Employing user-centered design to develop a remote technology kit for studying young children's social communication skills.

OBJECTIVE: The COVID-19 pandemic required behavioral researchers to rapidly pivot to the implementation of remote study protocols to facilitate data collection. Remote implementation required robust and flexible research protocols including reliable audio/visual technology that met all the quality, security, and privacy hallmarks of lab-based equipment, while also being portable and usable by nontechnical staff and participants. The project's primary purpose was to develop a technology kit that could be deployed for data collection in homes with young children. The secondary objective was to determine the feasibility of the kit for use longitudinally across four disparate sites. METHOD: User-centered design principles were employed in the development and implementation of a technology kit deployed across urban, suburban, and rural participant locations in four states. Preliminary feasibility and usability data were gathered to determine the reliability of the kit across three timepoints. RESULTS: In study 1, a technology kit was constructed addressing all project needs including the provision of the internet to connect remotely with participants. Staff training protocols and participant-facing materials were developed to accompany deployment procedures. In study 2, data gathered in technology logs demonstrated successful capturing of video footage in 96% of opportunities with most technology challenges mitigated. Subsequent behavioral coding indicated 100% of captured assessment footage has been successfully coded to date. Moreover, participants needed less support for technology setup at their later timepoints, and staff rated the kit as highly usable. CONCLUSION: This study offers a model for future development of technology use in remote community- and home-based pediatric research.

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.

Future Directions in Lay Health Worker Involvement in Children's Mental Health Services in the U.S.

Nearly half of children meeting criteria for a mental health disorder in the United States (U.S.) do not receive the treatment they need. Unfortunately, lack of access to and engagement in mental health services can be seen at even higher rates for historically marginalized groups, including low-income, racial, and ethnic minority youth. Lay Health Workers (LHWs) represent a valuable workforce that has been identified as a promising solution to address mental health disparities. LHWs are individuals without formal mental health training who oftentimes share lived experiences with the communities that they serve. A growing body of research has supported the mobilization of LHWs to address service disparities around the globe; however, challenges persist in how to scale-up and sustain LHW models of care, with specific barriers in the U.S. In this paper, we describe LHWs' different roles and involvement in the mental health field as well as the current state of the literature around LHW implementation. We integrate the RE-AIM Framework with a conceptual model of how LHWs address disparities to outline future directions in research and practice to enhance equity in the reach, effectiveness, adoption, implementation, and maintenance of LHW models of care and evidence-based practices for historically marginalized communities within the U.S.

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.

Features of children with positive celiac serology and type 1 diabetes mellitus.

Prior studies have reported disparate clinical presentations between children with celiac disease and type 1 diabetes mellitus and those with celiac disease alone. Studies focusing on differences in endoscopic and histopathological findings, however, are limited. We reviewed children aged 2-18 years, presenting for an initial evaluation between January 2000 and December 2010. Data on medical history, serologic markers, upper endoscopy, and histopathology were collected. Only the children with positive celiac serology who had upper endoscopy performed within 3 months of the initial visit were included. We identified 294 children who fulfilled the criteria, 21 of whom had diagnosed type 1 diabetes mellitus. Diabetic children were more likely to have absence of gastrointestinal symptoms. Erythematous duodenal and esophageal mucosa on endoscopy, and histopathology suggestive of reflux esophagitis were more common in the diabetes group. Diabetic children with positive celiac serology had different histopathological features as compared with their non-diabetic counterparts.

Use of the i2b2 research query tool to conduct a matched case-control clinical research study: advantages, disadvantages and methodological considerations.

BACKGROUND: A major aim of the i2b2 (informatics for integrating biology and the bedside) clinical data informatics framework aims to create an efficient structure within which patients can be identified for clinical and translational research projects.Our objective was to describe the respective roles of the i2b2 research query tool and the electronic medical record (EMR) in conducting a case-controlled clinical study at our institution. METHODS: We analyzed the process of using i2b2 and the EMR together to generate a complete research database for a case-control study that sought to examine risk factors for kidney stones among gastrostomy tube (G-tube) fed children. RESULTS: Our final case cohort consisted of 41/177 (23%) of potential cases initially identified by i2b2, who were matched with 80/486 (17%) of potential controls. Cases were 10 times more likely to be excluded for inaccurate coding regarding stones vs. inaccurate coding regarding G-tubes. A majority (67%) of cases were excluded due to not meeting clinical inclusion criteria, whereas a majority of control exclusions (72%) occurred due to inadequate clinical data necessary for study completion. Full dataset assembly required complementary information from i2b2 and the EMR. CONCLUSIONS: i2b2 was critical as a query analysis tool for patient identification in our case-control study. Patient identification via procedural coding appeared more accurate compared with diagnosis coding. Completion of our investigation required iterative interplay of i2b2 and the EMR to assemble the study cohort.

