Pediatric Parenting Connections Young Moms Program
Phase: NA
Conditions: Chronic Toxic Stress, Developmental/ Behavioral Regression in Young Children
Sponsor: Wake Forest University Health Sciences

Protocol version: 
Template updated 9.24.14 
1 
Official Title:  Pediatric Parenting Connections Young Moms Program 
NCT05082857 
IRB-Approved Date:  3/7/22 
 
 
 
 
 

Protocol version: 
Template updated 9.24.14 
2 
Study Title: Pediatric Parenting Connections Young Moms Program 
 
Principal Investigator, Co-investigator(s): Anna Miller-Fitzwater, Claudia Barrett, Elizbeth Jensen 
 
Sponsor or funding source: CTSI 
 
Background, Rationale and Context 
 
According to youth.gov, by age 22, only 50% of young moms have received a high 
school diploma and only 30% have received their GED. Births to young moms carry 
risks along with perpetuating the generational trend of teen births. Children born to 
moms less than 20 years old are more likely to drop out of school, become teen parents 
themselves, and have increased risk of experiencing abuse or neglect.i,ii.  Risks are 
enhanced when a young mother has additional childreniii.  While there have been 
declines in overall births to young moms in Forsyth County from 2008-2019, the 
absolute numbers of young moms with not only a first but multiple children still are 
alarming.  
 
Imprints Cares is a local early education nonprofit that has been providing services in 
Forsyth County for the past 50 years. Two services provided by Imprints Cares are 
important to this project.  One, Pediatric Parenting Connections (PPC), forms a 
partnership with medical providers by embedding a certified parent educator into local 
health clinics, Westgate Pediatrics, Downtown Health Plaza, and Winston East 
Pediatrics. This program serves as short term in-office parenting education for 
breastfeeding, behavior, and developmental concerns. It also serves as a referral point 
for the more intensive, Parents as Teachers (PAT) home visitation model. Both models 
are two-generation models devoted to addressing health disparities, promoting maternal 
health, and mitigating chronic toxic stress. Providing supports that recognize these 
challenges help young moms obtain positive outcomesiv. Intervening early with a two-
generation approach can have positive effects for both young moms and children.  
There also are societal benefits in that the lifetime benefits of supporting young moms 
and promoting healthy birth spacing exceed those of the costsv, vi, vii, viii.  The benefits of 
providing parenting support to young moms can include mother’s education, use of 
contraception, healthy birth spacing, child immunization compliance, reduction of child 
behavior problems (possibly), improvements in the home environment, and parents’ 
realistic expectations for childrenix,x, xi. The application of these services to young 
mothers comprises our Young Moms Program (YMP). As a community we are just 
beginning to realize the unintended outcome of COVID, one of which appears to be an 
increase in teen births.  
As we continue to recover from the impact of the global pandemic, we must look closely 
at the significance home visiting programs have on creating authentic relationships with 
families, which in turn create opportunities for working with young moms to solve 
problems, achieve personal goals, and access essential resources. According to a 
Washington State Institute for Public Policy study (2004) Parents as Teachers had the 
largest benefit per dollar of cost ($1.23) of all pre-kindergarten early education 
programs. Imprints Cares traditional PAT program costs $3,436 per family annually, 

Protocol version: 
Template updated 9.24.14 
3 
which is a return on investment of $4.70 – 5.60 in future educational remediation, 
juvenile delinquency, teen pregnancy, substance abuse, and mental illness xv. Providing 
support to young moms in Forsyth County is something we cannot afford not to do.   
Our project will address this emerging health crisis at a time when value-based care 
models as part of Medicaid transformation are rolling out throughout North Carolina and 
all programs have had to adapt to changing the delivery mechanisms to more remote 
offerings.  During the pandemic, Imprints Care developed a hybrid model for provision 
of services through Parents as Teachers.  Imprints Cares evidence-based Parents as 
Teachers hybrid model may have far reaching implications in establishing a pediatric 
value-based model that can be replicated throughout our community, state, and country. 
Since January 2021, Wake Forest Baptist Medical Center (WFBMC) has documented 
82 births to young moms ages 14 through 21. Since July 2020 Imprints Cares family 
educators have received approximately 400 referrals from pediatricians with more than 
320 families being served, 80%.  
Further, as we are considering the intersection of equity with health and social policy, 
the YMP is an opportunity to directly address disparities in behaviors such as 
breastfeeding, completion of developmental screenings, and enrollment in early 
intervention that may be correlated with different demographic groupings.  We know that 
while COVID-19 was traumatic for everyone, young children growing up in poverty were 
disproportionately impacted. The true impact of the pandemic and public health 
precautions (i.e., isolation) is just beginning to emerge. We continue to see increased 
trends in pregnancy in young moms, toxic stress and child maltreatment, food 
insecurity, and developmental/ behavioral regression in young children. As we enhance 
opportunities for young moms based on positive outcomes during the pandemic, we can 
rapidly embed responses to traumatic events into our approach.  To the extent that 
some young moms are perpetuating a multi-generational pattern of early births, the 
proposed hybrid program is an opportunity to break a cycle linked to poor outcomes for 
young moms and their children.   
 
