The influence of loss to follow-up in autism screening research: Taking stock and moving forward.

BACKGROUND: How best to improve the early detection of autism spectrum disorder (ASD) is the subject of significant controversy. Some argue that universal ASD screeners are highly accurate, whereas others argue that evidence for this claim is insufficient. Relatedly, there is no clear consensus as to the optimal role of screening for making referral decisions for evaluation and treatment. Published screening research can meaningfully inform these questions-but only through careful consideration of children who do not complete diagnostic follow-up. METHODS: We developed two simulation models that re-analyze the results of a large-scale validation study of the M-CHAT-R/F by Robins et al. (2014, Pediatrics, 133, 37). Model #1 re-analyzes screener accuracy across six scenarios, each reflecting different assumptions regarding loss to follow-up. Model #2 builds on this by closely examining differential attrition at each point of the multi-step detection process. RESULTS: Estimates of sensitivity ranged from 40% to 94% across scenarios, demonstrating that estimates of accuracy depend on assumptions regarding the diagnostic status of children who were lost to follow-up. Across a range of plausible assumptions, data also suggest that children with undiagnosed ASD may be more likely to complete follow-up than children without ASD, highlighting the role of clinicians and caregivers in the detection process. CONCLUSIONS: Using simulation modeling as a quantitative method to examine potential bias in screening studies, analyses suggest that ASD screening tools may be less accurate than is often reported. Models also demonstrate the critical importance of every step in a detection process-including steps that determine whether children should complete an additional evaluation. We conclude that parent and clinician decision-making regarding follow-up may contribute more to detection than is widely assumed.

Operationalizing Primary Outcomes to Achieve Reach, Effectiveness, and Equity in Multilevel Interventions.

When intervention scientists plan a clinical trial of an intervention, they select an outcome metric that operationalizes their definition of intervention success. The outcome metric that is selected has important implications for which interventions are eventually supported for implementation at scale and, therefore, what health benefits (including how much benefit and for whom) are experienced in a population. Particularly when an intervention is to be implemented in a population that experiences a health disparity, the outcome metric that is selected can also have implications for equity. Some outcome metrics risk exacerbating an existing health disparity, while others may decrease disparities for some but have less effect for the larger population. In this study, we use a computer to simulate implementation of a hypothetical multilevel, multicomponent intervention to highlight the tradeoffs that can occur between outcome metrics that reflect different operationalizations of intervention success. In particular, we highlight tradeoffs between overall mean population benefit and the distribution of health benefits in the population, which has direct implications for equity. We suggest that simulations like the one we present can be useful in the planning of a clinical trial for a multilevel and/or multicomponent intervention, since simulated implementation at scale can illustrate potential consequences of candidate operationalization of intervention success, such that unintended consequences for equity can be avoided.

Parental substance use and home visiting programs: Implementation considerations for relationship-based treatment.

Home visiting programs can provide critical support to mothers in recovery from substance use disorders (SUDs) and young children prenatally exposed to substances. However, families impacted by maternal SUDs may not benefit from traditional child-focused developmental home visiting services as much as families not impacted by SUDs, suggesting the need to adjust service provision for this population. Given the need to implement tailored services within home visiting programs for families impacted by SUDs, we sought to investigate the implementation barriers and facilitators to inform future integration of a relationship-based parenting intervention developed specifically for parents with SUDs (Mothering from the Inside Out) into home visiting programs. We conducted nine interviews and five focus groups with a racially diverse sample (N = 38) of parents and providers delivering services for families affected by SUDs in the USA. Qualitative content analysis yielded three most prominent themes related to separate implementation domains and their associated barriers and facilitators: (1) engagement, (2) training, and (3) sustainability. We concluded that the home visiting setting may mitigate the logistical barriers to access for families affected by SUDs, whereas relationship-based services may mitigate the emotional barriers that parents with SUDs experience when referred to home visiting programs.

