Randomized Controlled Trial of Prenatal Coparenting Intervention for African American Fragile Families
Phase: NA
Conditions: Parenting
Sponsor: University of South Florida

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
 
 
Cover Letter 
 
 
Randomized Controlled Trial of Prenatal Coparenting Intervention 
(CoparentRCT) 
NCT03097991 
 
Research Study Protocol 
Document Date 7.6.2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
Project Protocol:  Revision 24– July 7, 2020 
Randomized Controlled Trial of Prenatal Coparenting Intervention for African American 
Fragile Families (Alternative Title: Figuring it Out for the Child)  
James McHale PI  
 
1. General Information  
 
Strategies for addressing intractable disparities in the early development of African American 
infants must involve meaningful and sustained father engagement. Poor African American 
infants born to unmarried uncoupled parents are more likely to have such a presence by fathers if 
their parents create a positive coparenting alliance early on. No empirically-validated prenatal 
interventions that successfully encourage unmarried fathers and mothers to intentionally create 
enduring alliances in their babies’ best interest currently exist. The original IRB proposal for this 
project was submitted in April, 2015 in anticipation of funding ultimately secured on July 31, 
2015 from the National Institute of Child Health and Development. In the study, we are testing -- 
using randomized controlled trial (RCT) methodology -- the efficacy of the “Figuring It Out for 
the Child” (FIOC) intervention originally piloted as Pro00004412, and further studied in 
Pro00019385, New Applications for Promoting Coparenting Alliances in Unmarried Couples.  
 
FIOC was designed specifically to aid development of positive coparenting alliances between at-
risk (unmarried, uncoupled, low income) African American mothers and fathers having a first 
baby together. In the RCT,  randomly-assigned control group families (referred by already-
known referral agents and partners who worked closely with our team on the pilot projects) will 
receive Pinellas County services as-usual for pregnant parents and assistance of a Resource and 
Referral Navigator for referrals to desired community services (“Treatment as Usual”, or TAU). 
The remaining (experimental group) families will receive the same services and aid, plus the 6-
session FIOC prenatal intervention with a post-natal booster session. The first 150 families 
consented in will be assigned to groups via urn randomization.  The remaining families recruited 
up to 170 will be assigned to the experimental (FIOC) group to achieve  balance in  the number 
of families contributing postnatal follow-up data longitudinally in the two groups to allow 
minimally sufficient statistical power for analyses. The FIOC intervention addresses the 
importance of safe, healthy families for early infant development, the impact a cooperative and 
sustained coparenting alliance can have in promoting positive infant development, challenges 
unmarried parents face cultivating a coparenting alliance together when their commitment to one 
another as romantic or married partners is in doubt, and ways to surmount these obstacles, 
maintain rapport, and sustain a strong alliance.  
 
All 170 participating families, both at intake (prior to the intervention) and then again at 3 and 12 
months post-partum, will report beliefs about fatherhood; extent of depressive symptomatology; 
and quality of the mother-father partnership. State-of-the-field coparenting observations will be 
conducted at each follow-up, along with measures of parental stress, intimate partner violence 
(IPV), perceived coparenting support, father engagement, and infant socioemotional adjustment. 
Analyses will examine impact of the intervention on promoting more supportive, coordinated 
post-partum coparenting alliances and more positive adult and infant outcomes. Exploratory 
analyses will examine links between father involvement and child adjustment and whether this 
coparenting intervention also stands to prevent IPV. 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
 
2. Background information  
 
Strong, positive coparenting alliances play adaptive functions in a wide variety of family 
systems. Positive alliances foster competence in the parenting role, helping parents feel less 
distressed and more capable of handling challenges, protecting against abuse, and promoting 
healthy infant and toddler development (Fagan et al., 2007; Florsheim et al., 2003; McHale, 
2009; McHale & Lindahl, 2011, Minuchin, Colapinto & Minuchin, 2007). For unmarried parents 
in non-romantic relationships, the impediments to developing a positive coparenting alliance are 
formidable -- but must be overcome if fathers are to stay engaged and coparent their child 
(Carlson et al. 2008; Fagan et al., 2003; Fagan & Palkovitz, 2007). Most relationship 
enhancement efforts with higher-risk unmarried parents miss their mark. Dion and colleagues’ 
(2006) report on recruitment for the federally-funded Building Strong Families pilot study 
estimated that less than 1 in 10 families served by Healthy Start programs even qualified for BSF 
interventions based on project inclusion criteria (mother and father romantically involved, not 
living together). Hence despite its fine work, the HMI missed important opportunities to 
strengthen adaptations of many of the nation’s highest risk families. Problems connecting with 
and supporting high-risk families – including, and especially families of unmarried African 
American parents with young infants -- are deeply concerning. African American children 
experience significant health disparities that begin before birth and follow them throughout their 
lives (CDC Healthy People 2010 Database). Black infants remain over twice as likely as white 
infants to die before age one, to be born low birthweight, a core risk factor for infant mortality 
and childhood developmental disorders, and to continue to suffer childhood illnesses. A 
federally-sponsored African American Healthy Marriage Initiative (AAHMI) offered an 
intensive coupling focus that turned out to be in poor synch with the lived realities of many 
African American men and women in the underclass, where non marriage often owes to poverty 
and economic instability.  
 
Formidable relationship obstacles (gender mistrust; concerns about immaturity and readiness to 
commit, fear of or anger about sexual infidelity; children from prior unions) also influence 
strategic relational choices (Carlson et al., 2004; Edin, 2000; Furstenberg, 2001; McLanahan, et 
al., 2003; Ooms & Wilson, 2004). Low income young African American men encounter multiple 
barriers in their efforts to synchronize work and family participation (Roy, 2005), and many low 
income young African American women deliberately choose not to marry the fathers of their 
children if they believe the fathers will not be breadwinners (Wilson, 1987).  
 
This said, choosing to forego a committed marital relationship does not mean that expectant 
African American mothers in lower socioeconomic families exclude fathers from the lives of 
their children (Crosbie-Burnett & Lewis, 1993) or that expectant African American fathers 
abandon interests in their children. Though no published study has examined prenatal 
gatekeeping expectancies of primigravida African American women, Fragile Families and Well-
Being (FFWB) data indicate that 93% of expectant mothers surveyed reported wanting the 
child’s father involved in the baby’s life -- including two-thirds of mothers no longer even in 
relationships with children’s fathers when the child was born (McLanahan & Carlson, 2002). 
99% of expectant fathers surveyed reported a wish to help rear their child, and over 80% of 
FFWB fathers saw mothers episodically during her pregnancy. Hence at least during the 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
pregnancy, most first-time African American mothers are not harboring identifiable exclusionary 
beliefs about their baby’s father. 
 
