Acceptability and Utility of a Digital Group Intervention to Prevent Perinatal Depression in Youths via Interactive Maternal Group for Information and Emotional Support (IMAGINE): Pilot Cohort Study.

BACKGROUND: Perinatal depression (depression during pregnancy or the first year postpartum) affects 10%-25% of perinatal individuals, with a higher risk among youths aged <25 years. The Mothers and Babies Course (MB) is an evidence-based intervention for the prevention of perinatal depression, grounded in cognitive behavioral therapy, attachment theory, and psychoeducation. OBJECTIVE: We developed a digital adaptation of MB (Interactive Maternal Group for Information and Emotional Support [IMAGINE]) and evaluated it in a pre-post mixed methods pilot among young perinatal people in the United States. METHODS: IMAGINE was a structured digital group of up to 7 participants, with scheduled MB content and open discussion for 12 weeks, facilitated by a social worker. Scheduled content included asynchronous SMS text messages, graphics, prerecorded videos, mood polls, and optional weekly synchronous video calls. Eligible participants were pregnant or ≤80 days postpartum, aged 16 to 24 years, had access to a smartphone, spoke English, and had a Patient Health Questionnaire score <10. Participants were recruited throughout the United States from August 2020 to January 2021 through paid social media ads, in-person outreach at clinics, and respondent-driven sampling. Participants completed quantitative questionnaires at enrollment and 3 months, and qualitative interviews at 3 months. We determined uptake, acceptability (by Acceptability of Intervention Measure score), and utility (by use of cognitive behavioral therapy skills). We compared depression symptoms (by Patient Health Questionnaire score), social support (by abbreviated Social Support Behavior score), and perceived stress (by Perceived Stress Score) between enrollment and follow-up by paired 2-tailed t test. RESULTS: Among 68 individuals who contacted this study, 22 were screened, 13 were eligible, and 10 enrolled, for an uptake of 76.9%. Furthermore, 4 (40%) participants were pregnant at enrollment. Participants had a median age of 17.9 (IQR 17.4-21.7) years, 6 (67%) identified as Black, 5 (56%) Latinx, and 6 (67%) using Medicaid health insurance. Further, 9 (90%) participants completed follow-up. Among these, the mean acceptability score was 4.3 out of 5 (SD 0.6) and all participants said they would recommend IMAGINE to a friend. Participants reported using a median of 7 of 11 skills (IQR 5-7 skills) at least half the days. We found no significant changes in depression symptoms, perceived stress, or social support. Qualitatively, participants reported one-to-one support from the facilitator, connection with other parents, and regular mood reflection were especially helpful aspects of the intervention. Additionally, participants reported that the intervention normalized their mental health challenges, improved their ability to manage their mood, and increased their openness to mental health care. CONCLUSIONS: This pilot study provides promising evidence of the acceptability and utility of IMAGINE among perinatal youths. Our study's small sample size did not detect changes in clinical outcomes; our findings suggest IMAGINE warrants larger-scale evaluation.

Personalized Mobile Health-Enhanced Cognitive Behavioral Intervention for Maternal Distress: Examining the Moderating Role of Adverse Childhood Experiences.

BACKGROUND: Maternal history of trauma is a risk factor for distress during pregnancy. The purpose of this paper was to examine the theorized differential impact of a cognitive behavioral intervention (Mothers and Babies Personalized; MB-P) on maternal distress and emotional regulation for those with ≥ 1 adverse childhood experiences (ACEs; vs no ACEs) from pregnancy to 3 months postpartum. METHODS: Between August 2019 and August 2021, eligible pregnant individuals aged ≥ 18 years, < 22 weeks' gestation, and English-speaking were recruited from 6 university-affiliated prenatal clinics. Participants (N = 100) were randomized to MB-P (n = 49) or control (n = 51). Analyzable data were collected for 95 participants. Analyses tested progression of change (slope) and at individual timepoints (panel analysis) for perinatal mental health outcomes. RESULTS: The majority of participants (n = 68, 71%) reported experiencing > 1 ACE (median = 1, range: 0-11). Participants demonstrated significant differential effects for depressive symptoms in absence of ACEs (standardized mean differences [SMD] = 0.82; 95% confidence interval [CI] = [0.13-1.51]) vs in presence of ACEs (SMD = 0.39; 95% CI = [-0.20 to 0.97]) and perceived stress in absence of ACEs (SMD = 0.92; 95% CI = [0.23-1.62]) vs in presence of ACEs (SMD = -0.05; 95% CI = [-0.63 to 0.53]). A panel analysis showed significantly reduced depressive symptoms postintervention and increased negative mood regulation at 3 months postpartum for individuals with ACEs. CONCLUSIONS: Findings support effectiveness of the MB-P intervention to reduce prenatal distress for all pregnant individuals. Preliminary exploration suggests the possibility that individuals with ACEs may benefit from enhanced trauma-informed content to optimize the effects of a perinatal intervention.

