Feasibility, Acceptability, & Preliminary Efficacy of Text4Father for Improving Infant & Family Health
Phase: NA
Conditions: Fathers, Mhealth, Mobile Health, Nuclear Family
Sponsor: Johns Hopkins University

Date: May 20, 2023 
Principal Investigator: Arik V. Marcell 
Application Number: IRB00226367 
 
JHMIRB eFormA  01 
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Official title: 
Text4Father Pilot Feasibility, Acceptability Study 
 
NCT number: 
NCT04101565 
 
Document date: 
5/20/2023 
 
 

Date: May 20, 2023 
Principal Investigator: Arik V. Marcell 
Application Number: IRB00226367 
 
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Version 3 Dated:   06/2007 
 
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JHM IRB - eForm A – Protocol 
 
 
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1. 
Abstract 
 
While father engagement programming is widely advocated, few clinical and public health approaches 
engage expectant fathers early during pregnancy or in the first months after an infant’s birth. A large 
body of literature shows that fathers play a key role in promoting child health and development 
beginning even before their children are born. Interventions to actively engage fathers, particularly early 
in pregnancy, have been shown to improve infant outcomes (e.g., physical, social, and emotional health 
and development), the well-being of the parents, and transform couples’ relationships, especially among 
lower income individuals. However, readily scalable approaches that effectively translate evidence-
based guidance to engage lower income fathers during the prenatal period to improve infant and mother 
outcomes are lacking. Not engaging fathers not only fails men, but also compromises the quality of care 
delivered to mothers and children. Our formative work demonstrates that lower income fathers identify a 
variety of infant care knowledge, skill, and support gaps and are interested to receive such information 
via a text-messaging platform. Further, substantial research supports the use of texting interventions for 
vulnerable and difficult-to-reach populations. Thus, a readily-scalable, easily adaptable intervention that 
could reach lower income fathers has the potential to substantially impact child, parent, and family 
health at the population level. 
 
Text4Father, a multi-modal texting program, is designed to increase first-time lower income fathers’ 
knowledge, self-efficacy, and behavioral engagement on parenting and infant care. In a prior approved 
protocol (IRB00117690), we conducted formative research with lower income parents of young children 
in Baltimore and found fathers had substantial gaps in their knowledge and skills during their child’s 
prenatal and early postnatal periods but wanted to have learned more about infant physical and cognitive 
development and skills related to feeding, personal care, and safety; having few resource supports. They 
also shared that getting such information via text messages would have been helpful for them – 
indicating initial proof of concept. As part of this formative work, fathers shared that their access and 
strategies to engage with their pregnant partner and infant depended on their residence status. We also 
conducted a 6-week Text4Father feasibility pilot with 25 adult fathers at the Hopkins Fetal Assessment 
Center and found that it was feasible to recruit fathers and fathers reported being satisfied with the 
texting platform and messages. In this Text4Father study, we propose to examine feasibility, 
acceptability, and preliminary efficacy of Text4Father through the latter half of pregnancy up to 
approximately 2 months of postnatal life. The partners (pregnant women) will also be recruited to 
compare outcome data and the fathers’ interactions with parents and other caregivers. Study results will 
help determine if using a texting approach can be successful in building a bridge to underserved lower 
income and non-resident fathers, and to inform a larger randomized controlled trial. 
 
2. 
Objectives  
Primary objective: To evaluate feasibility, acceptability, and preliminary efficacy of Text4Father 
through 2 months of postnatal age, and to generate effect sizes to inform a larger trial. 
Secondary Objectives 

Date: May 20, 2023 
Principal Investigator: Arik V. Marcell 
Application Number: IRB00226367 
 
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1. To demonstrate the feasibility of implementing Text4Father with lower income resident and non-
resident fathers in Baltimore, MD as evidenced by recruitment and retention in the intervention. 
2. To demonstrate acceptability of Text4Father as indicated by technology usability and acceptability, 
and intervention satisfaction among participating fathers. 
3. To demonstrate preliminary efficacy of Text4Father on fathers’ knowledge, beliefs, and self-
efficacy in parenting and infant care (primary outcomes) and partner relationship quality and infant 
care behaviors (secondary outcomes) compared to usual care through 2 months of age. 
 
3. 
Background  
Even before their children are born, fathers play an important role in promoting child health and 
development. Paternal engagement in the prenatal and infant periods is associated with improved infant 
outcomes (e.g., physical, social and emotional health and development), and parental well-being.1-14 
While father engagement programming is widely advocated,15-17 few public health and clinical 
approaches aim to engage expectant fathers during the prenatal period and first months after birth. This 
critical window of opportunity has been insufficiently leveraged to promote father engagement.18-22 Not 
engaging fathers fails men, but also compromises the quality of care delivered to mothers and children.19 
Improving father engagement in prenatal care could reduce healthcare costs; even a moderate 25% 
increase in father engagement would yield from $105 to $169 million in cost savings in annual U.S. 
healthcare expenditures.23 
Past research, including our own, indicates that fathers, particularly lower income and non-resident 
fathers, feel left out of maternity care and have gaps in infant care knowledge, skills, and support, 
especially in the first months after an infant’s birth.20-22, 24-26 Father inclusive perinatal education 
improves father involvement through increased knowledge and skills.1 Cooperative coparenting 
education also increases partner relationship quality and father involvement.1, 2 Promoting positive 
relationships among fathers, mothers, and other caregivers is key to engaging fathers over time,27, 28 
especially non-resident fathers who are often still in relationships with their partners29 and a growing 
population over the past 50 years.30 Fathers who are attached and bonded with their infant are also more 
likely to continue to be involved postnatally31 and through toddlerhood.32-35 
Potential strategies to reach fathers include the use of mobile health (mHealth). mHealth can improve 
upon traditional in-person approaches that have, historically, limited reach and capacity, not engaged 
fathers early, and not successfully recruited and engaged fathers in greatest need (e.g., lower income, 
non-resident).9, 36 Texting is used by almost all U.S. adults (93%).37 It has been shown to more 
effectively change health behaviors compared to other mHealth approaches (e.g., apps)38 while reaching 
more difficult-to-reach populations.39-42 Text4baby, a well-known mHealth program that promotes infant 
care, is designed with mothers in mind,43-45 but has limited content to support expectant fathers.45 Not 
surprisingly, less than 3% of its users are fathers.46  
We developed Text4Father, an evidence-based texting intervention, to increase expectant fathers’ 
knowledge, self-efficacy, and behavioral engagement in parenting and infant care. Informed by the 
Integrated Behavioral Model,47 Text4Father consists of approximately twice-weekly texts written at a 5th 
grade reading level starting mid-pregnancy and continuing through 2 months of age. Texts included 
resource links and instructions to support behavior change (e.g., videos, infographics), starting mid-
pregnancy and through 2 months of postnatal age. Text4Father is programmed to push/receive reminders 
to tailor content based on: gestational age/infant age after birth, and father’s resident status (i.e., whether 
father lives with mother and child). Text design and content were informed by: 1) systematically-
collected consensus-based expert feedback,48 2) evidence-based guidance,2, 49, 50 3) formative feedback 
with lower income resident and non-resident fathers and mothers in Baltimore,24 and 4) a 6-week 