For African American men, prenatal engagement is an important prognosticator of things to 
come. Early Head Start Research and Evaluation Project data indicate that in contrast to White 
and Hispanic fathers, whose non-residential status at birth is the best predictor of the timing of 
eventual inaccessibility to their children, the best predictor for African American fathers is 
whether they were involved during the pregnancy, not non-residential status at birth (Lamb et al, 
2009). Although African-American children are far more likely than Asian, Hispanic, or White 
children to know non-co-resident biological fathers (Avenilla et al., 2006), the nature of the 
coparenting alliance unmarried parents create (or fail to create) is a critical determinant of 
whether fathers stay involved. Coparenting between non-co-resident FFWB parents during 
infancy strongly predicted later father involvement, but early father involvement only weakly 
predicted later coparenting (Carlson et al., 2008). Prenatal fatherhood programs that promote 
father involvement without also helping mothers and fathers coordinate as coparents hence may 
also miss their mark (McHale, 2007; 2009); unwelcome father involvement triggers more, not 
less, coparenting conflict (Talbot et al., 2009). In the lone fatherhood intervention study 
examining both father involvement and coparenting as distinct outcomes, Doherty (2005) found 
desired intervention effects on early father engagement -- but no effect on coparenting.  
 
In Pro00004412 (supported by funding from the Brady Education Foundation), we established 
that the FIOC intervention successfully promoted improvements in unmarried African American 
parents’ rapport, problem-solving and communication. In Pro00019385, New Applications for 
Promoting Coparenting Alliances in Unmarried Couples, we established the feasibility of 
successfully delivering the intervention with positive outcomes to parents positive for minimal 
(or situational) intimate partner violence (IPV). The NIH study protocol (assessment, 
intervention, safety plan) diverges very little from the prior studies. The main difference is more 
extensive pre- and post- assessments and, of course, random selection for participation in the 
experimental group to receive the FIOC intervention. Any referred families with more significant 
and serious IPV are ineligible for participation in the study, as they were in the prior projects. 
 
3. Research questions, objectives and purpose:  
 
• 
Aim 1: To determine the efficacy of FIOC in positively affecting first-year coparenting of 
unmarried African American parents, relative to early coparenting of comparison families 
Hypothesis 1: Families who participate in FIOC will demonstrate more cooperation and 
better communication in their post-natal coparenting systems at 3 and 12 months post-
partum than families receiving TAU 
• 
Aim 2: To determine the efficacy of FIOC in affecting first-year parental adjustment. 
Hypothesis 2: Mothers and father who participate in FIOC will show greater decreases in 
depressive symptomology from prenatal to postanatal assessments than parents receiving 
TAU. 
Hypothesis 3: Mothers and father who participate in FIOC will show lower levels of 
parenting stress at 3 and 12 months than families receiving TAU.  
• 
Aim 3: To determine the efficacy of FIOC in affecting early child outcomes. 
Hypothesis 4: Infants whose coparents participate in FIOC will show a more advanced 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
triangular capacity at 3 and 12 months 
Hypothesis 5: Infants whose coparents participate in FIOC will show better regulatory and 
socioemotional competence at 12 months than control group children.  
• 
Aim 4: To determine the efficacy of FIOC in affecting father involvement 
Hypothesis 6: Fathers who participate in FIOC will show greater involvement at 3 and 12 
months post-partum 
• 
Aim 5: To determine whether increased father involvement is associated with better 
socioemotional adjustment by the baby 
Hypothesis 7: Children of more involved fathers will show greater regulatory and 
socioemotional competence at 12 months post-partum 
• 
Aim 6: To explore whether the FIOC intervention has an impact on the emergence of 
intimate partner violence (IPV) 
Hypothesis 8: IPV will be more likely to emerge during the child’s first year among TAU 
families than among families who complete the FIOC intervention 
• Aim 7: To determine whether enrollment numbers, randomization rates, retention rates, 
and comparative RCT outcomes differ as a function of active versus passive recruitment 
methods for unmarried mother-father dyads. 
Hypothesis 9: Proportions of enrollment and randomization and retention rates will favor 
families identified via self-referral (passive recruitment), while outcomes for families 
completing the intervention will not differentiate the two groups. 
  
4. Study design including information needed to answer the research questions:  
 
This is a prospective longitudinal study using a pre-post randomized controlled treatment design 
that will allow comparisons of the extent to which study participants in experimental and control 
groups show pre-to-post changes in family functioning.  
 
All families are seen initially for a PRE Intake assessment (Time 1), during which mothers are 
screened for prior or active IPV using valid, standardized instruments, an IPV Screen and the 
Revised-Conflict Tactics Scale (CTS2). If mothers report a history of IPV, they may under 
specified circumstances still be eligible to participate depending upon results of an assessment 
performed by trained project staff using the Danger Assessment Scale (DAS; Campbell 2003) as 
a screening instrument (see inclusion and exclusion criteria). If certain indicators are present in 
the mother's IPV screen/CTS2 assessments at baseline, the father will not be given the IPV 
screen/CTS2. If the father is not be given the IPV screen/CTS2 at pre-assessment, he will not be 
given the IPV screen/CTS2 at either post assessment time-point. The decision about whether to 
enroll a family reporting IPV is made in consultation with Co-PI Stover after the session 
concludes. Families are notified that they will receive a phone call within 48 hours appraising 
them of whether or not they have been chosen to take part in the study and, if they are chosen, 
which group (treatment or control) they will be assigned to. All families for whom levels of IPV 
are NOT of substantive concern and who are not found ineligible for other valid exclusion 
factors are randomized to one of the 2 groups and notified of their assignment. Those for whom 
IPV is a concern or who are ineligible for other reasons are notified that they were not selected.  
 
For those to be enrolled (projected to be the overwhelming majority of all screened families who 
complete the intake process), subjects are assigned to treatment conditions through urn 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
randomization, to maximize the likelihood that treatment groups will be balanced with respect to 
demographic variables (presence of children from prior unions) and prognostic variables 
(frequency of IPV). We will use a Microsoft Access-based program previously developed for the 
Yale Department of Psychiatry NIDA-funded Psychotherapy Development Center and used in 
prior studies by Co-PI Stover. In urn randomization, an algorithm modifies ongoing 
randomization probabilities based on prior composition of treatment groups, and maximizes 
multivariate equivalence of treatment groups (Stout et al., 1994). Thus, urn randomization offers 
the benefits of balancing allocation of important prognostic variables in treatment groups, while 
still retaining other benefits of random assignment (Wei, 1978). 
 
Once enrolled, parents assigned to the treatment group are contacted by the Intake Coordinator 
or Resource and Referral Navigator who introduces their mentors and delivers the participants’ 
gift cards for completing the intake assessment. Mentors arrange two initial 1-on-1 mentorship 
sessions with the parents, as per the FIOC protocol, after which the FIOC intervention 
commences. Families randomized to the control group are contacted by the Intake Coordinator or 
Resource and Referral Navigator, who schedules a meeting to deliver gift cards for completing 
the intake assessment. The R&R Navigator also provides a listing of existing Pinellas County 
Services and offers parents the opportunity to contact her at any time for assistance with referrals 
to Pinellas County services for pregnant or parenting families. All families, regardless of 
assignment, are also reminded about the follow-up assessments that will be completed at 3 
months post-partum; and at 12 months post-partum. A formal check-in will be completed at 1-
month post-partum (Congratulations on the birth card sent), and episodic newsletters and 
reminder texts (for families consented after January 30, 2017) will be sent at staged intervals to 
help keep in touch. Texts or phone calls to keep in touch will be sent to female participants by 
female staff only to ensure comfort of research participants.   
All study participants will be offered the opportunity to be seen for initial assessments, follow-
ups and mentoring sessions in person or via the Microsoft Teams platform.  
For families who will be seen via the telehealth option, mothers will have an additional meeting 
with the resource person prior to the assessment in order to ensure safety and comfort with 
proceeding in the study via telehealth. 
 