Objectives 
The objectives of this study are to assess cost-effectiveness of a Young Moms Program 
that incorporates a traditional Parents as Teachers home visiting parenting program to 
that of a hybrid virtual/home based Parents as Teachers program, against short-term 
outcomes, which in turn will serve as leading indicators of longer-term results.  Specific 
outcomes are outlined in the measures section.  
 
Methods and Measures 
 
This is a community-engaged research collaboration between the non-profit Imprints 
Cares, the WFBMC Birth Center, and WFSOM. Because YMP is a tiered program 
model, services meet parents where they are through a “warm hand-off” approach that 
uses on one-on-one consultation and assessment-based interventions. The YMP is 
designed to address systemic barriers to the health and stability of young moms and 
their children such as the lack of coordination of service delivery or logistical barriers 
within the health system. The YMP also streamlines the referral pipeline, connecting 

Protocol version: 
Template updated 9.24.14 
4 
moms to evidence-based resources, and ensuring children complete all recommended 
assessments prior to kindergarten.  
 
This research project is a pilot randomized controlled trial. We expect a total of 30 
participants,15 in each arm of the study. For inclusion into this study participants must 
be an immediately post-partum mother, between 14-21 years of age who will reside with 
her newborn.  The mother must be referred from either the Birth Center at Wake Forest 
Baptist Health or from one of the Wake Forest Baptist Health PPC partner practices.  
Exclusion criteria include that newborn of participating mothers must be >= 35 weeks of 
gestation and not have an extended NICU stay. These populations are excluded 
because medically complex newborns and a prolonged separation during the 
intervention period will directly affect our outcome measures. Participants must speak 
English or Spanish given our parent educators and other group participants are limited 
to those languages.  Males are excluded as participants, the intervention and many of 
the outcome measures are only applicable to female participants.   
 
Participants will be randomly assigned to one of the two variants of the Parents as 
Teacher home visitation model, traditional or hybrid. The study’s research coordinator, 
who is not directly involved with the delivery of services, will manage the randomization 
and assignment process; all consented participants will be given a system-generated 
unique identifier, which cannot be linked to patient identity by anyone except the 
research coordinator.  This information will be securely maintained by the research 
coordinator.  The team will complement the treatment groups’ data with population data 
extracted from WFBMC’s Epic system.  Analysts will use rigorous techniques (e.g, 
Propensity Score Matching) to create a matched control group. 
 
Both formats and all interventions included in the study are the current models of care 
for our existing PAT/YMP services.  The hybrid model was developed in 2020 in 
response to the need to move services virtually as home visitation was not allowed 
during COVID-19 lockdown.   
 
Through the traditional PAT model, participants will be referred through a warm hand-off 
from the Birth Center or one of WFBH community pediatric centers to Imprints Cares. A 
PAT certified family educator will meet with the family focusing on a one-on-one 
consultation and assessment-based interventions. Participants in the traditional PAT 
model will receive two home visits a month and participate in monthly peer (group) 
connections throughout the study period.  
 
In the hybrid PAT model, participants will be referred through a warm hand-off to 
Imprints Cares from the Birth Center or one of WFBH community pediatric centers. A 
PAT certified family educator will meet with the family focusing on a one-on-one 
consultation and assessment-based interventions. Study participants will begin 
receiving services by participating in the virtual “What You Do Matters” program, an 
evidence-based PAT curriculum. After completion of the virtual program, young moms 
will begin receiving once a month home visits and participate in monthly peer (group) 
connections.  
 

Protocol version: 
Template updated 9.24.14 
5 
By including two variants in this pilot project, the study team will assess the cost-
effectiveness of the two approaches, against short-term outcomes, which in turn will 
serve as leading indicators of longer-term results.  At the end of the official study period, 
participants will be eligible to continue in the program until the child’s school entry into 
kindergarten. 
 