Date: May 20, 2023 
Principal Investigator: Arik V. Marcell 
Application Number: IRB00226367 
 
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feasibility pilot with 25 fathers in Baltimore.51  
The research team is led by Dr. Arik V. Marcell, MD, MPH (PI), an Associate Professor of Pediatrics 
and Public Health and expert on men’s health. His research aims to examine ways in which to improve 
young men’s healthcare use, and providers’ delivery of quality of care to young men. He has led 
national efforts to inform clinical care guidelines for care delivery to reproductive-aged men and 
adolescents. He conducts community- and clinic-based research, including working with lower income 
fathers of young children, using mixed-methods and interventional approaches. Dr. Alain Labrique, 
PhD, MHS (co-I), an Associate Professor of International Health and Epidemiology who directs the 
Hopkins Global mHealth Initiative, contributes expertise on developing, implementing, and evaluating 
this mHealth intervention, including providing guidance on mHealth evidence reporting and assessment, 
metrics of program scalability, and mHealth monitoring and evaluation, based on guidance he developed 
in collaboration with the WHO and UN Foundation. Dr. Tim Nelson, PhD (co-I), a Senior Lecturer and 
Sociologist at Princeton University, contributes expertise on his research with fatherhood experience 
among inner-city men and recruiting and retaining lower income couples in longitudinal research. Dr. 
Sara Johnson, PhD, MPH (co-I), an Associate Professor of Pediatrics, contributes expertise on 
program evaluation with vulnerable populations and social influences in child development. Dr. Dustin 
Gibson, PhD (co-I), an Assistant Scientist of International Health, contributes expertise on applying and 
evaluating mHealth technologies to strengthen health systems and generate demand for health services, 
and serve as lead quality control-treatment fidelity technician for Text4Father. Dr. Kathryn Van Eck, 
PhD (co-I), an Assistant Professor of Psychiatry, contributes expertise on advanced biostatistics, 
research on parenting and child development, database design, data collection and management, staff 
training on data quality, and quantitative analyses. 
 
4. 
Study Procedures 
STATEMENT OF COMPLIANCE 
This acceptability, feasibility, and preliminary efficacy study will be conducted in accordance with 
International Council on Harmonisation Good Clinical Practice (ICH GCP), applicable United States 
(US) Code of Federal Regulations (CFR), and the NICHD Terms and Conditions of Award. 
 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
 
Figure 1. Overview of Study Procedures 
 
 
 
 
 Baseline survey: 
Time 1 
 
 Monitoring responsive texts: 
 
2 months 
 4 months 
6 months 
 Follow-up survey: 
 
 
 
 
 
Time 2 (7-months) 
 

Date: May 20, 2023 
Principal Investigator: Arik V. Marcell 
Application Number: IRB00226367 
 
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Table 1. Schedule of Activities 
 
Pre- 
screening 
Pre-
consent) 
Visit 1/ 
Time 1 
Text 1  
2 months) 
Text 2  
4 months) 
Text 3  
6 months) 
Visit 2/ 
Time 2 
7 months+/1
4 weeks) 
Review eligibility (phone/in-person) 
X  
 
 
 
 
Informed consent (phone/in-person) 
 
X 
 
 
 
 
Demographics/background characteristics 
 
X 
 
 
 
 
Outcome evaluation 
 
 
 
 
 
rent knowledge, self-efficacy, behavior survey 
 
X 
 
 
 
X 
Intervention acceptability survey 
 
 
 
 
X 
Monitoring responsive texts 
 
X 
X 
X 
 
Randomization 
 
X 
 
 
 
 
Control & Experimental Interventions – Text4Father 
 
X 
X 
X 
X 
 
Adverse Events Reporting 
 
X 
X 
X 
X 
X 
 
Setting. We will conduct this study and recruit participants in Baltimore. Baltimore is a community with 
marked health disparities related to maternal and infant outcomes. In 2015 in Baltimore, the infant 
mortality rate was almost 2 times higher for black (9.7/1,000 live births) than white infants (5.4/1,000); 
this rate was 1.3 times greater than Maryland’s rate;52 and 12% of babies born were low birthweight 
versus a national average of 8%.53, 54 Settings will include the Hopkins Maternal-Fetal Medicine (MFM) 
Clinic and Fetal Assessment Center where we successfully collaborated for the 6-week feasibility pilot 
that informs this proposal. Dr. Jeanne Sheffield, Professor and Director of the Johns Hopkins’ Division 
of MFM, facilitated MFM staff education for the pilot and is committed to ensuring this project’s 
feasibility. The Center sees over 21,000 fetal ultrasound exams and delivers over 2,400 babies each year. 
The majority of patients are publicly insured (62%) and half are African American. Based on our 
preliminary work, we estimate that 865 infants each year will have first-time lower income fathers.  
 
Participants and Recruitment. Research staff will recruit 120 adult expectant fathers and their female 
partners (120 pregnant females) (60 dyads per study arm) from the Hopkins’ MFM Clinic and Fetal 
Assessment Center to be enrolled through 25 weeks gestation. The index participant and their partner 
will contact study staff to be scheduled for a research visit. An eligibility screener will be individually 
completed with both members of the dyad to determine study eligibility. Our target is to have complete 
data on 48 dyads so we set sample size at 60 in order to account for attrition.   
We will use the following recruitment strategy: 1) upon entry into prenatal care, pregnant women 
will receive informational study flyers to contact study staff for participation and referral of their male 
partners; 2) we will actively recruit at prenatal and ultrasound visits since many fathers accompany their 
partners to these visits and clinic staff will call prior to appointments to share study information, assess 
interest, and if interested share to have father join them at their appointment when they can complete 
study procedures; and 3) we will recruit unaccompanied pregnant women and get permission to recruit 
their male partners. We will build on established relationships with other metro Baltimore MFM settings 
if we need other settings for this trial. We will also plan to disseminate study flyers and posters to post 
and distribute at other locations, such as adult outpatient settings, WIC, home visiting programs for 
pregnant and parenting families, and other OB settings, share existing recruitment materials (e.g., study 
flyer) via website posting, and social media (e.g., Facebook). We will also inform interested participants 
that they can refer other individuals to the study.  
 