The project timeline and work plan are projected as follows: 
 
 Work Plan Timeline  
Major Activities per 6 Months
(Years 1-5) 
1-6 
7-
12 
13-
18 
19-
24 
25-
30 
31-
36 
37-
42 
43-
48 
49-
54 
55-
60 
Recruitment/Baseline 
Assessments (T1) 
 
 
 
 
 
 
 
 
 
 
Prenatal FIOC Intervention 
 
 
 
 
 
 
 
 
 
 
3 Month Assessments (T2) 
 
 
 
 
 
 
 
 
 
 
12 Month Assessments (T3)  
 
 
 
 
 
 
 
 
 
Analysis, Reports 
 
 
 
 
 
 
 
 
 
 
 
The table below summarizes major constructs of interest and timeline of administration.  
This is followed by summary descriptions of all measures. Individual scales and measures are 
embedded within an interview protocol. Response keys accommodate parents with poor reading 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
levels. In terms of participant burden, demographic and risk interviews (with surveys) average 45 
minutes; mother-father coparenting discussions (with debriefing) average 20 minutes, and post-
natal LTP assessments average 10 minutes inclusive of directions.  
Data Collection Measures, Schedule, and Respondent 
 
Measure 
Mother 
Father 
Baby 
B 
3P 
12P 
B 
3P 
12P 
B 
3P 
Risk History 
X 
 
 
X 
 
 
 
 
IPV (Conflict Tactics Scale) 
X 
X 
X 
X* X* 
X* 
 
 
Beliefs about Fathering 
X 
X 
X 
X 
X 
X 
 
 
The Role of the Father Questionnaire 
X 
X 
X 
X 
X 
X 
 
 
Depressive Symptoms 
X 
X 
X 
X 
X 
X 
 
 
Positive and Negative Quality Relationships 
Scale 
X 
X 
X 
X 
X 
X 
 
 
Collaboration/conflict (Coparenting Discussions) 
X 
X 
X 
X 
X 
X 
 
 
Parenting Stress Index 
 
X 
X 
 
X 
X 
 
 
Parenting Alliance Measure 
 
X 
X 
 
X 
X 
 
 
Coparenting during the LTP 
 
X 
X 
 
X 
X 
 
 
Father Engagement 
 
X 
X 
 
X 
X 
 
 
Infant Triangular Capacities (LTP) 
 
 
 
 
 
 
 
X 
Infant Socioemotional Development (BITSEA) 
 
 
X 
 
 
X 
 
 
Child Health Background Questionnaire 
 
 
X 
 
 
 
 
 
Note. B=Baseline; 3P=Post-Partum, 12P=12 months Post-Partum 
*Father is only administered the IPV screen/CTS2  at baseline if mother does not report 
certain levels/traits of violence, as specified in the IPV manual, on her IPV screen at baseline. 
Father is only administered the IPV screen/CTS2 at post assessment time points if he was 
administered the IPV screen/CTS2 at baseline. 
 
Measures 
Client Demographics – Detailed demographic and risk characteristics include age at intake, 
race/ethnicity, family composition, housing arrangements, employment status, relationship 
status, and prior substance, mental health and IPV issues. Demographic data are collected only 
once, at the pre-assessment prior to randomization. Data are continuously reviewed and updated 
throughout the study to identify and record any changes occurring in participant status. 
Psychiatric Symptomatology. Evaluated using select items from the Brief Symptom Inventory 
(BSI; Pearson, 2001) to determine if participants have concerning psychological symptoms that 
would prevent them from benefitting from study participation. The BSI helps make an 
assessment regarding inclusion vs exclusion at the pre-assessment prior to randomization, and is 
administered at subsequent assessments to establish whether any changes to client mental state 
have occurred since intake.  
 
Predictor Variables: Measures Taken at Time 1 Only  
1. Risk History reported by mother and by father: A scale assessing background degree of 
family risk is administered as a subset of the Time 1 protocol only.  

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
2. Early Childhood Adversity Risk Factors- are assessed using the standardized ACE 
screener, a validated demographic indicator of participant risk that is used nationally and 
allows comparison to other populations. The ACE is given once only at pre assessment. 
 
Outcome Variables: Changes in Measures Taken at Times 1, 2 and 3 
1. Intimate Partner Violence. IPV is estimated using the Revised-Conflict Tactics Scale 
CTS2; (Straus, Hamby, Boney-McCoy, & Sugarman, 1996).  Mothers and fathers report 
their own and their partners behaviors both over the preceding 12 months and over the 
lifetime of their relationship. Per the project’s Safety Protocol, fathers only receive the 
CTS2 if mothers’ screen does not reveal concern with serious IPV or dangerousness. The 
66-item CTS2 scale (33 behaviors or experiences, each asked once for respondent and 
once for partner) contains psychological aggression, physical assault, injury, and sexual 
coercion subscales (Straus et al., 2003). Response categories gauge the frequency with 
which acts were used during conflict with a partner in the past year, and include options 
of “Never in the last year, but it did happen before that,” and “This has never happened.” 
It has consistently been shown to have good reliability and validity.  The CTS2 is the 
most widely used measure in the research literature on IPV. 
2. Beliefs about Fathering. Positive beliefs about importance of father involvement rated by 
mother and by father will be assessed using a 6 item set for which national data exist. 
3. The Role of the Father Questionnaire.  The Role of the Father Questionnaire (ROFQ) 
measures the extent that a parent believes the father's role is important to child 
development (Palkovitz, 1984). The ROFQ contains 15 items. Subjects indicate their  
level of agreement or disagreement with each item on a 5-point scale. Total scores on the 
ROFQ can range from 15 to 75. Higher scores reflect attitudes that fathers are capable 
and should be involved with and sensitive to their children. 
4. Depressive Symptoms of mother and of father. The Edinburgh Depression Scale (Cox, 
Holden, & Sagovsky, 1987) consists of ten statements assessed on a 4-point scale (never 
to always). Reference is how the parent has felt over the past week. Each item is scored 
from 0 to 3, yielding a total range of 0–30.  
5. Overall Quality of Relationships as reported by mother and by father. Positive and 
Negative Quality in Relationships Scale (PANQIRS; Fincham & Linfield, 1997), a 6-
item global assessment of positive and negative relationship quality valid for use with 
unmarried partners (Mattson, Paldino & Johnson, 2007). 
6. Mother-Father Conflict and Collaboration during Coparenting Discussions.  Evaluated 
using a paradigm validated in the PI’s prior coparenting studies. Father and mother 
discuss areas of current child-related disagreement or uncertainty (e.g., overnights; 
paternal support; childcare; child temperament concerns; involvement of other kin 
caregivers; complications of children from prior unions). Raters observe and rate 
videotaped discussions using Lindahl and Malik’s (2000) System for Coding Interactions 
in Dyads (SCID). In the feasibility study, statistically-significant improvements were 
seen in SCID ratings of (increased) problem-solving communication; (increased) mother-
father cohesion; and (decreased) coerciveness 
 
