Effectiveness of an Online Parenting Training
Phase: NA
Conditions: Behavior Problem, Behavior, Child, Parents, Parent-Child Relations
Sponsor: University of Minnesota

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ANCILLARY REVIEWS 
DO NOT DELETE.  Submit the completed checklist below with your protocol. 
Which ancillary reviews do I need and when do I need them? 
Select yes or 
no 
Does your study… 
If yes… 
Impact on 
IRB Review 
☐ Yes 
X No 
 
Include Gillette resources, 
staff or locations 
Gillette Scientific review and Gillette 
Research Administration approval is 
required.  Contact: 
research@gillettechildrens.com   
Required 
prior to IRB 
submission 
☐ Yes 
X No 
Involve Epic, or Fairview 
patients, staff, locations, or 
resources? 
The Fairview ancillary review will be 
assigned to your study by IRB staff 
Contact: ancillaryreview@Fairview.org 
Approval 
must be 
received 
prior to IRB 
committee
/ 
designated 
review.   
 
Consider 
seeking 
approval 
prior to IRB 
submission
. 
☐ Yes 
X No 
Include evaluation of drugs, 
devices, biologics, tobacco, or 
dietary supplements or data 
subject to FDA inspection? 
STOP – Complete the Medical 
Template Protocol (HRP-590) 
 
The regulatory ancillary review will be 
assigned to your study by IRB staff 
Contact: medreg@umn.edu  
See 
https://policy.umn.edu/research/indid
e  
☐ Yes 
X   No 
Require Scientific Review? Not 
sure? See guidance in the 
Investigator Manual (HRP-
103).      
 
ONLY REQUIRED      BIOMEDICAL 
RESEARCH REVIEWED BY FULL 
COMMITTEE 
  
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radiopharmaceuticals, external 
beam or brachytherapy) 
 
Complete the AURPC Human Use 
Application and follow instructions on 
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Approval 
from these 
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s must be 
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☐ Yes 
X No 
Use the Center for Magnetic 
Resonance Research (CMRR) 
as a study location? 
Complete the CMRR pre-IRB ancillary 
review  
Contact: ande2445@umn.edu  
prior to IRB 
approval;  
 
These 
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infectious agents? 
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Include the use of human fetal 
tissue, human embryos, or 
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Include PHI or are you 
requesting a HIPAA waiver? 
If yes, HIPCO will conduct a review of this 
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The Information Exchange ancillary 
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Contact: ics@umn.edu  
Approval 
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These 
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additional 
informatio
n from the 
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may be 
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STOP – Complete the Medical 
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The BLS ancillary review will be 
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Contact: Jenny Pham 
Pham0435@umn.edu 
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interest? 
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Protocol Title 
A pilot test of a brief eHealth parent-focused prevention 
intervention with parents referred from primary care clinics - Aim 2 
Principal 
Investigator/Faculty 
Advisor 
Name: Chris Mehus 
Department: Center for Applied Research and Educational 
Improvement 
Telephone Number: 651.785.3660 
Email Address: CJMehus@umn.edu 
Student Investigator 
Name: 
Current Academic Status (Student, Fellow, Resident): 
  
Department: 
Telephone Number: 
Institutional Email Address: 
Scientific Assessment 
Choose an item. 
Version 
Number/Date: 
Version 1, September 29 2021 
 
 
 

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REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ABBREVIATIONS/DEFINITIONS 

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● PC personnel: Pediatric-serving primary care personnel, i.e. pediatric and family med 
physicians, nurses, medical assistants 
● GenPMTO: GenerationPMTO, formerly Parent Management Training - Oregon Model; an 
evidence-based prevention program 
● Therapist: Licensed mental health professional trained in this study to provide GenPMTO, 
e.g., Marriage and Family Therapist, Psychologist  
● FQHC: Federally Qualified Health Center; provide care regardless of one’s ability to pay 
● Parent: Term used for convenience but inclusive of any primary caregiver 
 
 

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1.0 
Objectives 
1.1 Purpose:  
The primary objective of this study phase is to test a brief training for PC personnel and 
a referral process to equip them to effectively refer parents to a brief eHealth parent intervention 
thereby increasing access to needed services through effective engagement in a trusted setting.  
We will evaluate the referral process and conduct a pilot test of the PC personnel training 
within  FQHC clinics. PC personnel (n=35) within two FQHC primary care clinics will be 
randomly assigned to receive communication skills training or a control condition. Control group 
personnel will receive a written description of  the referral process but no training. Aim a: Using a 
sequential mixed-methods approach with PC personnel, we will evaluate the acceptability and 
appropriateness of the referral process and the training. Aim b: We will pilot test the effectiveness 
of the training to  increase PC personnel’s communication skills. We will also use EHR data to 
pilot test the effect of the training on parent engagement in GenPMTO by comparing the referral 
rates among patients who had an appointment with personnel in the training arm to those seeing 
control personnel.  
[Note that a second arm of this study will examine the effectiveness of the brief, eHealth 
version of GenPMTO among the referred parents; this study is presented in a separate IRB 
protocol] 
2.0 
Background 
2.1 Significance of Research Question/Purpose:  
Nearly all effective prevention programs for young children target parenting behaviors as 
the mechanism of change and they have been shown to prevent behavioral health issues such 
as depression, anxiety, and conduct disorder.1-7 Unfortunately, these programs have extremely 
limited reach within the population; the programs are not widely available nor well-attended.8 
Pediatric primary care (PC) is a non-stigmatizing setting with nearly universal reach and, 
therefore, an ideal access point to increase availability.9 However, PC personnel are not trained 
to address behavioral health topics.10 Also, typical referral practices are inadequate.11  
To impact behavioral health at a population level, there is a significant need to develop effective 
referral practices to preventative services.12-13 The research proposed here is significant, because 
we will develop and test a strategy for increasing reach of an evidence-based parenting program 
through primary care referrals. 
 