Enrollment, and Consent. Recruiters will be available via phone during office and some evening hours 
for participant recruitment. Providers will refer eligible participants or expectant parents can contact 
study staff directly. Individuals who agree to be contacted will be approached by a recruiter in person or 
via phone and an eligibility screener will be individually completed with both members of the dyad to 

Date: May 20, 2023 
Principal Investigator: Arik V. Marcell 
Application Number: IRB00226367 
 
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determine study eligibility. If eligible, they will complete oral informed consent and intervention 
procedures. The index patient and partner will be consented individually. At enrollment, the research 
staff will perform a detailed review of the Text4Father study with informed consent, and collect baseline 
measures. Completion of informed consent will be documented in RedCap by study staff at the time of 
enrollment and online questionnaire will be automatically uploaded to a secure server for warehousing 
in a central database. This study will not involve linkage to medical records. 
 
Randomization Schedule will be set before the study and remain masked until after a father completes 
the consent process and baseline survey. Each father will then be randomly assigned to receive 
Text4Father or a usual care control arm to ensure group balance using a computer generated 
randomization assignment.  
 
Figure 2. Text4Father Study Recruitment Algorithm 
 
 
Intervention.  
Conceptual Framework. This study is informed by the Integrated Behavioral Model (IBM) that asserts 
behavior (i.e., father engagement) is influenced by core constructs of behavioral attitudes, perceived 
norms, and personal agency (Figure 1).47 Each construct is determined by underlying beliefs: attitudes 
are specific beliefs about performing a behavior, perceived norms are influenced by what others think 
about behavioral performance, and personal agency is one’s confidence to perform the behavior (self-
efficacy). Other constructs (e.g., background factors) influence behavior via these beliefs. Text4Father 
content focuses on improving fathers’ knowledge of infant development, father role beliefs, attachment 
beliefs, parenting self-efficacy, infant care self-efficacy, and cooperative coparenting (primary 
outcomes) 
that may 
result in 
increased 
partner 
relationship 
quality and 
behavioral 
engagement in infant care (i.e., specific activities and time spent with infant, use of infant safe sleep and 
Index Participant 
(Expectant mother 
or father)
Yes to 
Participation
Recruit partner & 
expectant father 
randomized to 
study arm
No to Participation or 
Unable to Recruit a 
Partner
Ask participant if 
she/he will complete 
brief refusal survey for 
self/partner
Complete Recruitment 
Screener  --> Eligible

Date: May 20, 2023 
Principal Investigator: Arik V. Marcell 
Application Number: IRB00226367 
 
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injury prevention behaviors) at follow-up. We are also interested to explore whether fathers’ baseline 
resident status, partner relationship quality, and caregiver conflict moderate the association between 
intervention receipt and study outcomes. 
Text4Father is a multi-modal texting program consisting of approximately twice-weekly texts written at 
a 5th grade reading level to initiate between 20-25 weeks gestation. Texts include resource links and 
instructions to support behavior change (e.g., videos, infographics) and start mid-pregnancy and 
continuing through 2 months of age. Text content provides a father with educational/informational 
guidance to support his infant, partner, and own well-being. Content was developed with feedback from 
the target population, consensus-building with experts, and an evidence-based review (see Prelim 
Studies). Text4Father is programmed to push/receive texts that tailor content receipt based on: 
gestational age/infant age after birth and father’s resident status, and will remind fathers to share 
updates. When developing texts, we relied on evidence about writing text messages for behavior change: 
1) using motivational language rather than just information; 2) actively involving learners with specific 
tasks to complete related to the desired behavior change; 3) sharing credible information; and 4) 
personalizing and tailoring messages. Personal health information will not be shared or requested as part 
of the text messaging platform.  
 
Table 1. Text4Father objectives, covered content, & example messages by fathers’ resident status 
 
 
We will use SMS services through a licensed commercial provider such as EngageSpark, TextNow, or 
RapidSMS for communicating with father and mother participants in all arms of the study. Each of these 
companies allow for texting and calling and can be enabled for use on a phone, tablet, or computer that 
makes this platform optimal for this study. Further, each of these companies has strict policies to protect 
the user to prevent unauthorized disclosure of information and physical, electronic, and procedural 
safeguards are in place according to industry standard procedures and security procedures. Research 
staff will be responsible for monitoring fidelity of the texts sent and using the online account to register 
and send any interim text-message to participants in the study. Since a telephone number is created with 
each account, the telephone number will be recognizable to participants as Text4Father communication. 

Date: May 20, 2023 
Principal Investigator: Arik V. Marcell 
Application Number: IRB00226367 
 
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Finally, all participants will be encouraged to use standard safety mechanisms such as a pin or password 
to lock access to their cell phones by others, if not already in place. 
 
Control Groups. The usual care arm will receive 3 interim texts (1 text each at 2 months, 4 months, and 
6 months) that will assess distress and perceptions of caregiver conflict between the father and other 
caregivers. The usual care arm will not receive any additional interaction since maternity care typically 
does not provide any organized educational approach.  
 
For ethical reasons all arms will receive at baseline a new parent handout about local birth 
resources/hotlines. 
 
End-of-Study Definition 
A participant is considered to have completed the study if he has completed the baseline assessment, 
participation in Text4Father if assigned to this study arm, and the 7-month follow-up assessment. The 
end of the study is defined as completion of the 7-month follow-up assessment as shown in the Table 1 
Schedule of Activities. 
 
Quality Control 
 
1. Quality Control-Treatment Fidelity. Drs. Marcell, Labrique, and Gibson will train and supervise 
research staff to ensure appropriate protocol execution. Research staff will activate Text4Father for 
consented participants randomly assigned to the intervention. Dr. Gibson will continually monitor and 
document fidelity via: 1) Technical functionality (Does technology operate as intended?) assessed by 
confirming that the system sends the welcome text and is received by participants at enrollment; 2) 
Technical stability (Does technology consistently operate as intended?) assessed by ensuring texts are 
consistently delivered as intended with minimum system failures/bounce backs. At the follow-up visit, 
study staff will ask participants assigned to the intervention arm to verify text receipt as well as to record 
unread texts. Study staff will ask them to open their phone to view the number of unread texts and then 
record the number of unread texts from Text4Father. If no texts are present, they will be asked why the 
texts were deleted. Study staff will also record texts that were received to ensure technical stability. The 
study team will also ensure 3) Technical quality assessed by keeping content up-to-date.  
 
2. Recruitment Screener. Includes collection of basic demographic data and the outcome of 
recruitment effort so that we can keep an accurate account of referral patients who are ineligible and/or 
refuse to participate in the intervention.  
 
3. Surveys. We developed a survey to collect information about fathers’ knowledge, self-efficacy, and 
behavioral engagement in parenting and infant care, as well as technology acceptability.  
 
From fathers, we will collect self-report responses about their background sociodemographic factors, 
including use of other pregnancy/parenting/infant care resources, perceptions of caregiver conflict, and 
about their infant, as well as their knowledge, self-efficacy, beliefs, and behaviors related to involvement 
in pregnancy and with their infant, cooperative coparenting, and relationship quality with partner and 
personal health behaviors, using a survey instrument at baseline and at 2 months of postnatal age (7-
month follow-up) in-person, via phone, or electronically via Qualtrics. At follow-up (7-months), we will 
also assess intervention fathers on technology usability, acceptability, and satisfaction. This survey takes 
about 40-45 minutes to complete.  
 