Examining Feasibility, Acceptability, and Preliminary Outcomes of a Culturally Adapted Evidence-Based Postpartum Depression Preventive Intervention for Women in Doha, Qatar: Protocol for a Randomized Controlled Trial.

BACKGROUND: Postpartum depression and anxiety are the 2 most common perinatal mental health disorders, with prevalence rates higher among women living in the Middle East than in most Western countries. The negative outcomes associated with postpartum depression and anxiety are profound and include less responsive parenting and compromised infant and young child development. Although interventions exist to prevent postpartum depression and anxiety, to date, there have been no studies that have attempted to prevent postpartum depression or anxiety among Arabic-speaking women in the Middle East, including Qatar. OBJECTIVE: The purpose of this study is to conduct a randomized controlled trial (RCT) of an evidence-based postpartum depression preventive intervention-Mothers and Babies (MB)-culturally adapted for use with Arabic-speaking women in Doha, Qatar. MB is guided by a cognitive behavioral therapy framework that focuses on increasing pleasant activities, promoting healthy thought patterns, and increasing the type and frequency of personal contacts. MB is tailored to specific needs and issues related to pregnancy and the postpartum period. METHODS: A multidisciplinary and multiethnic investigator team adapted MB to promote cultural and contextual fit for Arabic-speaking women. Intervention concepts were reviewed to ensure core content would be understood by Arabic-speaking women in Qatar. Subsequently, images, activities, and examples in the intervention manuals were adapted, as needed, to make the content more relevant to Arab culture. To deliver the adapted intervention, 30 Arabic-speaking individuals with mental health backgrounds were trained. The adapted intervention was subsequently pilot-tested with 10 pregnant women receiving prenatal care at Sidra Hospital in Doha. We are now conducting an RCT to examine the effectiveness of the adapted intervention. We plan to enroll 210 pregnant individuals who are Arabic-speaking, with 1:1 randomization to the MB intervention or usual prenatal care. Among the enrolled participants, a stratified subsample of 40 pregnant women with diabetes is being recruited. Data collection will take place at baseline and a 6-month follow-up. The primary outcomes are depressive and anxiety symptoms and perceived stress. Diabetes self-care is the exploratory outcome for the subsample of individuals with diabetes. Intervention implementation will be assessed via client and provider surveys during and after intervention delivery. Power and sample size were calculated using a 2-sided 5% effort rate and assumed analyses on the individual level, accounting for attrition of 20%. RESULTS: The cultural adaptation and pilot study of the adapted MB intervention are completed. A total of 157 women have been enrolled in the RCT as of March 31, 2023. CONCLUSIONS: This study is highly innovative, as it is the first study to our knowledge to examine the effectiveness of an evidence-based postpartum depression preventive intervention in the Middle East. Limitations include a single follow-up time point and a small subsample of individuals with diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04442529; https://www.clinicaltrials.gov/study/NCT04442529. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11623.

Perinatal Depression Screening Among Sexual Minority Women.

