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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.

OBJECTIVES: The American Academy of Pediatrics (AAP) recommends that pediatricians screen all young children for autism spectrum disorder (ASD). However, the U.S. Preventive Services Task Force stated that there is insufficient evidence about the potential harms and benefits of universal ASD screening. To address this gap, we conducted qualitative interviews with caregivers of children who received a false positive ASD screen to learn about families’ perceptions of the harms and benefits of universal ASD screening. METHODS: Culturally-diverse caregivers (N=26) of children with false-positive ASD screens completed qualitative interviews focused on parents’ experiences with and recommendations to improve the ASD screening and evaluation process. Interviews were transcribed verbatim, coded, and analyzed using applied thematic analysis. RESULTS: Parents explained that the ASD screening and evaluation process increased their knowledge about child development and substantiated existing concerns. The ASD screening and evaluation process resulted in connecting their child to services, which parents felt led to improvements in their child’s delays. Parents endorsed anxiety during wait times for the formal developmental assessment. However, all parents expressed that, if given the option, they would repeat the screening and evaluation process again. Caregivers recommended universal screening for ASD and suggested that screening extend beyond the pediatrician to other settings. CONCLUSIONS: From parents’ perspectives, the connection to developmental services and increased knowledge of child development that resulted from the false positive ASD screen outweighed the time-limited emotional distress triggered by a positive ASD screen. Overall, parents’ preferences for universal ASD screening align with the AAP’s recommendations.

Over the past 10 years, identification of Autism Spectrum Disorder (ASD) risk has dramatically increased due to the wide-spread implementation of screening programs; yet, there is limited understanding about parent perceptions and experiences during the time period when risk is identified, but prior to receiving a formal diagnosis—a period that can last months to years given the long wait-lists for formal ASD evaluations. The current study aimed to examine parent perceptions of family impact (i.e., the impact their child’s behaviors have on the family) between the time of risk-identification and formal diagnosis among 277 children identified as at-risk for ASD through screening positive in primary care. We aimed to compare family impact among those whose child met diagnostic criteria for ASD and those who did not. Parents of children who received a non-ASD diagnosis reported a higher baseline level of family impact (F[1, 274] = 5.82, p = .017); however, perceived difficult child behavior was a stronger predictor of family impact (t[6] = 13.11, p

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.

Objective Families, pediatric providers, and service systems would benefit from expanded knowledge regarding (1) who is most likely to receive a recommended diagnostic evaluation after a positive primary care-administered autism screen and (2) of those who screen positive, who is most likely to be diagnosed with autism? Method Participants included 309 predominantly low-income, racial/ethnic minority parents and their child, aged 15 to 27 months, who screened positive on the Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F). Generalized estimating equations were used to fit models of predictors for each binary outcome: receiving a diagnostic evaluation and receiving an autism diagnosis on evaluation. Results Significant predictors of diagnostic evaluation receipt included the parent being older or non-Hispanic and the child having private insurance, lower child communication functioning, or receiving Early Intervention services. Significant predictors of an autism diagnosis on evaluation included male child, lower child communication functioning, screening directly in the parent's preferred language, White/non-Hispanic parent, and no parent history of mood disorder. Conclusion Children with younger parents, Hispanic ethnicity, relatively higher communication skills, public insurance, and no Early Intervention services were less likely to receive recommended diagnostic care. Reduced likelihood of autism diagnosis after a positive screen in non-White/non-Hispanic subgroups supports previous research indicating issues with M-CHAT-R/F positive predictive power for racial/ethnic minorities. The use of telephonic interpreters to administer screens, as opposed to directly screening in families' preferred languages, may lead to identification of fewer true autism cases. Thus, multilingual clinical staff capacity may improve positive predictive power of autism screening.

Parents of children with autism spectrum disorder (ASD) show increased levels of parenting stress, but only one study has examined this association before a diagnostic evaluation. We conducted a cross-sectional study of parenting stress in 317 low SES parents with children at-risk for ASD before a diagnostic evaluation. Multiple regression modeling evaluated the associations between parenting stress and parent and child factors. Parenting stress was negatively associated with social support and positively associated with active avoidance coping and parental worry. However, parenting stress was not associated with the child’s ASD symptom severity or adaptive functioning, except for self-direction. Findings suggest parenting stress among parents of children at risk of ASD should be assessed prior to diagnosis.

