only 35% of these potential
participants completed the entire informed consent process, were randomly assigned and began the intervention. Given
this experience with online recruitment procedures, it is possible that around 1300 participants will need to initiate the
screening process in order for us to recruit, consent, enroll, and randomly assign 45 participants. We will continue to
recruit via a waitlist (facilitated by online Alchemer surveys) after we have reached our goal of 45 enrolled participants.
This waitlist will enable us to reach out to other eligible participants in the event that someone drops off before the
baseline survey and start of intervention.
3.2 Describe how prospective participants will be identified and recruited. Include information
about: how, when, where, and by whom (by position or role, not by name). Describe any
recruitment materials that will be used to recruit prospective participants.
Aim 1 - Qualitative Review:
Participants will be recruited and enrolled using phone outreach and online methods, including WTV developed
relationships with SUD treatment providers, as well as SAMHSA listed treatment providers and professional listservs. We
will start with our immediate network to fill the groups and reach out for referrals via our network as needed.
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WTV will telephone or email identified individuals and professional networks (if needed) informing recipients of the
opportunity to provide feedback in a focus group for this study. When necessary, they may also telephone treatment
programs and ask to speak with the person in charge of counselor training, family programs, or another appropriate
administrative staff member (e.g., program director). Staff will inform that person of the purpose of the call (seeking
feedback as part of federally-funded CRAFT Counselor training study), and for those who express an interest in the study,
provide a detailed description of the focus group and individual interview, including the voluntary nature of research
participation and requirements for audio taping focus groups and interviews. If appropriate, we will ask treatment
programs or professional networks to email potential participants a description of the study and provide a link to a
webpage for online screening. Subsequent 15-minute telephone/video meetings will be scheduled with interested
individuals to complete the screening process (if not completed online) and enroll individuals in the focus group sample.
Those who are not interested in volunteering for the study will be thanked, and no further action will be taken.
Aim 2 - Training Intervention:
Because we believe that counselors may have heightened willingness to participate in the study if the tutorial is
supported by their place of employment, we will recruit through free tutorials offered to OUD treatment clinics targeting
those focused on family services. Our recruitment efforts will be limited to the United States and will begin in the first
project quarter following IRB approval and grant award. Recruitment will continue through the first quarter of the
project or until we recruit up to 45 eligible participants, whichever comes first. We will track and document which
recruitment strategies yield the best engagement. Please see examples of images and messaging we will use for different
methods of recruitment. We plan to implement the following recruitment methods:
1.
Recruitment channels for Training Intervention
a.
WTV Promotions (e.g., website callouts, emails, social media posts and 1:1 message) to existing and
future WTV members.
b.
Engagement of the WTV membership group to suggest this opportunity to their network and make a
referral if they know anyone who fits the participant description.
c.
Outreach to existing partners who provide services to patients with OUD.
i.
Wholeview Wellness
ii.
Center for Motivation and Change
iii.
JoinGroups.Com (medication-assisted treatment (MAT) for opioid addiction)
d.
Provide free tutorials offered to OUD treatment clinics targeting those focused on family services and
programs
i.
Counselor listservs (such as: State chapters of Professional Liaison’s Association, e.g. NYPLA,
American Counseling Association, National Board of Certified Counselors)
ii.
Listings of treatment programs will be obtained from the SAMHSA website and web-based
directories associated with state related SUD offices.
e.
Develop recruitment strategies to increase diversification of study participants
i.
Promote research study on the following professional counseling member websites:
●
Association of Black Psychologists (ABPsi)
●
National Association of Black Social Workers (NABSW)
ii.
Develop new partnerships with providers who serve more diverse populations, including
communities of color and lower SES
f.
Targeted digital and local advertising efforts.
i.
NADAAC
ii.
Facebook
iii.
Instagram
iv.
Google
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Listings of treatment programs will be obtained from the SAMHSA website and web-based directories associated
with state SUD offices. We will also promote the free workshop and training through relevant counselor listservs (such
as: State chapters of Professional Liaison’s Association, e.g. NYPLA, American Counseling Association, National Board of
Certified Counselors) as we anticipate that these individuals have a high likelihood of opting into the study. We will also
run a small targeted digital ad to expand our reach. ​
WTV will call treatment programs and ask to speak with the person in charge of counselor training, family programs,
or another appropriate administrative staff member (e.g., program director). WTV will inform that person of the purpose
of the call: offering a free online CRAFT workshop and the potential for their staff to receive training
as part of
federally-funded CRAFT Counselor training study. Those who express an interest in the study will be provided a detailed
description of the training study emphasizing the voluntary nature of research participation, and describing
requirements for audio taping sessions, participation in digital lessons and then random assignment to the T, TM, or TMC
conditions. Treatment programs that express interest will be provided with an email describing the study and inviting
counselors to participate, and they will be asked to forward the email to their counselors.
Interested counselors will be asked to click on a link that takes them to a description of the study and asks them to
complete an anonymous screening form. After completing screening, counselors who are not eligible will be informed
and thanked, and no further action will be taken. Counselors that are eligible and still interested in participating in the
study will be asked to click on a link that begins the consent procedure.
3.3 Describe how prospective participants will be screened. Include information about: how,
when, where, and by whom (by position or role, not by name). Describe any instruments that will
be used or tests that will be performed during the screening process.
Aim 1 - Qualitative Review: Screening will occur by telephone or online. During a 15-minute phone call with
participants or by email linking to an online form, study staff will provide a brief overview of the focus groups and
individual interviews, and the requirements, risks and benefits of participating in the research. Those expressing interest
will be asked to answer questions assessing inclusion criteria including which of the four categories of participants they
belong to (WTV SMAB member, CRAFT trainer or expert; counselor working with CSOs or individuals with OUD; an
addiction program leader), whether they are over 19 years of age, and if they would consent to being audio-recorded
during the focus group and interview. Online screening will be a self-administered multiple choice online Alchemer tool
asking the same questions and programmed to inform participants immediately if they are eligible. Those meeting the
inclusion criteria will be sent a link to a consent to review and digitally sign. Individuals who do not meet the inclusion
criteria will be thanked and no further action taken.
Aim 2 - Training Intervention: When a prospective participant responds to a recruitment message, flyer, or referral, they
will be directed to visit the We the Village Counselor Training study webpage. On the study website, prospective
participants will have the opportunity to read a description of the study, including goals and expectations. If individuals
are still interested, they will be directed to click the Screening Survey link. The link will take them directly to the start of
the Screening Survey. The Screening Survey is a self-administered multiple choice online Alchemer tool. Potential
participants will be asked screening questions to confirm their year of birth, interest in learning CRAFT, that they are
working in a counselor-related profession, could provide 45 minute sessions of individual counseling sessions to at least
one CSO client, work or could work with clients affected by OUD, have no previous training in CRAFT, are able and willing
to submit the required session audiotapes and participate in the training activities over the 12-week study period, have
access to a computer or smartphone with internet access, email and word processing capabilities, and reside in the
United States. We will program automated scoring to inform participants immediately after filling out the screening
survey if they are eligible, unless their answers are not clearly eligible or ineligible. If the results of their screening survey
are indeterminate, they will receive a message to call the study number to speak with a study staff person or fill out a
contact form to request a call.
3.4 Describe the information you will obtain for screening. Explain whether you will retain this as
part of the study data.
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Aim 1 - Qualitative Review & Aim 2 - Training Intervention: We will not collect personal identifiers during the screening
process and will retain all the information we received as part of the screening process in a secure location. All screening
data will be de-identified and will not be connected to any future data collection activities.
3.5 Describe how screen failures will be handled and, if applicable, describe the conditions and
criteria upon which re-screening is acceptable.
Aim 1 - Qualitative Review: For the qualitative focus group study, potential participants will be screened live on a call or
via email and informed of their eligibility near the end of the phone call. Screen failure will be thanked, and no further
action taken. Rescreening will not occur.
Aim 2 - Training Intervention: A study phone number and email address will be listed on the study landing page for
prospective participants if they experience technical difficulties or have questions. If a prospective participant’s answers
do not make them clearly eligible or ineligible, they will be encouraged to call, or email the Research Coordinator for
additional information. We will attempt to communicate with participants within one business day. The Research
Coordinator will re-screen participants without collecting any identifying information to determine eligibility. If the
person is eligible, they will be redirected to complete the informed consent process and re-enter the digital enrollment
flow. This procedure will improve screening rates and minimize potential eligible participants screening out of the study.