Using virtual multiteam systems to conduct a multisite randomized clinical trial in the part C early intervention system: Benefits, challenges, and lessons learned.

BACKGROUND/AIMS: COVID-19 necessitated a shift to virtual data collection for many research projects, providing the opportunity for novel approaches to carrying out multi-site clinical trials. Virtual multiteam systems (VMTS) are a type of team structure in which multiple geographically dispersed teams collaborate using technology-mediated communication. The article presents a case study of our use of VMTS, in response to COVID-19, to carry out a multisite randomized hybrid effectiveness-implementation trial of a caregiver-implemented intervention. METHODS: We describe how we modified our team structure from predominantly site-specific, co-located teams to predominantly cross-site, virtual teams. We then present examples of how we have conducted the two primary data collection activities virtually. To demonstrate the feasibility of this approach, we present participant demographic information, the percent of cross-site data collection activities, and fidelity data. RESULTS: In the first 20 months of data collection, we have enrolled 108 EI providers and 132 families, with 17% and 9% attrition respectively. The family sample is highly diverse in terms of race/ethnicity, parent education, and household income. The majority of provider training activities and roughly 50% of family assessment activities have been conducted cross-site. Fidelity is high, with no differences across site. CONCLUSIONS: Our data illustrate the feasibility of using virtual teams, training, and assessment in a multisite clinical trial in the Part C system. We discuss the strengths and challenges of this approach, as well as lessons learned to facilitate the planning of future multisite randomized clinical trials which may benefit from this approach. CLINICAL TRIALS: NCT05114538.

Family Involvement During Comprehensive Developmental Evaluations: Perspectives of Diverse Mothers.

OBJECTIVE: Early diagnosis and social support postdiagnosis (i.e., family involvement) can lead to improved outcomes for children with autism spectrum disorder (ASD) and other developmental disorders. Children of minority ethnic and racial groups are typically diagnosed later in childhood compared with White children, contributing to disparities in outcomes. Research has not yet explored family involvement during comprehensive developmental evaluations nor accounted for cross-cultural differences in family roles and involvement. This qualitative study sought to characterize the nature and impact of family involvement during the developmental evaluation process among racially and ethnically marginalized mothers of children with developmental delays and possible ASD. METHODS: Mothers (N = 27) of children who had a positive autism screen during their 18- or 24-month well-child visit but did not receive an ASD diagnosis after comprehensive developmental evaluation participated in individual semi-structured interviews exploring experiences with developmental screening, related services, and family involvement/social support. Qualitative data were transcribed, coded, and analyzed using applied thematic analysis. Data were stratified by partner status (i.e., partnered vs. nonpartnered) to examine differences in support and family involvement across varying family compositions. RESULTS: Three qualitative themes emerged: (1) mothers sought family involvement when making decisions about pursuing developmental evaluations, (2) family involvement affected mothers' navigation of logistical challenges, and (3) mothers involved family members for emotional support. Differences by partner status emerged in themes 1 and 2. CONCLUSION: Findings highlight benefits of and potential approaches to harnessing family involvement to support parents' navigation of the developmental evaluation process and ultimately improve child outcomes.

Optimizing Care for Autistic Patients in Health Care Settings: A Scoping Review and Call to Action.

OBJECTIVE: We conducted a scoping review of interventions designed to improve the health care experiences of autistic individuals and assessed the methodology and outcomes used to evaluate them. METHODS: Literature from January 2005 to October 2020 was searched using PubMed, Excerpta Medica dataBASE (EMBASE), Cumulated Index to Nursing and Allied Health Literature (CINAHL), PsycINFO as well as hand searching. Studies included described an intervention for autistic individuals in inpatient or outpatient settings and evaluated the intervention using standardized methodology. Results were exported to Covidence software. Ten reviewers completed abstract screening, full text review, and then systematic data extraction of the remaining articles. Two reviewers evaluated each article at each stage, with a third reviewer arbitrating differences. RESULTS: A total of 38 studies, including three randomized controlled trials (RCTs) were included. Twenty-six (68%) took place in dental, psychiatric, or procedural settings. Interventions primarily focused on visit preparation and comprehensive care plans or pathways (N = 29, 76%). The most frequent outcome was procedural compliance (N = 15), followed by intervention acceptability (N = 7) and parent satisfaction (N = 6). Two studies involved autistic individuals and caregivers in study design, and no studies assessed racial/ethnic diversity on intervention impact. CONCLUSIONS: Well-designed evaluations of interventions to support autistic individuals in pediatric health care settings are limited. There is a need to conduct large multi-site intervention implementation studies.