BACKGROUND Research supports integrated pediatric behavioral health (BH), but evidence gaps remain in ensuring equitable care for children of all ages. In response, an interdisciplinary team codeveloped a stepped care model that expands BH services at 3 federally qualified health centers (FQHCs). METHODS FQHCs reported monthly electronic medical record data regarding detection of BH issues, receipt of services, and psychotropic medications. Study staff reviewed charts of children with attention-deficit/hyperactivity disorder (ADHD) before and after implementation. RESULTS Across 47 437 well-child visits, >80% included a complete BH screen, significantly higher than the state’s long-term average (67.5%; P < .001). Primary care providers identified >30% of children as having BH issues. Of these, 11.2% of children 12 years were referred for care. Children seen by BH staff on the day of referral (ie, “warm hand-off”) were more likely to complete an additional BH visit than children seen later (hazard ratio = 1.37; P < .0001). There was no change in the proportion of children prescribed psychotropic medications, but polypharmacy declined (from 9.5% to 5.7%; P < .001). After implementation, diagnostic rates for ADHD more than doubled compared with baseline, follow-up with a clinician within 30 days of diagnosis increased (62.9% before vs 78.3% after; P = .03) and prescriptions for psychotropic medication decreased (61.4% before vs 43.9% after; P = .03). CONCLUSIONS Adding to a growing literature, results demonstrate that integrated BH care can improve services for children of all ages in FQHCs that predominantly serve marginalized populations.

In this study, the relationships between child social functioning, parenting stress, and Part C Early Intervention (EI) enrollment were examined in 227 ethnically and racially diverse, low-income families of 15- to 27-month-old children. All toddlers in the sample were identified with or at high risk for developmental delay via universal screening in primary care; 41.4% were enrolled in EI at the time of study data collection and 83.3% ultimately enrolled in EI before turning 3 years old. Generalized linear mixed model results indicated no direct relationship between EI enrollment and parenting stress, but a significant inverse association was found between child social functioning and parenting stress (β = −0.61, p = .005) that was moderated by EI enrollment ( p < .001). This suggests potential benefits of timely referral and access to EI for families of children at risk of developmental delay in historically underserved communities. Furthermore, exploratory bivariate analyses indicated that clinically elevated parenting stress related to higher worry about the child’s development and higher M-CHAT-R/F scores; EI enrollment was related to parents not working outside the home, older age of both parent and child, and lower child social functioning level.

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.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 aged21 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.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.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.

Children in low-income families are at risk for delayed diagnosis of autism spectrum disorder (ASD). The cascade-of-care model, which examines steps of care for quality and efficacy, can identify lesions in the process for evaluation and diagnosis for children at risk for ASD. Little is known about predictors that influence key steps in this process. We performed a retrospective chart review of 110 children under age five years from an academic medical center with social communication concerns. We assessed predictors of age of referral for ASD diagnostic evaluation, time to diagnosis, and likelihood of diagnostic completion. Children with continuity of primary care were referred at an earlier age than those receiving primary care at multiple centers. Compared with children with missed visits, children attending all well-child visits had a shorter median time to diagnosis. These findings illustrate a need for primary medical homes to facilitate early and timely ASD evaluations.

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.

Maternity care in the United States is characterized by racial and income disparities in maternal and infant outcomes. This article describes an innovative, hospital-based doula model serving a racially and ethnically diverse, low-income population. The program's history, program model, administration requirements, training, and evaluations are described.

OBJECTIVE To identify factors associated with referral and enrollment in early intervention (EI) for infants with neonatal abstinence syndrome (NAS). METHODS We conducted a retrospective cohort study of 256 infants born with NAS (2006-2013) at a tertiary care hospital in (Springfield), Massachusetts, linking maternal-infant birth hospitalization records with Department of Public Health EI records. We calculated the percent of infants retained at each step in the EI enrollment process over the first 3 years of life. We conducted separate multivariable logistic regression analyses to identify factors associated with EI referral and enrollment. RESULTS Among mothers, 82% received medication-assisted treatment at delivery, 36% endorsed illicit drug use during pregnancy, and 76% retained custody of their child at discharge. Among infants, 77% were referred to EI and 48% were enrolled in services. Of infants discharged to biological parents, 81% were referred to EI versus 66% of infants discharged to foster care (p ≤ 0.05); this difference persisted in multivariable analysis [adjusted odds ratio, 2.30; 95% confidence interval (CI), 1.09-4.86]. Infants in the highest tertile for length of stay had 2.70 times the odds of EI enrollment (95% CI, 1.37-5.31). CONCLUSION Fewer than half of the eligible infants with NAS were enrolled in EI services. Discharge to a biological parent and longer hospital stay had the strongest associations with EI referral and enrollment, respectively. Efforts to improve EI referral rates during the birth hospitalization, particularly among infants discharged into foster care, and close follow-up for infants with shorter hospital stays would enhance the developmental supports for this vulnerable population.