If the person is not eligible, study staff will inform the person and ask them if they are interested in learning more about
other We the Village offerings.
Figure 1. Qualitative Focus Groups:
Figure 2. Training Intervention Pilot
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4
STUDY PROCEDURES
4.1 Provide a detailed description of the study procedures in chronological order. As applicable,
include information on: differences between the control and experimental groups, the number of
follow-up visits, study visit windows, participant time commitment per activity, and the
setting/location per activity.
Aim 1 - Qualitative Review:
After completing the consent form, participants will be contacted to schedule a meeting time for the focus group.
Once scheduled, they will be emailed information allowing them to join the secure web-based conferencing platform (i.e.
Zoom) to participate in the focus group. Prior to beginning the focus group we will ask that participants read and
acknowledge their adherence to a simple confidentiality agreement due to the sensitive commercial nature of the
various concepts or ideas presented in the focus groups. With supervision from our qualitative research consultant
(Sosinsky), and CRAFT experts (Kirby & Meyers), we will create interview guides with open-ended questions to guide the
discussions in virtual focus groups to surface insights from target end-users. Interview guides will build off quality
assurance testing that Mr. Handley, product marketing manager, will conduct, and cover all aspects of the CRAFT
counselor product including implementation potential. Focus groups will be led by research staff under the supervision
of our qualitative research consultant and will last about 60 to 90 minutes.
If needed, participants will be individually contacted to schedule a follow-up call to ask questions clarifying topics
discussed during the focus group. These follow-up contacts will be conducted within about six weeks of the initial focus
group and may occur by telephone or secure web conference. They may also include follow-up questions suggested by
our qualitative research consultant and CRAFT experts to elucidate focus group responses needing further clarification.
We anticipate that these follow-ups will take up to 45 minutes.
This study involves a total of four focus groups and up to twelve individual follow-up contacts (each participant is
involved in one focus group and one follow-up contact). All focus group and individual meetings will be audio recorded,
transcribed, and coded. An inductive approach will be used to identify themes and subthemes in the audiotaped
recordings. Under Dr. Sosinsky’s guidance, 3 reviewers will read a selection of audiotape transcripts and create an initial
codebook to undergo a grounded theory approach producing iterative revisions. The final codebook will be used in NVivo
software to assess transcripts. A content analysis will be performed and at least two coders will generate themes and
subthemes of key product refinements. Thematic content analysis will be conducted and used to identify refinement
themes. The product team (led by Macky & Handley) will confer with team experts where appropriate to propose
product solutions to the refinements surfaced and then create a prioritized product backlog based on an impact versus
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effort analysis of individual solution implementation. This analysis will inform which product refinements are made
pre-pilot, and which are stored in the product backlog for future implementation. We anticipate that all activities will be
completed within two months.
Aim 2- Training Intervention:
Study procedures are outlined in the figure below. After screening, eligible participants complete the online informed
consent form and the locator form. The locator form records the participant’s home and work telephone, address, email,
and the contact information of others who may be able to assist research staff to reach the participant, if needed. This
information will be used to prompt participants to join the scheduled interview. Only study staff will have access to this
information. Participants will be contacted primarily through email to ask them to complete surveys or to schedule
online mock counseling sessions, but we will secondarily use text, calls, letters, and social media direct messaging as
reminders. Participants will complete the self-administered baseline instruments using Alchemer software and be
scheduled to complete an online mock counseling session.
After both the baseline survey and mock counseling session have been completed, participants will be randomized
into one of three groups using a blocked randomization procedure. The block randomization procedure is used to control
for level of education (high school/GED, bachelors, masters, PhD) and training and experience in Cognitive Behavior
Therapy (CBT) and Applied Behavior Analysis (ABA), as CRAFT is a CBT based on ABA principles.
We will use an additive components design consisting of: 1) digital tutorial only (T), 2) digital tutorial plus digital
training materials (TM), and 3) digital tutorial and digital training materials plus feedback and coaching (TMC). This
design will allow us to assess whether the digital training materials improve counselor outcomes relative to the tutorial
only, but will not allow us to access their contribution, if any, to the full training product (TMC).
Follow-up assessments will be conducted after all three groups have completed the tutorial (at 2 weeks) and again at
12-weeks post baseline. All aspects of the study will be conducted completely virtually.
Table 1. Treatment Conditions
Treatment Conditions:
Digital Tutorial (T) - All participants will continue to have access to tutorial materials throughout the study. Participants
assigned to the T condition receive ONLY the tutorial. Afterwards they will be encouraged via weekly emails that are a
component of the training program to continue using the resources in the online tutorial to revisit the CRAFT lessons on
their own during the 10-week period between post-tutorial follow-up and the final follow-up assessment.
Digital Tutorial, with training materials (TM) - Participants assigned to the TM condition will complete the tutorial and
then receive access to the additional training materials. They will not receive any feedback or video-calls for coaching.
They will be encouraged via weekly emails to continue to learn CRAFT on their own during the 10-week post-tutorial
period by using the new resources in the online tutorial and the digital training materials.
Digital Tutorial, with training materials plus feedback and coaching (TMC) - Systematic feedback and coaching during
the 10-week post-tutorial to final assessment period (12 weeks post-baseline) will be provided to only to the 15
participants assigned to the TMC condition. Participants will be required to submit audio taped sessions with clients.
They will be provided with consent-to-audiotape forms that they will need to have the client complete prior to
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audiotaping sessions with that client. If their place of work also has required client consent-to-audiotape forms, they will
need to have the client sign both forms, or receive permission
from their place of employment to use the form we
provide instead. We will provide a brief training to prepare the counselors to attain informed consent to audiotape from
clients. The training will be delivered via a zoom session with supporting written materials. The training will emphasize
that the informed consent process is based on respect for the individual, and, in particular, the individual's autonomy or
capacity and right to make choices. They will be taught to convey accurate and relevant information about their reasons
for requesting permission to audio record, namely, to meet the requirements of a study that they are participating in,
letting the client know that the purpose of the study is to examine different counselor training methods and that it is the
counselor’s behavior that is the target of these recordings. Counselors will be taught to inform clients of the known risks
(the potential of breach of confidentiality) and that all audiotaping and management of audio files will be done using
HIPAA compliant methods to reduce risks. Counselors will be trained to inform clients that they may experience no
direct benefit from agreeing to audiotaping. We will emphasize that clients must be informed that they may refuse
taping without any penalty; they must not be treated any differently by the counselor or the clinic. They will be
instructed to allow clients to ask questions and have them answered so that they can make an informed decision about
whether to participate. The training will also emphasize that consent is always voluntary, and participants may withdraw
consent at any point in time. They will be asked to store the forms in a secure place where they normally keep
confidential patient materials. In order to protect client confidentiality, we will not collect or keep copies of these forms,
as they would provide additional client identifying information that is not required for the study.
In addition to providing training in the informed consent procedure, counselors will be trained in procedures to
protect the confidentiality of the audiotaped sessions. They will be trained to ask clients to avoid using names and
instead to refer to the IP in terms of their relationship (e.g., my son, my partner). Sessions will be taped using one of
three procedures. First, if the counselor has access to a HIPAA compliant electronic patient health platform that supports
audio recording sessions (e.g., SimplePractice) and securely transmitting them (e.g., vis encryption), we will accept use of
their established system. Second, if their practice does not provide this type of software, we will have counselors
download free software (i.e., Pocket Dictate Mobile Dictation Recorder) that allows them to audiotape the session on
their telephone and send the encrypted recording to us. Counselors will be instructed to delete the recording
immediately after receiving confirmation of receipt. As an additional precaution
, they will be shown how to adjust the
application settings so that the audio recordings are automatically deleted after 24 hours and instructed to password
protect their phone so that only they can access it. Third, if the counselor does not have access to either a HIPAA
compliant electronic patient health platform or a smartphone, we will provide them with a digital audio recorder that
allows them to securely upload files directly to
a HIPAA-compliant server. They will be instructed to delete the audio
recording from the device immediately after uploading to this system.
Participants will
digitally receive written feedback and live video-call coaching on their tapes (up to 12 allowed).