Los programas de visita a casa pueden ofrecer un apoyo clave a madres en recuperación de trastornos por abusos de sustancias (SUD) y los niños pequeños expuestos a sustancia prenatalmente. Sin embargo, las familias que recibieron el impacto de SUD materno pudieran no beneficiarse de los servicios tradicionales de visita a casa en cuanto al desarrollo enfocados en el niño tanto como las familias que no sufren el impacto de SDU, lo cual sugiere la necesidad de ajustar el ofrecimiento de servicios para este grupo de población. Dada la necesidad de implementar servicios amoldados dentro de los programas de visita a casa para familias que sufren el impacto de SUD, nos propusimos investigar las barreras y los aspectos que facilitan la implementación a manera de informar la futura integración de una intervención de crianza con base en la relación, específicamente desarrollada para progenitores con SUD (Cuidados Maternales Desde Dentro) en los programas de visita a casa. Llevamos a cabo nueve entrevistas y cinco grupos de enfoque con un grupo muestra racialmente diverso (N = 38) de progenitores y proveedores que ofrecen los servicios a familias que sufren el impacto de SUD en los Estados Unidos. Los análisis de contenido cualitativo arrojaron tres temas más prominentes relacionados con dominios de implementación separados y las asociadas barreras y aspectos que la facilitan: (1) involucramiento, (2) entrenamiento, y (3) sostenibilidad. Concluimos que el escenario de visita a casa pudiera mitigar las barreras logísticas de acceso para familias afectadas por SUD, mientras que los servicios con base en la relación pudieran mitigar las barreras emocionales que los progenitores con SUD experimentan cuando se les refiere a programas de visita a casa.

Les programmes de visite à domicile peuvent offrir un soutien critique aux mères qui se rétablissent d'un trouble lié à l'usage d'une substance (TUS) et aux jeunes enfants exposés à des substances avant leur naissance. Cependant les familles impactées par des TUS maternels ne bénéficient pas de services de visite à domicile traditionnels autant que des familles non impactées par un TUS, suggérant le besoin d'ajuster des prestations de service pour cette population. Vu le besoin de mettre en place des services adaptés au sein des programmes de visite à domicile pour les familles impactées par des TUS, nous avons décidé d'étudier les barrières et les facteurs de facilitation de mise en place afin d'éclairer l'intégration future d'une intervention de parentage basée sur une relation développée spécifiquement pour des parents avec des TUS (le maternage de l'intérieur suivant l'anglais Mothering from the Inside Out) dans des programmes de visite à domicile. Nous avons procédé à neuf entretiens et cinq groupes d'étude avec un échantille variés du point de vue racial (N = 38) de parents et de prestataires offrant des services pour des familles affectées par des TUS aux Etats-Unis d'Amérique. Une analyse qualitative de contenu a donné trois groupes importants lié à des domaines de mise en place séparés et les barrières et facteurs de facilitation y étant liés: (1) l'engagement, (2) la formation, et (3) la durabilité. Nous concluons que le contexte de visite à domicile peut mitiger les barrières logistiques à l'accès pour les familles affectées par des TUS, alors que les services relationnels peuvent mitiger les barrières émotionnelles dont les parents avec des TUS font l'expérience lorsqu'on leur recommande des programmes de visite à domicile.

Adapting Community Health Worker Care Models to Advance Mental Health Services Among LGBTQ Youth.

Lesbian, gay, bisexual, transgender, and queer (LGBTQ) youth of color experience high rates of mental health disorders, yet they experience challenges to accessing mental health services. Community health worker (CHW) models of care have potential to promote equitable mental health services among LGBTQ youth. Our aim was to understand how CHW models could be adapted to better support LGBTQ youth of color in accessing mental health services. Semi-structured qualitative interviews were conducted with LGBTQ youth of color (n = 16), caregivers of LGBTQ youth (n = 11), and CHWs (n = 15) in Massachusetts and California. Interviews were coded by 8 members of the research team. A Rapid Qualitative Analysis was conducted to identify themes. Caregivers, youth, and CHWs all endorsed the value of CHW models for this population. They also almost universally suggested multiple adaptations are needed for the model to be effective. Four main categories of themes emerged related to intervention adaptations: (1) Why adaptations are needed for LGBTQ youth, (2) Who should serve as CHWs providing care, (3) How CHWs should be trained, and (4) What content needs to be included in the intervention. Broadly, findings suggest the relevance of having CHW models for LGBTQ youth of color to address stigma and discrimination experienced, access to culturally and linguistically relevant services, and the need for caregiver support of LGBTQ youth. CHWs need increased training in these areas.

Five-Year Trends in Pediatric Mental Health Emergency Department Visits in Massachusetts: A Population-Based Cohort Study.