Significant disparities exist between Hispanic and non-Hispanic families in time-to-diagnosis among children identified as at risk of autism spectrum disorder; yet, little is known about parent experiences throughout the diagnostic process that may contribute to or help explain these disparities. The current study examined longitudinal trajectories of parenting stress, coping, and perceived family impact during the autism spectrum disorder diagnostic process among an ethnically and racially diverse low-income, urban sample, allowing for comparisons between Hispanic and non-Hispanic families. Hispanic families reported lower levels of parenting stress (χ2 = 5.35(1), p = 0.021), avoidant (χ2 = 9.66(1), p = 0.002) and approach (χ2 = 8.61(1), p = 0.003) coping, and negative family impact (χ2 = 5.39(1), p = 0.020) across time (main effects) compared with non-Hispanic families. Furthermore, there were differences in the change in use (Time Period × Ethnicity interaction effects) of both avoidant (χ2 = 10.80(3), p = 0.013) and approach (χ2 = 11.57(3), p = 0.009) coping, as well as negative family impact (χ2 = 9.81(3), p = 0.020), between Hispanic and non-Hispanic parents over time. These differences begin to shed light on the unique experiences of Hispanic parents. Because of the strengths that Hispanic families demonstrate, interventions that leverage those strengths and focus on education, empowerment, and resilience might be particularly beneficial for Hispanic families and may also better inform work to increase resilience in non-Hispanic families. Lay abstract Little is known about parent experiences throughout the diagnostic process for autism or how these parent experiences may help explain the disparities that exist between Hispanic and non-Hispanic families in time-to-diagnosis among children identified as at risk for autism. The current study examined trajectories of parenting stress, coping, and perceived family impact over time, throughout the autism diagnostic process among Hispanic and non-Hispanic families. Hispanic families reported lower levels of parenting stress, coping, and negative family impact across time. Further, there were differences in the change in use of coping and the amount of negative family impact reported between Hispanic and non-Hispanic parents over time. These differences shed light on the unique experiences and strengths of Hispanic families demonstrate. Interventions that leverage those strengths and focus on education, empowerment, and resilience might be particularly beneficial for Hispanic families and may also better inform work to increase resilience.

Perinatal mood and anxiety disorders (PMADs) impact multiple domains of maternal and child well-being. Estimates of postpartum depressive symptoms range from 6.5% to 12.9% and from 8.6% to 9.9% for postpartum anxiety. We sought to identify the role social support could play in mitigating PMADs.The data are drawn from the Listening to Mothers in California survey; results are representative of women who gave birth in 2016 in a California hospital. The Patient Health Questionnaire-4 was used to assess total symptoms of PMADs and anxiety and depressive symptoms individually. Two questions adapted from the Medical Outcomes Study Social Support Survey were used to assess emotional, practical, and functional (combined) social support. After exclusions for missing data related to PMADs or social support, we analyzed data from 2,372 women.At the time of survey administration (mean 5.7 months after birth), 7.0% of respondents reported elevated PMAD symptoms and 45.9% reported that they always received functional social support. In multivariable analysis, controlling for demographic and pregnancy-related factors and prenatal anxiety and depressive symptoms, women who reported consistent support had a prevalence of elevated PMAD symptoms one-half that of those who did not (adjusted odds ratio, 0.50; 95% confidence interval, 0.34-0.74).This study suggests that consistent social support serves as a robust protective factor against postpartum symptoms of PMADs. Because many predictors of PMADs are not modifiable, social support stands out as an important target for programmatic intervention, particularly in light of increased isolation related to the COVID-19 pandemic.

