Working out dads (WOD): a study protocol for a randomised controlled trial of a group-based peer support intervention for men experiencing mental health difficulties in early fatherhood.

BACKGROUND: Approximately one in ten men experience mental health difficulties during the early years of fatherhood, and these can have negative impacts on children and families. However, few evidence-based interventions targeting fathers' mental health are available. The aim of the trial is to evaluate the effectiveness and cost-effectiveness of Working Out Dads (WOD) - a facilitated peer support group intervention for fathers of young children, in reducing psychological distress and other mental health symptoms. METHODS: This trial will employ a parallel-arm randomised controlled trial (RCT) to evaluate the effectiveness and cost effectiveness of WOD peer support group intervention compared to usual care (a 30-min mental health and service focused phone consultation with a health professional). A total of 280 fathers of young children (aged 0-4 years) who are experiencing mental health difficulties and/or are at risk of poor mental health will be recruited. Randomisation and analyses will be at the level of the individual participant. The primary outcome is psychological distress symptoms, measured by the Kessler Psychological Distress Scale (K10) from baseline to 24 weeks post randomisation. A range of secondary outcomes will be assessed including suicidal ideation; mental health disorders, specific symptoms of depression, anxiety, and stress; social support, quality of life, health service use, and health care costs. Data will be collected at baseline, 10- and 24 weeks post-randomisation. DISCUSSION: This trial will examine the effectiveness of a novel group-based peer support intervention in reducing the psychological distress and other mental health symptoms of fathers compared to usual care. The economic and process evaluation will guide policy decision making along with informing the future implementation of WOD on a larger scale if effectiveness is demonstrated. TRIAL REGISTRATION: The current trial has been registered with ClinicalTrials.gov (Registration ID - NCT04813042 ). Date of Registration: March 22nd, 2021.

Pregnancy Risk Assessment Monitoring System for Dads: A piloted randomized trial of public health surveillance of recent fathers' behaviors before and after infant birth.

BACKGROUND: Becoming a father impacts men's health and wellbeing, while also contributing to the health and wellbeing of mothers and children. There is no large-scale, public health surveillance system aimed at understanding the health and behaviors of men transitioning into fatherhood. The purpose of this study was to describe piloted randomized approaches of a state-based surveillance system examining paternal behaviors before and after their infant's birth to better understand the health needs of men and their families during the transition to parenthood. METHODS: During October 2018-July 2019, 857 fathers in Georgia were sampled 2-6 months after their infant's birth from birth certificates files and surveyed via mail, online or telephone, in English or Spanish, using two randomized approaches: Indirect-to-Dads and Direct-to-Dads. Survey topics included mental and physical health, healthcare, substance use, and contraceptive use. FINDINGS: Weighted response rates (Indirect-to-Dads, 33%; Direct-to-Dads, 31%) and population demographics did not differ by approach. Respondents completed the survey by mail (58%), online (28%) or telephone (14%). Among 266 fathers completing the survey, 55% had a primary care physician, and 49% attended a healthcare visit for themselves during their infant's mother's pregnancy or since their infant's birth. Most fathers were overweight or had obesity (70%) while fewer reported smoking cigarettes (19%), binge drinking (13%) or depressive symptoms (10%) since their infant's birth. CONCLUSIONS: This study tests a novel approach for obtaining population-based estimates of fathers' perinatal health behaviors, with comparable response rates from two pragmatic approaches. The pilot study results quantify a number of public health needs related to fathers' health and healthcare access.

Outcomes from birth to 6 months of publicly insured infants born to mothers with severe acute respiratory syndrome coronavirus 2 infection in the United States.

OBJECTIVES: We evaluated inpatient management, transition to home, breastfeeding, growth, and clinical outcomes of infants born to mothers diagnosed with SARS-CoV-2 infection in pregnancy and followed in a Federally Qualified Health Center (FQHC), that serves a diverse and low-income patient population, from birth through 6 months of life. METHODS: Infants born between 4/3/20 and 7/26/20 at Prentice Women's Hospital with mothers who received prenatal care at Erie Family Health Center (Erie), the second largest FQHC in Illinois, and had confirmed SARS-CoV-2 during pregnancy were included. Data were abstracted from delivery hospital admission and outpatient follow-up appointments between 4/8/20 and 2/4/21. RESULTS: Thirty-three infants met inclusion criteria. Average gestational age was 38.9 weeks (IQR 37.6-40.4), 3 (10%) were premature and 5 (15%) required NICU admission. Nearly all (97%) mothers expressed intent to breastfeed. Outpatient follow-up rates were similar to historical cohorts and 82% (23/28) of infants were vaccination compliant. Growth parameters showed normal distributions at all time points. At 6 months, any and exclusive breast milk feeding rates were lower compared to historic cohorts (18 vs. 36%, p<0.05, 0 vs. 21%, p<0.01). Three infants (10%) received development-related referrals, one carried an underlying genetic diagnosis. Outpatient visits were predominantly face-to-face with telemedicine use comprising only 6% of visits (11/182). CONCLUSIONS: Longitudinal follow-up of 33 publicly insured infants born to mothers with SARS-CoV-2 infection in pregnancy followed in an FQHC showed high rates of follow-up and vaccination compliance, normal growth patterns and reassuring clinical status, and lower than expected rates of breastfeeding.