OBJECTIVES: To evaluate temporal changes in pediatric emergency department (ED) visits for mental health problems in Massachusetts based on diagnoses and patient characteristics and to assess trends in all-cause pediatric ED visits. STUDY DESIGN: This statewide population-based retrospective cohort study used the Massachusetts All-Payer Claims Database, which includes almost all Massachusetts residents. The study sample consisted of residents aged <21 years who were enrolled in a health plan between 2013 and 2017. Using multivariate regression, we examined temporal trends in mental health-related and all-cause ED visits in 2013-2017, with person-quarter as the unit of analysis; we also estimated differential trends by sociodemographic and diagnostic subgroups. The outcomes were number of mental health-related (any diagnosis, plus 14 individual diagnoses) and all-cause ED visits/1000 patients/quarter. RESULTS: Of the 967 590 Massachusetts residents in our study (representing 14.8 million person-quarters), the mean age was 8.1 years, 48% were female, and 57% had Medicaid coverage. For this population, mental health-related (any) and all-cause ED visits decreased from 2013 to 2017 (P < .001). Persons aged 18-21 years experienced the largest declines in mental health-related (63.0% decrease) and all-cause (60.9% decrease) ED visits. Although mental health-related ED visits declined across most diagnostic subgroups, ED visits related to autism spectrum disorder-related and suicide-related diagnoses increased by 108% and 44%, respectively. CONCLUSIONS: Overall rates of pediatric ED visits with mental health diagnoses in Massachusetts declined from 2013 to 2017, although ED visits with autism- and suicide-related diagnoses increased. Massachusetts' policies and care delivery models aimed at pediatric mental health may hold promise, although there are important opportunities for improvement.

Beyond Housing for Health: Using Flexible Funds to Improve Maternal and Child Health.

Upstreaming Housing for Health (UHfH) was a pilot program that aimed to improve housing stability and reduce health inequities among people experiencing high-risk pregnancies and their infants. It served 50 families from 2019 to 2020. One critical component of UHfH was an innovative flexible fund, which was originally designed to address housing stability (e.g., rent arrears) but expanded its scope to address material needs that promoted family stability within the context of their housing situation (e.g., housing safety or maternal-infant health while in shelter). Seventy-six percent of families accessed flexible funds for items such as rental assistance, cribs, and breast pumps, with average financial support of $1343 (standard deviation = $625). The flexible fund is an example of a cash transfer policy. Such policies have shown to positively impact family health and well-being in the USA and internationally. Similar funding should be considered as part of future programming to reduce housing instability and homelessness.

Racial inequities in the course of treating perinatal mental health challenges: Results from listening to mothers in California.

BACKGROUND: Concern with depression during the perinatal period has resulted in multiple states enacting legislation to require universal screening of mothers for postpartum depression. Despite this concern, rates of women receiving mental health counseling during pregnancy and postpartum remain low. This study examines factors, especially inequities in race/ethnicity, associated with receiving perinatal mental health counseling. METHODS: This study draws on data from the Listening to Mothers in California survey of 2539 women, based on a representative sample of birth certificate files of women who gave birth in 2016. The survey included a series of mental health questions, based on the 4-item Patient Health Questionnaire (PHQ-4), and questions on the receipt of counseling, whether a practitioner asked respondents about their mental health, and whether the respondent was taking medications for anxiety or depression. RESULTS: We found non-Latina Black women to experience both higher rates of prenatal depressive symptoms and significantly lower use of postpartum counseling services and medications than non-Latina White women. Among women with depressive symptoms, those asked by a practitioner about their mental health status reported a 46% rate of counseling compared with 20% who were not asked, and in a multivariable analysis, those asked were almost six times more likely (aOR 5.96; 95% CI 1.6-21.7) to report counseling. DISCUSSION: These findings lend evidence to those advocating for state laws requiring universal screening for depressive symptoms to reduce inequities and help address the underuse of counseling services among all women with depressive symptoms, particularly women of color.

Simulation and minimization: technical advances for factorial experiments designed to optimize clinical interventions.

