Promoting Resilience and Lowering Risk in Early Childhood: An mHealth Intervention Study
Phase: NA
Conditions: Child Abuse, Child Neglect, Parenting, Child Development
Sponsor: University of Oklahoma

 
 
 
 
 
 
 
 
 
 
 
 
 
Title of Project: Promoting resilience and lowering risk in early childhood: An 
mHealth intervention study 
 
NCT05479734 
 
November 14, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Principal Investigators: 
David Bard; PhD; Dept of Pediatrics, University of Oklahoma Health Sciences   
Helen Milojevich; PhD; Dept of Pediatrics, University of Oklahoma Health Sciences   
 
 

 
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RESEARCH PROTOCOL OUTLINE 
 
Abstract 
 
Early adversity exposure profoundly influences diverse aspects of brain and 
behavioral development and long-term risk for mental and physical illness. Rates of 
adverse childhood experiences (ACEs) in the United States remain high, with 1 in 6 
adults experiencing 4 or more ACEs. Nationwide, numerous efforts have been initiated to 
reduce rates of ACEs and promote resiliency of high-risk children. One such effort is 
home visiting (HV), which provides one-on-one coaching to help high-risk parents (e.g., 
living in poverty, mental health issues) learn skills to promote child development and 
improve family functioning. Findings on the impact of HV programs have at times been 
mixed and we have yet to significantly improve psychosocial adjustment of adversity-
exposed children. Here we propose to conduct an intervention study to provide in-the-
moment parenting tips with the goal of increasing healthy parent-child interactions 
leading to resiliency in high-risk children. Specifically, in a sample of parents 
participating in a HV program, we propose to use a smartphone app (mHealth app) to 
deliver twice-daily tailored messages with tips on monitoring and promoting child 
development. Daily assessments of parents’ emotions, parenting behaviors, and 
interactions with their children will also be collected via the app. We expect that parents 
will evidence greater engagement in positive parenting practices on days when they 
receive the mobile-based parenting tips and strategies relative to on days when they do 
not receive this content. 
A. 
Specific Aims 
This is an intervention study to provide in-the-moment parenting tips with the goal of 
educating parents about monitoring and promoting child development, thereby increasing 
healthy parent-child interactions leading to resiliency in high-risk children. Specifically, 
in a sample of parents participating in a HV program, we will use a smartphone app 
(mHealth app) to deliver twice-daily tailored messages with tips on monitoring and 
promoting child development. Ecological momentary assessments (EMA) of parents’ 
emotions, parenting behaviors, and interactions with their children will also be collected 
via the mHealth app. Building off our previous work we expect that parents will evidence 
greater engagement in positive parenting practices on days when they receive the mobile-
based parenting tips and strategies relative to on days when they do not receive this 
content.  
We hypothesize that in-the-moment parenting tips delivered around peak times of parent-
child interactions (i.e., before work/school, mealtimes, and bedtime) will promote 
positive parenting practices in a sample of parents at increased risk of adversity exposure. 
We aim to use EMA methodology to measure both group level differences (i.e., 
intervention vs. services as usual) and within-person fluctuations in harsh parenting, 
children’s emotional and behavioral functioning, and positive parenting practices. The 
study will evaluate the following aims and hypotheses:  
 
Aim 1. Conduct a 2-arm, randomized, controlled crossover trial to examine the 
feasibility and effectiveness of a mobile-based parenting app with parents 
participating in HV services. 

 
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Hypothesis 1a. Parents will report high rates of satisfaction and usability. Hypothesis 
1b. Parents will evidence greater engagement in positive parenting practices on days 
when they receive the mobile-based parenting tips and strategies relative to days 
when they do not receive this content. 
Hypothesis 1c. Groups will evidence increases in positive parenting subscale scores 
after a month of app engagement. 
Aim 2. Utilize EMA data and follow-up assessments to examine the impact of 
positive parenting practices on the promotion of child development. 
Hypothesis 2a. Hypothesis 2a. Children will demonstrate less challenging and more 
positive behavioral functioning on days when their parents receive positive parenting 
tips. 
Hypothesis 2b. Groups will evidence increases in developmental scores after a 
month of app engagement. 
 
B. 
Background and Significance 
Background:  
Exposure to early adversity has significant public health implications. A recent surge 
of empirical work has focused on how early experiences impact children’s developmental 
trajectories and ultimately the health and well-being of individuals across the lifespan. 
This increased attention is in part a result of large-scale epidemiological studies, such as 
the Adverse Childhood Experiences (ACEs) study1, documenting the far-reaching and 
lasting consequences of childhood adversity on a diverse set of outcomes, including rates 
of morbidity and mortality. ACEs capture a wide range of potentially traumatic events 
experienced in childhood (0-17 years), including exposure to violence, abuse, or neglect, 
witnessing home or community violence, and having a family member attempt or die by 
suicide. Rates of early adversity in the United States remain high, with 1 in 6 adults 
experiencing 4 or more ACEs2. Moreover, ACEs tend to have a cumulative impact, such 
that as ACE exposure increases so too does the risk of experiencing negative 
developmental outcomes3-4. ACEs also place a heavy burden on society, with an 
estimated annual financial loss of $748 billion due to criminal justice costs, productivity 
losses, and mental health services5. Overall, these figures underscore ACEs as a pressing 
public health issue with widespread implications for individuals, families, and society as 
a whole. 
As scientific evidence of the far-reaching consequences of ACEs has increased, so have 
surveillance efforts at both the state and national level, leading to a better understanding 
of the burden of childhood adversity and population level differences6. More recently, the 
shift from assessment to action is reflected in policies and practices that focus on 
increasing awareness of the negative outcomes associated with ACEs, alongside the 
promotion of strategies that mitigate risk and improve child outcomes and family well-
being7. Importantly, despite widespread consequences of ACEs, some individuals 
demonstrate resilience and experience healthy functioning. While less is known about 
how, and under what circumstances, protective mechanisms and positive experience 
buffer ACEs, safe, stable, nurturing relationships are key to child health and 
development. For children and families most at risk, promoting strategies that build 