Outcome Variables: Family and Child Measures Taken at Times 2 and 3 Only 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
1. Parenting and Coparenting Adjustment. Two sets of coparenting indicators and one 
parenting measure not yet possible to evaluate at Time 1 will be obtained as Time 2 and 3 
outcome measures: 
a) 
Coparenting: Felt Coparenting Support: Reported by both mothers and fathers, 
and a Assessed using Abidin and Konold’s (1999) 20-item Parenting Alliance Measure 
(PAM). The PAM is a five-point self-report scale (1 = strongly disagree; 5 = strongly 
agree), which evaluates how cooperative, communicative and mutually respectful parents 
are with regard to caring for the baby.  
b) Coparenting: Observed Coparenting Behavior during Trilogue Interaction. All 
families are assessed at 3-months and at 12-months post-partum in Fivaz-Depeursinge 
and Corboz-Warnery’s Lausanne Trilogue Play. The LTP has 4 parts: (a) first one parent 
plays with baby, other parent just present; (b) parents switch roles; (c) all 3 family 
members play together: (d) parents active and baby placed in the third party position. 
Coparenting during the LTP at 3 months postpartum is to be evaluated using the 3-month 
version of the Coparenting and Family Rating System (McHale & Coates, 2015). The 
standard CFRS is to be used to evaluate 12-month coparenting during the LTP. 
c) 
Degree of Parenting Stress: Reported by both mothers and fathers, and assessed 
using a 36-item Parenting Stress Index-Short Form, validated in a low-income, African 
American population (Reitman et al. 2002). The PSI-SF has 36 items from the original 
120-item PSI. Items are identical to those in the original version and yields scores on the 
following subscales: 1) Parental Distress, 2) Parent-Child Dysfunctional Interaction, and 
3) Difficult Child 
 
 
2. Father Engagement:  
a) Father engagement is assessed using relevant items from the HAPPI (Cabrera et al., 
2004). The HAPPI father-child engagement activities scale consists of 34 items on which 
the respondent reports the frequency with which various activities by the father with the 
child (socialization, management, didactic, physical play/warmth, and caregiving) took 
place over the past month. Questions are answered on a Likert-type scale from 1 (more 
than once a day) to 6 (not at all). 
b) Multiple measures introduced by the Fatherhood Research and Practice Network (FRPN) 
are also being used to estimate father engagement, coparenting decision making, and 
barriers to involvement at 3 and 12 months post assessment. Scales include the 
Fatherhood Research and Practice Network’s Father Engagement Scale (FRPN-ES, 
completed by fathers only), Maternal Gatekeeping Scale (completed by mothers only), 
Measure of Father’s Challenges (completed by fathers only) and Decision Making 
Responsibilities Scale (completed by both parents). Besides frequency of engagement, 
items from the HAPPI completed by both parents will be used to estimate father 
accessibility at both 3 and 12 month post assessment.  
c) The Father Involvement Scale (Hernandez & Coley, 2007) is comprised of a series of 
queries assessing fathers’ accessibility, responsibility, and involvement with the child.  
3. Infants’ Triangular Capacities. Infants’ deployment of attention and affect during the LTP 
interactions with their parents at 3 and at 12 months will be rated as follows: 
a. 
Gaze: Gaze frequency and duration (at mother’s face, at father’s face, elsewhere) 
will be coded.  

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
b. 
Affective configurations: Coding of affective configurations during periods of 
gaze at either parent, coded as social engagement, social monitoring, tense monitoring, 
active protest or non-engagement. 
c. 
Triangular bids: The term ‘bid’ covers infant response to parental solicitations as 
well as initiative by the infant. Four categories are coded: triangular engagement, 
triangular monitoring, triangular tension, and triangular protest. 
4. Child Health Background. Child’s health history during the first year of life will be assessed 
via a short self-report questionnaire.  
 
Child Outcome Measures at Time 3: An adapted version of the Infant Toddler Social 
Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006), comprised of the full Brief 
Infant Toddler Social Emotional Assessment (BITSEA) and select additional scale items from 
the longer ITSEA instrument, was developed in consultation with the scale’s author. The 
instrument measures both social-emotional/ behavioral problems and delays in competency for 
children ages 12-36 months. It is a 71-item parent-report index constituting of six sub-scales: 
Problem behavior, competence, compliance, negative emotionality, aggression, and sleep. 
 
5. Sample size justification:  
 
We employed a computer program provided by Murphy et al. (2009; the same information is 
available from the tables in Cohen, 1988) to compute the significance level required for a 
projected sample size, incorporating attrition estimates, of N=120 (60 each in the treatment and 
control groups, respectively). Assuming the null effect hypothesis and alpha set at .05 and power 
of .8, an F (1, 117) of 7.74 with a d = .514 is required for significance. Keeping the null 
hypothesis test, alpha .05 and lowering power to .5, an F (1, 117) = 4.03 with a d = .37 is 
required for significance. Drawing on effect size estimates from the feasibility study, even with 
low power (.5) resulting in a d=.37 we would be positioned to establish the effect of the FIOC 
treatment for 10 of the 12 FIOC variables (10 of the 12 SCID-evaluated couple problem-solving 
and communication variables summarized earlier had a d greater than .33).  
 
6. Sample type or inclusion and exclusion criteria for participating in the research:  
 
Inclusion criteria: Low-income, unmarried mothers and fathers, for whom the child will be the 
parents’ first baby together. The target population is African American, but mixed race parents 
may also enroll so long as at least one parent is African American. Underage parents (i.e., 16 and 
17-year olds) who are able to give consent for their own health care but may not be able to obtain 
parental consent for research because they are estranged from their parents/caregivers, would be 
offered the opportunity to take part in the project. For potential participants who wish to 
participate but are under 18 and not emancipated, we will assign a special advocate in situations 
where the participants’ parents cannot be contacted and/or parents refuse to talk to study staff. 
The advocate’s role will be to make certain that the minor parents understand the study fully 
before providing their informed consent to participate. The advocate will also sign the informed 
consent. This is an extra measure of protection for minor parents in fragile families and will 
allow them to participate and derive the benefits study participation offers. This exception to the 
normal consent process would be offered only to 16 and 17 year olds who are referred to and/or 
contact the study themselves and who expressly desire to take part in the project to derive benefit 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
from its opportunity to receive support in  pursuing resources for their child and family -- but 
who have indicated when describing their circumstances that although not legally emancipated, 
they cannot connect project staff to their parent or caregiver in order to obtain parental consent 
because they are estranged from and living apart from their parents or legal caregivers. All other 
minor parents will be recruited in the manner previously outlined to and approved by the IRB, 
taking part in the study only if they are legally emancipated or if written consent has been 
obtained from their parent or guardian.  
Exclusion Criteria:  Families will be excluded if they: 1) demonstrate evidence of psychotic 
symptoms or suicidal ideation on the Brief Symptom Inventory; 2) either partner has recently 
(over the past 12 months) been arrested and convicted for violence (assault) perpetrated against 
someone other than a current or former partner who is the co-parent of one of their children; or 
3) are deemed high risk or in need of more intensive intervention. Risk determination is made by 
weighing the parent’s report on the Danger Assessment Scale (DAS). As a rule of thumb, a DAS 
score of 9 or higher will result in automatic exclusion from the study. However, it is also 
possible that even with a score below 9, the parent may disclose one or more of the following 
issues during administration of the DAS, any of which would result in exclusion from the study: 
1) parent reports she has required medical care because of significant injuries due to his violence, 
2) parent says she fears for her life, 3) parent reports that the partner has threatened with a 
weapon and owns a gun or has a gun in the household; 4) parent reports that the partner has 
threatened to kill her; 5) parent reports that violence has escalated recently; 6) parent reports the 
partner’s use of illicit drugs such as cocaine, methamphetamines, hallucinogens, or opiates . 
7. Expected results of the research (reports, materials, discussion papers, contributions to theory):  
 
Results will equip the research team with answers to study objectives and determine whether 
there would be value in studying the curriculum in a future multi-site implementation trial.  
 