Both models will be staffed by qualified family educators that have been trained in the 
Parents as Teachers Foundational Curriculum, the Circle of Security model, and 
breastfeeding educator certification program. Imprints Cares also has a 
mental/behavioral health family educator on staff to address emergent 
mental/behavioral concerns as they arise. These approaches have been documented to 
nurture parental attachment and secure relationshipsxii.   
 
Outcome Measures 
The team will use several published assessments: 
Protective Factors Survey.  The Protective Factors Survey (PFS) is a validated parent survey 
designed that assesses protective factors in five areas: family functioning/resiliency, social 
support, concrete support, nurturing and attachment, and knowledge of parenting/child 
development.  The PFS will be implemented at week one, week six, and end of study, as it 
requires parent-child interactions for completion. 
Ages and Stages Questionnaire 3rd edition.  The Ages and Stages Questionnaire (ASQ 3) is a 
validated developmental screening designed for use by and with parents. The ASQ 3 screens 
for developmental milestones in communication, gross motor, fine motor, problem solving, and 
personal-social skills.  The ASQ 3 will be implemented at the recommended intervals designed 
by its publisher (2, 4, and 6 months). 
Ages and Stages Questionnaire: Social-Emotional 2nd edition.  Similar to the ASQ 3, the Ages 
and Stages Questionnaire: Social-Emotional (ASQ:SE 2) is a validated screening of social and 
emotional behaviors. The ASQ:SE 2 will be implemented at the recommended intervals 
designed by its publisher (2, 4, and 6 months). 
Patient Health Questionnaire.  The Patient Health Questionnaire (PHQ 9) is a self-administered 
questionnaire that is validated for use in assessing the severity of depression.  The PHQ 9 will 
be administered as a baseline assessment as well as an end-of-study assessment. 
StimQ2-I.  The StimQ2-I is a validated, interview-based assessment of home environments for 
use with infants ages five to 12 months.  The StimQ2-I focuses on cognitive stimulation by the 
primary caregiver and contains several scales: Availability of Learning Materials, Reading-
Verbal, Parental Involvement in Developmental Advance, and Parental Verbal Responsivity.  
The StimQ2-I will be implemented at the end of study, as it requires parent-child interactions for 
completion. 
 
In addition to these assessments, the team will use an intake questionnaire to capture parent 
demographic and health information as well as baseline knowledge about child development 
and parenting and a monthly questionnaire used to assess mother’s status on continuance of 
secondary education, breastfeeding, and use of contraception.  A monthly questionnaire, which 
will be developed for use in this study, also will assess infant developmental milestones.   
 
Further, the team will access health information captured in WFBMC’s Epic system, including 
completion of Well-Child Visits and recommended immunizations. A WFBMC study team 
member will extract data on participants as well as a matched control group. The study team will 
conclude the study with participant focus groups, to collect additional qualitative feedback and 
insights.  Finally, the team will develop and implement Fidelity of Implementation (FOI) quality 

Protocol version: 
Template updated 9.24.14 
6 
assurance guidelines and checklists to capture the degree to which project services are 
delivered as expected.  FOI scores will be used as a predictive variable with the goal of 
establishing a minimum service threshold for short-term outcomes. 
 
Proposed Statistical Analyses 
Descriptive Analyses.  All data will be subject to descriptive analyses, including measures of 
central tendencies and frequency distributions, as appropriate for the type of data collected.  
Descriptive analyses will support our understanding of participant characteristics and 
equivalency of samples in the traditional and hybrid models.   
Inferential Analyses.  Inferential analyses, such as t-tests, multiple regression, and Analysis of 
Variance, will be conducted to test for change between baseline and end-of-study data 
collections with the PHQ 9, and the PFS. The PFS will be administered at service week one, 
service week six, and at the end-of-study to assess differences between the models at 
promoting protective and nurturing behaviors.  Tests also will be used to assess differences 
between the models on maternal outcomes such as continuance of secondary education, 
breastfeeding, and use of contraception and child-focused outcomes such as STIMQ2-I, 
completion of Well Child Visits and immunizations. The study team will work with CTSI 
Biostatistical Support services to advise and guide the analytic approach. 
 
Proposed Cost Effectiveness Study Design.  One of the primary challenges of completing 
cost studies is fully accounting for all costs and benefits.  Therefore, the study team will use this 
project period to identify the spectrum of costs associated with serving one young mother and 
her child.  These data will be compiled to generate an average cost of service and establish 
outliers that exist when there are particularly risky or traumatic cases.  In addition, the team will 
establish short-term benefits (achievable after six-months of services) along with the program 
implementation conditions necessary to achieve them. We will utilize the services of BERD and 
Q-Pro to assist in advising in areas of study design, data analysis, and data management. 
 