 
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protective capacities is critical to reducing risk and improving outcomes, which in turn 
can mitigate the societal burden associated with ACEs.  
Influence of positive parenting. One particularly robust predictor of resilience in the 
face of adversity is parenting. Parents play a profound role in shaping their children’s 
developmental trajectories. Recently, the National Academy of Sciences, Engineering, 
and Medicine released Parenting Matters: Supporting Parents of Children Ages 0–8, 
which underscores the importance of quality parenting for child development8. 
Additionally, Sege and Browne9 proposed The Healthy Outcomes from Positive 
Experiences (HOPE) framework, which focuses on promoting positive childhood 
experiences to prevent or mitigate the effects of ACEs. HOPE identifies four broad 
categories of positive experiences and their effects on child development, including the 
need for (1) sustained supportive relationships, (2) growing and learning in safe, stable 
environments, (3) opportunities for constructive social engagement and connectedness, 
and (4) social and emotional competencies. Parents play direct and indirect roles in 
cultivating all four categories10-11. Positive parenting practices are associated with dose-
dependent reductions in adult mental health and relational health impairments resulting 
from ACE exposures12. Moreover, positive parenting practices, including engaging the 
child in reading stories, storytelling/singing, eating meals together, playing with similar-
age children, and family outings, are linked with behavioral, emotional, and cognitive 
improvements in children exposed to adversity13. Positive parenting practices are also 
tied to alterations in brain structure and functioning. For example, shared reading 
interactions between mothers and their children have been associated with activation in 
left-sided brain areas supporting expressive and complex language, socio-emotional 
functioning, and working memory14.  
Intervention efforts. Nationwide, numerous efforts have been initiated to promote 
positive parenting practices and reduce rates of ACEs in high-risk children. One such 
effort is home visiting (HV), which provides one-on-one coaching to help high-risk 
parents (e.g., living in poverty, mental health issues) learn safety, health, and parenting 
skills to promote child development and improve family functioning. Findings on the 
impact of HV programs on child development have at times been mixed and we have yet 
to move the needle on significant improvement in the psychosocial adjustment of 
adversity-exposed children15-16. Specifically, findings indicate that the potential of HV to 
improve child developmental outcomes depends in part on the model of HV, the training 
level of the provider, and the domain of child development in question17. Evidence also 
suggests that the effects of HV on child development may at times be indirect. For 
example, work by our team found that the association between HV and child 
development was mediated by the home environment, such that as parents received more 
home visits, they reported providing more emotional support and cognitive stimulation to 
their child, which in turn was associated with higher developmental scores for their 
children18. Moreover, the National SafeCare Training and Research Center recently 
administered an attitudinal survey to SafeCare providers on incorporating mHealth apps 
into programming. Findings suggested that the vast majority of providers felt that an 
mHealth app would improve client outcomes and help supplement existing curriculum, 
however over 70% reported never using an app of any kind (mHealth or otherwise) with 
their clients. Given the overwhelming public health crisis due to ACEs, the importance of 
positive parenting practices, and the inconsistent findings on HV’s impact on child 

 
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development, there is a dire need for low-cost, impactful interventions that can enhance 
and extend HV to large portions of high-risk families in a consistent and reliable manner. 
The goal of this project is to test such an intervention.   
 
Significance: Despite empirical support for HV models, evidence suggests that HV 
programs reach on average less than 4% of the population in need of such intervention, 
particularly low-income families and can be prohibitively costly to bring to scale17. 
Moreover, family engagement and retention in HV services are impeded by life 
circumstances such as unpredictable or inflexible work schedules, the need for visits 
outside of the typical work day, and living in other family members who may not want 
the services19. To address these obstacles, service providers and researchers alike are 
increasingly turning to technology, including mobile health apps, as a means to 
widespread, low cost service delivery.  Mobile health interventions (mHealth) are 
particularly appealing given their popularity, mobility, and extensive technological 
capabilities. Crucially, mHealth interventions can bolster service delivery to large 
numbers of high-risk individuals and families by (1) reaching resource-poor 
environments, (2) targeting content in an individualized and customized manner, and (3) 
delivering content at specific times when it is the most relevant and potentially impactful. 
As such, the project has the potential to develop a much-needed intervention that could 
be targeted to families receiving HV to bolster the effectiveness of those services, as well 
as, other at-risk population not involved in HV, but who would similarly benefit from the 
parenting tips and strategies.  
In addition to the service delivery benefits, mHealth apps also allow for researchers to 
collect extensive data from service recipients via ecological momentary assessment 
(EMA). EMA has emerged as one of the most promising ways to collect ecologically 
valid information about temporal and contextual factors that impact behavioral dynamics 
in real-world settings. EMA involves repeated sampling of participants’ current behaviors 
and experiences in real time, in their natural environments. As such, EMA minimizes 
recall bias, maximizes ecological validity, and permits the examination of microprocesses 
that inﬂuence behavior in real-world contexts. Through the use of EMA, the proposed 
study will move beyond examining parenting behaviors as a static marker of risk and 
resilience by testing for a more dynamic or proximal relation between parenting 
behaviors and developmental outcomes in at-risk children’s daily lives. Thus, the study 
would pilot test a much-needed low cost, far reaching intervention, provide preliminary 
data on dynamic relations of risk and resilience in high-risk families. 
 