Applying a User-Centered Design Framework to Develop a Remote Research Assessment Protocol for a Randomized Clinical Trial for Toddlers with Early Autism Characteristics.

COVID-19 required many research teams to shift from in-person to remote assessments, which posed both procedural and theoretical challenges. While research has explored the utility of remote assessments for autism diagnosis from the perspective of families and clinicians, less is known about their application in clinical trials. This paper describes the development of a remote research assessment protocol for a randomized clinical trial focusing on the implementation of reciprocal imitation teaching (RIT) with toddlers in Part C early intervention. This project spans two phases. For Phase 1, our team developed and documented a series of steps utilizing user-centered design (UCD) strategies (e.g., recruiting potential users, creating a prototype, engaging in iterative development) for the purpose of redesigning an assessment protocol for a remote environment. For Phase 2, we examined preliminary outcomes of the redesign process. Primary end users (assessors) rated post-redesign usability and acceptability, while acceptability was examined using attrition data from secondary end users (family participants). Preliminary fidelity of implementation was also examined. The iterative redesign process allowed the research team to refine aspects of the assessment that ultimately led to promising preliminary ratings of usability, acceptability, and feasibility, as well as high fidelity. Preliminary data suggest that the redesigned assessment appears to be an acceptable, feasible, and usable tool for autism clinical trial research and that assessors can use it with fidelity. Further research is needed to examine the reliability and validity of the assessment, as well as implementation characteristics on a larger scale.

Overcoming tensions between family-centered care and fidelity within Early Intervention implementation research.

LAY ABSTRACT: Early Intervention systems provide therapeutic services to families of young children birth to 3 years with developmental delays and are considered a natural access point to services for young children and their families. Research studies in the autism field have been interested in training providers to deliver evidence-based practices in Early Intervention systems to increase access to services for young children with an increased likelihood of being autistic. However, research has often overlooked that Early Intervention systems prioritize family-centered care, an approach to working with families that honors and respects their values and choices and that provides supports to strengthen family functioning. This commentary points out that family-centered care deserves greater attention in research being done in Early Intervention systems. We describe how family-centered care may shape how interventions are delivered, and discuss directions for future research to evaluate the impact of family-centered care alongside intervention delivery.

Health Care Bias and Discrimination Experienced by Lesbian, Gay, Bisexual, Transgender, and Queer Parents of Children With Developmental Disabilities: A Qualitative Inquiry in the United States.

INTRODUCTION: This study explored the impact of health care (HC) bias and discrimination on lesbian, gay, bisexual, transgender, and queer (LGBTQ) parents and their children with disabilities in the United States, including the timing of developmental screening and diagnosis. METHOD: We conducted semistructured interviews with 16 LGBTQ parents of children with developmental concerns or disabilities recruited through a prior national survey. Interviews were transcribed and analyzed using a combined inductive and deductive approach. RESULTS: Discrimination types reported included noninclusive forms, disclosure challenges, and providers dismissing nongestational parents and diverse families. Few parents reported screening and diagnosis delays. Parents' recommendations included: avoiding assumptions, honoring family diversity, increasing LGBTQ family support, improving HC forms, increasing antibias training, and convening a learning community. DISCUSSION: Our study advances the knowledge around HC bias and discrimination among LGBTQ parents of children with disabilities. Findings highlight the need for increased LGBTQ-affirming family support and research representing LGBTQ family diversity in U.S. health care.

Survey of Lesbian, Gay, Bisexual, Transgender, and Queer Parents' Experiences Accessing Health Care for their Children With Developmental Disabilities.

INTRODUCTION: This study explored the impact of health care (HC) bias and discrimination on lesbian, gay, bisexual, transgender, and queer (LGBTQ) parents and their children with developmental disabilities. METHOD: We conducted a national online survey of LGBTQ parents of children with developmental disabilities using social media and professional networks. Descriptive statistics were compiled. Open-ended responses were coded using inductive and deductive approaches. RESULTS: Thirty-seven parents completed the survey. Most participants identified as highly educated, White, lesbian or queer, cisgender women and reported positive experiences. Some reported bias and discrimination, including heterosexist forms, LGBTQ disclosure challenges, and, because of their LGBTQ identity, feeling mistreated by their children's providers or being refused needed HC for their child. DISCUSSION: This study advances knowledge around LGBTQ parents' experiences of bias and discrimination while accessing children's HC. Findings highlight the need for additional research, policy change, and workforce development to improve HC for LGBTQ families.

Identifying Components of Autism Friendly Health Care: An Exploratory Study Using a Modified Delphi Method.