8. Study Staff 
 
1. James McHale, Ph.D., P.I. Will provide all project oversight; serve as IRB officer; 
ensure research integrity and compliance; chair senior staff and other relevant team 
meetings; supervise fidelity-monitoring efforts; oversee proper implementation of all 
protocols, data collection, evaluation of videotaped infant and family data, data 
management and entry, analyses, report writing, and dissemination of findings. 
2. Carla Stover, Ph.D., Co-P.I. Provide oversight of all clinical aspects of project related 
to IPV assessment and safety planning, including training of assessment staff and Mentors 
and oversight of randomization of cases with IPV or other mental health issues; monitoring 
of clinical operations, clinical consultation, filing for mandatory reporting, direction of 
safety monitoring team, and compliance of all staff with clinical protocols. Attend senior 
staffings and other relevant meetings. 
 
9.  The risks to the subjects:  
 
While this is considered to be a minimal risk study, there is always the possibility of adverse 
effects resulting from participation. These include:  
 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
1. possible violation of confidentiality,  
2. possible discomfort due to assessment procedures,  
3. possible embarrassment in disclosing sensitive personal information,  
4. possible disclosure of information about intended physical harm to victims or abuse/neglect of 
children that would need to be reported to the child welfare agency and an investigation of the 
allegations(s) and further action, as indicated, that could ensue,  
5. possible disclosure of homicidal or  suicidal thoughts, threats, ideation, attempts, or plans 
requiring mandatory reporting if participants are at imminent risk of endangering themselves or 
others.  
6. possible dissatisfaction with the assessment/intervention procedures  
 
Procedures for managing risks are described below.  
 
10. Any experimental procedures including the use procedures already being performed on 
subjects for diagnostic or treatment purposes. 
 
All participants will take part in the curriculum (6- pre-natal sessions and 1 post-natal session) 
designed to support families and strengthen coparenting relationships across the transition to new 
parenthood. Participation in the intervention is the only experimental procedure used in this 
project. The assessments families will complete have all been previously used by the PI and 
other family researchers in studies with similar populations.  
 
11. The potential benefits to subjects:  
 
All participants will share the potential to benefit from reflecting on the factors that promote 
their baby’s adjustment (and from the coherence provided by the framework of the study) from 
their time of enrollment through the post-intervention follow up. Analyses of data collected in 
Pro00004412 indicated that participant couples showed improvements in rapport, problem-
solving and communication, reductions in coparenting conflict, reductions in maternal 
depression, and improvements in views of fathers’ roles and responsibilities. Some families also 
voiced appreciation knowing that findings from the study might benefit other non-co-resident 
parents like them planning ahead for life of their baby. In addition to the anticipated educational 
and intervention-based benefits study participants accrue, information from the study about 
benefits of interventions for unmarried parents having their first baby together will be of further 
help to Pinellas County agencies providing services to at-risk parents, to parents, and most of all 
to infants, by significantly enhancing environmental supports during the baby’s first months of 
life. Program planners and others in the position to develop services for families outside of 
Pinellas will also benefit.  
 
12. Human subjects considerations including a description of the informed consent process:  
 
Participants who indicate interest after learning of the study from community partners are 
contacted by project staff and given details of study participation. Mothers who continue to 
express interest in the study are asked by project staff to notify fathers and provide contact 
information if fathers express interest. When so requested, staff meet individually at either 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
parent's residence or elsewhere agreed upon to provide specific details of the project and answer 
the parent's (and if appropriate, the LAR's) questions about the study. Female staffer will meet 
with both parents and male staffer will join her for the visit of the father, if deemed beneficial 
and/or desired by the participants. Informed consent for the participating mother and father is 
obtained only later, at the time they appear for their intake assessment session.  
 
If a parent who is aged 16 or 17 and who has self-identified as being interested in participating in 
the study advises the project staffer that they no longer live with the parent or guardian, the 
staffer asks whether the parent has gone through the legal proceedings to become an emancipated 
minor. If the minor parent has not, the staffer asks permission to speak with his or her parent or 
guardian to explain the study. If the minor parent does not think he or she would have any 
success in contacting his or her parent to ask the parent to meet the project staffer to learn about 
the project and to provide parental consent, the staffer will ask the minor parent to provide last 
known residence information for his or her parent or guardian. If the minor’s parent or guardian 
is unreachable or refuses to speak with the project staffer, the staffer will ask the minor parent if 
he or she is interested in enrolling in the project and providing the same adult consent to 
participate as any 18-year-old. Assuming so, parental consent would be waived, and the minor 
parent would be consented in as an adult and would sign the adult consent form. At the time of 
consent signing, a mental health professional (holding a LMHC license or a license in a related 
clinical field) who is unaffiliated with the research study but who knows and understands the 
community and works with young people in the census areas served by this project will be on 
hand to serve as an advocate for the minor parent and to ask of answer any questions on the 
minor parent’s behalf. This LHMC would be contacted by project staff in advance of the meeting 
where the minor parent is asked to give consent to assure that she is available to be at the 
appointment with the parent. The advocate will explain her role as advocate to the minor parent, 
and will sign the consent form below the minor parent’s name. A note would be made in the 
family’s chart documenting that this was an exception involving the waiver of parental consent 
as per stipulations established through IRB review.  
 
At the intake and then subsequently at the time of each follow-up assessment, participants are 
reminded that they may discontinue any procedure at any time, or withdraw from the study 
altogether, without prejudice, and afforded opportunities to ask questions about any facet of the 
study. 
  
We take great care to assure that neither participants nor their families feel any coercion to take 
part in the project, and that participation in the study is a positive and affirming experience for 
those who do take part. Study participants are assured that they are free to withdraw at any time 
without prejudice and will still receive payment for the segment of the research assessment in 
which they had been participating at the time of withdrawal. For participants with low literacy 
levels, consent materials are conveyed verbally and all surveys are administered as interviews.  
  
Obtaining Participant’s Consent when using telehealth via HIPAA-approved platforms for 
participation in research for eligible participants: 
• 
When enrolling a new participant in services, the following process will be followed, 
conveyed orally to the participant: 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
• 
A verbal description of the study adhering to the existing consent language followed by 
an obtaining and recording of the participant’s verbal consent. 
• 
For minors, because a parent or guardian is consenting to the disclosure of confidential 
information for the minor child who is an expectant parent, assuring that it is understood 
all involved in the participation of the minor in the study, again adhering to current 
approved consent language. 
• 
An assurance that FIOC will not disclose any identifying information except as allowed 
by law 
• 
An assurance that the participant has a right to withdraw consent at any time. 
• 
An explanation of how long their verbal consent to continue participation remains in 
effect, i.e. until their child turns one year old, at which time they will complete the final 
study assessment. 
 