BACKGROUND: The Multiphase Optimization Strategy (MOST) is designed to maximize the impact of clinical healthcare interventions, which are typically multicomponent and increasingly complex. MOST often relies on factorial experiments to identify which components of an intervention are most effective, efficient, and scalable. When assigning participants to conditions in factorial experiments, researchers must be careful to select the assignment procedure that will result in balanced sample sizes and equivalence of covariates across conditions while maintaining unpredictability. METHODS: In the context of a MOST optimization trial with a 2x2x2x2 factorial design, we used computer simulation to empirically test five subject allocation procedures: simple randomization, stratified randomization with permuted blocks, maximum tolerated imbalance (MTI), minimal sufficient balance (MSB), and minimization. We compared these methods across the 16 study cells with respect to sample size balance, equivalence on key covariates, and unpredictability. Leveraging an existing dataset to compare these procedures, we conducted 250 computerized simulations using bootstrap samples of 304 participants. RESULTS: Simple randomization, the most unpredictable procedure, generated poor sample balance and equivalence of covariates across the 16 study cells. Stratified randomization with permuted blocks performed well on stratified variables but resulted in poor equivalence on other covariates and poor balance. MTI, MSB, and minimization had higher complexity and cost. MTI resulted in balance close to pre-specified thresholds and a higher degree of unpredictability, but poor equivalence of covariates. MSB had 19.7% deterministic allocations, poor sample balance and improved equivalence on only a few covariates. Minimization was most successful in achieving balanced sample sizes and equivalence across a large number of covariates, but resulted in 34% deterministic allocations. Small differences in proportion of correct guesses were found across the procedures. CONCLUSIONS: Based on the computer simulation results and priorities within the study context, minimization with a random element was selected for the planned research study. Minimization with a random element, as well as computer simulation to make an informed randomization procedure choice, are utilized infrequently in randomized experiments but represent important technical advances that researchers implementing multi-arm and factorial studies should consider.

A hybrid type I randomized effectiveness-implementation trial of patient navigation to improve access to services for children with autism spectrum disorder.

BACKGROUND: Significant racial, ethnic, and socioeconomic disparities exist in access to evidence-based treatment services for children with autism spectrum disorder (ASD). Patient Navigation (PN) is a theory-based care management strategy designed to reduce disparities in access to care. The purpose of this study is to test the effectiveness of PN a strategy to reduce disparities in access to evidence-based services for vulnerable children with ASD, as well as to explore factors that impact implementation. METHODS: This study uses a hybrid type I randomized effectiveness/implementation design to test effectiveness and collect data on implementation concurrently. It is a two-arm comparative effectiveness trial with a target of 125 participants per arm. Participants are families of children age 15-27 months who receive a positive screen for ASD at a primary care visit at urban clinics in Massachusetts (n = 6 clinics), Connecticut (n = 1), and Pennsylvania (n = 2). The trial measures diagnostic interval (number of days from positive screen to diagnostic determination) and time to receipt of evidence-based ASD services/recommended services (number of days from date of diagnosis to receipt of services) in those with PN compared to and activated control -Conventional Care Management - which is similar to care management received in a high quality medical home. At the same time, a mixed-method implementation evaluation is being carried out. DISCUSSION: This study will examine the effectiveness of PN to reduce the time to and receipt of evidence-based services for vulnerable children with ASD, as well as factors that influence implementation. Findings will tell us both if PN is an effective approach for improving access to evidence-based care for children with ASD, and inform future strategies for dissemination. TRIAL REGISTRATION: NCT02359084 Registered February 1, 2015.

Avoidance as an obstacle to preventing depression among urban women at high risk for violent trauma.

The impact of depression interventions is often attenuated in women who have experienced trauma. We explored whether psychological avoidance could explain this phenomenon. We synthesized two pilot randomized trials of problem-solving education (PSE) among a total of 93 urban mothers. Outcomes included depressive symptoms and perceived stress. Mothers with avoidant coping styles experienced an average 1.25 episodes of moderately severe depressive symptoms over 3 months of follow-up, compared to 0.40 episodes among those with non-avoidant coping (adjusted incident rate ratio [aIRR] 2.18; 95 % CI 1.06, 4.48). PSE tended to perform better among mothers with non-avoidant coping. Among mothers with non-avoidant coping, PSE mothers experienced an average 0.24 episodes, compared to 0.58 episodes among non-avoidant controls (aIRR 0.27; 95 % CI 0.05, 1.34). Among mothers with avoidant coping, PSE mothers experienced an average 1.26 episodes, compared to 1.20 episodes among avoidant controls (aIRR 0.76; 95 % CI 0.44, 1.33). This trend toward differential impact persisted when avoidance was measured as a problem-solving style and among traumatized mothers with and without avoidant PTSD symptoms. Further research is warranted to explore the hypothesis that psychological avoidance could explain why certain depression treatment and prevention strategies break down in the presence of trauma.