2.2 Preliminary Data:  
Dr. Mehus conducted a survey of parents at the same downtown pediatric clinic 
partnering in this proposed study, finding that 82% of parents were interested in behavioral 
health resources and were most likely to utilize online resources.14 He evaluated a pilot of 
a novel program called Behavior Checker in two safety-net clinics, in which PC personnel 
reported that having a parenting resource on hand increased efficiency of behavioral health 
discussions.15 
 
2.3 Existing Literature:  
In a paper co-lead by Mehus (PI),9 three primary benefits of primary care settings for 
parenting programs were highlighted: First, primary care may overcome stigma associated with 
parenting programs.16,17 Second, engaging parents through primary care would affiliate the 
programs with a stable and trusted service provider.18 Third, stable and sustainable funding 

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mechanisms are available for programs delivered in or referred to from primary care. But while 
disparate funding strategies for these programs do exist,19 research to demonstrate the 
effectiveness of the programs within a primary-care population is needed to facilitate more 
widespread and stable funding under the Affordable Care Act. 
Pediatric primary care reaches underserved communities. In general, 96% of parents 
report having a usual place of healthcare,20 and ~53%-90% of children attend their three-year and 
five-year well-child visit.21 Within low-income populations, primary care clinics still reach a large 
portion of the population; rates of well-child visit attendance at three and five years old have 
been found to be similar between uninsured families, those with private insurance, and those 
with public insurance.21 Furthermore, about 95% of Minnesotachildren receive the final Measles 
Mumps and Rubella (MMR) vaccine before kindergarten,22 indicating that the vast majority of 
children have contact with primary care before starting kindergarten. 
Need for strategies for primary care to effectively engage and refer parents to 
preventative services. Research shows that typical referral practices are inadequate. First, many 
pediatric patients and families who would benefit from a referral do not receive one or do not 
follow through.11,23-27 For example, only 26-42% of preschool children with mental health 
symptoms identified in PC received referrals.28 A number of factors contribute to this, including 
lack of clear policies and ambiguous roles among referring and specialty personnel.29,30 Second, 
referral completion rates can be improved through targeted efforts, such as technology-
enhanced referral tools or training26,31-32,33-35 and dedicated personnel for referral tracking and 
follow up.32,36 Third, parent engagement in parenting programs is generally low, but can be 
improved by targeted engagement efforts.37 Fourth, PC personnel are typically not trained to 
address behavioral or parenting topics,10 which requires specific knowledge as well as particular 
communication skills to address these sensitive topics in ways that are less likely to lead to 
resistance and defensiveness. This gap in training exists despite the fact that PC personnel are 
often the first point of contact when parents have concerns about a child’s behavior.38-39 Finally, 
implementation scientists have advocated for hybrid trials in which an intervention and an 
implementation strategy are both tested,40 which may speed the delay between research 
findings and real-world dissemination. Taken together, any effort to deliver parenting programs 
within a primary care population, in a scalable and effective way, must equip primary care to 
effectively engage and refer parents. 
This research is significant because it increases reach through targeted engagement, 
testing a brief training for PC personnel and a referral process to equip them to effectively refer 
parents to a brief eHealth parent intervention thereby increasing access to needed services 
through effective engagement in a trusted setting. Successful completion of this research will 
contribute to more fully realizing the public health benefits of parenting programs, increasing the 
return on past research investments.  
 
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome:  

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The primary study outcome is referral rates.  Note that parent engagement will also be 
measured in a separate arm of the study, captured in a separate IRB protocol. 
We will also assess acceptability, feasibility, and appropriateness of the training and 
referral process to PC personnel. Note that the acceptability of the referral process among 
parents will also be measured in a separate arm of the study, captured in a separate IRB. 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s):  
The secondary outcome is PC personnel communication skills.   
 
4.0 
Study Intervention(s)/Interaction(s) 
4.1 Description:  
Participating providers will be randomly assigned to either a communication skills training 
and training in the referral process or to receive a written description of the referral process.   
Data will be collected in the form of online surveys, audio recorded responses to vignettes, 
focus groups, and referral counts.  
We will develop 5 brief vignettes to measure communication skills related to parent 
engagement (e.g., “After learning about a parent spanking their child, you decide to raise the topic 
of discipline; how do you start?”). Verbal responses will be audio-recorded directly in the online 
survey. Because the communication skills in the PC training will mirror the therapist skills in 
GenPMTO, we will adapt relevant components of the Fidelity of Implementation Rating System41 
and two coders will rate the quality of response, accounting for confronting, teaching, supporting, 
and facilitating. 
 