They will be encouraged to re-submit their audio taped sessions until they meet the criteria needed for certification in
the CRAFT procedure or until the phase is over (whichever occurs first).
Participants will receive individual written Personal Performance Feedback on all audio taped sessions that they
submit. This feedback is generated by two CRAFT certified trainers (i.e., CRAFT Trainer or CRAFT Coder) who access the
digitally audio taped sessions via a secure server. The trainer listens to the audiotape and records a session content
checklist that indicates key procedures for each module. For each key component, the trainer indicates whether it was
addressed in the session, rates the quality of implementation for that component (1=poor to 5-excellent), and writes
comments praising specific behaviors or making suggestions for further improvement. This feedback is password
protected and emailed to the counselor. TMC participants will participate in weekly 30-min video-call Coaching Sessions.
In addition, the audio taped client sessions will be accessed by research team members charged with developing
software that would automatically complete the coding currently done by the CRAFT trainers.
Table 2. Study Activities By Program
STUDY ACTIVITIES BY PROGRAM
Tutorial
Tutorial + Materials
Tutorial, Materials, & Coaching
●
Digital Tutorial providing CRAFT
principles overview.
●
Digital Tutorial providing CRAFT
principles overview.
●
Digital Tutorial providing CRAFT
principles overview.
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●
Weekly emails encouraging
continued use of the online
tutorial to revisit CRAFT
lessons.
●
Additional training materials
providing in-depth instruction
on CRAFT protocol nuances and
techniques.
●
Additional training materials
providing in-depth instruction on
CRAFT protocol nuances and
techniques.
●
Weekly emails encouraging
continued use of the online
tutorial and materials to revisit
CRAFT lessons.
●
Systematic feedback and coaching
on CRAFT protocols and techniques
10-week period.
●
Program weekly emails encouraging
continued use of the online tutorial
and materials to revisit CRAFT
lessons.
Figure 3. Recruitment and Enrollment Flowchart
4.2 Briefly describe the sources or measures that will be used to collect data about participants.
As applicable, include information on: instruments or surveys that will be administered, tests
that will be performed, and the time points when each data will be accessed or obtained.
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Aim 1 - Qualitative Review:
The audiotaped focus group and individual interview is the primary data that will be collected from participants. The
only other information collected will be on a locator form. The locator form records the participant’s home and work
telephone, address, and email. This information will be used to schedule and prompt participants to join their focus
group and to contact them for any follow-up questions after the focus group, if needed for clarification.
As indicated above, an inductive approach will be used to identify themes and subthemes in the audiotaped
recordings. A codebook will be used in NVivo software to assess transcripts. A content analysis will be performed and
used to identify refinement themes. The product team will confer with team experts where appropriate to propose
product solutions to the refinements.
Aim 2- Training Intervention:
Data collected directly from participants:
Surveys for baseline, post tutorial (i.e, 2-weeks post baseline), and 12-weeks post baseline assessments will be
self-administered using Alchemer software since participants may be located anywhere across the country. The baseline
survey consists of socio-demographic questions, such as gender, age, race/ethnicity; other standardized
socio-demographic measures adapted from the GPRA instrument; a CRAFT Knowledge Test; and a Training Expectations
Form.
Each assessment point also will include an audiotaped mock client session conducted via web conferencing with a
standardized patient portrayed by a professional actor. Using a standardized patient will provide a consistent context for
measuring counselors’ CRAFT skill level at each time-point. The mock session will present the counselor with an
opportunity to roleplay CRAFT procedure: teaching the CSO to invite the IP to enter treatment (the same procedure is
required for the follow-up assessments). We chose to assess this procedure because a component analysis study12
showed it positively impacted treatment entry rates and it requires CRAFT skill accumulation (i.e., it incorporates and
builds upon skills trained in communication and positive reinforcement). Audio tapes will be coded using the CRAFT
Therapist Coding Manual32 used by Dr. Meyers to certify counselors.
At the post-tutorial and 12-week follow-up assessments additional surveys will be added regarding satisfaction with
the training program, perceptions of usefulness and usability, implementation potential, and program value. Finally, at
the 12-week follow-up only, participants will be asked to report the number of CSOs they have worked with over the past
10 weeks, how many of them they implemented CRAFT with, and how many of those CSOs had a loved one who entered
new treatment. The measures, their purposes, related hypotheses, and assessment points are provided in the Measures
Table below.
Table 3. Measures
Revised measures have been adapted specifically for professional participants as appropriate.
Data collected from other sources (identify each source; e.g., health care provider, parent, public records):
N/A. We will only collect information directly from the study participants. We will not collect information from clinic
records or directly from CSOs who participate in audio taping.
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4.3 Describe pre-defined criteria for removing participants from the study and the procedures for
informing participants of their removal from the study. Include information on the handling of
their data and measures to ensure individuals’ safety and privacy after ceasing research
activities.
We do not anticipate removing participants from the study, but participants may be removed if:
a)
they break the confidentiality of other participants in the focus group (Aim 1) or clients in audiotapes (Aim 2)
b)
it becomes clear after enrollment that they do not meet the inclusion/exclusion criteria.
Participants will be notified of their removal from the study by the Principal Investigator, Jane Macky. The PI will call the
participant to explain the reason for their removal. In addition, a formal letter will be sent to participants via email. Both
the phone call and letter will explain the reason for their removal, how their data will be handled, and provide referrals
for support, if needed.
If any participants are removed due to breaking confidentiality during the 10-week post tutorial period when client audio
tapes are submitted, we would use the data they had provided up to that point. Any participants who are removed
because it is discovered that they do not meet the inclusion/exclusion criteria will have their data deleted and will not be
included for analysis. All contact information will be deleted within two weeks after informing the participant of their
removal. We will track and document all reasons for removing participants in order to ensure they are not rescreened
and re-enrolled into the study.     
For protocols that meet the criteria for exempt research, skip to Section 7.
5
PARTICIPANT PAYMENT
5.1 Describe any compensation that will be given to participants for the completion of
research-related activities. Include the monetary value and type of compensation per activity.
Aim 1 - Qualitative Review: All participants will receive a $30 Amazon gift card for participating in their 60-90 minute
focus group, and may be contacted for a brief follow-up to answer clarification questions if needed.
Aim 2 - Training Intervention: In addition to the free training, all counselor participants will receive a $50 Amazon gift
card for each of the three (pre- and post-tutorial and 12-week follow-up) audio taped sessions ($150 total). Participants
in the TMC condition will have the opportunity to get certified in CRAFT at the end of the 12 week training, and
participants in conditions T and TM will have the opportunity to do so after their participation in the study is complete.
5.2 Describe any reimbursements that will be given to participants to repay them for costs they
may have incurred over the course of the study. Include the monetary value and type of
compensation per activity.
N/A. We will not reimburse participants for any costs that they may incur for participating in this online study, including
data or internet plans.
6
INFORMED CONSENT
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6.1 Provide a brief summary of the informed consent process by selecting all of the consent
procedures you will use and specifying for which study procedures. Complete the corresponding
appendix as indicated.
Consent Process
Specific Study Procedures
☒Standard written informed consent
All Aim 1 and Aim 2 activities
☐Waiver of documentation of consent
(Appendix D)
Alteration of informed consent (Appendix D)
☐Waiver of informed consent (Appendix D)
☐Short form (Appendix E)
☐Child assent and parental permission
(Appendix I)
☐Waiver of child assent (Appendix I)
☐Waiver of parental permission (Appendix I)
6.2 Describe in detail the assent and/or consent procedures in chronological order. Include
information about: how, when, where, and by whom (by position or role, not by name).
Aim 1 - Qualitative Review:
All participants will be consented using the IRB-approved digital consent form prior to enrollment in the study. Upon
completing screening and meeting eligibility requirements via phone or online survey, participants will have the option to
complete the informed consent process immediately. They will be sent a link to the written digital consent form that will
remain open for a period of 48 hours. The form will provide a description of the study and specify risks and discomforts,
potential benefits, confidentiality measures, compensation, and the voluntary nature of their participation. A contact
number will be provided for those who wish to ask questions before signing.