From mothers, we will collect self-report responses about their background sociodemographic factors, 
including use of other pregnancy/parenting/infant care resources, and their perceptions about fathers’ 
caregiver conflict, and about their infant, as well as their perceptions of father’s parenting and infant 
care self-efficacy, cooperative coparenting, relationship quality, and partner behavioral engagement in 

Date: May 20, 2023 
Principal Investigator: Arik V. Marcell 
Application Number: IRB00226367 
 
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infant care, using a shorter survey instrument at baseline and 2 months of postnatal age (7-month follow-
up) in-person, via phone, or or electronically via Qualtrics. This shorter survey takes about 15-20 
minutes to complete. 
 
Measures Table 
 
Item  
Variable 
# 
Content & references 
R 
Primary outcomes 
 
 
Infant develop. knowledge 30 
Higher score indicates higher knowledge of infant development55 
FR 
Father role beliefs 
15 
Higher score indicates more positive beliefs in father's role in child care56 FR 
Attachment beliefs 
35 
Higher scores indicate more positive beliefs about fetal/infant attachment57 FR 
Parenting self-efficacy 
17 
Higher score indicates greater confidence in overall parenting skills58, 59 
FR/MR 
Infant care self-efficacy 
15 
Higher score indicates greater confidence in infant care60  
FR/MR 
Cooperative coparenting 
10 
Higher scores indicate greater coparenting agreement & support61 
FR/MR 
Secondary outcomes 
 
 
Partner relationship quality 12 
Higher score indicates greater perceived partner relationship quality (T2)62 FR/MR 
Infant care behaviors 
 
 
Infant engagement 
17 
Higher score indicates higher father engagement in infant care activities63 FR/MR 
Time spent with infant 
2 
Days per week spent with infant; Hours per day spent with infant64 
FR/MR 
Safe sleep care 
14 
Higher score indicates greater adherence to 6 safe sleep AAP guidance65 FR 
Injury prevention care 
12 
Higher score indicates greater adherence to 5 child injury AAP risk areas66 FR 
Moderator factors 
 
 
Resident status 
3 
Living together with mother (current; history of gap; length of gap) 
FR/MR 
Caregiver conflict 
12 
Higher score indicates greater perceived caregiver conflict67, 68 
FR/MR 
Partner relationship quality 12 
Higher score indicates greater perceived partner relationship quality (T1)62 FR/MR 
Background factors 
 
 
About parents 
8 
Age, race/ethnicity, income, education, occupation, # people in household, 
relationship status, prior parenting experience, exposure to pregnancy/ 
parenting/infant care info69, father present at prenatal, birth, WCC 
FR/MR 
About father 
22 
Personal health behaviors (substance use, irritability) 
FR/MR 
About infant 
6 
Sex, gestation weeks, birth weight; WCC receipt 
FR/MR 
Process measures 
 
 
Technology usability 
12 
Higher score indicates greater technology usability70  
FR 
Technology acceptance 
8 
Higher score indicates greater technology acceptance71, 72 
FR 
Intervention satisfaction 
1 
Higher score indicates greater intervention satisfaction71 
FR 
R=Reporter; FR=Father report; MR=Mother report; WCC=Well-child care; T1=Time 1; T2=Time 2; AAP=Am Academy of 
Pediatrics 
 
b. Study duration and number of study visits required of research participants. 
The study will last 7 months. Participants will be recruited through 25 weeks of gestation and followed 2 
months after the infant’s birth. For fathers who meet the study criteria and consent to participate in the 
study, they will complete two study visits: a survey at baseline and another at 7-month follow up; fathers 
assigned to the Text4Father in the interim will receive approximately two texts a week for 7 months. For 
mothers who meet the study criteria and consent to participate in the study, they will complete two study 
visits: a shorter survey at baseline and another at 7-month follow up. All study participants (fathers and 
mothers)  will receive text at the beginning a flyer jpeg about the study to share with their partner and 3 
interim texts (1 text each at 2 months, 4 months, and 6 months) that will assess distress and perceptions 
of caregiver conflict between the father and other caregivers.  
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
This will not be a blinded study. The intervention consists of receiving text messages which, by 
definition, is a non-blinded activity.  
 
d. Justification of why participants will not receive routine care or will have current therapy 

Date: May 20, 2023 
Principal Investigator: Arik V. Marcell 
Application Number: IRB00226367 
 
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stopped. 
Not applicable.  
 
e. Justification for inclusion of a placebo or non-treatment group. 
Not applicable.  
 
f. Definition of treatment failure or participant removal criteria. 
For the purposes of this behavioral study, treatment failure is not applicable. Criteria for participant 
removal: if system error from text messaging platform indicates that a participant’s cell phone number is 
no longer active and we are unable to contact participants’ shared contacts after no more than 3 attempts 
with each contact in the first 10 days that is repeated no more than twice thereafter. 
 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
Participation in this study will not impact participants’ usual care regardless of how the study ends or if 
a participant’s participation in the study ends prematurely. 
 
5. 
Inclusion/Exclusion Criteria 
Inclusion criteria: In order to be eligible to participate in this study, an individual must meet all of the 
following criteria: 
1. Provision of signed and dated informed consent form 
2. Stated willingness to comply with all study procedures and availability for the duration of the study  
3. Self-reported expectant father and pregnant partner (expectant mother) 
4. Aged ≥18 years  
5. In a romantic relationship and expect to continue to be in this relationship during the study period 
6. Willingness to adhere to the Text4Father regimen (for fathers) 
7. English speakers only: The Text4Father content was not developed for use with non-English 
speakers or hearing-impaired individuals. Therefore, non-English speakers and hearing-impaired 
individuals will not be included.  
8. Lower socioeconomic status (SES) (e.g., less than a 4-year college degree,  or vocational/trade 
school or less, or qualify for Medicaid/public insurance) 
9. Access to necessary resources for participating in a technology-based intervention (i.e., cell phone) 
and willing/able to receive/send texts 
 
Exclusion criteria: An individual who meets any of the following criteria will be excluded from 
participation in this study: 
1. Individuals who are not able to provide informed consent.  
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
Not applicable 
 
b. Justification and safety information if FDA approved drugs will be administered for non-
FDA approved indications or if doses or routes of administration or participant populations 
are changed. 
Not applicable 
 

Date: May 20, 2023 
Principal Investigator: Arik V. Marcell 
Application Number: IRB00226367 
 
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c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.  
Not applicable 
 
7. 
Study Statistics 
Name 
Parenting Sense of Competence (PSOC) 
Type 
Primary 
Time Frame 
Baseline; post-treatment at follow-up 
Brief Description 
Measures parents’ perceived confidence (self-efficacy) with overall 
parenting and parenting skills 
 
Name 
Technology usability 
Type 
Other 
Time Frame 
Post-treatment at follow-up 
Brief Description 
Assesses technology usability among participants assigned to the 
intervention 
Name 
Technology acceptance 
Type 
Other 
Time Frame 
Post-treatment at follow-up 
Brief Description 
Assesses technology acceptance among participants assigned to the 
intervention 
 
a. Statistical plan including sample size justification and interim data analysis. 
Number of subjects expected to enroll: Total of N=240 (120 fathers; 120 mothers) or 60 couples per 
group (treatment, and standard of care control). 
 