All PC personnel in the study (including control and training conditions) will receive a 
written summary and process map of the referral process. The referral process will be modeled on 
an Institute for Healthcare Improvement (IHI) report, which documents a 9-step process for 
“closing the loop” on referrals. The referral process, in short, is that the medical care provider will 
make a referral using a designated form, the therapist will confirm receipt and take over 
responsibility for communication with the family, and the therapist will communicate with PC 
personnel at specified intervals with specified follow-up steps. PC personnel in both arms of the 
study will be informed of the referral process because a specified referral process constitutes a 
minimal implementation step, which should reasonably accompany a new resource; this will allow 
us to examine the effectiveness of communication skills training (which is also recommended in 
the IHI report) over and above the referral process.  
The training will focus on communication skills based on key constructs in the Health 
Belief Model and motivation/resistance research. Research of the Health Belief Model42 has shown 
that perceived benefits and perceived barriers are predictive of participation in preventive services;43 
which hold for preventive parenting programs.44, 45 For example, parents may not see benefits of 
prevention programs when children are young. Perceived (and real) barriers to attending parenting 
programs also adversely impact attendance and must be addressed to engage parents.16 In addition, 
studies of parent non-compliance within interventions has shown that when parents feel confronted and 
taught, the likelihood of resistance to change increases.46 This research informs the communication skills 
therapists learn to use in GenPMTO and will be included in the PC personnel training.47 These skills involve 
conveying information in motivating and supportive ways to facilitate and empower parents to 
change.The training will focus on: (1) conveying the benefits of parenting programs, (2) knowledge 

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of and responses to common perceived barriers to attending parenting programs, and (3) skills 
and strategies to effectively motivate and refer parents in ways that are least likely to elicit 
resistance. The training will include a 30-minute online introduction and a 56-60 minute in-person 
meeting. It will include a theoretical background and experiential learning; each step of the referral 
process will be demonstrated and role-played.  
 
 
5.0 
Procedures Involved 
5.1 Study Design:  
We will use a sequential mixed-methods  approach to address the research question: Are 
the referral process and training acceptable, feasible, and  appropriate? We will randomize PC 
personnel within two FQHC clinics to receive training or to a control group in which they only 
receive the information on how to refer to therapists  who provide eHealth GenPMTO. We will 
survey the PC personnel in the training and control arms after the training and after the  pilot year. 
We will conduct focus groups with a subset of PC personnel to gain a deeper understanding of  
survey results. The mixed methods design will be sequential in structure, with the purpose of the 
qualitative  research being to explain and expand on survey results (i.e., QUAN->QUAL).48-50 We 
will use a small-scale  randomized trial to address two pilot effectiveness research questions: 
Does the PC personnel training have a  direct effect on parent engagement? Is there an indirect 
effect through the mechanism of improved  communication skills? We hypothesize that point 
estimates will indicate such effects.   
 
5.2 Study Procedures:  
A diagram of the study flow for providers is provided below.   
PC personnel will be randomized to the training group or a control group. Personnel in the 
training group will participate in surveys after the completion of PC personnel training; PC 
personnel in both training and control group will complete surveys after the year-long pilot study. 
We will recruit personnel from the training group for a focus group (or interviews if scheduling is a 
barrier), and personnel from the control group for a focus group (or interviews) after the post-pilot 
surveys are completed. In addition, we will request aggregate referral rate data from HCMC 
medical records.  For each provider, we will request the number of children ages 2-5 seen during 
the pilot year and the number of referrals made.  
 
 

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Provider data will be collected in the form of online surveys, focus groups (which will be 
recorded and transcribed), and referral source counts. Providers will complete a survey immediately 
following their training or review of written referral process and after the pilot year; each survey will take 
30 minutes.  The survey will include 5 brief vignettes to measure communication skills related to parent 
engagement (e.g., “After learning about a parent spanking their child, you decide to raise the topic of 
discipline; how do you start?”). Verbal responses will be audio-recorded directly in the online survey. 
Because the communication skills in the PC training will mirror the therapist skills in GenPMTO, we will 
adapt relevant components of the Fidelity of Implementation Rating System41 and two coders will rate the 
quality of response, accounting for confronting, teaching, supporting, and facilitating. 
 
 
Construct 
Measure 
Time administered 
Demographics 
Age, gender, race/ethnicity, discipline, years of 
experience, etc. 
Post training, post pilot 
year 
Acceptability 
Acceptability of Intervention Measure (4 items) 
Post training, post pilot 
year 
Acceptability 
Readiness to Change Assessment, patient 
preferences (4 items) 
Post training, post pilot 
year 
Appropriateness 
Intervention Appropriateness Measure (4 items)95 Post training, post pilot 

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year 
Feasibility 
Feasibility of Intervention Measure (4 items)95 
Post training, post pilot 
year 
Communication Skills 
Vignettes (5 items), coded with adapted GenPMTO 
fidelity manual 
Post training, post pilot 
year 
Declined referrals 
Whether clinician made any referrals, parent 
responses, whether and how frequently parents 
declined a referral, and reasons for declining (5 
items) 
Post pilot year 
 
Participants will also be invited to participate in a focus group, which will take 90 minutes.  The 
focus group will address the acceptability, appropriateness, and feasibility of the training and referral 
process.  
The following participant-facing data collection forms are attached: 
● Provider survey (after the training, after the pilot year) 
● Provider focus group script 
● Provider referral count form  
5.3 Follow-Up: 
NA 
 
6.0 
Data Banking 
6.1 Storage and Access:  
All data will be stored in HIPAA compliant systems, including encrypted University storage 
systems requiring dual-factor authentication and only accessible to members of the research 
team. All research team members with access to data will have human subjects research (CITI 
training) and HIPAA training. 
6.2 Data:  
Data elements to be collected are included in the table below: 
 
Construct 
Measure 
Time administered 
Surveys (providers) 
 