 
C. 
Preliminary Studies/Progress Report   
The evaluation will be led by the Biomedical and Behavioral Methodology Core (BBMC) 
of the Department of Pediatrics. The development and implementation consultation will 
be provided by faculty and staff at the Center on Child Abuse and Neglect (CCAN), 
which is also housed in the Department of Pediatrics. The BBMC is a shared resource 
that consists of three primary and three jointly-appointed faculty members, 5 academic 
support staff and 2 administrative support staff. The BBMC mission is to support and 
enhance study design, data capture, and analytics for biomedical and behavioral research, 

 
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and this Core currently provides a variety of methods support for several ongoing clinical 
and translational research studies in the Department of Pediatrics as well as several other 
outside Departments and Colleges. BBMC faculty represent established federally funded 
scientific researchers with statistics, methods, and informatics expertise and extensive 
publication records. BBMC faculty and staff offer specialized methods expertise in 
Bayesian methods, clinical trials, field trials and survey research, study design and 
management, measurement and psychometrics, analysis of complex sampling designs, 
generalized linear modeling, generalized latent variable modeling, longitudinal and 
spatial analysis, time series and dynamic modeling, quantitative genetics, population 
genetics, computational programming and statistics, software development, database 
design and management, bioinformatics, and qualitative data methods. Faculty and staff 
participate in both independent and collaborative research, provide general research 
consultation, teach and mentor graduate and undergraduate students, and supervise 
research assistants at all levels of academic and non-academic rank. The BBMC has a 
strong working relationship with the Center on Child Abuse and Neglect (CCAN). 
CCAN is a university-based, interdisciplinary center dedicated to the prevention and 
treatment of child abuse and neglect, and has a long-standing history in the community, 
state, and nation in conducting clinical implementation and dissemination research on the 
prevention and treatment services for child maltreatment. As a research group, they have 
been able to demonstrate the capacity to accommodate reasonable scientific rigor within 
the demands and realities of services research, along with well-established research-
practice partnerships with state authorities and front-line service provider agencies. The 
overall focus of these collaborations has been to develop, adapt, rigorously test, refine 
and move to scaled-up implementation with evidence-based child welfare intervention 
models. The focus has been both on developing or adapting the evidence-based practices 
(EBPs) themselves and on improving strategies for how these models can be 
implemented with fidelity at-scale within large public sector child welfare service 
systems. CCAN team members include established federally funded scientific researchers 
with extensive publication records, including experience conducting treatment outcome 
trials in real-world field settings. Funding sources and implementation efforts related to 
the current demonstration project have included: NIMH (e.g., Effectiveness Trial of 
SafeCare for Neglect. (NIMH R01MH065667; Chaffin [PI], Hecht); Developing Multi- 
Component Evidence Based Practice for Child Abuse Service Systems. (NIMH-
1R34MH076972; Hecht [PI]), Mixed Methods Study of a Statewide EBP Implementation 
(NIMH R01MH072961; Aarons [PI], UCSD; Chaffin, Hecht, OUHSC); ACYF, 
Children’s Bureau (e.g., State of Oklahoma Title IV-E Waiver Demonstration Project, 
2015-2019. Bard, lead evaluator, PI of subcontract; Evidence-Based Child Maltreatment 
Prevention for High Risk Families: Expanding to Latino Communities, Enhancing 
Family Violence Prevention, and Sustaining Prevention Programs. USDHHS 
(90CA1764). Silovsky [PI]); The Centers for Disease Control and Prevention (e.g., 
Alternatives for Families III. # CCR622338. Chaffin [PI]); and HRSA (e.g., Maternal, 
Infant and Early Childhood Home Visiting (MIECHV) Competitive Grant Program, 
Independent Evaluator subcontract. D89MC23154 Bard, PI of subcontract). These 
projects demonstrate capabilities in evaluating EBP uptake at client, provider, 
organizational, and systems levels, and use of mixed methods approaches 
(quantitative/qualitative methods). 

 
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Personnel and Duties 
Principal Investigator: David Bard, Ph.D. Dr. Bard’s project responsibilities will include: 
(1) overseeing the day-to-day administration of the evaluation project and personnel, (2) 
maintaining regular contact with funding agencies as needed, (3) overseeing of the 
progress reports on the project, (4) proposing the research design and methodology, and 
(5) overseeing data collection and analysis. Note: Dr. Bard began fulfilling this role in 
July of 2022 due to a location change of Co-PI Milojevich.   
 