 
Documenting consent process:    
1. When using telehealth via Microsoft Teams, after the above has been discussed verbally 
with the participant with all questions answered, the staff member will sign and date the 
consent form with the note regarding obtaining of oral consent.  
2. The participant will receive a copy of the consent sent to their phone or computer and 
will reply with the following text/email: “I read the FIOC consent and agree to participate 
in the study. Name and date.” 
3. The staff will then save a screenshot of the received text/email, print and place in the 
participant’s file. 
 
(a) Confidentiality Safeguards. To protect confidentiality, all information is de-identified so it 
cannot be associated with any individual. No one except authorized USF administration and 
project staff will ever have access to study records identifying subjects' names. Once participants 
have contributed data to the study, the key linking participant identities to the code numbers they 
have been assigned is kept securely and confidentially, accessible only to designated project staff 
supervised by the PI, and maintained for the duration of consent form storage. All information 
gathered will be used only for scientific, educational, or instructional purposes.  
 
13. Data and safety monitoring plan:  
 
In the project, 170 families will be referred to take part in the investigation and will receive 
support from a Resource and Referral Navigator in connecting to existing support throughout 
Pinellas County.  
 
The following descriptions are covered below:  
1. Monitoring of the recruitment, enrollment and retention activities  
2. Potential adverse events resulting from participation  
3. Procedures to safeguard against adverse events  
4. Response procedures for adverse events  

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
5. Reporting procedures for adverse events  
6. Oversight  
 
1. Monitoring of the recruitment, enrollment and retention activities  
An important aspect of this work is carefully monitoring the experiences of the enrolled families. 
The entire project team will be involved in this endeavor, but major responsibilities for 
connecting with families will be shouldered by the Recruiter/Intake Coordinator. Her role 
involves talking with parents who have signaled their interest and enrolling them in the study. 
Each week’s recruitment, enrollment and retention activities are reviewed by the project 
operations team, and appropriate strategies for improvement are identified and implemented. 
Retention of parents who have been randomized to the control condition is always of special 
concern; in this project, retention of control group parents is promoted by episodic contacts with 
the assigned Resource and Referral Navigator, a Congratulations card after the baby is born, and 
episodic staged reminder texts and newsletters. Retention of parents who have been randomized 
to the intervention condition is likewise supported by a R&R Navigator, and Mentors are also 
important to retention efforts with intervention group families.  All families will be contacted by 
female Resource and Referral Navigator and mentors throughout the study duration as is needed 
for scheduling, follow-ups on missed appointments, formal check-ins at 1 and 9 months 
postpartum, and planning for 3- and 12-month post-partum follow-up visits. When deemed 
necessary to ensure retention, fathers will be contacted for the above purposes by male staff 
members. In addition, families will be contacted more frequently (at least once-monthly) during 
periods of elevated local or national stress or unrest to ensure any emergent, unforeseen needs 
they may have for new resources get addressed. Should challenging issues arise, Clinical 
Supervisors, kept informed of family situations by project Mentors during weekly supervision 
meetings, help guide Mentors in responding to clinical challenges and monitor potential adverse 
effects in an ongoing way during supervision meetings. Monitoring can also occur at any time 
and with any required frequency in the event a situation qualifying as an adverse event occurs in 
between weekly supervision meetings. If clinically concerning scenarios of any sort arise, the 
Mentors first attempt to resolve the situation through consultation with clinical supervisors, who 
in turn report weekly (and more often if needed) to the PI and Co-PI. If resolution of a clinically-
concerning scenario cannot be reached through use of supervision and rises to the level of an 
adverse event, the clinical team (co-PI and clinical supervisor (informed by the Mentors) and PI 
coalesce to form a plan that is then reported to the project’s Data and Safety Monitoring Board, 
who comment on the plan and provide guidance. Expert consultant Anne Menard can also be 
available to consult as needed on cases requiring additional expert input. Families will be 
retained in the project so long as they continue to express interest in participation and can 
continue to be safely enrolled. If a family must be withdrawn from the project based on 
assessments of concerns around safety, unresolved trauma, or other level of psychological or 
medical need beyond that which the project can safely provide, appropriate community resources 
and referrals are provided to the parents.  
 
Parents who before or after referral express no interest in coparenting, whether owing to a history 
of domestic violence or for other reasons, will not be pursued for this study.  
 
2. Potential adverse events resulting from participation  
 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
As indicated in Question 9 above, potential adverse effects resulting from participation in study 
assessments include:  
1. possible violation of confidentiality,  
2. possible discomfort due to assessment procedures,  
3. possible embarrassment in disclosing sensitive personal information,  
4. possible disclosure of information about intended physical harm to victims or abuse/neglect of 
children that would need to be reported to the child welfare agency and an investigation of the 
allegations(s) and further action, as indicated, that could ensue,  
5. possible disclosure of homicidal or suicidal thoughts, threats, ideation, attempts, or plans,  
requiring mandatory reporting if participants are at imminent risk of endangering themselves or 
others.  
6. possible dissatisfaction with the assessment/intervention procedures  
 
3. Procedures to safeguard against adverse events  
 
Confidentiality Safeguards and Informed Consent  
Consent will be obtained by approved study staff overseen by the PI, who is responsible for 
integrity monitoring of the informed consent process. Legally emancipated parents are eligible to 
take part in the study without parental consent if they elect to do so. LAR permission is obtained 
for under-aged mothers and fathers co-residing with parents or guardians; approved study staff 
travel to the caregiver’s residence to explain the study and seek consent when teens express 
interest in participation.  They will also provide the LAR with a Consent Form along with the 
Recruiter’s number to call to talk about and discuss the study further if they wish additional time 
or information before making a decision about the teen’s participation.  A male mentor is 
available to travel to the residence to discuss the study and obtain consent if any parent or 
caregiver wishes. Ethical guidelines prohibit 14-17-year-olds who are not emancipated and not 
co-resident with legal guardians from participation in the study. In addition, ethical guidelines 
preclude from participation potential teen participants whose co-resident parents are not home 
during research member visits and do not coordinate with the USF research staff to discuss 
consent. Section 7.4.2 Waiver or Alternation of Informed Consent Process in the study 
dashboard describes circumstance where the need for parental consent for a participating minor 
may be waived. Consent documents describe the length of the study, benefits, risks, payment, 
confidentiality of records, and the voluntary nature of participation.  
 
All Mentors and assessment specialists receive detailed pre-project and ongoing in-service 
training on Intimate Partner Violence screening and safety plans. All research staff are trained in 
participant protections and maintain Human Subjects Research certification, renewed every three 
years.  Certificates are kept on file.  
 
Once participants do contribute survey, interview, or observational data to the study, the key 
linking participant identities to code numbers is kept securely and confidentially, accessible only 
to designated project staff supervised by the PI, and maintained for the duration of consent form 
storage. All data entered into REDCAP and analyzed using SPSS are identified by subject code 
number only.  
 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
The USFSP computing system used for this project is protected from outside access by a three-
tiered firewall system: the VMware Cluster is protected by Symantec End Point, Cisco Security 
Agent and access control lists (ACL). The software allows us to define rules that block any 
attempt to compromise the system. Logs are maintained and generate reports of access attempts, 
which are reviewed by the System Administrator.  
 