 
Demographics 
Age, gender, race/ethnicity, discipline, years of 
experience, etc. 
Post training, post pilot 
year 
Acceptability 
Acceptability of Intervention Measure (4 items) 
Post training, post pilot 
year 
Acceptability 
Readiness to Change Assessment, patient preferences 
Post training, post pilot 

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(4 items) 
year 
Appropriateness 
Intervention Appropriateness Measure (4 items)95 
Post training, post pilot 
year 
Feasibility 
Feasibility of Intervention Measure (4 items)95 
Post training, post pilot 
year 
Communication Skills 
Vignettes (5 items), coded with adapted GenPMTO 
fidelity manual 
Post training, post pilot 
year 
Referral counts (HCMC) 
 
 
Referral counts 
Rates of referral and total number of children ages 3-5 
seen by provider 
Post pilot year 
Focus Group (providers) 
 
 
Demographics (aggregate) 
Age, gender, race/ethnicity, discipline, years of 
experience, etc. 
Post pilot year 
Acceptability, Appropriateness, 
Feasibility 
Transcript 
Post pilot year 
 
6.3 Release/Sharing:  
Prior to release, all data will be de-identified so that it cannot be linked back to 
individuals, following IRB-approved protocols for de-identification.  All de-identified quantitative 
data will be shared with the NIMH Data Archive (NDA) following study completion.  The 
quantitative data we make available will be cleaned and coded and will be accompanied by a data 
dictionary that documents the (a) response/coding definitions, (b) missing value definitions, (3) 
any skip patterns, and (4) reference for the origin of each measure. Qualitative data will be shared 
to the extent that it is feasibly de-identified when requested by outside researchers.  
7.0 
Sharing of Results with Participants 
No individual participant results will be shared with participants or others.  
An overview of the results of the survey will be presented to focus group participants to 
solicit their reflections and further insights. 
8.0 
Study Duration 
8.1 A study timeline is provided below. 
 
 
2021 
2022 
2022 
2022 
2022 
2023 
2023 
2023 
2023 
2024 
2024 
 
Sep - 
Nov 
Dec - 
Feb 
Mar - 
May 
Jun - 
Aug 
Sep - 
Nov 
Dec - 
Feb 
Mar - 
May 
Jun - 
Aug 
Sep - 
Nov 
Dec - 
Feb 
Mar - 
May 
Recruit PC personnel in two collaborating 
clinics 
 
 
 
 
 
 
 
 
 
 
 
Deliver training to PC personnel 
randomized to the training condition 
 
 
 
 
 
 
 
 
 
 
 

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Conduct post-training survey with PC 
personnel 
 
 
 
 
 
 
 
 
 
 
 
Preliminary analysis of post-training survey 
data 
 
 
 
 
 
 
 
 
 
 
 
Year-long pilot 
 
 
 
 
 
 
 
 
 
 
 
Conduct post-pilot survey with PC 
personnel 
 
 
 
 
 
 
 
 
 
 
 
Analysis of survey data 
 
 
 
 
 
 
 
 
 
 
 
PC personnel focus groups, based on 
survey results 
 
 
 
 
 
 
 
 
 
 
 
Analysis of focus group and interview data  
 
 
 
 
 
 
 
 
 
 
Analysis of referral and engagement rates 
between training & control PC personnel 
 
 
 
 
 
 
 
 
 
 
 
 
Provider participants are anticipated to participate in the survey for about fifteen months, 
beginning with the training or written description of referral process, participation in the survey and year-
long pilot, final survey, and concluding with a focus group. We estimate it will take four months to 
recruit all providers. 
Some data analysis will be completed concurrent with study procedures, and we estimate 
an additional six months of data analysis will be required following completion of all participant 
study procedures.   
9.0 
Study Population 
9.1 Inclusion Criteria:  
Inclusion criteria for providers include being an advanced practice provider 
(Physician, Resident, or RN) currently seeing clients at Hennepin Healthcare clinics, being 
willing to participate in the research, and be willing to participate in a referral training. 
Vulnerable populations will not be targeted for inclusion, although they will be 
included if they are advanced practice providers who meet the other inclusion criteria. 
9.2 Exclusion Criteria:  
There are no known criteria that would exclude participants form the final sample. 
9.3 Screening:  
Providers interested in participating will contact the research team.  The research team 
will review the study procedures and eligibility criteria.   
10.0 Vulnerable Populations 
10.1 
Vulnerable Populations:  
 
Population / Group 
Identify whether any of the following 
populations will be targeted, included 

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(not necessarily targeted) or excluded 
from participation in the study.  
Children 
Excluded 
Pregnant women/fetuses/neonates 
Included 
Prisoners 
Excluded 
Adults lacking capacity to consent 
and/or adults with diminished capacity 
to consent, including, but not limited 
to, those with acute medical conditions, 
psychiatric disorders, neurologic 
disorders, developmental disorders, 
and behavioral disorders 
Excluded 
Non-English speakers 
Included 
Those unable to read (illiterate) 
Excluded 
Employees of the researcher 
Excluded 
Students of the researcher 
NA 
Undervalued or disenfranchised social 
group 
Included 
Active members of the military (service 
members), DoD personnel (including 
civilian employees) 
Included 
Individual or group that is approached 
for participation in research during a 
stressful situation such as emergency 
room setting, childbirth (labor), etc. 
NA 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
Included 

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Individual or group with a serious 
health condition for which there are no 
satisfactory standard treatments. 
NA 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
NA 
Any other circumstance/dynamic that 
could increase vulnerability to coercion 
or exploitation that might influence 
consent to research or decision to 
continue in research. 
NA 
 