Co-Principal Investigator: Helen Milojevich, Ph.D. will assist Dr. Bard as a Co-PI. Roles 
and responsibilities include supervision of personnel, oversight of all contracts and sub 
awards, continued data base development, implementing the methodology for the study, 
conducting the data management and analysis, and disseminating findings. Note: Dr. 
Milojevich switched from PI to Co-PI in July of 2022 due to a location change. 
 
Co-Investigator: Sixia Chen, Ph.D. will serve as a data analyst on this project. He will 
advise the PIs in all statistical analyses required for the completion of this proposed 
study. Dr. Chen will also assist in writing reports and manuscripts. 
 
Co-Investigator: Debra Hecht, Ph.D. will assist in the design of the mHealth app content. 
Dr. Hecht will also assist in writing reports and manuscripts.  
 
Co- Investigator: Adam Alexander, Ph.D. will provide guidance in the development of 
the mHealth app and provide support throughout the grant on the use and functioning of 
the app and EMA data collection efforts. Dr. Alexander will also assist in writing reports 
and manuscripts.  
 
Postdoctoral Researcher: Amy Treat, Ph.D. will assist the PIs with IRB protocols, 
methodology development, guiding the GRA on participant recruitment and data 
collection, data coding and analysis, and writing up reports and manuscripts. 
 
Research Assistant: TBH is will recruit and test participants at all waves of data 
collection (baseline, EMA, and follow-up). They will also be in charge of android phone 
management and distribution as well as distribution of participant payments.  
 
Contract/Grant Coordinator: Angela Raper will provide financial management, budget 
monitoring, effort tracking, financial record keeping, contract set-up for the mHealth app, 
and purchasing management. She will supervise the android phone management and 
distribution. 
 
Senior Accounting Specialist: Tiffany Burris will assist with financial and purchasing 
management and record keeping. She will purchase and track participant incentives and 
project android phones as well as set up service and data plans. She will assist with 
android phone management and distribution. 
 

 
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Contractor: Lana Beasley, Ph.D. will conduct the focus group on app and intervention 
feedback, analyze the qualitative focus group data, aid in the interpretation of results, and 
assist in writing reports and manuscripts. 
 
Contractor: Kathryn Bigelow, Ph.D. will advise the PIs and research team on the content 
of the parenting app tips and OnDemand materials, meet quarterly to discuss project 
progress and help problem-solve any challenges, and assist with writing reports and 
manuscripts. 
 
Research Coordinator – The research coordinator will work closely with the PIs and Co-
Is on managing day-to-day study operations.  
 
Data Collection Supervisor – The data collection supervisor will work with the research 
coordinator to ensure timely and accurate data collection. 
 
Graduate Research Assistant: The GRA will work with the rest of the team to clean and 
analyze data collected during the surveys. This individual will ensure the data are 
structured, cleaned, and stored properly. 
 
D. 
Research Design and Methods (What, When, How, Where) 
Study Design 
We will use a 2-arm randomized, controlled cross over trial design to evaluate the 
effectiveness of the mHealth Intervention. We will recruit up to 50 participants from 
three home visiting programs (SafeCare at NorthCare, Latino Community Development 
Agency [LCDA], and Parent Child Center [PCCT]). All three of these programs utilize 
the SafeCare home visiting model, which includes modules on healthy parent-child 
interactions and promoting parenting skills in high-risk families. We plan to recruit 
existing and new families in these programs and randomly assign them to receive either 2 
weeks of the mHealth intervention + EMA data collection followed by 2 weeks of only 
EMA data collection or to receive 2 weeks of only EMA data collection followed by 2 
weeks of mHealth intervention + EMA data collection. All participants will receive both 
conditions in counterbalanced order.    
Study participation involves consenting to administrative record release and immediate 
baseline questionnaires assessing demographics, the child’s exposure to adversity, 
parental exposure to childhood adversity, parent’s emotional expression, emotion 
reactivity, and emotion regulation and the child’s emotion regulation and development, 
ecological momentary assessment (EMA) at fixed times twice a day (morning and 
evenings), and final assessments, which will be the same as the baseline assessments.  
EMA Only Condition In the EMA only condition, families will continue to receive 
services utilizing the SafeCare home visiting model, including modules on healthy 
parent-child interaction and promoting parenting skills in high-risk families, but they will 
not receive parenting tips via the mHealth app during this period. We plan to administer 
brief surveys via the mHealth app twice a day at pre-determined times (morning and 
evening). These surveys will ask parents to provide information about where they are and 

 
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with whom, their emotional state, recent parent-child interactions, current stressors or 
challenges, and their child’s emotional and behavioral functioning. Parents will receive 
these twice daily surveys every day for two weeks. 
mHealth Intervention Condition  
When families are in the mHealth intervention condition, the mHealth app will deliver 
parenting tips and strategies twice daily for 14 days. Furthermore, we plan to administer 
brief surveys via the mHealth app twice a day at pre-determined times (morning and 
evening). These surveys will ask parents to provide information about where they are and 
with whom, their emotional state, any recent parent-child interactions, and any current 
stressors or challenges. Parents will receive these twice-daily surveys and the parenting 
tips for every day for two weeks.  
Of note, during the 4-week EMA study, parents will receive either 2 weeks of the 
mHealth intervention + EMA data collection followed by 2 weeks of only EMA data 
collection or to receive 2 weeks of only EMA data collection followed by 2 weeks of 
mHealth intervention + EMA data collection. 
The order of mHealth intervention and EMA data collection will be counterbalanced 
across participants to allow for a within-subjects comparison. 
See the study diagram below for a visual depiction of our data collection schedule.   
 