Expected effect size: Moderate effect size (i.e., d ≥ 0.472). 
 
Power. We evaluated power for the fixed effects in a hierarchical linear model including four discrete 
covariates to consider the average rate of change in paternal parenting constructs due to the intervention 
over duration of the study time period. With a sample size of N=60 participants per study arm, we will 
have 80% power to detect moderate effect size (i.e., d ≥ 0.472) in outcomes. This power calculation 
also accounts for study attrition (anticipated at 20% loss to follow-up over the 7-month study period). 
We used one of the few studies that evaluated changes in parenting constructs comparing treatment for 
father engagement to a control group only at the end of treatment to inform these calculations and 
expected effect size.73 This study found treatment fathers had 12.7% higher paternal infant engagement 
at the end of the treatment compared to the control group; and parenting self-efficacy was 6.2% higher 
in treatment than in control group participants.73 
 
Statistical methods 
Aims 1 and 2. Feasibility and Acceptability. Using completed clinic appointment, screener, and 
consent data, we will assess feasibility of overall recruitment by calculating the proportion of eligible 
fathers who consent to study participation and recruitment by resident status. Based on our pilot work, 
we anticipate recruiting ≥70% of fathers who are approached. We will calculate feasibility of retention 
as the proportion of enrolled participants who complete 7-month follow-up survey (2-months of 
postnatal age). We will calculate study retention overall and separately by treatment assignment and use 
Chi-square tests to determine if we achieved follow-up of ≥80% by treatment assignment.  
In the Text4Father arm, we will calculate the proportion of individuals completing the 

Date: May 20, 2023 
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intervention and assess at exit these participants’ technology usability (12 items), acceptance (8 items), 
and satisfaction (1 item) (on 5-point scales from “strongly disagree” to “strongly agree”).70-72 We will 
examine whether we achieved ≥75% agree/strongly agree usability/acceptability rates and generate 
means (SD) for each. 
 
Aim 3. Efficacy. We will examine the effect of the randomization scheme and explore missing data due 
to survey non-response and attrition. We will then apply separate random intercept coefficient regression 
models for each study outcome accounting for two levels of nesting (repeated measures and 
individuals). Each model will estimate differences among intervention and usual care control arms 
identifying change in each study outcome between baseline and follow-up. This type of analysis will 
allow for examining 1) within-individual change over time in an outcome, accounting for dependency 
among observations within individuals by modeling within-person error,74 2) between-individual 
variation over time,75 and 3) between-subjects effects based on group assignment to identify significant 
differences in content (Text4Father) as compared to usual care. Our sample size should be large enough 
to adequately power analyses for examining change in fathers’ engagement (see below). The fixed 
effects from these analyses will help determine the expected effect size for other outcomes to inform 
power calculations for a larger R01-funded trial. 
Exploring moderating factors. We will explore the moderating effect of fathers’ resident status, 
partner relationship quality, and caregiver conflict from perspectives of both parents on the study’s 
outcomes given that each of these may influence fathers’ access and experience with infant engagement, 
as well as other background factors. These findings will inform sampling decisions and future research 
questions for a larger trial. We will also explore how infant sex as a biological variable might impact 
father engagement; however, this is not supported by past work in this area.  
We will also explore differences among intervention and usual care control arms for each maternal 
and infant outcome between baseline and follow-up. 
 
b. Early stopping rules. 
This study may be stopped prior to its completion if:  
(1) participants experience (adverse events) AEs or severe AEs (SAEs) that are felt to be related to study 
participation, at which point consideration will be given to temporarily or permanently suspending 
study activities and/or enrollment. This decision would be made in consultation with the study’s IRB 
and sponsor (NICHD);  
(2) difficulty in study recruitment or retention will significantly impact the ability to evaluate the study 
endpoints. The investigators will consult with the study monitors to assess the impact of significant 
data loss due to problems in recruitment, retention, or data collection; 
(3) any new information becomes available during the trial that necessitates stopping the trial; or  
(4) other situations occur that might warrant stopping the trial. 
 
8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
There are no significant medical risks involved in this study. This study falls in the category of “research 
not involving greater than minimal risk,” described by federal regulations as “the risks of harm 
anticipated in the proposed research are not greater considering probability and magnitude, than those 
ordinarily encountered in daily life or during the performance of routine physical or psychological 
examinations or tests.” Research in this category includes: “…confidential survey research that collects 
identifying information, with or without sensitive information.” 
 
This study will involve the use of surveys and receipt of text messages. All participants will be informed 

Date: May 20, 2023 
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that participation in the study is completely voluntary and will be reminded that they can decide not to 
answer any question on the brief survey and that they can stop participating at any time. Potential risks 
for participants who participate in this study include distress related to the research study (e.g., personal 
nature of questions asked). While the study will attempt to preserve patient confidentiality, there is 
potential for breaches of confidentiality, but miniscule given the limited number of personnel with 
access to participant information. It is also possible that by promoting father engagement, the 
intervention could increase friction between parents and/or other key caregivers that could also result in 
distress and/or conflict. However, past perinatal research focused on father involvement suggest that 
programs to enhance maternal-paternal relationships actually improve maternal mental health outcomes 
and has not found harms associated with father-mother relationships as a result of greater father 
involvement. We have developed a monitoring plan to assess for these issues and resources to refer 
participants as needed. 
 
b. Steps taken to minimize the risks. 
Human subject approval has been granted for prior formative work and pilot feasibility testing of this 
research protocol by the Johns Hopkins institutional review (IRB00117690) that has informed the 
current protocol. Significant attempts will be made to minimize risks to participants.  
 
The research team on this project has training and experience in the protection of human research 
participants and the treatment of protected health information as evidence by completion of their 
institutional compliance courses that are reviewed every 3 years per Johns Hopkins Medicine faculty 
and staff requirements. New staff without prior training must complete human subjects training through 
the Johns Hopkins Committee on Clinical Investigation courses as a part of orientation training and as a 
condition of their employment. All research staff who will conduct assessments and introduce program 
materials will also be trained about how to interact with participants in sensitive ways and watch for 
signs of distress during survey administration. Research staff will be supervised to ensure that they are 
following specified procedures. 
 