10.2 Additional Safeguards:  
 
The purpose of this study is to test the referral process to address barriers to access in the general 
population, including groups disadvantaged in the distribution of social goods and services, who speak 
different languages, and are from disenfranchised groups.  Primary care clinics reach a large portion of the 
population, including low-income individuals, underinsured individuals, and individuals speaking multiple 
languages.   
There is a significant need to increase access to effective preventive services among families who 
would benefit12,13.  Including these populations in our study is necessary to test whether this referral 
process facilitates access. The population impact of these programs on children’s behavioral health 
is a function of the effectiveness of the programs and the number of parents/families that 
participate. This research will contribute to a growing effort to integrate these programs into 
primary care settings, which is widely accessible and non-stigmatizing. The knowledge gained 
from this study is a step toward the effective integration of evidence-based prevention programs, 
which will potentially benefit the families involved in the research and will certainly benefit 
members of their communities.  
 
The risks of this study are minimal, and the risks or discomforts should not be greater for 
vulnerable populations than for other populations. 
 
 
11.0 Number of Participants 
11.1 Number of Participants to be Consented:  
We plan to enroll 35 medical providers who work with children between three-five  years old 
at the two clinics. Half of the participants will be  randomly assigned to each study arm; n=15 of 
the 35 will be recruited for focus groups.  

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This pilot study is not meant to provide conclusive fully-powered effectiveness results. These 
analyses will be useful in guiding focus group topics, and generating effect size estimates and variance 
components to guide proceeding with an R01 application for a fully-powered randomized trial. 
 
12.0 Recruitment Methods 
12.1 Recruitment Process:  
Two partners at HCMC, Drs. Coliani and Morissette, will share information by email to 
recruit providers.    
12.2 Source of Participants: 
Providers will be drawn from Hennepin Healthcare clinics. 
12.3 Identification of Potential Participants:  
Provider participants will then self-identify in response to email contacts by Drs. Coliani 
and Morissette at HCMC. 
 
12.4 Recruitment Materials:  
Providers will be recruited by sharing a flyer by email from Drs. Colianni and Morissette.   
A copy of the “Provider recruiting and expectations” flyer is attached. 
 
12.5 Payment:  
Provider incentives for surveys and focus groups.  Providers will receive a $50 gift 
card for survey completion at each time point (after the training and after the pilot year). A subset 
of providers will receive a $100 gift card for focus group participation.  The maximum amount of 
incentives would be $200.  Gift cards will be sent electronically using tango.com within a week 
following survey completion or focus group participation.   
 
 
13.0 Withdrawal of Participants 
13.1 
Withdrawal Circumstances:  
There are no specific foreseeable events that would preclude primary care personnel from 
participating.  
13.2 
Withdrawal Procedures:  
 
If a participant chooses to withdraw, they will contact the therapist or research team, so 
the research them can remove their name from the list of participants to send a follow-up survey or 
focus group invitation.  Data that was collected prior to withdrawal will be included in the database, unless 
the participant requests for it to be deleted.   
13.3 
Termination Procedures:  

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We do not believe there is any reason the study would be terminated.  If it were 
unexpectedly suspended or terminated, the researchers would notify all participants of the 
suspension or termination, as well as a plan for participating therapists to address any 
outstanding reimbursements.  The research team would notify the IRB with the reason for the 
suspension or termination, enrollment update, and the plan for notifying participants.  Data 
collected prior to termination would be used to assess feasibility of future research. 
14.0 Risks to Participants 
14.1 Foreseeable Risks:  
The primary potential risk is a breach of confidentiality. Given the nature of this study, this 
risk is minimal. There is also a small risk of frustration, stress, or sense of added burden by study 
activities. Nevertheless, every possible precaution will be taken to protect against these risks, as 
described below.  
Informed Consent and Assent (Protection against coercive recruitment) 
All participants in data collection will be given a consent form that highlights the voluntary 
nature of data-collection activities. Providers are free to participate in the research or not, without 
ramifications on future opportunities with the University of Minnesota. The value of the gift cards 
given to participants is consistent with the PI’s previous research and is not likely to be viewed as 
or function as coercive recruitment.  
Protections Against Risks 
To protect against breach of confidentiality, any raw and digital data will be closely 
protected by the study team. Electronic data will be transferred via encrypted hard drives and 
uploaded to a secure University of Minnesota server. Data will be de-identified and a document 
linking the participant names and random ID numbers will be encrypted and stored on a separate 
secure folder only accessible by the PI and the project manager. All team members with access to 
the de-identified data will be added to the IRB approval for the study and will have completed the 
Collaborative Institutional Training Initiative (CITI) ethics training and HIPAA training required by 
the University of Minnesota. Findings from these data that are published or given to participating 
clinics will be sufficiently aggregated and de-identified so that no reader would be able to identify 
individual quotes or data.   
Participants will be told that their names will not be attached to any of their answers and 
that nobody will ever know what they say in interviews. They will be told that the sole exception to 
this is if we were to learn about child abuse or imminent danger to self or another.  
Participants in focus groups will be reminded of confidentiality and instructed that this also 
pertains to sharing about the group discussions and other participants. They will be instructed to 
not share what was discussed or who was at the group.  
Providers will be instructed that feedback about any burdens or stress caused by the 
program are welcome and, in fact, provide valuable insight into the practicality and scalability of 
the model. We will ensure they have contact information for multiple study team members to 
share any concerns. Any concerns that are raised will be discussed among the research team 
members and will be addressed on a case-by-case basis. 
Response to adverse events 
Instances of abuse, suicidality, or imminent harm may be identified, although this is unlikely. This 
study does not specifically address abuse nor are there questions that would likely illicit this 
information. All therapists trained in this study to provide GenerationPMTO are licensed mental 
health professionals and are equipped to take appropriate actions if they learn about abuse or 
neglect. They will also be given the contact information for Dr. Mehus to consult if a situation 
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14.2 Reproduction Risks: NA  
14.3 Risks to Others: NA 
15.0 Incomplete Disclosure or Deception 
15.1 Incomplete Disclosure or Deception: NA 
16.0 Potential Benefits to Participants 
16.1 Potential Benefits: 
Providers will receive a referral list that may be a useful tool in serving families of children 
with behavior challenges and reduce provider load.  Half will receive communication skills 
training that may increase their skills in communicating with and motivating parents. 
 