Importance: A substantial number of births in the US are to sexual minority women (17% based on a nationally representative survey), yet there is little research on perinatal depression screening rates or symptom endorsement among sexual minority women (including women who identify as lesbian, bisexual, queer, pansexual, asexual, demisexual, and kinky as well as other-identified women who have sex with women). High rates of risk factors for perinatal depression (eg, intimate partner violence and history of mental illness) among sexual minority individuals magnify this gap in the literature. Objective: To describe the prevalence of female-identified sexual minority people giving birth in an academic medical center and compare perinatal depression screening rates and scores among sexual minority women and heterosexual cisgender women. Design, Setting, and Participants: This retrospective cohort study used deidentified medical record review of 18 243 female-identified individuals who gave birth at an academic medical center in Chicago, Illinois, between January 1 and December 31, 2019. Data were analyzed from April 5, 2021, to August 1, 2022. Main Outcomes and Measures: Proportion of women identified as having sexual minority status in the medical record, rates of standard care administration of the 9-item Patient Health Questionnaire between sexual minority women and heterosexual women, and depression screening scores and rates of positive depression screening results for sexual minority and heterosexual women. Results: Among 18 243 women (mean [SD] age, 33.8 [5.1] years; 10 453 [57.3%] of non-Hispanic White race and ethnicity), only 280 (1.5%; 95% CI, 1.3%-1.7%) were identified as having sexual minority status in the medical record. Significantly more sexual minority women vs heterosexual women attended at least 1 prenatal care visit (56 [20.0%] vs 2459 [13.7%]; P = .002) and at least 1 postpartum care visit (52 [18.6%] vs 2304 [12.8%]; P = .004). Sexual minority women were more likely to be screened for depression during postpartum care (odds ratio, 1.77; 95% CI, 1.22-2.52; P = .002) and more likely to screen positive for depression during the postpartum period (odds ratio, 2.38; 95% CI, 0.99-5.02; P = .03) than heterosexual women. Conclusions and Relevance: In this cohort study, sexual minority women identified in the medical record were highly engaged in obstetric care yet at high risk of postpartum depression. In addition, their sexual orientation was largely undocumented in medical records. These results highlight the need for investigations that include strategies for measuring sexual orientation because medical record review is unlikely to reliably capture these sexual identities during the perinatal period.

Implementation of a culturally competent APOL1 genetic testing programme into living donor evaluation: A two-site, non-randomised, pre-post trial design.

INTRODUCTION: While living donor (LD) kidney transplantation is the optimal treatment for patients with kidney failure, LDs assume a higher risk of future kidney failure themselves. LDs of African ancestry have an even greater risk of kidney failure post-donation than White LDs. Because evidence suggests that Apolipoprotein L1 (APOL1) risk variants contribute to this greater risk, transplant nephrologists are increasingly using APOL1 genetic testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counselling with LD candidates about APOL1 due to a lack of knowledge and skill in counselling. Without proper counselling, APOL1 testing will magnify LD candidates' decisional conflict about donating, jeopardising their informed consent. Given cultural concerns about genetic testing among people of African ancestry, protecting LD candidates' safety is essential to improve informed decisions about donating. Clinical 'chatbots', mobile apps that provide genetic information to patients, can improve informed treatment decisions. No chatbot on APOL1 is available and no nephrologist training programmes are available to provide culturally competent counselling to LDs about APOL1. Given the shortage of genetic counsellors, increasing nephrologists' genetic literacy is critical to integrating genetic testing into practice. METHODS AND ANALYSIS: Using a non-randomised, pre-post trial design in two transplant centres (Chicago, IL, and Washington, DC), we will evaluate the effectiveness of culturally competent APOL1 testing, chatbot and counselling on LD candidates' decisional conflict about donating, preparedness for decision-making, willingness to donate and satisfaction with informed consent and longitudinally evaluate the implementation of this intervention into clinical practice using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. ETHICS AND DISSEMINATION: This study will create a model for APOL1 testing of LDs of African ancestry, which can be implemented nationally via implementation science approaches. APOL1 will serve as a model for integrating culturally competent genetic testing into transplant and other practices to improve informed consent. This study involves human participants and was approved by Northwestern University IRB (STU00214038). Participants gave informed consent to participate in the study before taking part. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04910867. Registered 8 May 2021, https://register. CLINICALTRIALS: gov/prs/app/action/SelectProtocol?sid=S000AWZ6&selectaction=Edit&uid=U0001PPF&ts=7&cx=-8jv7m2 ClinicalTrials.gov Identifier: NCT04999436. Registered 5 November 2021, https://register. CLINICALTRIALS: gov/prs/app/action/SelectProtocol?sid=S000AYWW&selectaction=Edit&uid=U0001PPF&ts=11&cx=9tny7v.

Associations between air pollutants and blood pressure in an ethnically diverse cohort of adolescents in London, England.