Regarding participant assessments, we do not anticipate medical risks to the participant related to 
completing study assessments. If a participant shows any sign of significant psychological distress, they 
will be referred to the primary investigator or to the emergency department for further evaluation and 
management. Participants in our pilot research did not display or report discomfort or distress as a result 
of assessment procedures. 
 
We have developed a monitoring plan to specifically assess fathers’ and mothers’ distress as a parent 
and perceptions of caregiver conflict between the father and other caregivers over the course of the 
study. We will assess all participants in the baseline and follow-up surveys and assess all mothers and 
intervention fathers at 2-month intervals using text message queries of abbreviated measures. Any 
participant with an affirmative response will be provided resources/hotlines about supporting partner 
relationships, reducing stress, and mental health, including the Hopkins’ Division of MFM’s Social 
Work team. The monitoring approach is as follows: 
 
For father participants 
• At baseline, all fathers will receive a new parent resource handout, including birthing support groups 
and resources/hotlines to support relationships, stress, and mental health, and study contact 
information to reach out at any point to study team members for assistance. 
• Fathers will receive additional interval texts that will query him on the following: 
Q1. How’s your relationship with your partner (better, same, worse)? 
Q2. How’s your relationship with other caregivers in your infant’s life (better, same, worse)? 

Date: May 20, 2023 
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Q3. Becoming a father can be stressful. Would it help you to talk to somebody for support (yes, no, 
unsure)? 
Any father who answers “worse” to Q1 and/or Q2, or “yes” or “unsure” to Q3 will be provided contact 
information for the Hopkins Division of MFM’s Social Work team and the study team, and a weblink 
that will host resources/hotlines that address stress/mental health and relationship supports. 
 
For mother participants 
• At baseline, all mothers will receive a new parent resource handout, including birthing support groups 
and resources/hotlines to support relationships, stress, and mental health, and study contact 
information to reach out at any point to study team members for assistance. 
• All mothers will also receive interval texts that will query her on the following: 
Q1. How’s your relationship with your partner (better, same, worse)? 
Q2. How’s your partner’s relationship with other caregivers in your infant’s life (better, same, worse)? 
Q3. Becoming a mother can be stressful. Would it help you to talk to somebody for support (yes, no, 
unsure)? 
Any mother who answers “worse” to Q1 and/or Q2, or “yes” or “unsure” to Q3 will be provided 
contact information for the Hopkins Division of MFM’s Social Work team and the study team, and a 
weblink that will host resources/hotlines that address stress/mental health and relationship supports. 
 
If participants reveal that they or their children are currently being abused or harmed in any way, or this 
is suspected, steps will be taken to ensure their safety, which may include contacting local authorities 
(e.g., law enforcement, child protective services). If participants exhibit behaviors that indicate they may 
hurt themselves or others, steps will be taken to ensure their safety, and the participant will be referred 
for appropriate psychiatric evaluation, as is standard medical practice. 
 
As previously noted, all participants will provide informed consent and will be informed that their 
participation in the study will have no effect on subsequent medical care, that their study participation is 
voluntary, reminded they can choose not to answer any item, and can stop participating at any time. All 
patient data will be kept confidential and secure.  
 
Due to the longitudinal nature of this study, we will collect tracking information from participants. We 
will assign a unique identification number to each participant as they enter the study that will allow us to 
link data over time and to their partner. We will maintain a separate database from participant response 
data that links a participant’s unique identification number to personal tracking contact information and 
to their partner to ensure integrity of participants’ identification number across time. This master list will 
be kept on a password protected computer in the PI’s locked office. All other data will be non-
identifiable. All identifying information will be destroyed using paper shredders upon completion of the 
study.  
 
The research team will manage data and maintain records for all collected data including data checking, 
cleaning, coding and entering. Standard security procedures will be followed, including use of password 
protection and secure daily backup and storage locations. We will develop a database management 
system for all collected data that will be confidential, accurate, and secure to house all data. Data will be 
collected and stored within JHU’s secure, institutionally managed REDCap survey and research 
database platform. Data transferred for additional analysis will take place within JHU’s virtual cloud 
storage and analysis platform (SAFE Desktop) that maintains HIPAA security standardsUse of a 
computer-based survey platform will minimize data entry errors and missing data. The data manager 
will perform weekly systematic protocols for data cleaning, and check for consistency and completeness 
(e.g., skip pattern error, duplicate or inconsistent responses). 

Date: May 20, 2023 
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Data Safety Monitoring Plan. The study will employ a data safety-monitoring plan consistent with 
NIH guidelines. Dr. Marcell will be responsible for monitoring and handling adverse events and will 
assume responsibility for the ethical integrity of the proposed work. All investigators and research staff 
will meet weekly and a portion of these meetings will be dedicated to communicating about ethical 
issues related to the study, including patient safety, changes in risk/benefit ratio, and regulatory issues.  
 
The PI will review the safety and progress of the study on an ongoing basis. Enrolled participants will be 
monitored throughout the study for untoward incidents (e.g., “Adverse Events”) occurring during the 
study. Study Reports will be generated focusing on subject recruitment, retention, and adverse events 
(AEs) that will give an in-depth synopsis of (1) study accrual; (2) reason for dropouts from the study; (3) 
whether all participants met entry criteria; (4) whether continuation of the study is justified on the basis 
that additional data are needed to accomplish the stated aims of the study; and (5) conditions whereby 
the study might be terminated prematurely. The PI and co-Investigators will conduct regular monitoring 
for enrollment rates, study data acquisition, and safety events, as a part of continuous oversight to 
comply with human subject safety requirements.   
 
Frequency of Monitoring 
The PI will review Study Reports (e.g., acquired data and available safety information) on a weekly 
basis and will share safety and progress reports with all co-Investigators on a weekly basis.  
 
Formal interim monitoring will be performed by the PI annually. For both continuous and interim 
monitoring, safety occurrences will be evaluated for severity, attribution, and possible trends. 
• All adverse events that are anticipated or described in the informed consent form will be logged 
appropriately and reported to the IRB on at least an annual basis (e.g., at continuing review). 
• Any Unanticipated Problems or unexpected “Serious Adverse Events” (SAEs) related to the study 
intervention and affecting the risk/benefit profile of the study, will be reported to the IRB promptly, 
and, in all cases, within 10 business days of discovery. 
• Unplanned and non-emergent deviations from the IRB approved protocol will be logged, include a 
corrective action plan, if necessary, and be reported to the IRB annually at continuing review; all 
planned deviations will be submitted as a Change in Research to the IRB for approval and prior to 
implementation. All other event reporting requirements will be followed and all necessary parties will 
be notified of events/problems encountered in the study and/or changes in research, in accordance with 
all applicable regulations and guidelines. 
Interim monitoring findings and corrective actions will be summarized in a report to be retained in the 
regulatory file. 
 
Study report outline (Interim or Annual Reports): The study team will generate Study Reports and will 
provide information on accrual rates, retention, adverse, and severe adverse events to track the study’s 
progress. Study Report tables will be generated using aggregate data (not by group assignment). 
 