 
 

 
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Research Questions 
This investigation will: (1) test a low-cost, far reaching, evidence-based intervention 
delivered via mHealth app technology, (2) examine the effectiveness of a mHealth app 
intervention at improving positive parenting practices, and (3) investigate within and 
between person differences via EMA thereby strengthening causal implications. This data 
will be used to inform the following key study questions: 
Research Question 1: How effective and feasible is a mobile-based parenting app 
intervention for parents participating in Home Visiting services.  

 
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Research Question 2: What is the impact of positive parenting practices on the promotion 
of child development?  
 
Data Sources 
Quantitative Researcher- Assisted Surveys and Assessments 
Participants will complete baseline and follow-up assessments with a trained research 
assistant. The parent receiving HV services with the index child will complete 
questionnaires assessing demographics, adversity exposure, positive parenting practices, 
child development, and relevant covariates and potential mediators/moderators.  
Ecological Momentary Analysis (EMA) Data 
Parents will be asked to complete brief surveys via the mHealth app twice a day at pre-
determined times (morning and evening). These surveys will ask parents to provide 
information about where they are and with whom, their emotional state, recent parent-
child interactions, current stressors or challenges, and their child’s emotional and 
behavioral functioning via the mHealth app.  
App Feasibility and Effectiveness Data 
We will also collect data on parents’ perceptions of app feasibility and effectiveness via 
survey and a focus group selected from a subset of the 50 participants (up to n =30). We 
will also track app use (e.g., assessment response rates, number of missing assessments, 
time spent on app, type of OnDemand content viewed) to provide insight into participant 
compliance and app interaction. 
Administrative Data 
The Oklahoma State Department of Health (OSDH) will provide access to administrative 
data housed in their centralized Efforts To Outcomes (ETO) data system in use by all 
Maternal, Infant, and Early Childhood Home Visiting (MIECHV) contracted agencies 
(which includes the three SafeCare programs participating in the proposed study). This 
system stores benchmark outcome data the research team can utilize to examine whether 
individual characteristics of parents and families (e.g., number of home visits, completion 
level of the SafeCare curriculum) predict app utilization outcomes. 
 
E. 
Procedures 
Recruitment and enrollment 
All participants in the proposed study will be recruited from three home visiting (HV) 
programs that deliver the SafeCare+ HV model, which includes modules on healthy 
parent-child interactions and promoting parenting skills in high-risk families. Families 
who are eligible for SafeCare+ services generally have one of the following risk factors: 
mental health issues, intimate partner violence, or substance abuse. We plan to recruit 
existing and new families in these programs and randomly assign them to one of the two 
counterbalanced intervention arms. 
Consenting procedures 

 
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All project consents and HIPAA forms will be collected electronically using REDCap 
regardless of if the assessment occurs in-person or via telehealth services. REDCap has a 
feature which allows for version control, automatic time and date stamp, and electronic 
signature (using a fingertip, computer mouse, or stylus on a tablet screen). After the 
consent and HIPAA forms are signed in REDCap, these documents will automatically be 
sent to and stored on the OUHSC secure server as .pdf files. An electronic version of this 
signed consent and HIPAA form can be emailed directly, or if the participant requests, a 
paper copy will be provided. If a participant requests additional time to discuss the study 
with family/friends, a paper or electronic copy of the forms will be provided to the 
participant to review. 
Quantitative procedures  
Baseline assessments. The research assistant will administer all baseline assessment 
measures in a virtual interview that will take place via zoom or phone (in person 
interviews in the participant’s home may take place if COVID-19 precautions are lifted). 
The parent receiving HV services with the index child will complete questionnaires 
assessing demographics, the child’s exposure to adversity, positive parenting practices, 
child development, and relevant covariates and potential mediators/moderators. (See list 
of measures below).  
  
Adversity exposures. Parents will report on their own (PHL ACEs) and their 
child’s (ACEs) adversity exposure. Children’s maltreatment exposure will be assessed 
via the Parent-Child Conflict Tactics Scale52 and the Child Abuse Potential Inventory.  
Positive Parenting Practices. Positive parenting practices will be assessed via the 
Alabama Parenting Questionnaire- Parenting Form.  Three subscales of relevance to the 
aims will be scored and assessed: Inconsistent Parenting, Punitive Parenting, and Positive 
Parenting.  
Child Development. The Developmental Profiles-4 will be administered to assess 
child development. This measure covers multiple domains of development including 
gross and fine motor skills, adaptive behavior, social-emotional functioning, cognitive 
functioning, problem-solving, and communication skills.  
Covariates. Relevant covariates and potential mediators and moderators include 
family demographics, parent mental health (Center for Epidemiological Studies 
Depression), parent emotional functioning (Self-Expressiveness in the Family 
Questionnaire, Emotion Reactivity Scale, Difficulties in Emotion Regulation Scale), child 
emotional functioning (Emotional Regulation Checklist), parent’s protective and 
compensatory experiences (PACEs), and family economic disadvantage (MacArthur 
Scale). 
These measures will be administered in the baseline and follow-up assessments. For the 
EMA portion of the proposed project at least one measure from each construct will be 
administered in a condensed, briefer format.  
 