17.0 Statistical Considerations 
17.1 Data Analysis Plan:  
In order to measure communication skills, we will code the audiorecorded responses to vignettes.  
Because the communication skills in the PC training will mirror the therapist skills in GenPMTO, we will 
adapt relevant components of the Fidelity of Implementation Rating System41 and two coders will rate the 
quality of response, accounting for confronting, teaching, supporting, and facilitating. 
We will examine the preliminary effectiveness of the PC personnel training. We 
hypothesize that communication skills and referral rates, will both be higher in the training group 
compared to the control group. While this pilot study is not meant to provide sufficient power for 
significance testing, these hypotheses will guide our analyses. We will analyze differences 
between training and control groups on outcomes including communication skill and referral rates, 
using generalized linear multivariate regression. We will examine communication skill items 
individually and assess the psychometrics of the items as a scale and as indicators of a latent 
variable. Each outcome will be analyzed in a separate model. In the first analysis, we will only 
enter training condition as a dummy variable (i.e., t-test) to examine between group differences. In 
subsequent analyses we will include covariates to account for clinical experience and 
demographic variables. Primary covariates include discipline (i.e., family medicine or pediatrics 
department) and years of experience. We will also examine differences by clinic location and 
examine intra-class correlations. These analyses will be useful in guiding focus group topics, 
examining the usefulness of the survey items we adapt and create, and generating effect size 
estimates and variance components for a fully-powered trial. Finally, we will examine the indirect 
effect of the PC personnel training on parent engagement through the mechanism (mediation) of 
PC personnel communication skills. For mediation analyses, we will use path models in MPlus 
with bootstrapped indirect effects.  
As benchmarks for comparison, other studies that have targeted referral practices and 
behaviors have found medium-sized effects (e.g., d=.50-.66) on some PC practice outcomes. In 
these same studies, researchers reported attrition ranging from 0-15%.34-35 These estimates 
correspond with minimum sample sizes ranging from 76-148 to achieve power of .80 to detect a 
difference between the study arms. Our sample size of 35 results in power of .47 to detect an 
effect of .66, or power of .61 with a one-tailed test. These power analyses illustrate why this study 
is needed in preparation for an R01. The effect size estimates we produce in this study and the 
attrition that we observe will allow us to determine if the effect of the PC personnel training is in 
the same range as effects seen in other studies. These estimates will inform the sample size we 

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propose in a subsequent R01 application; without the estimates from the present study we may 
significantly over or under estimate the sample size needed.   
 
Based on the estimates we generate from the current study, we will run Monte Carlo simulations 
in MPlus to determine reasonable sample sizes for our R01 application. We will conduct these 
simulations to determine optimal sample sizes and allocation ratios between study arms. In 
addition, using the estimates of effect sizes, variance components, and attrition, we will model 
various analytic strategies and measurement approaches. We will conduct these advanced 
simulations with support and consultation of the college’s Research Methodology Consulting 
Center. 
17.2 Power Analysis:  
NA 
 
17.3 Statistical Analysis:  
See section 17.1 
17.4 Data Integrity:  
The PI, in collaboration with the data safety monitoring committee, will monitor the data 
integrity.  In weekly meetings with the project manager, the PI will review the data collected that 
week, that random assignment with blinding is carried out appropriately, and that data is being 
collected securely and in accordance with best practices.  A brief report of the data integrity will 
be included in twice annual updates to the data safety monitoring committee.   
18.0 Health Information and Privacy Compliance 
18.1 
Select which of the following is applicable to your research: 
X  My research does not require access to individual health information and 
therefore assert HIPAA does not apply.   
☐ I am requesting that all research participants sign a HIPCO approved HIPAA 
Disclosure Authorization to participate in the research (either the standalone 
form or the combined consent and HIPAA Authorization). 
☐ I am requesting the IRB to approve a Waiver or an alteration of research 
participant authorization to participate in the research. 
Appropriate Use for Research:  
☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the U 
of M stand-alone HIPAA Authorization.  Note: External IRB must be serving as 
the privacy board for this option. 
 

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18.2 
Identify the source of Private Health Information you will be using for your 
research (Check all that apply)   
NA 
☐ I will use the Informatics Consulting Services (ICS) available through CTSI (also 
referred to as the University's Information Exchange (IE) or data shelter) to pull 
records for me 
☐ I will collect information directly from research participants. 
☐ I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT (Hematopoietic 
Stem Cell Transplant) database. 
☐ I will pull records directly from EPIC. 
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another institution  
☐ Other.  Describe:  
18.3 
Explain how you will ensure that only records of patients who have agreed to have 
their information used for research will be reviewed. 
 