Bringing life course home: a pilot to reduce pregnancy risk through housing access and family support.

Proponents of life course comment that while the theory is persuasive, translating theory to practice is daunting. This paper speaks to the challenges and possibilities of intervention based on life course theory. It describes Healthy Start in Housing (HSiH), a partnership between the Boston Public Health Commission (BPHC) and the Boston Housing Authority (BHA) to reduce stress due to housing insecurity among low-income, pregnant women. HSiH seeks improved birth outcomes and long term health of mothers and infants. BHA goals are improved quality of life for participants, greater public housing stability and enhanced impact of housing on community well-being. HSiH is a 1 year pilot offering 75 housing units to pregnant women at risk of adverse birth outcomes and homelessness. BHA provides housing and expedites processing of HSiH applications; BPHC staff oversee enrollment, guide women through the application process, and provide enhanced, long-term case management. Of 130 women referred to HSiH to date, 53 were ineligible, 59 have submitted applications, 13 are preparing applications and 5 dropped out. Nineteen women have been housed. Among eligible women, 58 % had medical conditions, 56 % mental health conditions, and 14 % prior adverse outcomes; 30 % had multiple risks. Standardized assessments reflected high levels of depressive symptoms; 41 % had symptoms consistent with post-traumatic stress disorder. Life course theory provides both the framework and the rationale for HSiH. HSiH experience confirms the salience of daily social experience to women's health and the importance of addressing stressors and stress in women's lives.

Extended Postpartum Medicaid In Colorado Associated With Increased Treatment For Perinatal Mood And Anxiety Disorders.

Perinatal mood and anxiety disorders (PMAD), a leading cause of perinatal morbidity and mortality, affect approximately one in seven births in the US. To understand whether extending pregnancy-related Medicaid eligibility from sixty days to twelve months may increase the use of mental health care among low-income postpartum people, we measured the effect of retaining Medicaid as a low-income adult on mental health treatment in the postpartum year, using a "fuzzy" regression discontinuity design and linked all-payer claims data, birth records, and income data from Colorado from the period 2014-19. Relative to enrolling in commercial insurance, retaining postpartum Medicaid enrollment was associated with a 20.5-percentage-point increase in any use of prescription medication or outpatient mental health treatment, a 16.0-percentage-point increase in any use of prescription medication only, and a 7.3-percentage-point increase in any use of outpatient mental health treatment only. Retaining postpartum Medicaid enrollment was also associated with $40.84 lower out-of-pocket spending per outpatient mental health care visit and $3.24 lower spending per prescription medication for anxiety or depression compared with switching to commercial insurance. Findings suggest that extending postpartum Medicaid eligibility may be associated with higher levels of PMAD treatment among the low-income postpartum population.

Implementing Parenting Programs in Primary Care: A Framework and a Call for Action.

Healthy parent-child relationships are clearly critical to healthy child development. Parenting programs develop caregivers' skills to support the health and well-being of children. Rigorous evidence has demonstrated the efficacy of these programs. Rising rates of child and youth depression, anxiety, grief, and suicide, both prior to and compounded by the COVID-19 pandemic, provide further reasons to implement parenting programs that support all parents in their essential roles. Parents can act as a buffer to stressors and support for children's well-being when they have the knowledge and skills to do so. Pediatric primary care practices are a natural setting for parenting programs, but challenges, including stigma, technology, workflow issues, and funding, have prevented their broad dissemination, implementation, and sustainability. In this article, we develop a framework for implementing parenting programs in primary care and present key considerations for selecting programs that fit the needs of parents, providers, patients, and the practice. We offer lessons from our experiences in overcoming these challenges, using the updated Consolidated Framework for Implementation Research to structure our discussion. We also provide an initial stepwise process which readers may use to plan their own parenting program implementation. Pediatric clinicians and practices can use this article and associated resources to plan, implement, and evaluate parenting programs in their practices as a strategy to help address the growing youth mental health crisis. Improving parenting behaviors can reduce the need for current or future mental health interventions by supporting optimal child development, emotional regulation, and parent-child relationships.

