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.

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).

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.

Acceptability and appropriateness of a perinatal depression preventive group intervention: a qualitative analysis.

BACKGROUND: Perinatal depression is a prevalent public health concern. Although preventive interventions exist, there is limited literature on the acceptability and appropriateness of these interventions, especially those delivered by paraprofessionals. The Mothers and Babies Program (MB) is a group-based perinatal depression preventive intervention delivered prenatally. A cluster-randomized controlled trial examined the acceptability, appropriateness, and effectiveness of MB delivered by mental health professionals compared to paraprofessional staff from home visiting programs. METHODS: The full study enrolled 874 pregnant women. Fifty-three facilitators were trained and delivered the MB intervention to women in one of seven states in the United States. Semi-structured interviews were attempted with a randomly-selected subset of the full sample of pregnant women who received the MB intervention and with all facilitators. Specifically, interviews were conducted with 88 women who received the MB group intervention (45 in the paraprofessional-led arm and 43 in the mental health professional-led arm) and 46 women who facilitated the groups (27 home visiting staff and 19 mental health professionals). Interviews were conducted over the phone in English or Spanish and audio recorded. The recordings were translated into English, as needed, and transcribed. Thematic analysis was conducted using NVIVO to identify key themes related to intervention acceptability and appropriateness. Similarities and differences between study arms were explored. RESULTS: Clients and facilitators found the MB content and group format acceptable. Challenges included maintaining group attendance, transportation issues, and managing group discussion. Overall, facilitators found the intervention appropriate for pregnant clients with some challenges presented for clients in crisis situations, experiencing housing instability, and with literacy and learning challenges. Participants provided suggestions for improvement, both for the course content and implementation. There were no significant differences found between study arms. CONCLUSIONS: Overall, clients and facilitators enjoyed MB irrespective of study arm, and facilitators found the intervention appropriate for the population. These findings add to the qualitative literature on perinatal depression preventive interventions, specifically those delivered by paraprofessionals. TRIAL REGISTRATION: This trial is registered on ClinicalTrials.gov (Initial post: December 1, 2016; identifier: NCT02979444).

Comparing Fidelity Outcomes of Paraprofessional and Professional Delivery of a Perinatal Depression Preventive Intervention.

Mothers and Babies (MB), a perinatal depression preventive intervention, has proven effective in decreasing depressive symptoms and preventing onset of major depression. An ongoing cluster-randomized trial is comparing the effectiveness of the six-session MB group intervention led by paraprofessionals versus mental health professionals. Twenty percent of all audio-recorded intervention sessions were randomly selected for fidelity checks. Analyses assessed mean facilitator adherence and competency overall, by study arm, and by session; and, examined site, facilitator, and client-specific effects. There were no significant differences found between study arms. Findings show paraprofessionals can deliver MB with similar fidelity as mental health professionals.

Patient and Caregiver Perspectives on the Relationship Between Atopic Dermatitis Symptoms and Mental Health.

Background: Atopic dermatitis (AD) patients have increased likelihood of developing depression and anxiety. The patient and caregiver's perceptions of the correlation of mental health (MH) and AD symptoms are not well understood. Objective: To evaluate patient-reported MH symptoms and their correlation with AD disease severity and understand patient-perceived associations of AD with impacts to their MH. Methods: Adult AD patients (18+ years) or caregivers of AD patients (8-17 years) were recruited to complete a survey about MH and their perception of its relationship with AD. Results: Of 1496 respondents, 954 met inclusion criteria and completed the survey. Respondents were primarily adults (83.3%) with moderate AD (31.4%). In total, 26.0% reported MH symptoms >10 days per month, and most adults (65.5%) scored in the borderline/abnormal range on the Hospital Anxiety and Depression Scale. Most (70.6%) respondents perceived their MH was negatively affected by AD in the past 12 months. AD severity impacted the perception of the relationship between AD and MH; respondents were more likely to believe MH was impacted by AD when they/their child had severe AD. Conclusion: Our study highlights patient and caregiver awareness of the detrimental impact of AD on MH. Addressing MH in AD care settings early in the disease journey may be beneficial.

Evaluating Access to Prescription Medications in the Atopic Dermatitis Patient Population in the USA.