Prior to data analysis all identifying information except for participant IDs is removed from all 
data. No pictures or likenesses of study participants will ever be published or presented at 
scientific conferences without participants’ explicit written permission. No names of participants 
will ever be disclosed in publications or presentations.  
 
Discomfort Due to Assessment Procedures 
USF research staff will place a premium on establishing rapport with project participants to 
mitigate any potential discomfort due to assessment procedures. In addition, the USF research 
staff will strive to diminish additional concerns about assessment procedures via the informed 
consent process and assurance of confidentiality. Participants will also be reminded at each stage 
of participation that they may terminate participation in the project should their level of 
discomfort outweigh the potential perceived benefits of participation.  
 
Discomfort with Assessment/Intervention Procedures  
Mild discomfort from tasks in the coparenting intervention is expected. For some parents a 
childhood or earlier relationship history involving domestic violence, infidelity in the current 
relationship, and having other children with one or more different partners may all present 
stresses as parents work to strengthen their coparenting alliance. These issues will be dealt with 
in a sensitive and forthright manner during intervention sessions, and debriefed after sessions 
during clinical supervision.  
 
Mild discomfort may also be experienced by some participants during the prenatal or post-
partum assessment visit, or any of the FIOC intervention sessions. One source of discomfort 
during the assessment procedures may be the problem-solving discussion about areas of 
difference between the mother and father. To address any residual distress or arousal parents 
may be experiencing, parents will be asked to rate their current level of anger after the 
assessment has ended. Relaxation debriefing will be used if a client rates their level of anger as a 
4 (considerable) or 5 (very strong). The relaxation exercise is one that has been used successfully 
by the Co-PI in prior studies and is presented in a matter-of-fact manner if a parent ever rates 
themselves as a 4 or 5. Parents listen to a soothing relaxation audio called “Special Place”, after 
which they re-rate their anger. Further debriefing instructions are scripted into the protocol 
Assessors use with parents. A second source of discomfort can occur as parents consider and 
discuss unmet expectations of caregiving support. Third, there is always the possibility that high 
levels of depression and/or potential suicidal ideation even in this minimal risk setting could be 
disclosed by a parent during the assessment interviews and/or the intervention sessions. All 
assessors and mentors are experienced community-connected professionals who have also 
received training in the project’s Suicidality Protocol. Additional guidance is provided in the 
interview protocols for Assessors directing them to inquire should a parent report a recent 
increase in significant symptomatology. Assessors report this occurrence in an Assessor note 
they complete for every participant at the conclusion of pre- and post-natal interview 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
assessments. If the need arises, the project's Resource and Referral Navigator (following an 
assessment) or Mentors (following an intervention session), in consultation with the Co-PI 
and/or Clinical Supervisor, stand ready and are will be able to provide necessary referrals and/or 
access emergent care if ever needed..  
 
Embarrassment in Disclosing Sensitive Personal Information  
As part of establishing rapport, the Mentors and USF research staff will explain, both during 
outreach visits to families and again during the formal informed consent process, the study’s 
concern with potentially sensitive personal information relevant to understanding family 
adjustment. Participants will be assured that all such information will be kept confidential and 
will not be disclosed to parties beyond the research team.  
 
Mandatory Reporting Safeguards  
Procedures to prevent violation of confidentiality in accordance with reporting requirements are 
limited by the mandatory nature of these requirements. Parents will be informed in the consent 
document that staff must report to authorities 1) physical injury to any child caused by other than 
accidental means, as required by Florida Statute 39.201; and 2) information from a study 
participant which leads staff to believe a person is in imminent danger of physical harm. To 
further assure participant understanding of safety, a Program Agreement will be signed by both 
parents and Mentors at the first FIOC intervention session with Mentors. 
 
Disclosure of Domestic Violence  
Following consultation with local and national experts, we designed best-practice means of 
responding to any significant problems with IPV that surface. A Safety Protocol, developed 
together and reviewed annually with the project's nationally-recognized IPV expert consultant 
Anne Menard, details steps in responding to any IPV issues that may be encountered. 
Assessment staff and mentors are trained on the Safety Protocol prior to commencing their work 
with participants. They are also trained on mandatory Baker Act reporting procedures should a 
study participant ever become actively homicidal, and on a Suicidality Protocol that was 
developed should a parent ever express active suicidality. Relevant staff are trained in the 
procedure for assisting a study participant in the event a dangerous level of IPV is revealed by a 
participant. Staff are regularly provided updated trainings and in-services covering the 
consenting process, reporting responsibilities; interview administration, and response recording.  
 
Safety is our paramount concern. Any mother referred to the study who thought she would be in 
danger if she took part in a coparenting intervention with the father would not be recruited to the 
study, but instead would be referred to a community agency more properly situated to provide 
needed support services. The same is true if a family is assessed and reports a level of trauma 
beyond the capacity of the project to safely accommodate. If after a family has been randomized 
to the study, high levels of conflict without violence are reported or witnessed during the course 
of the intervention -- but the participating mother does not express concern that she is in danger -
- the female Mentor has been trained to work with the mother to identify a "mother-specific" 
mechanism for checking back in with her later, after the individual session ends, to ascertain (in 
an ongoing way, if indicated) whether all remains well. For higher-conflict couples randomized 
to the intervention, gender-specific individual preparatory sessions (part of the usual individual 
Mentorship meetings completed individually with mothers and fathers following the intake 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
assessment and before the FIOC curriculum commences) addresses with the parent how violence 
is bad for both the parents and the baby. Parents are enjoined to form a plan for safe, supportive 
participation in coparenting. After the individual mentorship sessions parents and Mentors come 
together for FIOC session 1, and at the end of this session all four individuals sign a Project 
Agreement symbolizing their commitment to a safe and violence-free pregnancy..  
 
Additional Staff Training Safeguards  
In addition to the opportunity for weekly clinical supervision, project staff who work directly 
with the mothers and fathers) also are provided both initial and ongoing trainings and in-service 
workshops that regularly revisit work with pregnant women, safety issues, Intimate Partner 
Violence and procedures in handling high levels of depression and suicidality.  These trainings 
are offered bi-annually or more frequently if needed. 
 
Dissatisfaction Safeguards  
Participants are encouraged to discuss with the project P.I. and/or relevant project staff any 
experiences of dissatisfaction with any assessment/intervention activity. Dissatisfaction disclosed 
by mothers or fathers will be shared among the PI, Co-PI and Clinical Supervisors.  As 
appropriate, relevant issues will be discussed in supervision and/or at team conferences or 
trainings. If ever needed, amendments would be made to the project protocol to respond to any 
recurring issues raised by multiple participants, while taking care to assure that any 
accommodations do not materially influence the integrity of the research protocol.. Referrals to 
appropriate community services will always be made at time in cases where project staff and 
participants concur that such referrals could be of help to the family.  
 
4. Response procedures for adverse events  
 
Discomfort with disclosure  
Participants will be reminded that their participation is voluntary and they may choose not to 
disclose any information that creates extreme discomfort for them.  
 