Because informed consent will be obtained using online methods, a written signature will not be possible. We will
require participants to check a box agreeing to join the study and to type in their first and last name. We will download
the checked consent form and save the file as a PDF in a protected folder secured on PHMC’s network drive. All
participants will receive an automatic email from Alchemer after completing the consent form. In addition, all
participants will be able to download a copy of the informed consent form with the box agreeing to join the study
checked off and with their name typed into the “I agree” section.
Aim 2 - Training Intervention:
Eligible participants will have the option to complete the informed consent process immediately after completing the
Screening Survey if they meet eligibility requirements. They will be directed to click a link that will remain open for a
period of 48 hours. They will be provided a brief explanation of time estimates for enrollment activity prior to clicking the
appropriate link. After clicking the link, they will be directed to a self-administered online consent form. The form will
provide a description of the study, specify risks and discomforts, potential benefits, confidentiality measures,
compensation, and the voluntary nature of their participation. A contact number will be provided for those who wish to
ask questions before signing.
Informed consent will be obtained using online methods, so a written signature is not possible. We will require
participants to check a box agreeing to join the study and to type in their first and last name. We will download the
checked consent form and save the file as a PDF in a protected folder secured on PHMC’s network drive. All participants
will receive an automatic email from Alchemer after completing the consent form. In addition, all participants will be
able to download a copy of the informed consent form with the box agreeing to join the study checked off and with their
name typed into the “I agree” section.
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6.3 Describe any measures to ensure or test participants’ understanding of the information
presented during the informed consent process.
All participants will be provided with a telephone number for a research coordinator who will provide the opportunity to
ask questions about the consent forms or to receive additional information about the study.
6.4 If a child who provided assent to participate in the study becomes 18 years old during the
course of the study, describe the process to re-consent the participant.
N/A. We will not enroll children. Study participants must be over 19 years old (which meets or exceeds the criterion age
of legal consent in all 50 states).
7
STUDY DATA
7.1 Select all of the personal identifiers you will access and obtain during this study.
Access means to view or to perceive data, but not to possess or record it. Obtain means to possess or record
in any fashion (writing, electronic, video, email, voice recording, etc.) and to retain for any length of time.
☒Names
☒Address (street address, city, county, precinct,
ZIP code)
☒Dates related to an individual (birth date,
admission/discharge dates, date of death)
☒Telephone numbers
☐Fax numbers
☒Electronic mail addresses
☐Social security numbers
☐Medical record numbers
☐Health plan beneficiary numbers
☐Account numbers
☐Certificate/license numbers
☐Vehicle identifiers and serial numbers
☐Device identifiers and serial numbers
☒Web URLs
☒Internet protocol (IP) addresses
☐Biometric identifiers including fingerprints and
voiceprints
☐Full-face photographic images
☒Any other unique identifying number,
characteristic, or code
7.2 Does your study involve PHI and need to comply with HIPAA regulations?
HIPAA regulations apply to covered entities that access, collect, use, or disclose protected health information
(PHI). PHMC is a HIPAA-covered entity and thus, any study that involves PHI must comply with HIPAA
regulations. HIPAA only covers identifiable health information. Studies that involve only (A) health
information without any of the 18 personal identifiers listed above or (b) non-health related information
that contain identifiers do not need to comply with HIPAA because neither form of data meets the definition
of PHI. Use the guide below to verify if your study involves PHI.
All or some study data:
(a) Contain one or more of the 18 personal
identifiers.
☒Yes ☐No
If you answered “No” to (a), then
HIPAA regulations do NOT apply.
If you answered “Yes” to (a) AND
(b), (c), or (d), then HIPAA
regulations apply to this
project. Submit Appendix C.
(b) Relate to an individual’s past, present, or future
physical or mental health or condition.
☐Yes
☒No
(c) Relate to an individual’s past, present, or future
provision of healthcare.
☐Yes ☒No
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(d) Relate to an individual’s past, present, or future
payment for the provision of healthcare.
☐Yes ☒No
7.3 Is there a possibility that de-identified information or biospecimens will be used for future
research studies or distributed to another investigator for future research studies without
additional informed consent from participants?
This only applies to studies that prospectively collect information or biospecimens. Select “No” if your study
involves secondary analysis only.
☒Yes, de-identified information or biospecimens may be used or distributed for future research.
☐No, de-identified information or biospecimens will not be used or distributed for future research.
8
PRIVACY AND CONFIDENTIALITY
8.1 Describe procedures to protect participants’ privacy during the study (i.e., precautions you
have taken to protect the participant from being recognized as a research subject).
1.
The participant enrollment spreadsheet will be password-protected and sent to WTV via encrypted email. (WTV
will be responsible for contacting enrolled participants to inform them of their random assignment, to discuss
next steps, if needed, and to provide a $50.00 gift card incentive payment for completing a survey.)
2.
Electronically obtained consent forms will be stored in a separate, restricted folder located on a secure network
drive at Public Health Management Corporation, accessible only by key study staff.
3.
When contacting participants for study-related purposes, staff will follow a locating and contact protocol that will
decrease the chances of someone being identified as a research subject. They will leave messages approved by
the participant that do not identify the person as a research participant.
4.
Participants will be instructed to create a username that does not use their last name or email address.
Participants can request for their usernames to be changed at any time during the study.
5.
Participants will be instructed to make sure that they are in a private area before revealing any personal
information while completing assessments and during an online focus group, interview, training, or, if applicable,
during a video or telephone meeting with a CRAFT trainer or an audio taped session with a client. They will also
be asked to consider using private telephones (no extension lines) when possible. For those participating via
Zoom, Zoom ensures information is not stored in their network; the data is only transmitted during a session.
WTV will pay to use a HIPAA protected Zoom account to reduce risks associated with privacy. Participants will
receive a secure link to access sessions, so no one other than the intended counselor and staff can attend.
Participants who elect to receive text messages or emails will be instructed to use a password to access
telephone/email content and to delete messages immediately after responding to them. Focus group
participants will be instructed to keep the identity of other participants in the group private.
8.2 Describe all of the procedures you will use to protect participants’ confidentiality during the
study (i.e., precautions you have taken to protect participants’ data from being unnecessarily and
inappropriately disclosed; e.g., authorization of access, password protection, encryption, physical
controls, certificates of confidentiality, separation of identifiers and data). Include information on
any measures that will be taken during storage, access, use, and transmission of study data.
If you will obtain information on participants’ substance use disorder from a treatment provider, then only
answer this question for all other data not related to substance use records (e.g., self-report data). All
confidentiality and data security questions around substance use records should be recorded in Appendix J.
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1.
Participants will be assigned an identification number which will be affixed to all collected assessment data.
Linkage between participant identity and identification numbers will be stored in a password protected
electronic file on a secure network drive at Public Health Management Corporation accessible by key study staff.
2.
The password-protected participant enrollment sheet will not be connected to study data. Data collected in the
study will be kept strictly confidential and will not be shared with anyone outside of the research team.
3.
All computer spreadsheets containing data and SPSS data sets will be saved in password protected files on a
secure server located at Public Health Management Corporation and accessible only to designated research staff.
4.
All research instruments will be computerized for this study, and the data will be entered via the Web using
SurveyGizmo platform. R&E Group maintains a Business Associate Agreement with Alchemer (formerly called
Surveygizmo), allowing staff to securely collect private and confidential information in compliance with the
Health Insurance Portability and Accountability Act (HIPAA), Family Educational Rights and Privacy Act (FERPA),
and other applicable data security and protection laws.
5.
All study staff will be required to undergo training in confidentiality procedures which reviews data handling
procedures as well as addresses questions about participants posed by individuals outside of the immediate
project staff and by project staff members who do not need the information requested. Certification of
successful completion of this training is kept in the appropriate project folder. Should any breaches of participant
confidentiality occur during the course of the study, they will be reported to the relevant IRB and DSMB.
6.
Focus group participants will be instructed to keep the information shared by other participants in the group
confidential.
In addition, for Aim 2:
7.
Data collected as part of the online training activities will also be kept confidential. Participants will be instructed
to create a unique username that does not use their last name or email address. For those participating in
training activities via Zoom, Zoom ensures information is not stored in their network; the data is only transmitted
during a session. We will provide participants with a secure link to ensure no one other than the participant can
enter. WTV agreed to purchase the higher-level membership account that is HIPAA compliant.
8.