Cultural mediation among individuals, communities, and health and social service systems addresses how Community Health Workers (CHWs) play a role in informing individuals’ experiences and interactions with health and social service systems. This role includes educating individuals and communities about how to use health and social service systems, educating systems about community perspectives and cultural norms, and building health literacy and cross-cultural communication. In this chapter, two teams demonstrate how CHWs serve as cultural “brokers” or intermediaries who understand and are sensitive to both sides in cross-cultural encounters. The first team describes clinic-based CHW/promotores as cultural liaisons between healthcare providers and patients and how they are models for cultural humility to clinical staff in the inland region of Southern California. CHW/Ps in a clinical team have much to teach healthcare staff due to their cultural affinity and shared lived experience with the patient. The second team summarizes best practices and challenges across five different Boston-area CHW behavioral health prevention and promotion projects (healthcare and community-based) using a dual-generation approach in pediatric settings to highlight the importance of CHWs as cultural mediators. CHWs fill an important role in mediating how communities understand behavioral health in a culturally relevant manner and assist clients in obtaining needed behavioral health services.

Parents of children with autism spectrum disorder (ASD) show increased levels of parenting stress, but only one study has examined this association before a diagnostic evaluation. We conducted a cross-sectional study of parenting stress in 317 low SES parents with children at-risk for ASD before a diagnostic evaluation. Multiple regression modeling evaluated the associations between parenting stress and parent and child factors. Parenting stress was negatively associated with social support and positively associated with active avoidance coping and parental worry. However, parenting stress was not associated with the child's ASD symptom severity or adaptive functioning, except for self-direction. Findings suggest parenting stress among parents of children at risk of ASD should be assessed prior to diagnosis.

* Abbreviations: FERPA — : Family Educational Rights and Privacy Act HIPAA — : Health Insurance Portability and Accountability Act PHI — : protected health information STI — : sexually transmitted infection In the American Academy of Pediatrics statement “Role of the School Nurse in Providing School Health Services,” the authors acknowledge that misinformation about federal privacy laws can be problematic,1 creating misunderstandings among pediatricians and school nurses that impact student care. Confusion arises when clinicians, covered by the Health Insurance Portability and Accountability Act (HIPAA), work collaboratively with school nurses, covered by the Family Educational Rights and Privacy Act (FERPA), to conduct health programs. The majority of school nurses report working with their local health department2 but are unsure about what procedures to follow for documenting and communicating health information, and existing federal guidance does not speak adequately to the complications arising from cross-sector collaboration.3 In this article, we use an example of a school-based sexually transmitted infection (STI) screening program to highlight the 2 main federal privacy laws that impact school and health provider collaboration: FERPA and HIPAA. State privacy laws and institutional policies impose restrictions beyond federal law. These local laws and policies vary, as does their intersection with federal law. School and health department collaborators must negotiate this complex web when they plan joint projects. Passed in 1974, FERPA is designed to protect students’ educational records.4 Any educational institution receiving funding from the US Department of Education must allow parents or an eligible student (>18 years of age or has begun postsecondary education) to access the student’s … Address correspondence to Patricia A. Elliott, DrPH, Department of Community Health Sciences, School of Public Health, Boston University, 801 Massachusetts Ave, Room 440, Boston, MA 02118. E-mail: pelliott{at}bu.edu

This study aimed to define the core components of Family Navigation for autism spectrum disorder, a promising intervention to reduce disparities in care for this population. Teams from four trials of Family Navigation for autism spectrum disorder completed the Template for Intervention Description and Replication checklist to outline intervention components. Through intervention component analysis and qualitative synthesis, we identified 11 core components across three domains: Training and Supervision, Navigator Tools, and Navigator Activities. We discuss the importance of identifying these core components and implications for future research and practice.

The authors sought to determine whether a multicomponent, community-based program for preventing maternal depression also promotes engagement with mental health services for individuals with persistent symptoms.Mothers of children enrolled in Head Start were randomly assigned between February 2011 and May 2016 to Problem-Solving Education (PSE) (N=111) or usual services (N=119) and assessed every two months for 12 months.Among 230 participants, 66% were Hispanic; 223 participants were included in the analysis. For all PSE participants, engagement with specialty mental health services increased from approximately 10% to 21% between two and 12 months. The PSE group was more likely than the control group to be engaged in specialty services at 12 months (adjusted odds ratio [AOR]=2.36, 95% confidence interval [CI]=1.07-5.20), and the rate of engagement with specialty services over time (treatment × time interaction) favored PSE (p=.016). Among PSE participants with persistent depressive symptoms over the follow-up period, engagement with specialty services increased from 12% (two months) to approximately 46% (12 months), whereas among control group participants, engagement fluctuated between 24% and 33%, without a clear trajectory pattern. At 12 months, PSE participants with persistent symptoms were more likely to engage with specialty care compared with their counterparts in the control group (AOR=6.95, CI=1.50-32.19). The treatment × time interaction was significant for the persistently symptomatic subgroup (p=.029) but not for the episodically symptomatic or the asymptomatic subgroups.Embedding mental health programs in Head Start is a promising strategy to engage parents with depressive symptoms in care, especially those with persistent symptoms.