Mandatory reporting  
1. Suicidal thoughts, ideation, attempts, or plan  
 
Staff who work with families have been trained in the project's Suicidality Protocol. In the event 
of disclosures of suicidal ideation or thoughts by participants, appropriate referrals for 
counseling will be provided by the interventionists. In addition, the interventionists will notify 
the /Co-PI and Clinical Supervisor of such revelations. Disclosures of suicide attempts or plans 
will be handled by assisting the parent(s) with accessing services via the Pinellas Emergency 
Mental Health service system.  
 
2. Abuse/neglect  
 
In the event that child abuse or neglect is disclosed or observed (e.g., bruises, burns, or black-
eyes) whose origin appears to differ from the explanation given of the injury during the 
assessments or intervention, the Mentor will further question the participant(s) and obtain 
additional information. If any of the above conditions lead the Mentor to suspect abuse or neglect 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
of a child, the Mentor will compile a report from the collected information. Based on the 
information provided, the Co-P.I. and Clinical Supervisor will advise the Mentors regarding 
communication with parents, appropriate further inquiry, and proper reporting.  
 
3. Threat of danger to others  
 
Threats of danger to others include disclosure of potential physical harm by a participant to 
others, including members of the participant's family or other individuals in the community. 
Mentors will report such disclosures to the Co-PI and Clinical Supervisor. These disclosures will 
be handled in accordance with Florida law, requiring reporting to proper legal authorities by 
project staff.  
 
4. Family crisis  
 
Family crisis involves a range of situations that threaten the ability of subjects to provide 
essential supports for their children. Mentors will provide appropriate referrals to assist parents 
with relieving crisis situations.  
 
5. Domestic Violence  
 
A coordinated response to disclosures of domestic violence will be initiated, tailored to the 
particular issues disclosed during the intervention. All staff who work with families have been 
trained on the project's safety plans, and how to assist the mother in taking actions she has 
deemed appropriate to increase her safety. Plans can include, but not be limited to, project-
specific safety planning, working with CASA (Community Action Stops Abuse, 1011 First 
Avenue North, St. Petersburg), the local certified domestic violence center, taking steps to go 
into shelter, contacting law enforcement, obtaining an Injunction for Protection, and/or 
terminating participation in the project. The project safety plan is included as a separate 
document. 
 
5. Reporting procedures for adverse events  
 
Potential adverse events during assessments/intervention are limited to those described above 
and will be addressed in a timely manner by the Mentors, Co-PI, Clinical Supervisor and P.I.  
Reporting Procedure for Serious Unanticipated Adverse Events. In the event of any 
unanticipated serious adverse event, the P.I. will ensure that the event is reported to the proper 
authorities within 24 hours by phone, fax, and/or email and will submit a written report to the 
Program Official no more than two days later. The project staff will also utilize the following 
reporting procedures: 
 
1. When project staff and/or the P.I. become aware of a serious adverse event, reporting 
requirements must be implemented in a timely manner.  
2. The P.I. will complete an "Adverse Event Reporting Form" and submit the form to the 
University of South Florida IRB Officer.  
3. The IRB Officer immediately distributes the form to USF IRB Officials.  

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
4. The IRB Officer will convene an expedited meeting of the IRB either on site or via telephone. 
The IRB, with the input of the PI will review the study protocol and determine what further 
action to take based on the best interests of the participants and of the research.  
 
 
 
6. Oversight  
 
The Data and Safety Monitoring Board consists of 3 non-USF-affiliated field experts (Tricia 
Bent-Goodley, Bonnie Rosendale, Wendy Loomas) in randomized controlled trials and research 
and in working with fragile families and domestic violence. The Safety Officer, Stover, in 
consultation with supervisors and Mentors, will monitor potential adverse effects. When such 
occur she will be contacted immediately by supervisors who will be in position to ascertain in 
ongoing fashion whether any such events have occurred during the weekly supervision meetings 
(and more frequently, if adverse events occur between supervision meetings).  
 
If a serious adverse event (SAE) occurs that may be study related, the safety officer, Stover, will 
send a report to the DSMB along with the IRB for their review and recommendations about 
modification and continuation of the study.  Outside of SAEs, a quarterly DSM report will be 
prepared and sent to the board for review and their comment on continuation of the study will be 
attained. 
 
USF’s Human Research Protection Program (HRPP) is responsible for the general oversight for 
all grant activities at the university and will inform the P.I. about changes and requirements for 
the DSMP. The project will have a yearly review of its DSMP by the USF IRB during the 
continuing review process, outlining the following points:  
 
Reassessment of the risks and benefits to study participants  
Participant recruitment, accrual, and retention  
Data quality and confidentiality  
Consideration of external scientific or therapeutic developments with impact on the safety of 
participants or the ethics of the study  
Review any adverse events  
 
The HRPP will update the general DSMP procedures as needed.  
 
14. Research references: 
McHale, J. (2007) Charting the Bumpy Road of Coparenthood. Washington DC: Zero To 
Three Press. 
McHale, J. & Lindahl, K. (2011). Coparenting: A clinical and conceptual examination of 
family systems. Washington DC: APA Press.  
McHale, J., Salman-Engin, S. & Coovert, M. (2015). Improvements in unmarried African 
American parents’ rapport, communication and problem-solving following a prenatal 
coparenting intervention. Family Process, 54(4), 619-629. 
 

FIOC Project NIH Study Protocol, ver. 24- Revised 07.06.2020               IRB Number: Pro00021462 
Appendix A 
Community Recruitment Activities (Scope of Work)  
Completed by Community Development & Training Center (CDAT)  
During Fall/Winter 2019-20 
Responsive to Specific Aim 7 of USF’s NIH–sponsored FIOC project 
  
Community Development & Training Center (CDAT) will lead a collaborative media and 
marketing campaign to reach potential participants for the University of South Florida’s NIH-
supported “Figuring it Out for the Child” (USF FIOC) Program. The campaign will leverage the 
marketing reach and organizing capacity of several partner organizations, combined with the 
USF FIOC network of existing community contacts, to implement a comprehensive approach.  
Media partners to the campaign will include the following:  
• The New Image Project  
• Tampa Bay Breakfast Club  
• The Power Broker magazine  
• TheBurgVotes.com 
• The Weekly Challenger Newspaper  
• The Bulletin Newspaper  
• On the Beat St. Pete  
• 96.3 FM (radio)  
• 99.1 FM (radio)  
The campaign’s scope of work will include the following:  
• CDAT’s production of creative content including graphic designs (infographics, memes, and 
advertisements) and video interviews with parents who participated in the FIOC program and 
expressed their satisfaction with the program and their openness to being recontacted.  
• Print ad placements  
• Digital ad placements  
• Social media ad placements  
• On-air radio interviews and special programs  
• Facebook Live interviews and special programs  
• Print & digital articles (shared via social media)  
• Outreach for and facilitation of a Final Push Luncheon with Key Partners (targeting 
attendance by 50 partners and prospective partners and 4 media outlets)  
The campaign will operate from October 23, 2019 through March 1, 2020. New graphic content 
generated will be submitted for approval by Amendment through USF’s Internal review Board.  
The goal of the campaign is to generate as many as 65 new in-bound inquiries from prospective 
participants and for the inquiries to result in 20-25 new participants to help complete enrollment 
in the NIH-sponsored FIOC program.