Opportunities to Address Men's Health During the Perinatal Period - Puerto Rico, 2017.

Decreased use of health care services (1), increased exposure to occupational hazards, and higher rates of substance use (2) might contribute to men's poorer health outcomes when compared with such outcomes for women (3). During the transition to fatherhood, paternal health and involvement during pregnancy might have an impact on maternal and infant outcomes (4-6). To assess men's health-related behaviors and participation in fatherhood-related activities surrounding pregnancy, the Puerto Rico Department of Health and CDC analyzed data from the paternal survey of the Pregnancy Risk Assessment Monitoring System-Zika Postpartum Emergency Response (PRAMS-ZPER)* study. Fewer than one half (48.3%) of men attended a health care visit for themselves in the 12 months before their newborn's birth. However, most fathers attended one or more prenatal care visits (87.2%), were present at the birth (83.1%), and helped prepare for the newborn's arrival (e.g., by preparing the home [92.4%] or purchasing supplies [93.9%]). These findings suggest that opportunities are available for public health messaging directed toward fathers during the perinatal period to increase attention to their own health and health behaviors, and to emphasize the role they can play in supporting their families' overall health and well-being.

Paternal Involvement and Maternal Perinatal Behaviors: Pregnancy Risk Assessment Monitoring System, 2012-2015.

OBJECTIVES: Paternal involvement is associated with improved infant and maternal outcomes. We compared maternal behaviors associated with infant morbidity and mortality among married women, unmarried women with an acknowledgment of paternity (AOP; a proxy for paternal involvement) signed in the hospital, and unmarried women without an AOP in a representative sample of mothers in the United States from 32 sites. METHODS: We analyzed 2012-2015 data from the Pregnancy Risk Assessment Monitoring System, which collects site-specific, population-based data on preconception, prenatal and postpartum behaviors, and experiences from women with a recent live birth. We calculated adjusted prevalence ratios (aPRs) and 95% confidence intervals (CIs) to examine associations between level of paternal involvement and maternal perinatal behaviors. RESULTS: Of 113 020 respondents (weighted N = 6 159 027), 61.5% were married, 27.4% were unmarried with an AOP, and 11.1% were unmarried without an AOP. Compared with married women and unmarried women with an AOP, unmarried women without an AOP were less likely to initiate prenatal care during the first trimester (married, aPR [95% CI], 0.94 [0.92-0.95]; unmarried with AOP, 0.97 [0.95-0.98]), ever breastfeed (married, 0.89 [0.87-0.90]; unmarried with AOP, 0.95 [0.94-0.97]), and breastfeed at least 8 weeks (married, 0.76 [0.74-0.79]; unmarried with AOP, 0.93 [0.90-0.96]) and were more likely to use alcohol during pregnancy (married, 1.20 [1.05-1.37]; unmarried with AOP, 1.21 [1.06-1.39]) and smoke during pregnancy (married, 3.18 [2.90-3.49]; unmarried with AOP, 1.23 [1.15-1.32]) and after pregnancy (married, 2.93 [2.72-3.15]; unmarried with AOP, 1.17 [1.10-1.23]). CONCLUSIONS: Use of information on the AOP in addition to marital status provides a better understanding of factors that affect maternal behaviors.

Adverse Experiences and Special Health Care Needs Among Children.