Participants will be completing standard patient sessions for review and coding. Audio will be recorded by our
trained SP and uploaded to
a secure system similar to the one that Dr. Meyers uses when providing counselor
training, and then deleted from the recording device. Participants in the TMC condition (n=15) will also be
submitting their own audiotaped sessions with actual clients for review, coding, and feedback by our CRAFT
trainer. Once the counselor has uploaded the audiotape and it has been verified by the CRAFT trainer, it will be
deleted from the recording device.   
9.
CRAFT trainers
will code CRAFT procedure session fidelity using the coding checklist. Additional research
team members will access the audiotapes and checklists for the purpose of developing an automated system to
electronically code procedure fidelity in the same manner that CRAFT trainers. The checklists will not have a
participant’s name or other identifying information on them. They will only have their ID numbers.
10. After collecting and cleaning all data from the baseline and follow-up time points, PHMC will upload the final
clean and de-identified data set to the study’s secure Google drive in order to share the data with the study’s
statistician for analysis purposes.
8.3 If identifiers will be obtained, indicate how the identifiers will be stored.
If you will obtain information on participants’ substance use disorder from a treatment provider, then only
answer this question for all other data not related to substance use records (e.g., self-report data). All
confidentiality and data security questions around substance use records should be recorded in Appendix J.
☐Not applicable; identifiers will not be obtained.
☒Identifiers will be stored separately from study data and a key or code will be kept.
Describe where the data study, identifiers, and key will be stored, and state the retention period:
Page 20 of 29

1.
Participants will be assigned an 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 on a secure
network drive at Public Health Management Corporation accessible only by key study staff.
2.
Participant enrollment spreadsheet containing identifying information will be sent to WTV via encrypted email
and in a password protected spreadsheet. This file will not be connected to study data.
3.
Electronic obtained consent forms will be stored in a separate restricted folder located on a secure network drive
at Public Health Management Corporation accessible only by key study staff.
4.
Identifying data (e.g., informed consent forms), screening data, and survey data will be kept for a period of five
years after the end of the pilot study as required by NIH/NIDA and then deleted. The information will enable us
to ensure pilot study participants do not enroll in a future full research trial.
5.
Contact information will be deleted one year after the end of the pilot study.
☒Identifiers will be removed or destroyed.
Describe how identifiable data will be de-identified or destroyed. Include information on how, when, and by whom
(by role or position, not by name):
5 years after study completion, all identifying information will be destroyed by PHMC staff.
☐Identifiers will not be removed or destroyed.
Provide the rationale for retaining identifiable data and state the retention period. Include information on how and
where the identifiable information will be stored:
9
RISKS AND BENEFITS
9.1 Select all of the reasonably foreseeable risks of harm, discomforts, and hazards to the
participants and others as a result of study participation.
☒Breach of confidentiality to records containing identifiable private information or biospecimens
☐Disclosure of participants’ responses outside of the research context could place the subjects at risk of criminal or
civil liability
☐Disclosure of the participants’ responses outside of the research context could be damaging to the participants’
financial standing, employability, insurability, education, reputation, social relationships, services, or eligibility services
☒Psychological discomfort or distress from providing or being exposed to personal or sensitive information
☒Possibility of or perceived invasion of privacy to the participant or their family
☒Possibility of or perceived coercion or undue influence to participate in the study (in Aim 2)
☐Presentation of materials which some participants may consider sensitive, offensive, or threatening
☐Physical or psychological harm such as pain, injury, or disease including side effects from drugs and devices
☒Other (please specify):   Disappointment with the randomly assigned training program.   
☐No risks
9.2 For each risk selected above, describe the magnitude, probability, duration, and/or
reversibility of the harm, discomfort, or hazard.
This study poses minimal risks to participants. Any individuals experiencing significant psychological distress or perceived
invasion of privacy from audiotaping are free to refuse to participate or to withdraw from the study. For other
participants, if the risks outlined above do occur, we anticipate the magnitude to be low because of the protections we
have put in place to protect identity, privacy and confidentiality of participants. The possibility of perceived or undue
Page 21 of 29

influence to participate in the study is likely to be low due to the precautions we have put in place to mitigate this risk.
All of these potential harms are transitory or reversible.
9.3 For each risk selected above, describe how you will manage or minimize the risk.
1.
Risk Resulting from a 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. We have developed strict protocols for collecting, securing,
storing, and transmitting data. All study staff must complete a Human Subjects training protocol.
All research specific materials will be coded with a research number to de-identify the data and will contain no other
identifying information to protect participant confidentiality. Participants will be assigned an 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. In addition, linkage between participant identity and online user name
will be stored in a password protected electronic file. PHMC computer spreadsheets containing data and SPSS data
sets will be saved in password protected files on a secure server located at Public Health Management Corporation
and accessible only to designated research staff. WTV computer spreadsheets containing data will be saved in a
restricted project folder on a secure Google drive. All research instruments will be computerized for this study, and
the data will be entered via the Web using Alchemer platform. R&E Group maintains a Business Associate Agreement
with Alchemer, allowing staff to securely collect private and confidential information in compliance with the Health
Insurance Portability and Accountability Act (HIPAA), Family Educational Rights and Privacy Act (FERPA), and other
applicable data security and protection laws.
2.
Risk Resulting from Discomfort or Distress Completing Research Measures and Procedures – Before giving consent,
participants will be informed of potential discomforts from completing research activities.
a.
Discomfort associated with being audiotaped during the focus group, individual interviews, or mock or actual
sessions. We will help participants to understand that feeling uncomfortable when being audiotaped is usually
transitory. For participants submitting audiotapes of mock or actual client sessions, we will clarify that our goal is
to evaluate the training programs, not their abilities per se. If participants experience significant distress such
that it makes participation uncomfortable for them, they will be reminded that they can leave the study at any
time.
b.
Discomfort associated with the training intervention (Aim 2 only) - The level of distress associated with training
interventions is expected to be similar to that which they would experience during any training program and is
not a function of the research participation per se. Nonetheless, participants will be informed about this possible
risk before consenting and will be told that they can withdraw from the study at any time without penalty. If
participants in the TMC condition are experiencing difficulty, discomfort, or distress associated with locating
CSOs for actual client sessions, we will help facilitate a client match for them from our We The Village community
of family members with a loved one struggling with OUD. If they are experiencing discomfort due to concerns
about protecting client confidentiality for those clients participating in videotaped sessions, we will discuss with
them steps to ensure client consent and to protect client confidentiality.
3.
Disappointment associated with the training intervention (Aim 2 only) – It is possible that counselors will be
disappointed with the training condition to which they are randomly assigned. Counselors assigned to the T and TM
conditions may be disappointed that they did not receive a more intensive training opportunity that would allow
them to become certified as CRAFT counselors. Should these individuals wish to pursue CRAFT certification through
We The Village after their research participation has ended they will not be charged for the components they have
already received and can complete certification at a reduced cost Counselors who are randomly assigned to the
TMC training program may be disappointed that they did not receive a less intensive training program. These
individuals, like all study participants, are free to withdraw from the study at any time.
4.
Risk Resulting from Possible or Perceived Invasion of Privacy - Participants are at risk for harm as a result of being
identified as a study participant. Participants will be informed of this risk during the consent process. Participants will
receive instruction on how to protect their identity by creating strong passwords, completing training and research
activities when they have enough time and privacy to participate, and using unique usernames when participating in
online study activities. The likelihood of this occurring is small.
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a.
All project staff will be required to undergo training in confidentiality procedures), which reviews data handling
procedures as well as addressing questions about participants posed by individuals outside of the immediate
project staff and by project staff members who do not need the information requested. Certification of
successful completion of this training is kept in the appropriate project binder. Should any breaches of
participant confidentiality occur during the course of the study, they will be reported to the relevant IRB and
DSMB.
Aim 2 only:
b.
Efforts to contact participants for the 12-week post enrollment follow-up assessment will make no mention of
the study until it is established that the participant has been reached. Access to participants’ contact information
will be limited only to research staff members who need to contact a participant for study purposes. Any
information on paper documents containing participant identifiers will be kept in a locked filing cabinet separate
from the data. Research staff affiliated with this project will destroy all identifying information 5 years after the
study has been completed.
c.