Ecological momentary analysis (EMA) study. Parents will receive twice daily 
parenting tips and strategies throughout the day. These tips will focus on educating 
parents about positive parenting practices as a way to promote healthy development in 

 
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their child via an adapted SafeCare curriculum. Parents will also be asked to complete 
brief surveys via the mHealth app once a day at a pre-determined evening time. These 
surveys will ask parents to provide information about where they are and with whom, 
their emotional state, recent parent-child interactions, current stressors or challenges, and 
their child’s emotional and behavioral functioning. Parents will receive these once daily 
surveys and the twice daily parenting tips for two weeks. Of note, during the 4-week 
EMA study, parents will receive either 2 weeks of the mHealth intervention + EMA data 
collection followed by 2 weeks of only EMA data collection or to receive 2 weeks of 
only EMA data collection followed by 2 weeks of mHealth intervention + EMA data 
collection. The order of mHealth intervention and EMA data collection will be 
counterbalanced across participants to allow for a within-subjects comparison. 
Assessment responses will be continuously tracked and stored on a university data server. 
Additionally, a subset (n =30) of parents will be asked to participate in a brief focus 
group, during which parents will discuss their experiences with the mHealth app.  
 
Follow-up assessments. At the end of the EMA study, parents in both groups will be 
asked to complete a series of measures in the same manner as the baseline assessment. 
All measures completed at the baseline assessment will also be completed at follow-up. 
This final assessment will also include an ease of use and satisfaction survey about the 
overall app experience. 
Withdrawal criteria  
The participant will be withdrawn from the study at their request, or if the questions in 
the survey are causing severe emotional distress, she may be involuntarily withdrawn at 
the discretion of the PI. If they become incarcerated, they will also be withdrawn, but if 
they are released at a subsequent interview, they may be re-consented and resume the 
original data collection schedule. 
Disclosure to participants 
In the instance of clinically relevant research results affecting the health and well-being 
of the participant/child, participants will be contacted and notified. Published results 
using study data will be made available upon request to all participants. Identifiers might 
be removed and the de-identified information may be used for future research without 
additional informed consent from the subject. 
Information security  
All survey data are collected using REDCap. REDCap is a secure web application for 
managing survey data. REDCap allows for live data capture, meaning data are 
immediately stored on secure University servers. REDCap data may only be accessed by 
study staff using University encrypted devices. Access to study survey data is provided 
only to data collectors (so they may keep in contact with survey participants) and to 
personnel who will use data for analysis and reporting. 
All trial data related to the parenting intervention will be collected and monitored via the 
Insight mHealth Platform. The InsightTM Platform will enable the researcher team to 
create an innovative mobile application that: 1) identifies proximal and distal antecedents 
to imminent risk behaviors using self-report surveys (i.e., ecological momentary 
assessments [EMAs]); and 2) conduct a Just-in-Time Adaptive Intervention (JITAI) that 

 
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tailors intervention content in real-time based upon survey responses. InsightTM is utilizes 
a web-based content management system (CMS) for easy access across multiple 
browsers, and uses architecture that enables the incorporation of new features. Users of 
this service log into a web-based CMS and follow step-by-step guidance to create and 
manage research studies, enroll and monitor study participants, create EMA items, create 
different types of EMAs (e.g., random, daily, participant-initiated) and create specific 
assessment rules (e.g., two vs. four random assessments per day). Once study parameters 
and content have been created in the CMS, researchers transfer their study materials into 
the smartphone application shell. The customized smartphone application can be made 
available on the Android app store, and will soon be available on the Apple app store. 
Data are encrypted within the smartphone application and automatically and securely 
uploaded into mHealth servers. Encrypted data can be downloaded from the server by 
users at any time. The PIs will monitor the incoming data from the InsightTM platform on 
a monthly basis to ensure that the trial is conducted according to the approved protocol.  
All paper forms are kept in locked filing cabinets behind a locked door in an office 
requiring a security badge for entry.  
Consents will be collected electronically through REDCap and stored electronically on a 
secure OUHSC server. 
 
F. 
Inclusion / Exclusion Criteria 
Inclusion Criteria 
Any new or currently enrolled parent in Oklahoma or Tulsa County in MIECHV-funded 
SafeCare home visiting programs. 
Exclusion Criteria 
Parents residing outside of Oklahoma or Tulsa Counties will not be recruited (although if 
they move to another county between baseline and follow-up, they may be eligible to 
complete the follow-up survey at the discretion of the Principal Investigator).  
 
Parents who cannot read/speak English or Spanish at an 8th-grade level or higher will not 
be recruited. 
 
Parents under age 16 will not be recruited. Parents ages 16-17 meeting other eligibility 
requirements may be recruited using the assent form with signatures from both of his/her 
parents.  
 
G. Gender/Minority/Pediatric Inclusion for Research 
Women and minorities will be recruited as a part of this study, including pregnant 
women. Data collectors are trained on fully explaining the consent with the participant, 
including emphasizing the voluntary of nature of research and reminding them that 
refusal to participate will not affect services they would otherwise receive. 
 
