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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

Mobile and online consumer tools to screen for autism do not promote equity.

LAY ABSTRACT: Many parents wonder if their child might have autism. Many parents use their smartphones to answer health questions. We asked, "How easy or hard is it for parents to use their smartphones to find 'tools' to test their child for signs of autism?" After doing pretend parent searches, we found that only one in 10 search results were tools to test children for autism. These tools were not designed for parents who have low income or other challenges such as low literacy skills, low English proficiency, or not being tech-savvy.

Addressing current barriers to autism diagnoses through a tiered diagnostic approach involving pediatric primary care providers.

Formal autism diagnosis from a specialist trained in autism assessment is customary prior to a child accessing early, intensive autism-specific services. However, long wait lists for diagnostic evaluations and limited specialty workforce have created substantial delays. Additionally, lengthy multidisciplinary evaluations are costly to insurers, inconvenient to families, and disproportionally impact under-resourced families. Diagnostic delays can impede access to intervention services. These barriers, combined with evidence regarding the importance of receiving early, autism-specific treatment, demand new approaches enabling access to autism specific services before comprehensive evaluation. Pediatric primary care providers (PCPs) are often the only health care professionals with whom a family interacts during early childhood and can play a crucial role in helping children with autism symptoms access services. Many strategies for autism diagnosis in primary care are being developed and tested; however, they have yet to be broadly adopted by PCPs, primarily due to critical implementation barriers in primary care settings. There is also not enough evidence on the accuracy of PCPs' diagnostic impressions without extensive specialty support, resulting in PCP hesitancy in diagnosing ASD, as well as family and service provider hesitancy in accepting a PCP autism diagnosis. In this commentary, we explore the acute need for shortening waitlists for autism evaluations through a tiered diagnostic approach, in which PCPs can rule in or rule out autism in children, for whom diagnosis is clear, and refer more complex cases for specialist evaluations, and explore implementation challenges to this approach.

Presenting a New Framework to Improve Engagement in Physical Activity Programs for Children and Adolescents With Social, Emotional, and Behavioral Disabilities.

Children and adolescents with psychiatric and neurodevelopmental diagnoses such as anxiety, depression, autism, and attention-deficit/hyperactivity disorder (ADHD) face enormous health disparities, and the prevalence of these disorders is increasing. Social, emotional, and behavioral disabilities (SEBD) often co-occur with each other and are associated with unique barriers to engaging in free-living physical activity (PA), community-based exercise and sports programming, and school-based physical education. Some examples of these barriers include the significantly depleted parental reserve capacity associated with SEBD in children, child dysregulation, and previous negative experiences with PA programming and/or exclusion. Importantly, most SEBD are "invisible," so these parents and children may face more stigma, have less support, and fewer inclusive programming opportunities than are typically available for children with physical or intellectual disabilities. Children's challenging behavioral characteristics are not visibly attributable to a medical or physical condition, and thus are not often viewed empathetically, and cannot easily be managed in the context of programming. Existing research into PA engagement barriers and facilitators shows significant gaps in existing health behavior change (HBC) theories and implementation frameworks that result in a failure to address unique needs of youth with SEBD and their parents. Addressing these gaps necessitates the creation of a simple but comprehensive framework that can better guide the development and implementation of engaging, effective, and scalable PA programming for these youth and their families. Therefore, the aim of this article is to: (1) summarize existing research into SEBD-related child and parent-level barriers and facilitators of PA evidence-based program engagement; (2) review the application of the most commonly used HBC and disability health theories used in the development of evidence-based PA programs, and implementation science frameworks used in adaptation and dissemination efforts; (3) review the SEBD-related gaps that may negatively affect engagement; and (4) describe the new Pediatric Physical Activity Engagement for Invisible Social, Emotional, and Behavioral Disabilities (PAID) Framework, a comprehensive adapted PA intervention development and implementation adaptation framework that we created specifically for youth with SEBD and their parents.

CENTER-IT: a novel methodology for adapting multi-level interventions using the Consolidated Framework for Implementation Research-a case example of a school-supervised asthma intervention.

BACKGROUND: Implementation science frameworks advise the engagement of multi-level partners (at the patient, provider, and systems level) to adapt and increase the uptake of evidence-based practices (EBPs). However, there is little guidance to ensure that systems-level adaptations reflect the voices of providers who deliver and patients/caregivers who receive EBPs. METHODS: We present a novel methodology, grounded in the Consolidated Framework for Implementation Research (CFIR), which anchors the engagement of multi-level partners to the voices of individuals who deliver and receive EBPs. Using the CFIR domains: intervention adaptation, individuals involved, inner/outer setting, and process, we illustrate our 4-step methodology through a case example of Asthma Link, a school-supervised asthma management intervention. In step 1, we interviewed "individuals involved" in the intervention (providers/caregivers/patients of Asthma Link) to identify implementation barriers. In step 2, we selected systems-level partners in the "inner and outer setting" that could assist with addressing these barriers. In step 3, we presented the barriers to these systems-level partners and conducted semi-structured interviews to elicit their recommended solutions (process). Interviews were audio-recorded, transcribed, and open-coded. A theoretical sampling model and deductive reasoning were used to identify solutions to implementation barriers. In step 4, we utilized multi-level input to adapt the Asthma Link intervention. RESULTS: Identified barriers included inability to obtain two inhalers for home and school use, inconsistent delivery of the inhaler to school by families, and challenges when schools did not have a nurse. Interviews conducted with school/clinic leaders, pharmacists, payors, legislators, and policymakers (n=22) elicited solutions to address provider and patient/caregiver-identified barriers, including (1) establishing a Medicaid-specific pharmacy policy to allow dispensation of two inhalers, (2) utilizing pharmacy-school delivery services to ensure medication reaches schools, and (3) identifying alternate (non-nurse) officials to supervise medication administration. The iterative process of engaging multi-level partners helped to create an adapted Asthma Link intervention, primed for effective implementation. CONCLUSIONS: This novel methodology, grounded in the CFIR, ensures that systems-level changes that require the engagement of multi-level partners reflect the voices of individuals who deliver and receive EBPs. This methodology demonstrates the dynamic interplay of CFIR domains to advance the field of implementation science.