Data collected as part of the online training procedures will also be kept confidential. Participants will be
instructed to create a username that does not use their last name. Participants can request for their user names
to be changed at any time during the study. Participants will be instructed to make sure that they are in a private
area before revealing any personal information during an online session or, if applicable, during a video or
telephone meeting with a CRAFT trainer. They will also be asked to consider using private telephones (no
extension lines) when possible. For those participating via Zoom, Zoom ensures information is not stored in their
network; the data is only transmitted during a session. WTV will pay to use a HIPAA protected Zoom account to
reduce risks associated with confidentiality and privacy. Participants will receive a secure link to access sessions,
so no one other than the intended counselor and staff can attend. Participants who elect to receive text
messages or emails will be instructed to use a password to access telephone/email content and to delete
messages immediately after responding to them. Audio recorded sessions will be recorded by our trained
standardized patient (SP) or participants who have been assigned to receive coaching (Program 3). Both will be
trained to upload the audiotape immediately to a secure system, which is no different than if they were to seek
certification outside of the study. Once uploaded it will be deleted from the recording device.
5.
Risk Resulting from Perceived Pressure to Participate by Employers – It is possible that some participants (e.g.,
counselors) could learn of the focus groups or the training pilot study from their employers and feel pressure to
participate or to answer questions or give feedback in a particular way. To protect against this risk:
a.
All employers who are approached to assist with recruitment will be informed of the necessity that research
participation is voluntary. They will be told that they cannot require counselors to participate and cannot
administer consequences to counselors who do not participate. They will be told that counselors must meet
eligibility criteria to participate, so the fact that a counselor does not participate does not mean that they
refused to do so. Should an employer inquire about the reasons a counselor did not participate, they will be told
the person was not eligible (voluntary participation is an eligibility criterion) and reminded that they should not
pressure employees to participate.
b.
All participants will be assured that their participation is voluntary and that we will not provide any information
about their participation (i.e. whether they agreed to participate or their responses) to any outside parties.
Counselors will not participate in the same focus groups as their supervisors or administrators at their place of
employment.
For protocols that meet the criteria for exempt research, skip to Section 10.
9.4 Are there any risks to individuals related to pregnancy, fertility, lactation, or effects on a fetus
or neonate? If yes, describe how you will manage or reduce this risk.
Some studies will require unique considerations if a participant becomes pregnant during the study (e.g.,
discontinuation of a diet-based intervention or medications).
Page 23 of 29

No. We are conducting a behavioral online intervention that poses no risks to participants who are pregnant or who
become pregnant during the study.
9.5 Describe whether participants who become pregnant will be able to continue their
participation in the study. If they will continue to be included in the study, describe any measures
to accommodate the pregnancy, if applicable.
Yes. Participants who become pregnant during the study will be able to continue. The proposed study is a behavioral
health training intervention and is conducted online. We do not expect pregnant participants to require additional
accommodations, because they can participate via a smartphone or computer at any location.
9.6 Describe the potential direct benefits to individual participants or to others as a result of
study participation. Indicate if there may not be any direct benefits to participants or to others.
Aim 1 - Qualitative Review: Some professionals enjoy providing feedback and sharing their experience to improve future
programs; however, we anticipate no direct personal benefit to participants beyond this.
Aim 2 - Training Intervention: All counselor participants receive training free of charge, which they may perceive as a
benefit. It is possible that the training will increase their effectiveness as counselors or allow them to work with new
populations (e.g., CSOs), which they may perceive as benefits. However, we anticipate no direct benefit to counselors
beyond this.
9.7 Define reportable and non-reportable Adverse Events (AEs).
Reportable AEs:
Will be defined as: significant discomfort from answering research questions or participating in the focus group,
individual interview, or training intervention such that the participant decides to stop their participation or reports new
diagnoses of depression, anxiety, or panic attacks. We will also report coercion or perceived coercion to participate in the
study as an AE.
Non-reportable AEs:
Clinically insignificant events are not considered AEs. 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 or accidents. As per the definition of AEs, only significant worsening of problems or new problems
will be reported as AEs. We will monitor attrition rates, but drop out from the study will not be reported as an AE.
Reportable SAEs: will be defined as death; a life-threatening event such as suicidal attempt, or inpatient hospitalization
(including psychiatric hospitalizations) due to suicidal behavior, or psychiatric distress; or substance use overdose; or an
event that extends an existing hospitalization as defined above.
9.8 Define reportable Serious Adverse Events (SAEs). Choose one or both as applicable to your
study.
☒Any adverse event that:
1.
Results in death;
2.
Is life-threatening (places the subject at immediate risk of death from the event as it occurred);
3.
Results in inpatient hospitalization or prolongation of existing hospitalization;
4.
Results in a persistent or significant disability/incapacity;
5.
Results in a congenital anomaly/birth defect; or
Page 24 of 29

6.
Based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or
surgical intervention to prevent one of the other outcomes listed above.
(OHRP Guidance on Unanticipated Problems and Adverse Events; January 15, 2007)
☐Other, or in addition to the above (please describe):
9.9 Describe plans to identify, monitor, manage, and report AEs and SAEs. Include information on
the method and frequency of collecting AE and SAE information (e.g., weekly through telephone
calls, monthly at study visits, every time the subject comes to the clinical setting), the individuals
responsible for collecting this information (e.g., research assistants, case managers, counselors),
and the start and end of collection (e.g., from the participant’s first exposure to the intervention
to their last study visit).
All WTV and PHMC staff who interact with participants will be trained on the definitions of reportable and
non-reportable AEs and SAEs and the way to complete the forms reporting them. The PI and Dr. Kimberly Kirby meet
regularly with CRAFT trainers to track and to document any AEs and SAEs. The WTV clinical team will be interacting with
participants in the CRAFT interventions on a regular basis and will be responsible for collecting AE and SAE information
shared during their interactions and reporting them to the PHMC team. In addition, the Research Coordinator will
document information related to AEs and SAEs shared when contacting participants.
All adverse and serious adverse events occurring during the study are documented on a form, reviewed and signed by
the PI, Jane Macky or Dr. Kirby, and reported to the IRB. All SAEs are reported to the IRB within 48 hours of our
awareness of the event (24 hours for fatal events). A summary of all SAEs and AEs that occurred during six-month pilot
study will be included in any progress reports to the IRB. We will begin to collect AE and SAE information between the
first intervention session and their 12-week post enrollment assessment.
9.10 Will you submit or have you submitted the protocol for additional oversight by a Data and
Safety Monitoring Board (DSMB)?
☒Yes:
☒The protocol will be submitted to PHMC’s DSMB.
☐The protocol will be submitted to an external DSMB.
☐An external DSMB or monitoring committee has reviewed the study. All reports are attached.
☐No, a DSMB is not needed for this study
10 REFERENCES
Bibliography and References Cited
1.
Roozen HG, de Waart R & van der Kroft P. (2010). Community reinforcement and family training: an effective
option to engage treatment-resistant substance-abusing individuals in treatment. Addiction, 105, 1729-38.
https://doi.org/10.1111/j.1360-0443.2010.03016.x, 10.1111/j.1360-0443.2010.03016.x
2.
Brigham, G. S., Slesnick, N., Winhusen, T. M., Lewis, D. F., Guo, X., & Somoza, E. (2014). A randomized pilot clinical
trial to evaluate the efficacy of Community Reinforcement and Family Training for Treatment Retention (CRAFT-T)
for improving outcomes for patients completing opioid detoxification. Drug and alcohol dependence, 138,
240–243. https://doi.org/10.1016/j.drugalcdep.2014.02.013
3.
Bischof G, Iwen J, Freyer-Adam J, Rumpf HJ. Efficacy of the Community Reinforcement and Family Training for
concerned significant others of treatment-refusing individuals with alcohol dependence: A randomized
Page 25 of 29

controlled trial. Drug Alcohol Depend. 2016 Jun 1;163:179-85. doi: 10.1016/j.drugalcdep.2016.04.015. Epub
2016 Apr 19. PMID: 27141840.
4.
Ray, G. T., Mertens, J. R., & Weisner, C. (2007). The excess medical cost and health problems of family members
of persons diagnosed with alcohol or drug problems. Medical care, 45(2), 116–122.
https://doi.org/10.1097/01.mlr.0000241109.55054.04
5.
https://www.drugabuse.gov/publications/research-reports/medications-to-treat-opioid-addiction/overview
6.