REVIEW TABLE 
Data type 
Frequency of 
review 
Reviewer 
Subject accrual (including compliance with protocol enrollment 
criteria) 
Quarterly 
Investigators 
Status of all enrolled subjects, as of date of reporting  
Semi-annually 
Investigators 
Adherence data regarding study visits and intervention 
Quarterly 
Investigators 
AEs and rates (including out-of-range lab values) 
Semi-annually 
Investigators 
SAEs 
Per  
occurrence 
Investigators, Sponsor 
(NICHD) 
 

Date: May 20, 2023 
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c. Plan for reporting unanticipated problems or study deviations. 
Any unanticipated problems or adverse events will be reported to the IRB immediately. Deviations from 
the original study protocol will be requested through a change in research request. 
 
Collection and Reporting. For this study, the following standard AE definitions will be used:  
Adverse Event (AE): Any unfavorable and unintended diagnosis, sign (including an abnormal 
laboratory finding), symptom, syndrome, or disease which either occurs during the study, having been 
absent at baseline, or if present at baseline, appears to worsen. All adverse events will be recorded. 
Unanticipated Problems (UP): Unanticipated problems involve risks to subjects or others include, in 
general, any incident, experience, or outcome that meets all of the following criteria: 
− Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the IRB-approved research protocol and informed 
consent document; and (b) the characteristics of the subject population being studied; 
− Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
− Suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
Unanticipated problems will be recorded in the data collection system throughout the study. 
Serious Adverse Event (SAE): Any AE that results in any of the following outcomes:  
− Death  
− Life-threatening event 
− Event requiring inpatient hospitalization or prolongation of existing hospitalization  
− Persistent or significant disability/incapacity 
− An important medical event based upon appropriate medical judgment 
All serious adverse events will be recorded. 
 
Characteristics of an AE: 
Relationship to Study Intervention: To assess relationship of an event to study intervention, the 
following guidelines will be used: 
1. Related (Possible, Probable, Definite) 
a. The event is known to occur with the study intervention. 
b. There is a temporal relationship between the intervention and event onset. 
c. The event abates when the intervention is discontinued. 
d. The event reappears upon a re-challenge with the intervention. 
2. Not Related (Unlikely, Not Related) 
a. There is no temporal relationship between the intervention and event onset. 
b. An alternate etiology has been established. 
Expectedness of SAEs: The PI will be responsible for determining whether an SAE is expected or 
unexpected. An adverse event will be considered unexpected if the nature, severity, or frequency of the 
event is not consistent with the risk information previously described for the intervention.   
Severity of Event: We will use the following scale to grade adverse events: 
1. Mild: no intervention required; no impact on activities of daily living (ADL) 
2. Moderate: minimal, local, or non-invasive intervention indicated; moderate impact on ADL 
3. Severe: significant symptoms requiring invasive intervention; subject seeks medical attention, needs 
major assistance with ADL 
 
Reporting Procedures: The anticipated potential adversity inherent in participation is limited to those 

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situations described above and will be addressed by the timely intervention of research staff members 
skilled in risk assessment and mandatory reporting requirements.  
Reporting Procedure for Serious Unanticipated Adverse Events: In the event of an unanticipated 
serious adverse event occurring during study enrollment, the project PI will ensure that these events are 
reported to the IRB and sponsor (NICHD) within 7 days by phone, fax, and/or email. Incidents or events 
that meet the criteria for unanticipated problems require the creation and completion of an unanticipated 
problem report form. The following information will be included when reporting an adverse event, or 
any other incident, experience, or outcome as an unanticipated problem to the IRB: 
− Appropriate identifying information for the research protocol, such as the title, investigator’s name, 
and the IRB project number; 
− A detailed description of the adverse event, incident, experience, or outcome;  
− An explanation of the basis for determining that the adverse event, incident, experience, or outcome 
represents an unanticipated problem;  
− A description of any changes to the protocol or other corrective actions that have been taken or are 
proposed in response to the unanticipated problem. 
To satisfy the requirement for prompt reporting, unanticipated problems will be reported using the 
following timeline:  
− Unanticipated problems that are serious adverse events will be reported to the IRB and sponsor 
(NICHD) within 7 days of the investigator becoming aware of the event.  
 
AE Reporting of Non-Investigational New Drug (IND) Studies: SAEs that are unanticipated, serious, 
and possibly related to the study intervention will be reported to the IRB and sponsor (NICHD) in 
accordance with requirements.   
• Unexpected fatal or life-threatening SAEs will be reported to the IRB and the sponsor (NICHD) within 
3 days of the PI becoming aware of the event. Other serious and unexpected AEs related to the 
intervention will be reported within 7 days. 
• Anticipated or other SAEs will be handled in a less urgent manner but will be reported to the IRB and 
sponsor (NICHD), and other oversight organizations in accordance with their requirements.  
All other AEs documented during the course of the trial will be reported to the sponsor (NICHD) on an 
annual basis by way of inclusion in the annual report and in the annual AE summary which will also be 
provided to the IRB. 
 
Data Sharing Plan (as required per NIH guidance) 
Data Access and Security. Quantitative survey data will be de-identified (all sensitive identifiable or 
potentially identifiable information will be protected). Data will be stored on an enterprise network 
encrypted secure server for direct access at JH’s institutional OneDrive, which has HIPAA security 
levels, as a secondary location for data that has removed non-essential direct identifiers. No data will be 
used and/or released without prior approval by the principal investigator. Any activity through this site is 
log accessible to the editor. Any material with personal health information (i.e., consent forms with 
identifiers) will be kept separately from data in a key-locked filing cabinet in a secure/private office 
space during the project period and destroyed immediately after the project period. Appropriate consents 
for deposition of survey data into public databases for future use will be obtained through the formal 
consent process. 
Data Documentation. The research team will develop data documentation materials that describe the 
method of data collection, data codebook/data dictionary, and other documentation of the study 
variables that will be useful during later access by the study team and with the final archival files. 

Date: May 20, 2023 
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Data Archiving and Long-term Preservation. The final version of the collected dataset will be made 
available within thirty (30) months after the end of the data collection. For data underlying scientific 
publication, the data will be made available to coincide with publication of the paper, unless the dataset 
is already available via a release or sharing mechanism. At a minimum, release of the dataset will 
consist of a machine-readable version of the data tables shown in the paper. 
 