Objective Depression is highly prevalent among caregivers of children with attention-deficit/hyperactivity disorder (ADHD). We examined the association between caregiver depressive symptom trajectories and changes in child ADHD symptoms. Methods We analyzed data from a randomized trial of 2 ADHD care management systems for children aged 6 to 12 years and their caregivers (n = 156 dyads). Child ADHD symptoms were measured using the Swanson, Nolan, and Pelham rating scale (SNAP-IV). Caregiver depressive symptoms were measured using the Quick Inventory of Depressive Symptomatology (QIDS). Measures were assessed at baseline, 6 months, and 12 months. We used multivariable models to examine associations between changes in caregiver depressive symptoms and changes in child ADHD symptoms. Results From baseline to 12 months, children of caregivers with improved depressive symptoms had significantly greater reductions in SNAP-IV scores (change score: -1.43) compared with those whose depressive symptoms did not change (change score: -0.97) or worsened (change score: -0.23, p = 0.003). In adjusted models, improved caregiver depressive symptoms were associated with greater reductions in SNAP-IV scores over the 12-month period. Compared with those with worsening caregiver depressive symptoms, children whose caregivers showed no significant changes in depressive symptoms had a -0.78 point (95% confidence interval [CI]: -1.40 to -0.17) greater reduction in the SNAP-IV score, and those children whose caregiver depressive symptoms improved had a -1.31 point greater reduction in the SNAP-IV score (95% CI: -1.97 to -0.66). Conclusion Given the longitudinal association between caregiver depressive symptom and child ADHD symptom trajectories, interventions that address the behavioral health needs of the family unit may offer promise for urban children with ADHD.

In 2013, the National Institute of Mental Health funded five trials of unique, multicomponent, systems-based innovations designed to improve access to early screening, diagnosis, and treatment of autism spectrum disorder—collectively known as the Autism Spectrum Disorder Pediatric, Early Detection, Engagement, and Services Network. As part of an ongoing effort to pool data and learn from shared experience, we collected information across all studies about innovation components and implementation strategies. First, each study group completed standardized checklists based on the Template for Intervention Description and Replication and the Expert Recommendation for Implementing Change. Then, we interviewed principal and co-investigators of each study (n = 9) to further explore innovation components and assess barriers and facilitators to implementation. Innovation strategies were diverse (five different autism spectrum disorder screeners were used, 40% included early intervention trainings, 60% involved new technology). Common implementation strategies included developing stakeholder relationships and provider trainings. Barriers included inefficient systems of care, difficulty engaging families in the innovations, provider attitudes, and organizational culture (e.g. difficulty changing clinic processes). These findings suggest that—despite diverse settings and a variety of innovation content—common facilitators and challenges exist in implementing innovations to enhance access to early autism spectrum disorder screening, diagnosis, and treatment.

We sought to assess potential mechanisms of action of a patient navigation intervention in Head Start, designed to help depressed mothers engage with mental health care. We employed mixed methods, linking qualitative interviews (n = 21) to a randomized intervention pilot (n = 47). Early in follow-up, navigated mothers had lower mean depressive symptom scores than non-navigated mothers (9.61 vs. 12.95, p = 0.03). These differences attenuated but preceded a greater likelihood of engaging with care among navigated mothers. Navigated mothers reported greater self-esteem (score 21.45 vs. 18.60, p = 0.05) and greater confidence in their ability to self-manage depression (7.65 vs. 5.67, p = 0.01). In qualitative interviews, navigated mothers linked decreased symptom burden to feeling activated; they communicated optimism toward the future and a willingness to work toward symptom improvement by trying something new. Early symptom relief, behavioral activation, self-esteem, self-management, and optimism represent plausible navigation mechanisms of action. These constructs require formal testing.