Longitudinal evidence on the association between air pollution and blood pressure (BP) in adolescence is scarce. We explored this association in an ethnically diverse cohort of schoolchildren. Sex-stratified, linear random-effects modelling was used to examine how modelled residential exposure to annual average nitrogen dioxide (NO2), particulate matter (PM2.5, PM10) and ozone (O3), measures in µg/m3, associated with blood pressure. Estimates were based on 3,284 adolescents; 80% from ethnic minority groups, recruited from 51 schools, and followed up from 11-13 to 14-16 years old. Ethnic minorities were exposed to higher modelled annual average concentrations of pollution at residential postcode level than their White UK peers. A two-pollutant model (NO2 & PM2.5), adjusted for ethnicity, age, anthropometry, and pubertal status, highlighted associations with systolic, but not diastolic BP. A µg/m3 increase in NO2 was associated with a 0.30 mmHg (95% CI 0.18 to 0.40) decrease in systolic BP for girls and 0.19 mmHg (95% CI 0.07 to 0.31) decrease in systolic BP for boys. In contrast, a 1 µg/m3 increase in PM2.5 was associated with 1.34 mmHg (95% CI 0.85 to 1.82) increase in systolic BP for girls and 0.57 mmHg (95% CI 0.04 to 1.03) increase in systolic BP for boys. Associations did not vary by ethnicity, body size or socio-economic advantage. Associations were robust to adjustments for noise levels and lung function at 11-13 years. In summary, higher ambient levels of NO2 were associated with lower and PM2.5 with higher systolic BP across adolescence, with stronger associations for girls.

Lability of prenatal stress during the COVID-19 pandemic links to negative affect in infancy.

The association between prenatal stress and children's socioemotional development is well established. The COVID-19 pandemic has been a particularly stressful period, which may impact the gestational environment. However, most studies to-date have examined prenatal stress at a single time point, potentially masking the natural variation in stress that occurs over time, especially during a time as uncertain as the pandemic. This study leveraged dense ecological momentary assessments from a prenatal randomized control trial to examine patterns of prenatal stress over a 14-week period (up to four assessments/day) in a U.S. sample of 72 mothers and infants. We first examined whether varied features of stress exposure (lability, mean, and baseline stress) differed depending on whether mothers reported on their stress before or during the pandemic. We next examined which features of stress were associated with 3-month-old infants' negative affect. We did not find differences in stress patterns before and during the pandemic. However, greater stress lability, accounting for baseline and mean stress, was associated with higher infant negative affect. These findings suggest that pathways from prenatal stress exposure to infant socioemotional development are complex, and close attention to stress patterns over time will be important for explicating these pathways.

Development of an Online Training to Engage Home Visitors as Research Stakeholders.

BACKGROUND: Home visiting (HV) has demonstrated positive impacts across family well-being domains. Home visitors receive training in HV model requirements as well as to develop knowledge and various skills. Despite growth in HV research, we are not aware of existing training or required competencies in research design, research methods, or dissemination of research findings for home visitors. OBJECTIVES: Via ongoing collaboration with an Advisory Board of key HV stakeholders, we developed a three-module online training that incorporated examples from HV research and practice to address the gap in research training for home visitors and to promote home visitors' engagement as research stakeholders. METHODS: A convenience sample of home visitors (n = 176) was surveyed on research knowledge, research self-efficacy, and priority training topics, with results used to create a beta version of the training completed by six home visitors. Home visitor feedback on the beta version, coupled with Advisory Board recommendations, led to creation of the final online training. Forty home visitors viewed the final training and completed pre- and post-training surveys to assess changes in research knowledge and self-efficacy. Twelve home visitors also completed a semi-structured qualitative interview. Home visitors demonstrated improvements in research knowledge and self-efficacy and found the training easy to understand and useful. CONCLUSIONS: Guidance from stakeholders led to development of an online training that was effective in improving home visitors' research knowledge and self-efficacy. This training can be used by HV researchers and practitioners as a tool to promote home visitors' active engagement as stakeholders in research.

A qualitative examination of the implementation of a perinatal collaborative care program.

AIM: To identify implementation strategies for collaborative care (CC) that are successful in the context of perinatal care. BACKGROUND: Perinatal depression is one of the most common complications of pregnancy and is associated with adverse maternal, obstetric, and neonatal outcomes. Although treating depressive symptoms reduces risks to mom and baby, barriers to accessing psychiatric treatment remain. CC has demonstrated benefit in primary care, expanding access, yet few studies have examined the implementation of CC in perinatal care which presents unique characteristics and challenges. METHODS: We conducted qualitative interviews with 20 patients and 10 stakeholders from Collaborative Care Model for Perinatal Depression Support Services (COMPASS), a perinatal collaborative care (pCC) program implemented since 2017. We analyzed interview data by employing the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to organize empirically selected implementation strategies from Expert Recommendations for Implementing Change (ERIC) to create a guide for the development of pCC programs. FINDINGS: We identified 14 implementation strategies used in the implementation of COMPASS. Strategies were varied, cutting across ERIC domains (eg, plan, educate, finance) and across EPIS contexts (eg, inner context - characteristics of the pCC program). The majority of strategies were identified by patients and staff as facilitators of pCC implementation. In addition, findings show opportunities for improving the implementation strategies used, such as optimal dissemination of educational materials for obstetric clinicians. The implementation of COMPASS can serve as a model for the process of building a pCC program. The identified strategies can support the implementation of this evidence-based practice for addressing postpartum depression.