H. 
Risks and Benefits 

 
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There is little-to-no risk to participant health, but there is a risk of some emotional 
distress due to the sensitive nature of some of the measures contained in the survey. The 
data collector will assure participants that refusal to respond to a particular question (with 
exception of certain demographic measures) or measure will not make them ineligible to 
participate. If a participant seems to be reacting negatively to items asked (e.g., questions 
about their history of trauma or intimate partner violence), the data collector may help the 
participant skip that specific measure.   
 
There may be some risks to privacy. This is addressed in the following section. 
Minimizing risks 
To address the risks related to information security, all survey data are collected using 
REDCap. REDCap is a secure web application for managing survey data. REDCap 
allows for live data capture, meaning data are immediately stored on secure University 
servers. REDCap data may only be accessed by study staff using University encrypted 
devices. Access to study survey data is provided only to data collectors (so they may keep 
in contact with survey participants) and to personnel who will use data for analysis and 
reporting. 
 
Data collected via the mHealth app are encrypted within the smartphone application and 
automatically and securely uploaded into mHealth servers. Encrypted data can be 
downloaded from the server by users at any time. All paper forms are kept in locked 
filing cabinets behind a locked door in an office requiring a security badge for entry. 
Consents will be collected electronically through REDCap and stored electronically on a 
secure OUHSC server. 
 
Describe potential benefits and importance to the participants and others 
There are no direct benefits to participating. Information obtained as part of this study 
will serve as pilot data for federal grant applications launching a more comprehensive 
expansion of the intervention study regionally and through our international 
collaborations. Moreover, this work will inform the feasibility and scalability of a novel 
intervention aimed at (1), the promotion of resiliency and child development in children 
growing up in high-risk environments, (2) the prevention of child maltreatment and early 
adversity exposure, and (3) the reduction of lifetime disease and health consequences 
linked to adversity. 
 
Discuss why risks are reasonable in relation to benefit 
The risks in this protocol are minimal to participants. Families are connected to SafeCare 
programs designed to improve child and family outcomes. The benefits of this study aid 
in the improvement of services for families exposed to adversity.  
  
I. 
Statistical Methods  
Data Analysis 
Analyses. Analyses will be guided by Drs. Bard (Quantitative Psychologist) and Chen 
(Biostatistician).  

 
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For Hypothesis 1a we will analyze the satisfaction and usability responses gathered at 
the post-intervention, follow-up assessment using descriptive and inferential statistics. 
Descriptively, we will report central tendency (means, medians) and dispersion (standard 
deviation, interquartile range) measures for response distributions. To evaluate the 
significance of app appeal, we will conduct one sample Wilcoxon signed rank tests to 
determine if the central location of the data departs from point values that reflect slight or 
minimal satisfaction/usability.     
Additionally, analysis of the qualitative focus group transcription will be completed using 
NVivo software. Broad themes within the transcription will be identified using a template 
approach67. Dr. Beasley (qualitative contractor) will code a sample and develop a specific 
codebook. Reliability will be established between Dr. Beasley and one of her graduate 
students. Themes identified from the focus group will be used to update and finalize the 
mHealth app for future grants and studies. 
Hypothesis 1b will involve mixed effects model analyses where positive parenting 
outcomes are regressed on a Tips indicator (tips delivered vs tips not delivered), a period 
indicator, and a random intercept term.  The period indicator will assess outcome 
variability associated with the first two weeks vs the last two weeks of app engagement. 
An interaction term between the Tips factor and period factor will also be examined to 
determine if the intervention effect differs by order of presentation. We expect that 
parents will evidence greater engagement in positive parenting practices on days when 
they receive the mobile-based parenting tips and strategies relative to on days when they 
do not receive this content. Assuming no Tips by period interaction, the focal effect for 
testing this hypothesis will be the main effect of Tips Delivered.   
Hypothesis 1c will be tested using a mixed effects model analysis where parenting 
subscale scores at baseline and post-intervention are regressed on an assessment time 
indicator, a randomization condition indicator, and a random intercept term. Assuming no 
interaction between assessment time and randomization group, the focal effect is the 
main effect of assessment time, which represents the pre-to-post difference in parenting 
scores.   
Hypothesis 2a will be analyzed in the same manner as Hypothesis 1b replacing the 
parenting outcomes with child challenging and positive behavior counts. The hypothesis 
of behavioral improvement during weeks where parents receive tips will be tested by 
focusing on the main effect of the Tips indicator.  
Finally, Hypothesis 2b will be analyzed in the same fashion on Hypothesis 1c.  We 
hypothesized the child development scores will increase at the post-intervention 
assessment and this will be evaluated by testing the main effect of assessment timing.    
Power Analysis  
Hypothesis 1a is largely descriptive in nature, but all other hypotheses involve inferential 
tests of a within-group (repeated measures) effect.  To evaluate statistical power, we 
calculated necessary sample sizes for a paired t-test. Analyses considered both a medium 
(0.35) and large (0.55) Becker g pre-post standardized mean difference ([Mpost – 
Mpre]/SDpre) under two pre-post correlation conditions.  With a Type I and II error set at 
0.05 and 0.20, we estimated necessary sample sizes of 79 and 34 for medium and large 