Carroll, K. M., & Rounsaville, B. J. (2007). A vision of the next generation of behavioral therapies research in the
addictions. Addiction (Abingdon, England), 102(6), 850–869. https://doi.org/10.1111/j.1360-0443.2007.01798.x
7.
Miller, W. R., Yahne, C. E., Moyers, T. B., Martinez, J., & Pirritano, M. (2004). A randomized trial of methods to
help clinicians learn motivational interviewing. Journal of consulting and clinical psychology, 72(6), 1050–1062.
https://doi.org/10.1037/0022-006X.72.6.1050
8.
Rubel, E. C., Sobell, L. C., & Miller, W. R. (2000). Do continuing education workshops improve participants' skills?
Effects of a motivational interviewing workshop on substance-abuse counselors' skills and knowledge. The
Behavior Therapist, 23(4), 73-77.
9.
VandeCreek, L., & Brace, K. (1991). Mandatory continuing education in the health professions. Journal of Training
& Practice in Professional Psychology, 5(1), 23–36.
10. Sholomskas et al., 2005 - Sholomskas DE & Carroll KM (2006). One small step for manuals: Computer-assisted
training in twelve-step facilitation. Journal of Studies on Alcohol, 67, 939-45
11. Kirby, K. C., Marlowe, D. B., Festinger, D. S., Garvey, K. A., & LaMonaca, V. (1999). Community reinforcement
training for family and significant others of drug abusers: A unilateral intervention to increase treatment entry of
drug users. Drug and Alcohol Dependence, 56(1), 85-96.
12. Kirby, K.C., Benishek, L.A., Kerwin, M.E., Dugosh, K.L., Carpenedo, C.M., Bresani, E., Haugh, J.A., Washio, Y., &
Meyers, R.J. (2017). Analyzing Components of Community Reinforcement and Family Training (CRAFT): Is
Treatment Entry Training Sufficient? Psychology of Addictive Behaviors, 31(7), 818-827.
http://dx.doi.org/10.1037/adb0000306
13. Manuel, J. K., Austin, J. L., Miller, W. R., McCrady, B. S., Tonigan, J. S., Meyers, R. J., Smith, J. E., & Bogenschutz, M.
P. (2012). Community Reinforcement and Family Training: a pilot comparison of group and self-directed delivery.
Journal of substance abuse treatment, 43(1), 129–136. https://doi.org/10.1016/j.jsat.2011.10.020
14. Meyers, R. J., Miller, W. R., Smith, J. E., & Tonigan, J. (2002). A randomized trial of two methods for engaging
treatment-refusing drug users through concerned significant others. Journal of Consulting and Clinical
Psychology, 70(5), 1182-1185.
15. Miller, W. R., Meyers, R. J., & Tonigan, J. (1999). Engaging the unmotivated in treatment for alcohol problems: A
comparison of three strategies for intervention through family members. Journal of Consulting and Clinical
Psychology, 67(5), 688-697
16. Sisson, R. W., & Azrin, N. H. (1986). Family-member involvement to initiate and promote treatment of problem
drinkers. Journal of Behavior Therapy & Experimental Psychiatry, 17(1), 15-21.
17. ONDCP, 2004: https://www.ncjrs.gov/pdffiles1/ondcp/203722.pdf
18. The U.S. Bureau of Labor Statistics:
https://www.bls.gov/ooh/community-and-social-service/substance-abuse-behavioral-disorder-and-mental-healt
h-counselors.htm#:~:text=in%20May%202019.-,Job%20Outlook,addiction%20and%20mental%20health%20coun
seling.
19. https://www.whitehouse.gov/wp-content/uploads/2020/02/FY-2021-National-Drug-Control-Budget-Highlights.p
df
20. https://www.bls.gov/ooh/community-and-social-service/social-workers.htm
21. https://www.cdc.gov/drugoverdose/epidemic/index.html
22. https://www.drugabuse.gov/publications/principles-drug-addiction-treatment-research-based-guide-third-editio
n/frequently-asked-questions/drug-addiction-treatment-worth-its-cost
23. Hartzler, B., & Rabun, C. (2014). Training addiction professionals in empirically supported treatments:
perspectives from the treatment community. Substance abuse, 35(1), 30–36.
https://doi.org/10.1080/08897077.2013.789816
Page 26 of 29

24. Archer, M., Harwood, H., Stevelink, S., Rafferty, L., & Greenberg, N. (2020). Community reinforcement and family
training and rates of treatment entry: a systematic review. Addiction (Abingdon, England), 115(6), 1024–1037.
https://doi.org/10.1111/add.14901
25. Abbott, P. J., Weller, S. B., Delaney, H. D., & Moore, B. A. (1998). Community reinforcement approach in the
treatment of opiate addicts. American Journal of Drug and Alcohol Abuse, 24(1), 17-30.
26. Kirby, K.C., Versek, B., Kerwin, M.E., Meyers, K., Benishek, L.A., Bresani, E., Washio, Y., Arria, A.M., & Meyers, R.J.
(2015). Developing Community Reinforcement and Family Training (CRAFT) for parents of treatment-resistant
adolescents. Journal of Child and Adolescent Substance Abuse, 24(3), 155-165.
27. Meyers, R. J., Miller, W. R., Hill, D. E., & Tonigan, J. S. (1998). Community reinforcement and family training
(CRAFT): Engaging unmotivated drug users in treatment. Journal of Substance Abuse, 10(3), 291-308.
28. Macky J, Kirby KC, Fitzpatrick, B, Bearnot, B, Handley, C (in preparation). Scalable digital delivery of
evidence-based training for family to maximize treatment admission rates of opioid use disorder in loved ones.
29. Hall K, Staiger PK, Simpson A, Best D, Lubman DI. After 30 years of dissemination, have we achieved sustained
practice change in motivational interviewing?. Addiction. 2016;111(7):1144-1150. doi:10.1111/add.13014
30. Carroll, K. M., Nich, C., & Rounsaville, B. J. (1998b). Utility of therapist session checklists to monitor delivery of
coping skills treatment for cocaine abusers. Psychotherapy Research, 8(3), 307-320.
31. Miller WR, Sorenson JL, Selzer JA & Brigham GS. (2006). Disseminating evidence-based practices in substance
abuse treatment: A review with suggestions, Journal of Substance Abuse Treatment, 31, 25– 39
32. Smith JE & Meyers RJ (2007). Community Reinforcement Approach and Family Training (CRAFT) Therapist Coding
Manual. Bloomington. IL: Lighthouse Institute.
33. Thew, G. R., Powell, C. L., Kwok, A. P., Lissillour Chan, M. H., Wild, J., Warnock-Parkes, E., Leung, P. W., & Clark, D.
M. (2019). Internet-Based Cognitive Therapy for Social Anxiety Disorder in Hong Kong: Therapist Training and
Dissemination Case Series. JMIR formative research, 3(2), e13446. https://doi.org/10.2196/13446
34. Kobak, K. A., Craske, M. G., Rose, R. D., & Wolitsky-Taylor, K. (2013). Web-based therapist training on cognitive
behavior therapy for anxiety disorders: a pilot study. Psychotherapy (Chicago, Ill.), 50(2), 235–247.
https://doi.org/10.1037/a0030568
35. Kobak, K. A., Wolitzky-Taylor, K., Craske, M. G., & Rose, R. D. (2017). Therapist Training on Cognitive Behavior
Therapy for Anxiety Disorders Using Internet-Based Technologies. Cognitive therapy and research, 41(2),
252–265. https://doi.org/10.1007/s10608-016-9819-4
36. O'Connor, M., Morgan, K. E., Bailey-Straebler, S., Fairburn, C. G., & Cooper, Z. (2018). Increasing the Availability of
Psychological Treatments: A Multinational Study of a Scalable Method for Training Therapists. Journal of medical
Internet research, 20(6), e10386. https://doi.org/10.2196/10386
37. Worrall, J. M., & Fruzzetti, A. E. (2009). Improving peer supervisor ratings of therapist performance in dialectical
behavior therapy: An Internet-based training system. Psychotherapy (Chicago, Ill.), 46(4), 476–479.
https://doi.org/10.1037/a0017948
38. Beidas RS & Kendall PC. (2010). Training Therapists in Evidence-Based Practice: A Critical Review of Studies From
a Systems-Contextual Perspective. Clinical Psychology-Science & Practice, 17, 1-30.
https://doi.org/10.1111/j.1468-2850.2009.01187.