Examining Participant Dosage and Skill Utilization Associated with Receipt of a Perinatal Depression Preventive Intervention.

This study assessed participant, facilitator, and program-level characteristics associated with intervention dosage among women receiving an evidence-based perinatal depression preventive intervention, Mothers and Babies (MB). We also explored how intervention dosage affected the use and maintenance of core skills taught in the six-session group-based intervention. We conducted a secondary analysis of data from a cluster-randomized controlled trial in which 679 women enrolled in home visiting (HV) programs received MB prenatally. High dose of intervention was defined as attendance at > 50% of MB sessions, while MB skill utilization was measured by asking participants to indicate at 12 and 24 weeks postpartum the extent to which they used 12 core MB skills taught during the intervention. Age and racial concordance between participant and facilitator were significantly associated with intervention dosage. Those receiving higher intervention dosage tended to be older (27.25 ± 5.96 vs. 24.99 ± 5.60, p < 0.01, OR = 1.068 [1.038-1.098]), and received MB from a facilitator with a self-identified race similar to their own (58% vs. 48%, p = 0.04, OR = 1.485 [1.014-2.176]). Primary language of participants was marginally associated with dosage. Participants receiving a higher dose of intervention tended to exhibit greater MB skill utilization, on average at 24 weeks postpartum. These results can be used to identify strategies to promote intervention engagement. They further suggest that greater intervention dosage leads to increased use of core intervention skills that can promote improvements in participants' behaviors and thoughts.

Predicting the Next-Day Perceived and Physiological Stress of Pregnant Women by Using Machine Learning and Explainability: Algorithm Development and Validation.

BACKGROUND: Cognitive behavioral therapy-based interventions are effective in reducing prenatal stress, which can have severe adverse health effects on mothers and newborns if unaddressed. Predicting next-day physiological or perceived stress can help to inform and enable pre-emptive interventions for a likely physiologically and perceptibly stressful day. Machine learning models are useful tools that can be developed to predict next-day physiological and perceived stress by using data collected from the previous day. Such models can improve our understanding of the specific factors that predict physiological and perceived stress and allow researchers to develop systems that collect selected features for assessment in clinical trials to minimize the burden of data collection. OBJECTIVE: The aim of this study was to build and evaluate a machine-learned model that predicts next-day physiological and perceived stress by using sensor-based, ecological momentary assessment (EMA)-based, and intervention-based features and to explain the prediction results. METHODS: We enrolled pregnant women into a prospective proof-of-concept study and collected electrocardiography, EMA, and cognitive behavioral therapy intervention data over 12 weeks. We used the data to train and evaluate 6 machine learning models to predict next-day physiological and perceived stress. After selecting the best performing model, Shapley Additive Explanations were used to identify the feature importance and explainability of each feature. RESULTS: A total of 16 pregnant women enrolled in the study. Overall, 4157.18 hours of data were collected, and participants answered 2838 EMAs. After applying feature selection, 8 and 10 features were found to positively predict next-day physiological and perceived stress, respectively. A random forest classifier performed the best in predicting next-day physiological stress (F1 score of 0.84) and next-day perceived stress (F1 score of 0.74) by using all features. Although any subset of sensor-based, EMA-based, or intervention-based features could reliably predict next-day physiological stress, EMA-based features were necessary to predict next-day perceived stress. The analysis of explainability metrics showed that the prolonged duration of physiological stress was highly predictive of next-day physiological stress and that physiological stress and perceived stress were temporally divergent. CONCLUSIONS: In this study, we were able to build interpretable machine learning models to predict next-day physiological and perceived stress, and we identified unique features that were highly predictive of next-day stress that can help to reduce the burden of data collection.

Results from an effectiveness-implementation evaluation of a postpartum depression prevention intervention delivered in home visiting programs.