Effectiveness of an Enhanced Community Doula Intervention in a Safety Net Setting: A Randomized Controlled Trial.

Background: Racial inequities in maternal health outcomes, the result of systemic racism and social determinants of health, require maternity care systems to implement interventions that reduce disparities. One such approach may be support from a community doula, a health worker who provides emotional support, peer education, navigation, and advocacy for pregnant, birthing, and postpartum people who share similar racial identities, cultural backgrounds, and/or lived experiences. While community support during birth has a long tradition within communities of Black Indigenous and People of Color (BIPOC), the reframing of community doula support as a social intervention that reduces disparities in clinical outcomes is recent. Methods: We conducted a pragmatic randomized trial at an urban safety net hospital, comparing standard maternity care with standard care plus enhanced community doula support. We tested the effectiveness of a community doula program embedded in a safety net hospital in improving birth outcomes and explored the association between community doula support and health equity. Participants were nulliparous, insured by publicly funded health plans, and had lower risk pregnancies. The primary outcome was cesarean birth. Secondary outcomes included preterm birth and breastfeeding outcomes. Exploratory subgroup analysis was conducted by race-ethnicity. Results: Three hundred sixty-seven participants were included in the primary analysis. In the intent-to-treat analysis, outcomes were similar between groups. There was a trend toward increased breastfeeding initiation (p=0.08). There was a statistically nonsignificant 12% absolute reduction in cesarean birth and 11.5% increase in exclusive breastfeeding during delivery hospitalization among Black non-Hispanic participants. Discussion: While outcomes for the study sample were similar between randomization groups, health outcomes were improved for Black birthing people in cesarean and breastfeeding rates. Conclusion: This study demonstrates the need for larger studies of community doula support for Black birthing people. Clinicaltrials.gov ID: NCT02550730.

Pediatric Provider and Staff Burnout in Federally Qualified Community Health Centers.

This study examined changes in provider and staff burnout in 4 Boston-area federally qualified community health centers (FQHCs) participating in a pediatric behavioral health integration project. Utilizing the Maslach Burnout Inventory-Human Services Survey for Medical Personnel (MBI-HSSMP), the study found that emotional exhaustion among primary care providers ( M = 20.5; confidence interval [CI], 17.8-23.2) was higher ( P = .001) than that among behavioral health clinicians ( M = 13.6; CI, 10.4-16.8) and ( P = .00005) community health workers ( M = 10.8; CI, 7.3-14.2). Emotional exhaustion among staff increased ( P = .04) from baseline ( M = 16.8; CI, 15.0-18.6) to follow-up ( M = 20.8; CI, 17.5-24.2), but burnout at follow-up was lower than national averages. FQHCs are integral in caring for marginalized patients; therefore, supporting a stable workforce by minimizing burnout is essential.

Implementation of a Novel Pediatric Behavioral Health Integration Initiative.

This study explores healthcare professionals' perspectives about the impact of behavioral health integration (BHI) on pediatric primary care delivery in community health centers (CHCs). A concurrent, qualitative-dominant mixed methods empirical study design was utilized, applying semi-structured interviews with healthcare professionals at the end of the implementation phase of a 3-year co-development, implementation, and evaluation process. Surveys were also administered at three time points. Via thematic analysis, emergent qualitative themes were mapped onto the Relational Coordination (RC) conceptual framework to triangulate and complement final qualitative results with quantitative results. Interview findings reveal five emergent themes aligning with RC domains. Survey results show that healthcare professionals reported increased behavioral healthcare integration into clinic practice (p = 0.0002) and increased clinic readiness to address behavioral health needs (p = 0.0010). Effective pediatric BHI and care delivery at CHCs may rely on strong professional relationships and communication. Additional research from the patient/caregiver perspective is needed.

Adaptation of an evidence-based parenting intervention for integration into maternal-child home-visiting programs: Challenges and solutions.