Background Delivery of behavioral interventions is complex, as the majority of interventions consist of multiple components used either simultaneously, sequentially, or both. The importance of clearly delineating delivery strategies within these complex interventions—and furthermore understanding the impact of each strategy on effectiveness—has recently emerged as an important facet of intervention research. Yet, few methodologies exist to prospectively test the effectiveness of delivery strategies and how they impact implementation. In the current paper, we describe a study protocol for a large randomized controlled trial in which we will use the Multiphase Optimization Strategy (MOST), a novel framework developed to optimize interventions, i.e., to test the effectiveness of intervention delivery strategies using a factorial design. We apply this framework to delivery of Family Navigation (FN), an evidence-based care management strategy designed to reduce disparities and improve access to behavioral health services, and test four components related to its implementation. Methods/design The MOST framework contains three distinct phases: Preparation, Optimization, and Evaluation. The Preparation phase for this study occurred previously. The current study consists of the Optimization and Evaluation phases. Children aged 3-to-12 years old who are detected as “at-risk” for behavioral health disorders (n = 304) at a large, urban federally qualified community health center will be referred to a Family Partner—a bicultural, bilingual member of the community with training in behavioral health and systems navigation—who will perform FN. Families will then be randomized to one of 16 possible combinations of FN delivery strategies (2 × 2 × 2× 2 factorial design). The primary outcome measure will be achieving a family-centered goal related to behavioral health services within 90 days of randomization. Implementation data on the fidelity, acceptability, feasibility, and cost of each strategy will also be collected. Results from the primary and secondary outcomes will be reviewed by our team of stakeholders to optimize FN delivery for implementation and dissemination based on effectiveness, efficiency, and cost. Discussion In this protocol paper, we describe how the MOST framework can be used to improve intervention delivery. These methods will be useful for future studies testing intervention delivery strategies and their impact on implementation. Trial registration ClinicalTrials.gov, NCT03569449. Registered on 26 June 2018.

OBJECTIVES: Family Navigation (FN), a care management strategy, helps families overcome systems and person-level barriers to care. We previously demonstrated FN’s feasibility, acceptability, and potential efficacy for increasing access and reducing time to autism-related diagnostic services among low-income, minority children. In this paper, we describe modifications to FN in response to concerns raised in our first pilot randomized controlled trial (RCT), and then assess these modifications in a second pilot RCT. METHODS: An advisory group recommended modifications to recruitment procedures and study conditions. 40 parent-child dyad participants with autism-related concerns were randomized to receive modified usual care (UC) or modified FN. We compared whether the first and second pilot RCTs differed in: participant enrollment, satisfaction with clinical care, and timely completion of the diagnostic assessment. RESULTS: Recruitment improved under the modified protocol with significantly fewer potentially eligible families refusing (19.5% vs. 4.8%, p < .05) or being excluded from study enrollment (43.6% vs. 0%, p < 0.01). Comparing the first and second pilot RCTs, regardless of study arm, families in the second pilot were more likely to complete diagnostic assessment (UC: HR 3.41, 95% CI [1.20, 9.68]; FN: HR 2.64, 95% CI [1.31, 5.30]) and report greater satisfaction with clinical care. In the second pilot, compared to UC, FN continued increase the likelihood of completing the diagnostic assessment (HR: 2.57; 95% CI [1.22, 5.40]). CONCLUSIONS: Easy-to-implement system-level enhancements improved study recruitment, satisfaction with care, and completion of a diagnostic assessment. With enhancement, FN continued to confer benefits to families.