BACKGROUND: Building on growing research examining lay health professionals delivering postpartum depression preventive interventions, we conducted a hybrid effectiveness-implementation Type 2 trial to examine implementation metrics and determine whether pregnant women receiving Mothers and Babies 1-on-1 delivered by lay home visitors exhibit greater reductions in depressive symptoms and perceived stress than women receiving usual home visiting. METHODS: 1229 (672 control, 557 intervention) pregnant women were enrolled, with intervention participants receiving Mothers and Babies 1-on-1 delivered by a lay home visitor and control participants receiving usual home visiting services. Baseline and six-month follow-up assessments measured client mental health outcomes, with management information system data collected to assess intervention dosage. Surveys were administered nine months post-training to agency managers as well as home visitors who delivered any intervention content. RESULTS: Intent-to-treat analyses indicated a significant reduction in perceived stress among intervention participants compared to controls, while as-treated analyses showed significant reductions in perceived stress and depressive symptoms. Although all study sites adopted the intervention, <50 % of eligible women received the intervention. Over two-thirds of home visitors made at least one fidelity-consistent adaptation, with client recruitment and retention in home visiting highlighted as challenges to delivery. LIMITATIONS: Unmeasured historical events may have affected study outcomes and caution should be used generalizing to perinatal women from different racial/ethnic groups and home visiting models. CONCLUSION: Mothers and Babies 1-on-1 delivered by lay home visitors leads to reductions in perceived stress and depressive symptoms, suggesting task shifting to non-mental health professionals is viable when appropriate training and supervision is provided.

Cultural Adaptation of the Mothers and Babies Intervention for Use in Tribal Communities.

OBJECTIVE: While one in five women may experience mood and anxiety disorders during pregnancy and postpartum, Indigenous identity increases that risk by 62%, especially among younger Indigenous women. The need for evidence-based perinatal mental health interventions that provide culturally relevant well-being perspectives and practices is critical to improving maternal, child, and community outcomes for Indigenous peoples, and reducing health inequities. METHODS: Through a collaboration between community maternal and child health professionals, intervention researchers, and a cultural consultant, our workgroup developed cultural adaptations to Mothers and Babies, an evidence-based perinatal depression prevention intervention. Applying a cultural interface model, the workgroup identified existing intervention content for surface adaptations, as well as deep, conceptual adaptations to incorporate traditional teachings into this evidence-based intervention. RESULTS: This collaboration developed a culturally adapted facilitator manual for intervention providers, including guidance for implementation and further adaptation to represent local tribal culture, and a culturally adapted participant workbook for Indigenous perinatal women that reflects cultural teachings and traditional practices to promote well-being for mother and baby. IMPLICATIONS: Committing to a culturally respectful process to adapt Mothers and Babies is likely to increase the reach of the intervention into Indigenous communities, reengage communities with cultural practice, improve health outcomes among parents, children, and the next generation's elders, and reduce disparities among Indigenous groups. Replication of this community-engaged process can further the science and understanding of cultural adaptations to evidence-based interventions, while also further reducing health inequities. Future steps include evaluating implementation of the culturally adapted intervention among tribal home visiting organizations.

Examining the Effectiveness of the Fathers and Babies Intervention: A Pilot Study.

There is increasing recognition of the importance of addressing the mental health of fathers, including during the perinatal period. Fathers exhibiting mental health concerns during the perinatal period are at heightened risk for future negative mental health outcomes and are less likely to engage in nurturing relationships with their children, leading to a sequalae of negative child outcomes during infancy and into adolescence. Although interventions have been developed for perinatal fathers, they typically do not focus directly on addressing paternal mental health. To fill this gap, we developed the Fathers and Babies intervention to be delivered to perinatal fathers whose partners (mothers) were enrolled in home visiting programs. A pre-post longitudinal study was conducted in which 30 father-mother dyads were recruited from home visiting programs. Fathers received the 12-session Fathers and Babies intervention while the mother concurrently received the Mothers and Babies intervention delivered to her by a home visitor. Baseline, 3- and 6-month self-report surveys were conducted with both fathers and mothers. Fathers and mothers had statistically significant decreases in perceived stress between baseline and both follow-up time points, with moderate effect sizes generated for both sexes. No statistically significant differences were found for depressive symptoms, anxiety symptoms, or perceived partner support, although we found small effects for reductions in depressive symptoms among fathers, as well as increases in the percentage of fathers and mothers who reported high levels of emotional and instrumental support post-intervention. While preliminary, these findings suggest the potential for Fathers and Babies to positively impact the mental health of fathers in the perinatal period, and also signal the viability of home visiting as a setting for delivering this intervention. Future research should employ a comparison group to generate stronger evidence of intervention effectiveness and include measurement of dyadic relationships and paternal parenting practices.