OBJECTIVES: To evaluate the association of exposure to adverse childhood experiences (ACEs) and being a child with special health care needs (CSHCNs), and risks of specific ACE exposures with CSHCN status. METHODS: An analysis of 91,219 children from the 2011-2012 National Survey of Children's Health. Multivariable logistic regression was used to compare the odds of CSHCN status based on total ACE exposure and on distinct types of ACE exposure. RESULTS: Overall, 20% of children met CSHCN criteria. Although 57% of children had no ACEs, 23% had experienced 1, 13% had experienced 2-3 ACEs, and < 1% had experienced 4 or more ACEs. The odds of CSHCN status increased by 38% with 1 ACE [adjusted odds ratio (aOR) 1.38, 95% confidence interval (95% CI) (1.25-1.52)], but with ≥ 4 ACEs, the odds of CSHCN status increased nearly threefold [aOR 2.95 (95% CI 2.54-3.45)]. Presence of mental illness in the family [aOR 2.12 (95% CI 1.89-2.38)], domestic violence [aOR 1.69 (95% CI 1.48-1.93)], and neighborhood violence [aOR 1.89 (95% CI 1.67-2.14)] were the ACEs most strongly associated with CSHCN status. CONCLUSIONS FOR PRACTICE: Each additional ACE exposure increased the likelihood of CSHCN status, and family and community-level ACEs were associated with increased risk for CSHCN status. The findings suggest that systems of care for CSHCN, including public health, health care, education, and social welfare, should incorporate supports for addressing ACEs among this population and a trauma-informed approach.

Longitudinal Study of Body Mass Index in Young Males and the Transition to Fatherhood.

Despite a growing understanding that the social determinants of health have an impact on body mass index (BMI), the role of fatherhood on young men's BMI is understudied. This longitudinal study examines BMI in young men over time as they transition from adolescence into fatherhood in a nationally representative sample. Data from all four waves of the National Longitudinal Study of Adolescent Health supported a 20-year longitudinal analysis of 10,253 men beginning in 1994. A "fatherhood-year" data set was created and changes in BMI were examined based on fatherhood status (nonfather, nonresident father, resident father), fatherhood years, and covariates. Though age is positively associated with BMI over all years for all men, comparing nonresident and resident fathers with nonfathers reveals different trajectories based on fatherhood status. Entrance into fatherhood is associated with an increase in BMI trajectory for both nonresident and resident fathers, while nonfathers exhibit a decrease over the same period. In this longitudinal, population-based study, fatherhood and residence status play a role in men's BMI. Designing obesity prevention interventions for young men that begin in adolescence and carry through young adulthood should target the distinctive needs of these populations, potentially improving their health outcomes.

Access to leave benefits for primary caregivers of children with special health care needs: a double bind.

OBJECTIVE: Family leave benefits are a key tool that allow parents to miss work to care for their ill children. We examined whether access to benefits varies by level of childcare responsibilities among employed parents of children with special health care needs (CSHCN). METHODS: We conducted telephone interviews with 3 successive cohorts of employed parents of CSHCN, randomly sampled from a California children's hospital. At Wave 1 (November 2003 to January 2004), we conducted 372 parent interviews. At Wave 2 (November 2005 to January 2006), we conducted 396 parent interviews. At Wave 3 (November 2007 to January 2008), we conducted 393 parent interviews. We pooled these samples for bivariate and multivariate regression analyses by using wave indicators and sample weights. RESULTS: Parents with more childcare responsibilities (primary caregivers) reported less access to sick leave/vacation (65% vs 82%, P < .001), access to paid leave outside of sick leave/vacation (41% vs 51%, P < .05), and eligibility for Family and Medical Leave Act benefits (28% vs 44%, P < .001) than secondary caregivers. Part-time employment and female gender largely explained 2 of the 3 associations between more childcare responsibilities and less access to leave benefits. Even in the context of part-time employment, however, primary caregivers were just as likely as secondary caregivers both to miss work due to their child's illness and to report being unable to miss work when they needed to. CONCLUSIONS: Due in part to employment and gender differences, leave benefits among parents of CSHCN are skewed away from primary caregivers and toward secondary caregivers. Thus, primary caregivers may face particularly difficult choices between employment and childcare responsibilities. Reducing this disparity in access to benefits may improve the circumstances of CSHCN and their families.

Economic impact of paclitaxel shortage in patients with newly diagnosed ovarian cancer.