BACKGROUND AND OBJECTIVES: Opioid-exposed infants frequently qualify for early intervention (EI). However, many eligible families choose not to enroll in this voluntary service. This study aims to understand the perceptions and experiences that may impact engagement with, and the potential benefits of, EI services among mothers in recovery from opioid use disorders (OUDs). METHODS: We conducted semistructured qualitative interviews (n = 22) and 1 focus group (n = 6) with mothers in recovery from OUDs in western Massachusetts. Transcripts were coded and analyzed by using a descriptive approach. RESULTS: The mean participant age was 32 years, and 13 had a high school degree or less. Five major themes emerged revealing mothers’ development through stages of engagement in EI services: (1) fear, guilt, and shame related to drug use (emotions acting as barriers to enrollment); (2) the question of whether it is “needed” (deciding whether there is value in EI for opioid-exposed infants); (3) starting with “judgment” (baseline level of perceived stigma that parents in recovery associate with EI); (4) breaking down the “wall” (how parents overcome the fear and perceived judgment to build partnerships with providers); and (5) “above and beyond” (need for a personal connection with mothers and concrete supports through EI in addition to the child-focused services provided). CONCLUSIONS: Barriers to engagement in EI among mothers in recovery from OUDs include a range of emotions, perceived stigma, and ambivalence. An effort to purposefully listen to and care for mothers through a strengths-based, bigenerational approach may help establish greater connections and foster stronger EI engagement among families affected by OUDs.

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.

Importance Early identification of autism spectrum disorder (ASD) is associated with improved cognitive and behavioral outcomes. Targeted strategies are needed to support equitable access to diagnostic services to ensure that children from low-income and racial/ethnic minority families receive the benefits of early ASD identification and treatment. Objective To test the efficacy of family navigation (FN), an individually tailored, culturally informed care management strategy, to increase the likelihood of achieving diagnostic ascertainment among young children at risk for ASD. Design, Setting, and Participants This randomized clinical trial of 249 families of children aged 15 to 27 months who had positive screening results for possible ASD was conducted in 11 urban primary care sites in 3 cities. Data collection occurred from February 24, 2015, through November 5, 2018. Statistical analysis was performed on an intent-to-treat basis from November 5, 2018, to July 27, 2020. Interventions Families were randomized to FN or conventional care management (CCM). Families receiving FN were assigned a navigator who conducted community-based outreach to families to address structural barriers to care and support engagement in recommended services. Families receiving CCM were assigned to a care manager, who did limited telephone outreach. Families received FN or CCM after positive initial screening results and for 100 days after diagnostic ascertainment. Main Outcomes and Measures The primary outcome, diagnostic ascertainment, was measured as the number of days from randomization to completion of the child's clinical developmental evaluation, when a diagnosis of ASD or other developmental disorder was determined. Results Among 250 families randomized, 249 were included in the primary analysis (174 boys [69.9%]; mean [SD] age, 22.0 [3.5] months; 205 [82.3%] publicly insured; 233 [93.6%] non-White). Children who received FN had a greater likelihood of reaching diagnostic ascertainment over the course of 1 year (FN, 108 of 126 [85.7%]; CCM, 94 of 123 [76.4%]; unadjusted hazard ratio [HR], 1.39 [95% CI, 1.05-1.84]). Site (Boston, New Haven, and Philadelphia) and ethnicity (Hispanic vs non-Hispanic) moderated the effect of FN (treatment × site interaction; P = .03; Boston: HR, 2.07 [95% CI, 1.31-3.26]; New Haven: HR, 1.91 [95% CI, 0.94-3.89]; and Philadelphia: HR, 0.91 [95% CI, 0.60-1.37]) (treatment × ethnicity interaction; P

CONTEXT Women seeking timely and affordable abortion care may face myriad challenges, including high out-of-pocket costs, transportation demands, scheduling difficulties and stigma. State-level regulations may exacerbate these burdens and impede women's access to a full range of care. Women's reports of their experiences can inform efforts to improve pathways to abortion care. METHODS In 2014, semistructured qualitative interviews were conducted with 45 women obtaining abortions in South Carolina, which has a restrictive abortion environment. Interviews elicited information about women's pathways to abortion, including how they learned about and obtained care, whether they received professional referrals, and the supports and obstacles they experienced. Transcripts were examined using thematic analysis to identify key themes along the pathways, and a process map was constructed to depict women's experiences. RESULTS Twenty participants reported having had contact with a health professional or crisis pregnancy center staff for pregnancy confirmation, and seven of them received an abortion referral. Women located abortion clinics through online searches, previous experience, and friends or family. Financial strain was the most frequently cited obstacle, followed by transportation challenges. Women reported experiencing emotional strain, stress and stigma, and described the value of receiving social support. Because of financial pressures, the regulation with the greatest impact was the one prohibiting most insurance plans from covering abortion care. CONCLUSIONS Further research on experiences of women seeking abortion services, and how these individuals are affected by evolving state policy environments, will help shape initiatives to support timely, affordable and safe abortion care in a climate of increasing restrictions.