Study Timeline 
Study Milestone 
M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12 
Achieve IRB approval 
● 
 
 
 
 
 
 
 
 
 
 
 
Enrollment of teen moms 
 
● 
● 
● 
 
 
 
 
 
 
 
 
Baseline data collected 
 
● 
● 
● 
 
 
 
 
 
 
 
 
Services delivered 
 
● 
● 
● 
● 
● 
● 
● 
● 
● 
● 
 
Week one data collected 
 
● 
● 
● 
 
 
 
 
 
 
 
 
Week six data collected 
 
 
● 
● 
● 
 
 
 
 
 
 
 
ASQ/ASQ-SE data 
collected (2,4, and 6m) 
 
 
 
● 
● 
● 
● 
● 
● 
● 
● 
● 
Monthly questionnaires and 
FOI checklists completed 
 
 
● 
● 
● 
● 
● 
● 
● 
● 
● 
 
End of study data collected 
 
 
 
 
 
 
 
 
 
 
● 
● 
Analysis and reporting 
completed 
 
 
 
 
 
 
 
 
 
 
 
● 
The project will track numerous milestones, including: 
• 
Submission of IRB application and receipt of IRB approval.  This milestone is critical as the 
project will not move forward without IRB approval. 
• 
Enrollment of young moms by the project’s four month.  All participants will need to be 
enrolled by month four to ensure moms in both models can receive at least six months of 
home visitation services.  In the traditional model, home visitation starts immediately upon 

Protocol version: 
Template updated 9.24.14 
7 
enrollment.  In the hybrid model, home visitation starts at the completion of the six-week 
What You Do Matters virtual class. 
• 
Collection of all baseline data.  Baseline data will be collected at the time of enrollment and 
will consist of the enrollment form and the PHQ 9.  
• 
Collection of week one and week six data.  Data will be collected during the participant’s first 
and sixth week (at the close of the What You Do Matters course) of services in both models 
(PFS). 
• 
Collection of monthly questionnaires.  Monthly questionnaires will be implemented with each 
participant, on a schedule developed by the family educator. 
• 
Collection of ASQ and ASQ:SE data as recommended by the publisher (2, 4, 6m). 
• 
Collection of end-of-study data (6 months after enrollment).  In the final month of services, 
the team will collect the ASQ, ASQ:SE, PHQ 9, the PFS and the StimQ2-I. 
• 
Collection of FOI checklist data.  Project staff and supervisors will complete FOI checklists 
on a monthly basis.  Each model will have its own checklist. 
• 
WFBMC data extraction and compilation of analysis files.  One of the WFBMC team 
members will work to securely extract health data for treatment and matched control group 
participants from the Epic system.   
 
Human Subjects Protection 
 
Subject Recruitment Methods 
No additional PHI will be accessed or printed/transcribed above and beyond what is part of 
standard patient care and pre-defined job descriptions. 
 
OB Home Visiting Staff 
1) Our OB Home Visiting Nursing Staff as part of their standard workflow identify and visit all 
post-partum mothers that reside in Forsyth County, NC. 
2) Of those, they will identify mothers that meet inclusion criteria for the study (14-21 years old, 
Spanish or English Speaking, will reside with their newborn upon discharge, and will follow up 
with a Wake Forest Baptist Health Pediatrician). 
3) During their standard meeting, while the mother is still inpatient from her delivery, OB home 
visiting staff per their standard workflow will ask if the mother would like referral to Imprints 
Cares.  If they identify a likely eligible participant, they will introduce study at that time, without 
promising the patient they are eligible.  If the patient is interested in referral for either the study 
or services not provided as part of the study, the team will make a referral to Imprints Cares.  
The referral will indicate if the patient appears to be eligible for the study or not. 
 
Imprints Cares 
1) After referral from the PPC primary care physician or the OB Home Visiting Nursing Staff to 
the Imprints Cares program, intake staff will assess if new mothers meet criteria for participation 
in the study (14-21 years old, Spanish or English Speaking, will reside with their newborn upon 
discharge, and will follow up with a Wake Forest Baptist Health Pediatrician).  
2) Imprints Cares intake staff will ask if the mother would like to participate in the study, explain 
the risks and benefits, and obtain consent/assent from all required parties  This may be done in 
person if at the time of a clinic or intake home/community visit OR remotely via secure 
Docusign. 
3) Imprints Cares staff will not directly benefit if a patient does or does not consent to the study, 
and patients are eligible for services if they do not consent, therefore it is not an undue influence 
to enroll patients. 
 