OBJECTIVE: To determine the potential economic impact of a paclitaxel drug shortage in patients with newly diagnosed, untreated ovarian cancer. METHODS: A modified Markov state transition model with a 6 cycle time horizon compared two scenarios: (1) Standard treatment (STD): paclitaxel 175 mg/m2/carboplatin AUC 5 × 6 cycles; (2) Paclitaxel drug shortage (DS): docetaxel 75 mg/m2/carboplatin AUC 5 × 6 cycles. Adverse events, quality of life, and costs of chemotherapy, neuropathy, febrile neutropenia, and anemia were incorporated. Key assumptions: (1) Costs and consequences were assigned only to grade 2+ neuropathy, febrile neutropenia, and grade 3-4 anemia; (2) Grade 2+ neuropathy prompted a switch from paclitaxel/carboplatin to docetaxel/carboplatin or from docetaxel/carboplatin to carboplatin alone; (3) Febrile neutropenia resulted in inpatient hospitalization followed by G-CSF prophylaxis. RESULTS: The mean cost of 6 cycles of chemotherapy was $4939 in the STD and $16,107 in the DS scenario, for a cost difference of $11,168 per patient over 6 cycles of treatment. STD was the dominant strategy (less expensive and more effective than the drug shortage scenario). In sensitivity analysis, DS was more costly over a wide range of clinical estimates in each arm. A drug shortage that affects approximately 50% of women initiating chemotherapy is expected to impact 779 women and cost third party payers an additional $8,699,872 monthly. CONCLUSIONS: Our model indicates that chemotherapy drug shortages can have a significant negative impact on the average cost of primary treatment for ovarian cancer and have the potential to negatively impact health system costs.

Impact of FDA drug risk communications on health care utilization and health behaviors: a systematic review.

OBJECTIVE: To review literature on the impact of The Food and Drug Administration (FDA) drug risk communications on medication utilization, health care services use, and health outcomes. DATA SOURCES: The authors searched MEDLINE and the Web of Science for manuscripts published between January 1990 and November 2010 that included terms related to drug utilization, the FDA, and advisories or warnings. We manually searched bibliographies and works citing selected articles and consulted with experts to guide study selection. STUDY SELECTION: Studies were included if they involved an empirical analysis evaluating the impact of an FDA risk communication. DATA EXTRACTION: We extracted the drug(s) analyzed, relevant FDA communication(s), data source, analytical method, and main outcome(s) assessed. RESULTS: Of the 1432 records screened, 49 studies were included. These studies covered 16 medicines or therapeutic classes; one third examined communications regarding antidepressants. Most used medical or pharmacy claims and a few rigorously examined patient-provider communication, decision making, or risk perceptions. Advisories recommending increased clinical or laboratory monitoring generally led to decreased drug use, but only modest, short-term increases in monitoring. Communications targeting specific subpopulations often spilled over to other groups. Repeated or sequential advisories tended to have larger but delayed effects and decreased incident more than prevalent use. Drug-specific warnings were associated with particularly large decreases in utilization, although the magnitude of substitution within therapeutic classes varied across clinical contexts. CONCLUSIONS: Although some FDA drug risk communications had immediate and strong impacts, many had either delayed or had no impact on health care utilization or health behaviors. These data demonstrate the complexity of using risk communication to improve the quality and safety of prescription drug use, and suggest the importance of continued assessments of the effect of future advisories and label changes. Identifying factors that are associated with rapid and sustained responses to risk communications will be important for informing future risk communication efforts.

Improving communication between patients and providers using health information technology and other quality improvement strategies: focus on Asian Americans.

Disparities in provider-patient communication have been shown to exist among Asian Americans, especially those who are low-income and have limited English proficiency. These disparities have resulted in unmet health care needs and poor quality care. To identify strategies for improving provider-patient communication in this population, we conducted a systematic review of the literature and in-depth interviews with key informants. Little published literature on interventions focused on Asian Americans was found. Most interventions were conducted among White populations and occurred in the waiting room before patients' visits with their providers. Interventions ranged from a leaflet encouraging patients to ask more questions, to more intensive face-to-face coaching before office visits. Health information technology (health IT) has not been widely used to improve communication, especially among patients with limited English proficiency. More research is needed using new health IT strategies to improve care for Asian Americans and other vulnerable populations.

Improving communication between patients and providers using health information technology and other quality improvement strategies: focus on low-income children.

Effective communication between providers and patients has been linked to improved outcomes. Previous reviews of quality improvement strategies, including health information technology (health IT), have not focused on the needs of low-income children. The authors conducted a systematic review of the literature on studies of communication surrounding the care of low-income children, with an emphasis on interventions and health IT.The search yielded six studies that focused on low-income children; three of the studies used health IT. Key informant interviews provided insight to the current use of health IT for provider-patient communication in geographically diverse, underresourced settings.The authors identify gaps between existing literature and clinical practice. Future research should focus on the specific impact of health IT in pediatric medicine, particularly in underresourced and safety net settings. These efforts should focus on the use of technological innovations to improve care for low-income children and their families.

Where is the F in MCH? Father involvement in African American families.