Testing the effects of a prenatal depression preventive intervention on parenting and young children's self-regulation and functioning (EPIC): protocol for a longitudinal observational study.

BACKGROUND: Perinatal depression is a pervasive public health concern that disproportionately affects low-income women and can have negative impacts on parenting and child developmental outcomes. Few interventions focus on preventing perinatal depression. Previous studies suggest that Mothers and Babies is efficacious in preventing the worsening of depressive symptoms and the onset of postpartum depression. This manuscript presents the protocol of the EPIC study (Effects of a Prenatal Depression Preventive Intervention on parenting and young children's Self-Regulation and Functioning) to test the effects of Mothers and Babies on parenting and child developmental outcomes through 54 months postpartum. EPIC is an observational study that builds on a completed cluster-randomized trial (CRT). Innovations of this study are direct observations of a subsample of mother-child dyads and the inclusion of fathers/caregivers' variables as moderators of maternal mental health. METHODS: For this study, we plan to enroll 738 women with children under 30 months old, ≥18 years old, and who speak English or Spanish. Additionally, 429 fathers, partners, or other adult caregivers will be recruited through women participating in the study. Women will be recruited through the parent study (intervention and control participants) or through one of 10 home visiting programs in Illinois (control participants). Data collection will take place through maternal self-report at five time points (when the child is 30, 36, 42, 48, and 54 months), paternal self-report at three time points (when the child is 30, 42, and 54 months), and through mother-child observations at three time points (when the child is 36, 42, and 48 months). Outcome domains include maternal mental health, cognitive-behavioral and parenting skills, and child self-regulation and functioning. Moderators include the contributions of fathers/caregivers, race-ethnicity, and socioeconomic disadvantage. Power and sample size were calculated assuming a two-sided 5% type I error rate and assumed analyses on the individual level. DISCUSSION: This study has several key strengths and innovations, as well as great potential significance to influence the long-term trajectories of parenting and child development via prenatal intervention. TRIAL REGISTRATION: The study was retrospectively registered at ClinicalTrials.gov (Identifier: NCT04296734 ) on March 5, 2020.

Air pollution and trajectories of adolescent conduct problems: the roles of ethnicity and racism; evidence from the DASH longitudinal study.

PURPOSE: No known UK empirical research has investigated prospective associations between ambient air pollutants and conduct problems in adolescence. Ethnic minority children are disproportionately exposed to structural factors that could moderate any observed relationships. This prospective study examined whether exposure to PM2.5 and NO2 concentrations is associated with conduct problems in adolescence, and whether racism or ethnicity moderate such associations. METHODS: Longitudinal associations between annual mean estimated PM2.5 and NO2 concentrations at the residential address and trajectories of conduct problems, and the potential influence of racism and ethnicity were examined school-based sample of 4775 participants (2002-2003 to 2005-2006) in London, using growth curve models. RESULTS: Overall, in the fully adjusted model, exposure to lower concentrations of PM2.5 and NO2 was associated with a decrease in conduct problems during adolescence, while exposure to higher concentrations was associated with a flattened trajectory of conduct symptoms. Racism amplified the effect of PM2.5 (ß = 0.05 (95% CI 0.01 to 0.10, p < 0.01)) on adolescent trajectories of conduct problems over time. At higher concentrations of PM2.5, there was a divergence of trajectories of adolescent conduct problems between ethnic minority groups, with White British and Black Caribbean adolescents experiencing an increase in conduct problems over time. CONCLUSION: These findings suggest that the intersections between air pollution, ethnicity, and racism are important influences on the development of conduct problems in adolescence.

Evaluating performance of covariate-constrained randomization (CCR) techniques under misspecification of cluster-level variables in cluster-randomized trials.