OBJECTIVES: Autistic individuals report lower health care satisfaction. However, there is currently no set of "best practice" standards about caring for autistic individuals. In this exploratory study, we aim to identify features of Autism Friendly practice according to a sample consisting of mainly professionals whose interests include autism using a modified 3-round Delphi-a method that identifies a consensus view across subject participants. METHODS: Statements about components of an Autism Friendly health care practice were compiled in consultation with the steering committee of an Autism Friendly Initiative at a single, urban academic safety-net hospital. Participants were recruited through our national network of professionals and patients/families mailing list. Examples of invited professionals included researchers, health care workers, and educators. In the first 2 rounds, we distributed electronic surveys to participants, who scored statements from 1 to 9 regarding importance. In round 2, statements that were scored low by all stakeholder groups were eliminated. Seventy-eight participants responded to the first-round survey, and 51 participants responded to the second-round survey. In the third round, 38 participants ranked 16 statements from most to least important. Statements are summarized and presented in the Results section. RESULTS: Topics that emerged from highly ranked statements include environmental/operational modifications (e.g., longer appointment times) and staff training to support autistic patients. CONCLUSION: Highly ranked statements represented previously reported barriers, including the need for staff training and inclusive engagement with the autistic community. The findings can help inform health care organizations to determine priorities when building an Autism Friendly health care practice.

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.

Optimizing ATTAIN implementation in a federally qualified health center guided by the FRAME-IS.

Implementation strategies are methods or techniques used to adopt, implement, and sustain evidence-based practices (EBPs). Implementation strategies are dynamic and may require adaptation to fit implementation contexts, especially in low-resource settings, which are most likely to serve racially and ethnically diverse patients. The framework for reporting adaptations and modifications to evidence-based implementation strategies (FRAME-IS) was used to document adaptations to implementation strategies to inform an optimization pilot of Access to Tailored Autism Integrated Care (ATTAIN; an integrated care model for children with autism and co-occurring mental health needs) in a federally qualified health center (FQHC) near the United States/Mexico border. Quantitative and qualitative data were collected from 36 primary care providers who participated in the initial ATTAIN feasibility pilot to inform adaptations. Adaptations were mapped to the FRAME-IS through an iterative template analysis to inform an optimization pilot at a FQHC 1-year from the start of the COVID-19 pandemic. Four implementation strategies (training and workflow reminders, provider/clinic champions, periodic reflections, and technical assistance) were employed during the feasibility pilot and were adapted for the optimization pilot to fit the needs of the FQHC and service delivery changes prompted by the pandemic. Findings demonstrate the utility of using the FRAME-IS to systematically inform EBP optimization in a FQHC providing care to underserved communities. Findings will inform future research studies implementing integrated mental health models in low-resourced primary care settings. Implementation outcomes and provider perceptions of ATTAIN at the FQHC are also reported. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Provider perspectives on equity in use of mobile health autism screening tools.

LAY ABSTRACT: Families may find information about autism online, and health care and education providers may use online tools to screen for autism. However, we do not know if online autism screening tools are easily used by families and providers. We interviewed primary care and educational providers, asking them to review results from online tools that screen for autism. Providers had concerns about how usable and accessible these tools are for diverse families and suggested changes to make tools easier to use.

Effect of Family Navigation on Participation in Part C Early Intervention.

OBJECTIVE: Part C Early Intervention (EI) services have been shown to reduce autism symptoms and promote healthy development among young children. However, EI participation remains low, particularly among children from structurally marginalized communities. We investigated whether family navigation (FN) improved EI initiation following positive primary care screening for autism compared to conventional care management (CCM). METHODS: We conducted a randomized clinical trial among 339 families of children (ages 15-27 months) who screened as having an increased likelihood for autism at 11 urban primary care sites in 3 cities. Families were randomized to FN or CCM. Families in the FN arm received community-based outreach from a navigator trained to support families to overcome structural barriers to autism evaluation and services. EI service records were obtained from state or local agencies. The primary outcome of this study, EI service participation, was measured as the number of days from randomization to the first EI appointment. RESULTS: EI service records were available for 271 children; 156 (57.6%) children were not engaged with EI at study enrollment. Children were followed for 100 days after diagnostic ascertainment or until age 3, when Part C EI eligibility ends; 65 (89%, 21 censored) children in the FN arm and 50 (79%, 13 censored) children in the CCM arm were newly engaged in EI. In Cox proportional hazards regression, families receiving FN were approximately 54% more likely to engage EI than those receiving CCM (1.54 (95% confidence interval: 1.09-2.19), P = .02). CONCLUSIONS: FN improved the likelihood of EI participation among urban families from marginalized communities.