OBJECTIVES: To: 1) review the historical contexts and current profiles of father involvement in African American families; 2) identify barriers to, and supports of, involvement; 3) evaluate the effectiveness of father involvement programs; and 4) recommend directions for future research, programs, and public policies. METHODS: Review of observational and interventional studies on father involvement. RESULTS: Several historical developments (slavery, declining employment for Black men and increasing workforce participation for Black women, and welfare policies that favored single mothers) led to father absence from African American families. Today, more than two thirds of Black infants are born to unmarried mothers. Even if unmarried fathers are actively involved initially, their involvement over time declines. We identified multiple barriers to, and supports of, father involvement at multiple levels. These levels include intrapersonal (eg, human capital, attitudes and beliefs about parenting), interpersonal (eg, the father's relationships with the mother and maternal grandmother), neighborhoods and communities (eg, high unemployment and incarceration rates), cultural or societal (eg, popular cultural perceptions of Black fathers as expendable and irresponsible, racial stratification and institutionalized racism), policy (eg, Earned Income Tax Credit, Temporary Assistance for Needy Families, child support enforcement), and life-course factors (eg, father involvement by the father's father). We found strong evidence of success for several intervention programs (eg, Reducing the Risk, Teen Outreach Program, and Children's Aid Society - Carrera Program) designed to prevent formation of father-absent families, but less is known about the effectiveness of programs to encourage greater father involvement because of a lack of rigorous research design and evaluation for most programs. CONCLUSION: A multi-level, life-course approach is needed to strengthen the capacity of African American men to promote greater involvement in pregnancy and parenting as they become fathers.

Perceived effects of leave from work and the role of paid leave among parents of children with special health care needs.

OBJECTIVES: We examined the perceived effects of leave from work among employed parents of children with special health care needs. METHODS: Telephone interviews were conducted from November 2003 to January 2004 with 585 parents who had missed 1 or more workdays for their child's illness in the previous year. RESULTS: Most parents reported positive effects of leave on their child's physical (81%) and emotional (85%) health; 57% reported a positive effect on their own emotional health, although 24% reported a negative effect. Most parents reported no effect (44%) or a negative effect (42%) on job performance; 73% reported leave-related financial problems. In multivariate analyses, parents receiving full pay during leave were more likely than were parents receiving no pay to report positive effects on child physical (odds ratio [OR] = 1.85) and emotional (OR = 1.68) health and parent emotional health (OR = 1.70), and were less likely to report financial problems (OR = 0.20). CONCLUSIONS: Employed parents believed that leave-taking benefited the health of their children with special health care needs and their own emotional health, but compromised their job performance and finances. Parents who received full pay reported better consequences across the board. Access to paid leave, particularly with full pay, may improve parent and child outcomes.

Need for and use of family leave among parents of children with special health care needs.

OBJECTIVE: Parents of children with special health care needs are especially vulnerable to work-family conflicts that family leave benefits might help resolve. We examined leave-taking among full-time-employed parents of children with special health care needs. METHODS: We identified all children with special health care needs in 2 large inpatient/outpatient systems in Chicago, Illinois, and Los Angeles, California, and randomly selected 800 per site. From November 2003 to January 2004, we conducted telephone interviews with 1105 (87% of eligible and successfully contacted) parents. Among the sample's 574 full-time-employed parents, we examined whether leave benefits predicted missing any work for child illness, missing >4 weeks for child illness, and ability to miss work whenever their child needed them. RESULTS: Forty-eight percent of full-time-employed parents qualified for federal Family and Medical Leave Act benefits; 30% reported employer-provided leave benefits (not including sick leave/vacation). In the previous year, their children averaged 20 missed school/child care days, 12 doctor/emergency department visits, and 1.7 hospitalizations. Although 81% of parents missed work for child illness, 41% reported not always missing work when their child needed them, and 40% of leave-takers reported returning to work too soon. In multivariate regressions, parents who were eligible for Family and Medical Leave Act benefits and aware of their eligibility had 3.0 times greater odds of missing work for child illness than ineligible parents. Parents with >4 weeks of employer-provided leave benefits had 4.7 times greater odds of missing >4 weeks than parents without benefits. Parents with paid leave benefits had 2.8 times greater odds than other parents of missing work whenever their child needed them. CONCLUSIONS: Full-time-employed parents of children with special health care needs experience severe work-family conflicts. Although most have leave benefits, many report unmet need for leave. Access to Family and Medical Leave Act benefits and employer-provided leave may greatly affect leave-taking.

Fathers and pediatricians: enhancing men's roles in the care and development of their children.

Research substantiates that fathers' interactions with their children can exert a positive influence on their children's development. This report suggests ways pediatricians can enhance fathers' caregiving involvement by offering specific, culturally sensitive advice and how pediatricians might change their office practices to support and increase fathers' active involvement in their children's care and development.