Covariate constrained randomization (CCR) is a method of controlling imbalance in important baseline covariates in cluster-randomized trials (CRT). We use simulated CRTs to investigate the performance (control of imbalance) of CCR relative to simple randomization (SR) under conditions of misspecification of the cluster-level variable used in the CCR algorithm. We use data from a Patient-Centered Outcomes Research Institute (PCORI)-funded CRT evaluating the Mothers and Babies (MB) intervention (AD-1507-31,473). CCR methodology was used in the MB study to control imbalance in, among other baseline variables, the percent minority (i.e., non-White) participants at each study site. Simulation schemes explored variation in degree of misspecification in the baseline covariate of interest, and include correct report, observed misspecification, and a range of simulated misspecification for intervals within and beyond that observed in the MB study. We also consider three within-site sample size scenarios: that observed in the MB study, small (mean 10) and large (mean 50). Simulations at every level of baseline covariate misspecification suggest that use of the CCR strategy provides between-arm imbalance that is simultaneously lower and less variable, on average, than that produced from the SR strategy. We find that the gains to using CCR over SR are nearly twice as high with accurate reporting (Δ = -5.33) compared to the observed study-level misspecification (Δ = -3.03). Although CCR still outperforms SR as the level of misspecification increases, the gains to using CCR over SR decrease; thus, every effort should still be made to obtain high-quality baseline data.

Comparing the effectiveness of home visiting paraprofessionals and mental health professionals delivering a postpartum depression preventive intervention: a cluster-randomized non-inferiority clinical trial.

To determine whether pregnant women receiving the Mothers and Babies group-based intervention exhibited greater depressive symptom reductions and fewer new cases of major depression than women receiving usual community-based services, and to examine whether groups run by paraprofessional home visitors and mental health professionals yielded similar depressive symptom reductions and prevention of major depression. Using a cluster-randomized design, 37 home visiting programs were randomized to usual home visiting, Mothers and Babies delivered via home visiting paraprofessionals, or Mothers and Babies delivered via mental health professionals. Baseline assessments were conducted prenatally with follow-up extending to 24 weeks postpartum. Eligibility criteria were ≥ 16 years old, ≤ 33 gestation upon referral, and Spanish/English speaking. Depressive symptoms at 24 weeks postpartum was the primary outcome. Eight hundred seventy-four women were enrolled. Neither intervention arm was superior to usual care in decreasing depressive symptoms across the sample (p = 0.401 home visiting paraprofessional vs. control; p = 0.430 mental health professional vs. control). Post hoc analyses suggest a positive intervention effect for women exhibiting mild depressive symptoms at baseline. We have evidence of non-inferiority, as the model-estimated mean difference in depressive symptoms between intervention arms (0.01 points, 95% CI: -0.79, 0.78) did not surpass our pre-specified margin of non-inferiority of two points. Although we did not find statistically significant differences between intervention and control arms, non-inferiority analyses found paraprofessional home visitors generated similar reductions in depressive symptoms as mental health professionals. Additionally, Mothers and Babies appears to reduce depressive symptoms among women with mild depressive symptoms when delivered by mental health professionals. This trial is registered on ClinicalTrials.gov (initial post: December 1, 2016; identifier: NCT02979444).

Overestimation of Postpartum Depression Prevalence Based on a 5-item Version of the EPDS: Systematic Review and Individual Participant Data Meta-analysis.

OBJECTIVE: The Maternal Mental Health in Canada, 2018/2019, survey reported that 18% of 7,085 mothers who recently gave birth reported "feelings consistent with postpartum depression" based on scores ≥7 on a 5-item version of the Edinburgh Postpartum Depression Scale (EPDS-5). The EPDS-5 was designed as a screening questionnaire, not to classify disorders or estimate prevalence; the extent to which EPDS-5 results reflect depression prevalence is unknown. We investigated EPDS-5 ≥7 performance relative to major depression prevalence based on a validated diagnostic interview, the Structured Clinical Interview for DSM (SCID). METHODS: We searched Medline, Medline In-Process & Other Non-Indexed Citations, PsycINFO, and the Web of Science Core Collection through June 2016 for studies with data sets with item response data to calculate EPDS-5 scores and that used the SCID to ascertain depression status. We conducted an individual participant data meta-analysis to estimate pooled percentage of EPDS-5 ≥7, pooled SCID major depression prevalence, and the pooled difference in prevalence. RESULTS: A total of 3,958 participants from 19 primary studies were included. Pooled prevalence of SCID major depression was 9.2% (95% confidence interval [CI] 6.0% to 13.7%), pooled percentage of participants with EPDS-5 ≥7 was 16.2% (95% CI 10.7% to 23.8%), and pooled difference was 8.0% (95% CI 2.9% to 13.2%). In the 19 included studies, mean and median ratios of EPDS-5 to SCID prevalence were 2.1 and 1.4 times. CONCLUSIONS: Prevalence estimated based on EPDS-5 ≥7 appears to be substantially higher than the prevalence of major depression. Validated diagnostic interviews should be used to establish prevalence.