NA 
18.4 
Approximate number of records required for review: 
 
NA 
18.5 
Please describe how you will communicate with research participants during the 
course of this research.  Check all applicable boxes 
☐ This research involves record review only. There will be no communication with 
research participants. 
☐ Communication with research participants will take place in the course of 
treatment, through MyChart, or other similar forms of communication used 
with patients receiving treatment.  
X☐ Communication with research participants will take place outside of treatment 
settings. If this box is selected, please describe the type of communication and 
how it will be received by participants.  
Interview invitations will be sent by email or text, depending on participant preference.  
18.6 
Access to participants 
 
 
NA 
 

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18.7 Location(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply).   
☐ In the data shelter of the Information Exchange (IE)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In REDCap (recap.ahc.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 
X In Qualtrics (qualtrics.umn.edu) 
 X Store ☐ Analyze 
☐ Share 
☐ In OnCore (oncore.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In the University’s Box Secure Storage (box.umn.edu) 
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In an AHC-IS supported server. Provide folder path, location of server and IT 
Support Contact: 
 
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices: 
 
 ☐ Store 
☐ Analyze 
☐ Share 
X Other.  
Indicate if  data will be collected, downloaded, accessed, shared or stored using a 
server, desktop, laptop, external drive or mobile device (including a tablet computer 
such as an iPad or a smartform (iPhone or Android devices) that you have not 
already identified in the preceding questions 
Data will be stored on the department shared drive, which is a secure server. 
☐I will use a server not previously listed to collect/download research data 
☐I will use a desktop or laptop not previously listed 

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☐I will use an external hard drive or USB drive (“flash” or “thumb” drives) not 
previously listed  
☐I will use a mobile device such as an tablet or smartphone not previously listed 
 
18.8 Consultants. Vendors. Third Parties.  
 
Focus group and interview data will be analyzed using Deedose software. For the 
vignette questions in the provider survey, the Phonic.ai media recording widget will be 
embedded into the Qualtrics survey.  Audio-recordings of provider responses to vignettes 
will be stored on phonic.ai servers, with no linked identifying information other than the 
Qualtrics ID which is randomly assigned.  
18.9 Links to identifiable data:  
Data will be de-identified and a document linking the participant names and random ID 
numbers will be encrypted and stored on a separate secure folder only accessible by the PI and 
the project manager. All team members with access to the de-identified data will be added to the 
IRB approval for the study and will have completed the Collaborative Institutional Training 
Initiative (CITI) ethics training and HIPAA training required by the University of Minnesota.  
 
18.10 Sharing of Data with Research Team Members.  
 
Research team members will have access to the de-identfied data on the shared drive on 
a secure folder.  Participant names and random ID numbers will be encrypted and stored on a 
separate secure folder only accessible by the PI and the project manager.  
 
18.11 Storage of Documents:  
 
Electronic documents containing participant data will be stored on the shared drive on a 
secure folder.  Study materials and other documents containing no participant information may 
be stored in a google folder.   
Study materials and other documents containing no participant information may be stored 
in a locked filing cabinet in the PI’s office in the Department of Family and Social Science. 
 
 
18.12 Disposal of Documents: 
 
In accordance with NIH guidelines, research documents will be stored for three years after 
study completion.  The document linking IDs to participant names will be deleted after three 
years.  De-identified quantitative study data will be shared with the NIMH Data Archive (NDA) 
following study completion and de-identified qualitative data will be stored and available upon 
request by other researchers.   
 
19.0 Confidentiality 
19.1 Data Security: 
Any raw and digital data will be closely protected by the study team. Electronic data will be 
transferred via encrypted hard drives and uploaded to a secure University of Minnesota server. 
Data will be de-identified and a document linking the participant names and random ID numbers 

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will be encrypted and stored on a separate secure folder only accessible by the PI and the project 
manager. All team members with access to the de-identified data will be added to the IRB 
approval for the study and will have completed the Collaborative Institutional Training Initiative 
(CITI) ethics training and HIPAA training required by the University of Minnesota. Any documents 
or recording devices containing identifiable information will be stored locked in Dr. Mehus’s office, 
which is in a secure office suite. A copy of the database will be stored in a password-protected file 
on a removable hard drive, stored in a safe when not in use. Data will be copied to the password-
protected file quarterly, to ensure a data back-up.   
20.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
20.1 Data Integrity Monitoring.  
The PI, in collaboration with the data safety monitoring committee, will monitor the data 
integrity.  In weekly meetings with the project manager, the PI will review the data collected that 
week, that random assignment with blinding is carried out appropriately, and that data is being 
collected securely and in accordance with best practices.  A brief report of the data integrity will 
be included in twice annual updates to the data safety monitoring committee.   
20.2 Data Safety Monitoring. 
The PI (Dr. Mehus) will be primarily responsible for monitoring the study protocols and 
safety. Dr. Mehus will serve as the chief data and safety monitoring officer, facilitating this data 
safety and monitoring plan. The safety plan will include a committee, consisting of Drs. Mehus, 
Cook, and Coliani, as well as one therapist from the study. All clinic personnel and therapists will 
be informed at the time of the study introduction that any procedural, data, or safety concerns 
can be reported to any of the three investigators or the University of Minnesota’s IRB. Contact 
information will be included in all communications. Any safety or clinical concerns (e.g., concerns 
about abuse or neglect) will be reported to the PI (Mehus, Licensed Marriage and Family 
Therapist) immediately; if the PI is unavailable, and collaborator Dr. Colianni (Pediatrician, 
assistant chief of pediatrics in the collaborating clinics), are likewise professionally capable to 
advise any personnel in any adverse event. 
The data safety committee will meet once in the first month of the study to establish 
procedures and protocols. The committee will include Dr. Mehus, Dr. Cook, Dr. Coliani from 
HCMC Pediatrics, and one therapist from the study.  All committee members will be empowered 
to bring reports of adverse events to the rest of the committee. If any event is reported, the 
committee will meet to address the report as soon as possible to decide on appropriate next 
steps. Because the risk of adverse events is deemed to be low, the committee will check-in via 
email twice yearly to determine if there is a need for a formal meeting.  
Identified procedures include:  
Participants will be told that their names will not be attached to any of their answers and 
that nobody will ever know what they say in interviews. They will be told that the sole exception to 
this is if we were to learn about child abuse or imminent danger to self or another.  
Participants in focus groups will be reminded of confidentiality and instructed that this also 
pertains to sharing about the group discussions and other participants. They will be instructed to 
not share what was discussed or who was at the group.  
Providers will be instructed that feedback about any burdens or stress caused by the 
program are welcome and, in fact, provide valuable insight into the practicality and scalability of 
the model. We will ensure they have contact information for multiple study team members to 