Background: The objective of this study was to assess potential challenges, prioritize adaptations, and develop an implementation and research approach to integrate and study a parenting intervention for mothers in recovery from substance use disorders in community-based home-visiting programs. Method: An explanatory mixed-methods design, guided by process mapping with Failure Modes and Effects Analysis tools, and an Advisory Panel of 15 community members, identified potential implementation challenges and recommended solutions for the proposed intervention within five pre-specified domains. Thematic content analysis identified themes from detailed field notes. Results: The Advisory Panel identified 44 potential challenges across all domains. They determined that the recruitment domain was most likely to create challenges. Regarding the potential challenges, two cross-domain themes emerged: (1) development of mistrust in the community and (2) difficulty initiating and sustaining engagement. Potential solutions and adaptations to protocols are reported. Conclusion: Mistrust in the community was cited as a potentially important challenge for the delivery and study of an evidence-based parenting intervention for mothers in recovery through home-visiting programs. Adaptations to research protocols and intervention delivery strategies are needed to prioritize the psychological safety of families, particularly for groups that have been historically stigmatized.

Changes Over Time in Outcomes of School-Age Children and Parents Receiving Integrated Mental Health Care in Federally Qualified Health Centers.

OBJECTIVE: The purpose of this study is to understand change in parent-reported outcomes of mental health symptoms, health-related quality of life (QoL), and school-related functioning among children receiving mental health care at 3 federally qualified health centers engaging in a comprehensive pediatric mental health integration model. METHODS: Trained personnel enrolled English- or Spanish-speaking families of 6- to 12-year-old children who had recently started receiving integrated mental health care and surveyed their parent/caregiver at 3 time points: entry into the cohort, 6-month follow-up, and 12-month follow-up (unique N = 51). Primary outcomes included validated measures of child symptoms, child health-related QoL, and child school-related functioning. Secondary outcomes focused on parental functioning and included validated measures of parental stress and depressive and internalizing symptoms. A multilevel mixed-effects generalized linear model was used to estimate the change in parent-reported outcomes over time, with inverse probability weights used to address attrition. Additional analyses were conducted to determine the degree to which changes in symptoms over time were associated with improvements in school-related functioning. RESULTS: Over 12 months, children's mental health symptoms, health-related QoL, and school-related functional outcomes significantly improved. No changes in parental functioning were observed. In addition, improvements in mental health symptoms and health-related QoL were associated with improvements in school-related functional outcomes over time. CONCLUSION: Findings demonstrate that outcomes of children who received integrated mental health care improved over time, both in regard to mental health and school functioning.

Recommendations for post-implementation adaptations to optimize family navigation in pediatric primary care: a qualitative study with parents and navigators.

BACKGROUND: Family Navigation (FN) is an evidence-based care management intervention designed to reduce disparities in access to care by providing families with individually tailored support and care coordination. Early data suggest FN is effective, but effectiveness is significantly influenced by both contextual (e.g. setting) and individual (e.g., ethnicity) variables. To better understand how FN could be tailored to address this variability in effectiveness, we set forth to explore proposed adaptations to FN by both navigators and families who received FN. METHODS: This study was a nested qualitative study set within a larger randomized clinical trial of FN to improve access to autism diagnostic services in urban pediatric primary care practices in Massachusetts, Pennsylvania, and Connecticut serving low-income, racial and ethnic minority families. Following FN implementation, key informant interviews were conducted based on the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) with a purposeful sample of parents of children who received FN (n = 21) and navigators (n = 7). Interviews were transcribed verbatim and were coded using framework-guided rapid analysis to categorize proposed adaptations to FN. RESULTS: Parents and navigators proposed 38 adaptations in four domains: 1) content of the intervention (n = 18), 2) context of the intervention (n = 10), 3) training and evaluation (n = 6), and 4) implementation and scale-up (n = 4). The most frequently endorsed adaptation recommendations focused on content (e.g., lengthening FN, providing parents with additional education on autism and parenting children with autism) and implementation (e.g., increasing access to navigation). Although probes targeted critical feedback, parents and navigators were overwhelmingly positive about FN. CONCLUSIONS: This study builds upon prior FN effectiveness and implementation research by providing concrete areas for adaptation and refinement of the intervention. Recommendations by parents and navigators have the potential to inform improvement of existing navigation programs and development of new programs in similarly underserved populations. These findings are critical as adaptation (cultural and otherwise) is an important principle in the field of health equity. Ultimately, adaptations will need to be tested to determine clinical and implementation effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov, registration number NCT02359084, February 9, 2015.