 
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effect detection with the pre-post correlation equal 0.40.  If the pre-post correlation was 
somewhat higher, at 0.60, necessary sample sizes drop to 54 and 23. Results suggest the 
study is powered to detect a moderate to large effect provided the pre-post correlation is 
of moderate strength.    
J. 
Data and Safety Monitoring Plan  
Participant safety will be monitored in the following ways. First, the service agency will 
routinely complete Critical Incident Reports (CIR’s) on all cases experiencing any sort of 
adverse event, regardless of whether the event might be related to study participation. 
This includes incidents such as any hospitalization, any child welfare reports, any serious 
medical condition, etc. This also includes incidents that are not adverse events such as 
unplanned dropout from service. The research team has established a procedure to 
receive these CIR’s electronically on all study subjects, and each report will be reviewed 
by the PI, and passed on to the IRB as prescribed in our IRB regulations. Second, data 
collectors are trained to recognize and report any potential adverse events they might 
observe or that are reported to them by participants. Other organizations, such as the 
OUHSC Institutional Review Board may inspect and/or copy research records for quality 
assurance and data analysis. 
 
K. 
Confidentiality  
All consent forms will be collected and retained automatically on the OUHSC server in a 
group user protected folder. If paper copies are collected, they will be scanned to the 
server and stored in a folder in a locked cabinet behind a locked door in CCAN (which 
also requires a security badge for entry). 
Data will be stored with identifiers for up to 10 years past the study conclusion date. 
Data will be stored in REDCap and on SQL Server. Some data may be manipulated and 
stored on the CCAN group rights protected folder on the server.  SQL Server and 
REDCap have user rights protected groups, and to access SQL Server, the user must be 
connected to Pulse Secure VPN.  
 
L. 
Literature Cited 
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2. Centers for Disease Control (2020). Adverse childhood experiences. 
www.cdc.gov/violenceprevention/aces   
3. Hughes, K., Bellis, M. A., Hardcastle, K. A., Sethi, D., Butchart, A., Mikton, C., ... & 
Dunne, M. P. (2017). The effect of multiple adverse childhood experiences on health: A 
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Giles, W. H. (2009). Adverse childhood experiences and the risk of premature mortality. 
American Journal of Preventive Medicine, 37, 389-396. PMID: 19840693 

 
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5. Bellis, M. A., Hughes, K., Ford, K., Rodriguez, G. R., Sethi, D., & Passmore, J. 
(2019). Life course health consequences and associated annual costs of adverse childhood 
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The Lancet Public Health, 4, e517-e528A PMCID: PMC7098477 
6. Bethell, C. D., Carle, A., Hudziak, J., Gombojav, N., Powers, K., Wade, R., & 
Braveman, P. (2017). Methods to assess adverse childhood experiences of children and 
families: Toward approaches to promote child well-being in policy and practice. 
Academic Pediatrics, 17, S51-S69. PMCID: PMC6035880 
7. Sege, R., & Linkenbach, J. (2014). Essentials for childhood: promoting healthy 
outcomes from positive experiences. Pediatrics, 133, e1489-e1491. PMID: 24799538 
8. National Academies of Sciences, Engineering, and Medicine. 2016. Parenting 
Matters: Supporting Parents of Children Ages 0-8. Washington, DC: The National 
Academies Press. 
9.  Sege, R. D., & Browne, C. H. (2017). Responding to ACEs with HOPE: Health 
outcomes from positive experiences. Academic Pediatrics, 17, S79-S85. PMID: 
28865664 
10. Healy, K. L., & Sanders, M. R. (2018). Mechanisms through which supportive 
relationships with parents and peers mitigate victimization, depression and internalizing 
problems in children bullied by peers. Child Psychiatry & Human Development, 49, 800-
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11. Morris, A. S., Silk, J. S., Steinberg, L., Myers, S. S., & Robinson, L. R. (2007). The 
role of the family context in the development of emotion regulation. Social Development, 
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12. Bethell, C., Jones, J., Gombojav, N., Linkenbach, J., & Sege, R. (2019). Positive 
childhood experiences and adult mental and relational health in a statewide sample: 
Associations across adverse childhood experiences levels. JAMA Pediatrics, 173, 
e193007-e193007. PMCID: PMC6735495 
13. Yamaoka, Y., & Bard, D. E. (2019). Positive parenting matters in the face of early 
adversity. American Journal of Preventive Medicine, 56, 530-539. PMID: 30772146 
14. Hutton, J. S., Phelan, K., Horowitz-Kraus, T., Dudley, J., Altaye, M., DeWitt, T., & 
Holland, S. K. (2017). Shared reading quality and brain activation during story listening 
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PMC5728185 
15. Olds, D. L., & Kitzman, H. (1993). Review of research on home visiting for pregnant 
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Teachers program with low-income parents and children. Topics in Early Childhood 
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Toward population impact from home visiting. Zero to Three, 33, 17. PMCID: 
PMC3606025 18. Johnson, S., Yamaoka, Y., & Bard, D. E. (2020, April). Putting the 

 
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HOME in Home Visiting: Evaluation of the Mediating Effect of Home Environment on 
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program: A longitudinal study on the effects upon depression, anxiety and parenting 
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