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share any concerns. Any concerns that are raised will be discussed among the research team 
members and will be addressed on a case-by-case basis. 
 
21.0 Compensation for Research-Related Injury 
Research involves only minimal risk to participants 
21.1 Compensation for Research-Related Injury: NA 
 
21.2 Contract Language: NA 
 
22.0 Consent Process 
22.1 Consent Process (when consent will be obtained):  
All participants in data collection will be given a consent form that highlights the voluntary 
nature of data-collection activities. Participants are free to participate in the study or not, without 
ramifications on future opportunities with the University of Minnesota.  
 
PC personnel who express interest will be contacted by the research team, who will review 
the study information and consent form and share a link for the PC personnel to review and sign 
the consent form.  The study information will also be shared immediately prior to the 
communication skills training to ensure ongoing consent.   
 
22.2 Waiver or Alteration of Consent Process (when consent will not be obtained, 
required information will not be disclosed, or the research involves deception):  
N/A 
22.3 Waiver of Written/Signed Documentation of Consent (when written/signed consent 
will not be obtained):  
N/A 
22.4 Non-English Speaking Participants:  
N/A 
22.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years of 
age): 
N/A 
22.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent: 
 
Providers are presumed to have the capacity to consent. 
  
22.7 Adults Unable to Consent: 
 
NA 

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● 
Permission 
● 
Assent:  
● 
Dissent:  
23.0 Setting 
23.1 Research Sites:  
 
Participants will be identified and recruited from Hennepin Healthcare clinics.  A study 
description will also be submitted to the Hennepin Healthcare Human Research Protection 
Office.  The training will occur online or at Hennepin Healthcare.  Data collection will occur 
through online survey links and focus groups held on zoom.   
 
23.2 International Research: N/A  
23.3 Community Based Participatory Research:  
 
N/A 
24.0 Multi-Site Research 
N/A 
 
25.0 Coordinating Center Research 
N/A 
25.1 Role:  
25.2 Responsibilities:  
25.3 Oversight: 
25.4 Collection and Management of Data:  
26.0 Resources Available 
26.1 Resources Available:  
Between  the two primary collaborating clinics, there are approximately 50 providers, as 
well as residents and fellows who see children in this age range. Half of the participants will be  
randomly assigned to each study arm; n=15 of the 35 will be recruited for focus groups. If we fall 
short of this  sample size (either because of sampling difficulty or if nurses are selected as the 
personnel to be trained), we  will expand recruitment to other Hennepin Healthcare clinics, of 
which there are 6. Participants will receive $50  for participating in each survey and $100 for focus 
group participation. 
 Dr. Mehus (PI) has 24% of his time in 2021 and 30% of his time in 2022-2024 dedicated to this 
project, including this stage and a later stage submitted under a separate IRB.  Jaime Ballard, 
Project Manager, has 30% of her time dedicated to this project. Other partners have also 
dedicated time to support, including Dr. Cook (Co-I).  
 

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Drs. Mehus has access to adequate office space and office resources in Family Social Science.  
Resources include: individual offices and workstations with private phones and voicemail, fax 
capabilities, secure Internet access, and locking file cabinets for research teams; training and 
conference rooms available free of charge for sponsored projects.  The project has staff support 
through the Center for Applied Research and Educational Improvement business office with 
expertise managing federal grant funds, HR, and Finance. 
 
To safeguard against frustration and stress of PC personnel, all personnel will be 
encouraged to share concerns or issues with Drs. Mehus and/or Colianni. It will be stressed that 
all concerns provide useful information and opportunities to improve the protocol. In the unlikely 
event that PC personnel experience psychological strain, they will be provided a list of mental 
health professionals. 
 
The PI and Project Manager will meet weekly to review study progress and assess any 
needs relating to the study protocol and procedures.  The data safety committee will review 
study progress and assess needs twice annually.   
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3. Menting ATA, Orobio de Castro B, Matthys W. Effectiveness of the Incredible Years parent 
training to modify disruptive and prosocial child behavior: A meta-analytic review. Clin 
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4. Perrino T, Pantin H, Prado G, et al. Preventing internalizing symptoms among Hispanic 
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doi:10.1016/j.vaccine.2017.09.080 
23. Lipkin PH, Macias MM, Baer Chen B, et al. Trends in pediatricians’ developmental 
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