Datasets 1 and 2 (see table below) will be preserved and made accessible along with the data codebook 
and other relevant documentation via the chosen repository. We will make the data available through 
open access (Open Inter-university Consortium for Political and Social Research (ICPSR)) if possible. 
JHU School of Medicine will review the disclosure protection of the de-identified datasets. If they 
conclude that the risk of disclosure is too great for public access, then ICPSR’s Traditional Restricted 
Data or Physical Data Enclave will be used for some or all of the data, with restricted access solely to 
approved researchers. The project may consider the SOM’s fee-based service for de-identifying the 
dataset. Open ICPSR is a research data-sharing service of the Inter-university Consortium for Political 
and Social Research. ICPSR is a leading resource in the field for social science, government, and public 
health data and has a nearly 50-year track record for preserving and making data available. Through 
ICPSR, whether using the open archive or the restricted options, these particular research datasets and 
associated documentation will be preserved and made accessible to researchers in the social sciences, 
public health, medical communities, and beyond. JHU may provide a restricted access data repository at 
that time which we may consider as an alternative, as well as any repositories recommended by NIH for 
this grant. 
 
Datasets (Input and/or Output)  
Format(s)  Est size/amount  
Shared?  
1 Quantitative acceptability of technology 
usability, acceptance, and satisfaction data 
among father participants assigned to 
Text4Father 
CSV 
60 respondents 
Yes, de-identified or with 
restricted access only 
2 Quantitative baseline and follow-up data of 
father and mother participants in all arms 
CSV 
Baseline: 120 respondents  
Follow-up: 96 respondents  
Yes, de-identified or with 
restricted access only 
 
Descriptions of the data to be produced in the proposed project 
• Quantitative acceptability of technology usability, acceptance, and satisfaction data will be collected 
among father participants assigned to Text4Father.  
• Quantitative baseline and follow-up data will be collected among father and mother participants in 
all arms assessing fathers’ resident status, exposure to pregnancy/parenting/ infant care information, 
and caregiver conflict; and knowledge about infant development, beliefs about father role and 
attachment, self-efficacy about parenting and infant care, cooperative coparenting, relationship 
quality, and behavioral engagement in infant care, including safety/injury prevention. 
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
There are no anticipated legal risks associated with study participation except if participants reveal that 
they or their children are currently being abused or harmed in any way, or this is suspected. In these 
circumstances steps will be taken to ensure their safety, which may include contacting local authorities 
(e.g., law enforcement, child protective services). 
 
e. Financial risks to the participants. 
There are no anticipated financial risks to participations that are unaccounted for in the support and 
remuneration plan. 

Date: May 20, 2023 
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9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
All father and mother participants will receive information about local resources for new parents, and 
some subjects will receive additional knowledge, skills, and resources as part of Text4Father text 
messaging program. 
 
Despite well-documented benefits of early father engagement on child development and maternal and 
paternal outcomes, and fathers’ interest to learn how to be involved during maternity and infant care, no 
standard approach exists to engage expectant fathers, particularly lower income fathers, that can be 
easily disseminated. This feasibility, acceptability and preliminary efficacy study will provide important 
evaluation data for Text4Father and its ability to better meet the needs of lower income fathers, and 
improve fathers’ knowledge, confidence, and ability to be engaged during pregnancy and early infancy. 
The potential benefits of the knowledge to be gained from the proposed study outweigh the potential 
risks to the subjects. 
 
10. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, proposed 
bonus, and any proposed reductions or penalties for not completing the protocol. 
Father participants who consent, enroll, and complete the baseline survey will receive $35 in 
remuneration; mother participants who complete the shorter baseline survey will receive $15 in 
remuneration. After 7 months, father participants who complete the follow-up exit survey will receive 
$75 in remuneration and mother participants who complete the shorter follow-up exit survey will receive 
$40. Remuneration accounts for incentives and costs related to participating in the study (e.g., 
transportation, receiving/sending mobile phone text messages, data associated with viewing internet-
related resources on phone, etc.). For retention, participants will be instructed to share with us any 
changes in their contact information or mobile phone number and $5 gift cards will be provided to 
participants who contact us with any changes during the course of the study period. Participants who 
refer others who complete an eligibility screener will also be provided a $5 gift card. 
 
11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them. 
There are no anticipated costs to participants that are unaccounted for in the support and remuneration 
plan for the study and/or usual care. 
 
12. 
References 
 
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Systematic Review. Pediatrics. Jul 2018;142(1). 
2. Marcell AV, Aqil A, Johnson S, Labrique AB, Nelson T, Allport BS. Systematic literature synthesis of interventions 
with fathers from pregnancy through early infancy. Maternal and Child Health Journal (manuscript under preparation). 
3. Alio A. Rationale and strategies for engaging fathers in maternal and infant health programs: A Summary of Promising 
Practices. Rochester, NY: University of Rochester Medical Center, NYS Maternal & Infant Health Center of Excellence; 
2017. 
4. Allen S, Daly K. The Effects of Father Involvement: An Updated Research Summary of the Evidence. Guelph, ON: 
Centre for Families, Work & Well-Being, University of Guelph; 2007. 
5. Yargawa J, Leonardi-Bee J. Male involvement and maternal health outcomes: systematic review and meta-analysis. J 
Epidemiol Community Health. 2015;69(6):604-612. 

Date: May 20, 2023 
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6. Sarkadi A, Kristiansson R, Oberklaid F, Bremberg S. Fathers' involvement and children's developmental outcomes: A 
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8. Alio AP, Salihu HM, Kornosky JL, Richman AM, Marty PJ. Feto-infant health and survival: Does paternal involvement 
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9. Panter-Brick C, Burgess A, Eggerman M, McAllister F, Pruett K, Leckman JF. Practitioner review: Engaging fathers--
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10. Palkovitz R. Fathers' birth attendance, early contact, and extended contact with their newborns: a critical review. Child 
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11. Rominov H, Pilkington PD, Giallo R, Whelan TA. A systematic review of interventions targeting paternal mental health 
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12. Magill-Evans J, Harrison MJ, Rempel G, Slater L. Interventions with fathers of young children: Systematic literature 
review. J Adv Nurs. 2006;55(2):248-264. 
13. Shorey S, He HG, Morelius E. Skin-to-skin contact by fathers and the impact on infant and paternal outcomes: An 
integrative review. Midwifery. 2016;40:207-217. 
14. Garfield CF, Clark-Kauffman E, Davis MM. Fatherhood as a component of men's health. Jama. 2006;296(19):2365-
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15. Yogman M, Garfield CF. Fathers' roles in the care and development of their children: The role of pediatricians. 
Pediatrics. 2016;138(1):e20161128. 
16. Johnson K, Posner SF, Biermann J, et al. Recommendations to improve preconception health and health care--United 
States. A report of the CDC/ATSDR Preconception Care Work Group and the Select Panel on Preconception Care. 
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17. Office of Child Support Enforcement, Division of Policy and Training. Final Rule: Flexibility, Efficiency, and 
Modernization in Child Support Enforcement Programs. Federal Register. 2016;81(244):93492. 
18. Lu MC, Jones L, Bond MJ, et al. Where is the F in MCH? Father involvement in African American families. Ethn Dis. 
2010;20(1 Suppl 2):S2-49-61. 
19. Burgess A. Fathers and Parenting Interventions: What Works? Preliminary Research Findings and Their Application. 
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