INTRODUCTION: Despite advances in atopic dermatitis (AD) treatments, many patients face challenges obtaining medications. This study aimed to determine the frequency and causes of insurance coverage delays and denials for AD prescriptions and characterize the associated wait times and extent to which patients understand what to do when faced with a coverage issue. METHODS: This was a cross-sectional, observational study in which adult U.S. residents (aged 18+ years) with AD or caregivers of pediatric U.S. patients with AD (aged 0-17 years) completed an online survey (3 June-16 July 2021). RESULTS: Respondents (N = 978) were primarily adults with AD (81.8%), female (67.7%), and white (70.2%). There were 645 insurance delays or denials for AD prescriptions, with 48.1% (470/978) of respondents experiencing at least one delay/denial in the past year. Most delays/denials were for topical steroids (39.2%, 253/645), the most highly used prescription treatment class (83.9%, 821/978). However, the highest rate of delay/denials was for biologics, of which 43.6% (109/250) of all prescriptions faced a delay or denial. Denials were caused primarily by step therapy (27.6%) and delays by prior authorization (55.1%). Only 56.0% of respondents said they would know what to do if they faced an issue with AD prescription coverage. CONCLUSIONS: Patients with AD frequently experience insurance-related barriers to obtaining recommended therapies, and many do not know how to respond when these barriers arise. Strategies to improve timely therapeutic access are needed.

Factors related to eczema clinical trial participation among adult patients and caregivers.

Background: Eczema can be difficult to treat due to its chronic, heterogeneous nature. Effective long-term treatments for adults and children are needed. Little is known about what considerations influence eczema patient and caregiver decision-making regarding clinical trial participation (CTP). This study identifies factors that adult patients and caregivers consider important for CTP and determines if differences exist between these groups. Methods: A 46-question survey was administered May 1-June 6, 2020, to adults and caregivers of children with eczema. Respondents were asked to rate the importance of a series of factors when considering CTP; adults and caregivers were compared. Results: Out of 31 total factors queried, eleven factors differed significantly in importance ratings between adults (n = 470) and caregivers (n = 134). The route of therapy (p = 0.030), side effects (p = 0.014), washout period (p = 0.028), receiving a placebo (p = 0.027), rescue therapy option (p = 0.033), access to test drug after trial (p = 0.027), sticking with the clinical trial regimen (p = 0.025), fit with work/school (p = 0.005), impact on overall health (p = 0.008), and satisfaction with current treatment (p = 0.033) were all more likely to be rated as important by caregivers than by adult patients. Only altruism was rated more highly by adult patients than caregivers (p = 0.027). Conclusions: Caregivers are more likely than adults to attribute high importance to factors that may affect their child's eczema or well-being when considering CTP. Patient-centered CTP education materials and decision aids may support patients and caregivers in CTP decision-making.

COVID-19 related substance use services policy changes: Policymaker perspectives on policy development & implementation.

INTRODUCTION: Due to the COVID-19 pandemic, regulations for substance use services changed to accommodate stay-at-home orders and physical distancing guidelines. METHODS: Using in-depth interviews (N = 14) and framework analysis, we describe how policymakers developed, adopted, and implemented regulations governing services for substance use disorders during COVID-19, and how policymakers' perceived the impacts of these regulations in New York State. RESULTS: During the COVID-19 pandemic, policymakers shifted to more inclusive approaches of knowledge generation and co-production of recommendations. Barriers to adoption and implementation of new regulations included medication/services supply, lack of integration, stigma, and overcriminalization. CONCLUSION: Findings from this study highlight the potential feasibility and benefits of co-produced policies for substance use services and the need for consistent service supply, better integration with health care services, reduced stigma, improved funding structures, best practice guidelines, criminal justice reform, and harm reduction support. These considerations should inform future policy maintenance and modifications to substance use services related to COVID-19.

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.

Using a micro-level model to generate a macro-level model of productive successful aging.

PURPOSE OF THE STUDY: Aging successfully entails good physical and cognitive health, as well as ongoing participation in social and productive activity. This study hones in on participation in productive activity, a factor that makes an important contribution to successful aging. One conceptual model of productive activity in later life specifies the antecedents and consequences of productivity. This study draws on that micro-level model to develop a corresponding macro-level model and assesses its utility for examining the predictors of and explaining the relationships between one form of productivity (labor force participation rates) and one aspect of well-being (average life expectancy) among males and females. DESIGN AND METHODS: Random effects regression models and path analysis were used to analyze cross-national longitudinal data for 24 high-income Organization for Economic Co-operation and Development (OECD) countries at seven time points (1980-2010; 168 observations total). RESULTS: OECD countries with higher labor force participation rates among older workers have higher life expectancies. Labor force participation mediates the effects of gross domestic product per capita on male and female life expectancy, and it mediates the effect of self-employment rate for men, but it acts as a suppressor with regard to the effect of public spending on male and female life expectancy. IMPLICATIONS: A well-known micro-level model of productive activity can be fruitfully adapted to account for macro-level cross-national variation in productivity and well-being.