Protocol version: 
Template updated 9.24.14 
8 
Informed Consent 
 
Signed informed consent/assent and parental permission to participate will be obtained from 
each subject as defined by participant age.  Informed consent/assent and parently permission to 
participate will either be obtained in person if at the time of a clinic visit or intake 
home/community visit OR remotely via secure Docusign at by Imprints Cares Intake Staff 
approved as study staff by the IRB. 
 
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study 
outcomes, minimizing to the fullest extent possible the collection of any information that could 
directly identify subjects, and maintaining all study information in a secure manner.  To help 
ensure subject privacy and confidentiality, only a unique study identifier will appear on the data 
collection form.  Any collected patient identifying information corresponding to the unique study 
identifier will be maintained on a linkage file, store separately from the data.  The linkage file will 
be kept secure, with access limited to designated study personnel.  Following data collection 
subject identifying information will be destroyed at the time the newborn is 6 years old, 
consistent with data validation and study design, producing an anonymous analytical data set.  
Data access will be limited to study staff.  Data and records will be kept locked and secured, 
with any computer data password protected.  No reference to any individual participant will 
appear in reports, presentations, or publications that may arise from the study. 
 
Data and Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of 
study participants.  The principal investigator will be assisted by other members of the study 
staff. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol 
changes will be promptly reported by the principal investigator or designated member of the 
research team to the IRB and sponsor or appropriate government agency if appropriate. 
 
References 
i Suellentrop, K. (2010). The Costs and Consequences of Teen Childbearing.  Presentation for 
the National Campaign to Prevent Teen and Unplanned Pregnancy. 
ii Hechtman, L. (1989).Teenage mothers and their children: risks and problems: A 
review. Can J Psychiatry. Aug;34(6):569-75 
iii See, for example, https://www.cdc.gov/vitalsigns/teenpregnancy/index.html 
iv Cox, J.E., Harris, S.K., Conroy, K., Engelhart, T., Vyavaharkar, A., Frederico, A., and Woods, 
E.R. (2019).  A parenting and life skills intervention for teen mothers: A randomized controlled 
trial.  Pediatrics, 143, number 3 
v Willis, Susan Beth, "Cost-benefit and cost-effectiveness of case management for a teen 
pregnancy and parenting program" (1993). Theses Digitization Project. 630. 
vi Harding, J.F., Knab, J., Zief, S., Kelly, K., and McCallum, D. (2020).  A systematic review of 
programs to xv promote aspects of teen parents’ self-sufficiency: Supporting educational 
outcomes and health birth spacing.  Maternal and Child Health Journal, 24 (Suppl 2):S84–S104  
vii Brace, A.M., Hall, M., and Hunt, B.P. (2008). Social, economic and health costs of 
unintended teen pregnancy: The Circle of Care intervention program in Troup County, 
Georgia.  Journal of the Georgia Public Health Association, 1, No. 1, 33-46. 

Protocol version: 
Template updated 9.24.14 
9 
viii Rosenthal, M.S., Ross, J.S., Bilodeau, R., Richter, R.S., Palley, J.E., and Bradley, E.H. 
(2009).  Economic evaluation of a comprehensive teenage pregnancy prevention program: Pilot 
program.  Am J Prev Med. December; 37(6 Suppl 1): S280–S287 
ix Chrisler, A. and Moore, K. A. (2012). What works for disadvantaged and adolescent parent 
programs: Lessons from experimental evaluations of social programs and interventions for 
children.  Child Trends Publication #2012-19. 
x Harding, et.al. (2020).  
xi Cox et.al. (2019). 
xii See, for example, https://parentsasteachers.org/research-and-quality-improvement-
index#research-results and https://www.circleofsecurityinternational.com/circle-of-security-
model/research/. 
xiii Rubio, D.M., Schoenbaum, E.E., Lee, L.S., Schteingart, D.E., Marantz, P.R., Anderson, K.E., 
Platt, L.D., Baez, A., and Esposito, K. (2010).  Defining translational research: Implications for 
training.  Acad Med. March ; 85(3): 470–475 
xiv Linton, J.M., Stockton, M.P., Andrade, B., and Daniel, S. (nd).  Integrating parenting support 
within and beyond the pediatric medical home.  
xv Washington State Institute for Public Policy, 2004 report. 
http://www.wsipp.wa.gov/pub.asp?docid=04-07-3901 
 
Appendix (see relevant sections of IRB application) 
1. Data collection form 
2. Copies of each questionnaires or surveys that will be used 
3. Consent form if one will be used