39. Chu, B. C., Carpenter, A. L., Wyszynski, C. M., Conklin, P. H., & Comer, J. S. (2017). Scalable Options for Extended
Skill Building Following Didactic Training in Cognitive-Behavioral Therapy for Anxious Youth: A Pilot Randomized
Trial. Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and
Adolescent Psychology, American Psychological Association, Division 53, 46(3), 401–410.
https://doi.org/10.1080/15374416.2015.1038825
40. Kanter, J. W., Tsai, M., Holman, G., & Koerner, K. (2013). Preliminary data from a randomized pilot study of
web-based functional analytic psychotherapy therapist training. Psychotherapy (Chicago, Ill.), 50(2), 248–255.
https://doi.org/10.1037/a0029814
41. Smith JL, Carpenter KM, Amrhein PC, Brooks AC, Levin D, Schreiber EA, et al. (2012). Training substance abuse
clinicians in motivational interviewing using live supervision via teleconferencing. Journal of Consulting & Clinical
Psychology, 80, 450-64. https://doi.org/10.1037/a0028176, 10.1037/a0028176
42. Smith, J. E., Meyers, R. J., & Delaney, H. D. (1998). The community reinforcement approach with homeless
alcohol-dependent individuals. Journal of Consulting and Clinical Psychology, 66(3), 541-548.
Page 27 of 29

43. Andrzejewski, M. E., Kirby, K. C., Morral, A. R., Iguchi, M. Y. (2001) Technology transfer through performance
management: the effects of graphical feedback and positive reinforcement on drug treatment counselors’
behavior. Drug And Alcohol Dependence, 63(2), 179-186.
44. Benishek, L.A., Kirby, K.C., Dugosh, K.L. & Padavano, A. (2010). Beliefs about the empirical support of drug abuse
treatment interventions: A survey of outpatient treatment providers. Drug and Alcohol Dependence, 107,
202-208.
45. Kirby, K.C., Carpenedo, C.M., Stitzer, M.L., Dugosh, K.L., Petry, N.M., Roll, J.M., Saladin, M.E., Cohen, A.J.,
Hamilton, J., Reese, K., Silo, G.R., Stabile, P.Q., & Sterling, R.C. (2012). Is Exposure to an Effective Contingency
Management Intervention Associated with More Positive Provider Beliefs? Journal of Substance Abuse
Treatment, 42(4), 356-365. NIHMS ID:340520
46. Kirby, K. C., Stahler, G., Williams, M., Rosenwasser, B., Sapadin, K., Simons, L., et al. (2001). Developing a
community of reinforcement through African-American churches. Drug and Alcohol Dependence, 63(Supplement
1), S81.
47. Kirby, K.C., Kerwin, M.E., Benishek, L.A., Padovano, A., Corbin, R., & Stahler, G.J. (2008). CREST: A faith-based
intervention for cocaine dependent African American women. In Raghavan, C., Edwards, A.E., & Vaz, K.M.,
Benefitting by Design: Women of Color in Feminist Psychological Research. Newcastle, Tyne and Wear, UK:
Cambridge Scholars Publishing.
48. Kirby, K. C., Kerwin, M. E., Carpenedo, C. M., Rosenwasser, B. J., & Gardner, R. S. (2008). Interdependent group
contingency management for cocaine-dependent methadone maintenance patients. Journal of Applied Behavior
Analysis, 41, 579-595.
49. Brooks, A.C., DiGuiseppi, G., Laudet, A., Rosenwasser, B., Knoblach, D., Carpenedo, C.M., Carise, D., Kirby, K.C.
(2012). Developing an evidence-based, multimedia group counseling curriculum toolkit. Journal of Substance
Abuse Treatment, 43, 178-189.
50. Brooks AC, Carpenedo CM, Fairfax-Columbo J, Clements NT, Benishek LA, Knoblach D, Carise D, Kirby KC. (2013).
The RoadMAP Relapse Prevention Group Counseling ToolkitTM: counselor adherence and competence
outcomes. Journal of Substance Abuse Treatment, 45, 356-62.
51. Brooks, A.C., Chambers, J.E., Lauby, J., Byrne, E., Carpenedo, C.M., Benishek, L.A., Medvin, R., Metzger, D.S., &
Kirby, K.C. (2016). Implementation of a Brief Treatment Counseling Toolkit in Federally Qualified Healthcare
Centers: Patient and Clinician Utilization and Satisfaction. Journal of Substance Abuse Treatment, 60, 70-80.
52. Chambers, J.E., Brooks, A.C., Medvin, R., Metzger, D.S., Lauby, J., Carpenedo, C.M., Favor, K.E., Kirby, K.C. (2016).
Examining multi-session brief intervention for substance use in primary care: research methods of a randomized
controlled trial. Addiction Science & Clinical Practice, 11(1), 8. PMCID: PMC4835884
53. Kirby, K.C., Kerwin, M.Eenishek, L.A., Padovano, A., Corbin, R., & Stahler, G.J. (2008). CREST: A faith-based
intervention for cocaine dependent African American women. In Raghavan, C., Edwards, A.E., & Vaz, K.M.,
Benefitting by Design: Women of Color in Feminist Psychological Research. Newcastle, Tyne and Wear, UK:
Cambridge Scholars Publishing.
54. https://digest.bps.org.uk/2018/05/04/learning-by-teaching-others-is-extremely-effective-a-new-study-tested-a-k
ey-reason-why/#:~:text=The%20learning%2Dby%2Dteaching%20effect,the%20same%20time%20re%2Dstudying
55. Zentgraf, K., Zaslav, D., Bresani, E., & Kirby, K.C. (2015). Developing home-based continuing care: Exploring
feasibility and acceptance with parents and young adults. Washington DC: The Addictions Newsletter, Summer,
20-22.
56. Rounsaville, B. J., Carroll, K. M., & Onken, L. S. (2001). A stage model of behavioral therapies research: Getting
started and moving on from stage I. Clinical Psychology: Science and Practice, 8(2), 133-142.
57. Comer, J. S., & Barlow, D. H. (2014). The occasional case against broad dissemination and implementation:
retaining a role for specialty care in the delivery of psychological treatments. The American psychologist, 69(1),
1–18. https://doi.org/10.1037/a0033582
58. McHugh, R. K., & Barlow, D. H. (2010). The dissemination and implementation of evidence-based psychological
treatments. A review of current efforts. The American psychologist, 65(2), 73–84.
https://doi.org/10.1037/a0018121
Page 28 of 29

59. Gillespie, M. L., Huey, S. J., Cunningham, P. B. (2017). Predictive validity of an observer-rated adherence protocol
for multisystemic therapy with juvenile drug offenders. Journal of Substance Abuse Treatment, 76, 1-10.
https://dx.doi.org/10.1016/j.jsat.2017.01.001
60. Hogue, A., Henderson, C. E., Dauber, S., Barajas, P. C., Fried, A., Liddle, H. A. (2008). Treatment adherence,
competence, and outcome in individual and family therapy for adolescent behavior problems. Journal of
Consulting & Clinical Psychology, 76, 544-55. https://dx.doi.org/10.1037/0022-006X.76.4.544
61. Cohen, J (1988) Statistical Power Analysis for the Behavioral Sciences (2nd ed), Hillsdale: Lawrence Erlbaum.
62. Festinger, D. S., Marlowe, D. B., Dugosh, K. L., Croft, J. R., & Arabia, P. L. (2008). Higher magnitude cash payments
improve research follow-up rates without increasing drug use or perceived coercion. Drug and alcohol
dependence, 96(1-2), 128–135. https://doi.org/10.1016/j.drugalcdep.2008.02.007
63. Kirby KC, Meyers KM, Bresani E, Meyers RJ, Benishek LB, Dugosh K (in preparation). Randomized controlled trial
of Community Reinforcement and Family Training (CRAFT) for parents of treatment-resistant youth
64. https://www.zippia.com/substance-abuse-counselor-jobs/demographics/
Page 29 of 29