A cluster randomized controlled trial comparing the effectiveness of two school-based interventions for autistic youth with anxiety.

BACKGROUND: Recent systematic reviews have indicated that cognitive behavioral therapy (CBT) is effective in reducing anxiety symptoms for autistic and non-autistic children. However, the vast majority of CBT research for autistic youth has been implemented within university settings and primarily by mental health providers. Schools hold great promise to equitably manage the mental health symptoms of autistic youth. Although preliminary research evaluating CBT within schools has been promising, CBT has not yet been compared to another readily available school mental health program. The goal of this protocol paper is to describe a multi-site study comparing two school-based interventions, Facing Your Fears-School Based (FYF-SB) and Zones of Regulation (ZOR) via a cluster randomized controlled type 1 hybrid effectiveness-implementation trial to determine which of the two interventions will best support autistic youth with anxiety in schools. METHODS: Up to 100 elementary and middle schools will be randomized into FYF-SB or ZOR. Once schools are randomized, a minimum of two interdisciplinary school providers at each school will be trained to deliver either FYF-SB or ZOR over the course of 12 weeks to groups of 2-5 autistic students ages 8-14 years. Over the course of two years, a total of 200 autistic students will receive either ZOR or FYF-SB. The primary outcome of this trial is child anxiety, as rated by masked evaluators and via caregiver- and student-report, which will be measured at baseline, post-treatment, and 6-month follow-up. Semi-structured interviews will also be conducted with a purposive sample of students, caregivers, and school providers to understand the acceptability, appropriateness, and feasibility of either ZOR or FYF-SB. Stakeholder engagement is a central component of this project via two stakeholder advisory boards that will directly inform and oversee the project. DISCUSSION: Results of this study will provide evidence about the relative impact of two school-based mental health interventions on outcomes reported as meaningful by caregivers and school providers. The additional focus on evaluating factors that support the implementation of FYF-SB and ZOR will allow future studies to test targeted implementation strategies that support mental health programming uptake and implementation within public schools. TRIAL REGISTRATION: This trial is registered with clinicaltrials.gov (NCT05863520).

We Must Consider Infrastructure when Attempting to Scale up Autism EBIs: A Case Example from Early Intervention Systems.

In the autism field, there is increasing interest in translating evidence-based interventions (EBIs) into systems that serve young autistic children and their families. Public Early Intervention systems have been a focal point of research-based implementation efforts given that these systems are federally mandated to provide services to children birth to three years of age with developmental delays under Part C of the Individuals with Disabilities Education Act. Although a growing number of research studies are now training Early Intervention providers to deliver autism EBIs, this work has been conducted on a relatively small scale and has only just begun to consider the alignment of these models with Early Intervention systems and whether sufficient infrastructure exists to scale up these training efforts and to sustain their public health impact. This commentary aims to address this gap by reviewing factors that have been found to uniformly impact the scale-up of EBIs across diverse public systems (Fagan 20, 1147-1168, 2019), and to extend this framework to the implementation of EBIs within public Early Intervention systems. These factors include developer and funder capacity, the public's awareness of and support for EBIs, the system's leadership support for EBI use, the capacity for community engagement in implementation efforts, the availability of a skilled workforce capable of delivering EBIs, and the capacity for data monitoring and quality improvement. This commentary discusses how these factors may specifically impact the scale-up of autism EBIs within EI systems to support toddlers and young, autistic children, and implications for autism researchers.

Using Causative Methods to Determine System-Level Factors Driving the Uptake and Use of Evidence-Based Practices in a Public Early Intervention System.

Part C Early Intervention (EI) systems are an entry point to services for autistic toddlers and can be leveraged to facilitate access to autism evidence-based practices (EBPs). However, EI systems are complex and limited research has examined how an EI system's infrastructure (i.e. system-level factors) impacts the adoption and implementation of EBPs. To address this gap, 36 EI providers and 9 EI administrators completed a semi-structured interview or focus group about factors impacting the implementation of autism EBPs. Qualitative analysis included a combination of grounded theory and causative coding. Analyses were refined by input from providers, administrators, and family stakeholders in the form of round tables and presentations at the state's interagency coordinating council. Primary themes centered on: (1) the costs associated with independent contracting structures; (2) operational demands; (3) workforce stability; (4) communication consistency; and (5) implementation supports for EBP implementation. Causative coding helped to demonstrate the perceived relationships between these factors and underscored the important role of incentivization structures, collaboration opportunities, and championing in supporting the use of EBPs within a system that primarily uses independent contracting structures. The current study extends previous research by demonstrating how several system-level factors are perceived to play a role in the adoption and implementation of EBPs by independently contracted EI providers. These findings underscore the need for implementation strategies, such as incentivization strategies and social network building, to increase providers' implementation of autism EBPs within EI systems.

A Mixed-methods Examination of Culturally Responsive Adaptation to an Evidence-based Parent-mediated Intervention Implemented for Autistic Children.

Parent-mediated interventions (PMIs) are considered an evidence-based practice for fostering social communication skills in young autistic children and for promoting parent responsivity and empowerment, yet barriers to caregiver engagement are evident when PMIs are implemented within historically underserved community settings. Issues of caregiver engagement can reflect a lack of fit between PMIs and the needs of diverse families. We used a mixed methods approach to examine barriers to participating in an evidence-based PMI, Project ImPACT (Ingersoll & Dvortcsak, 2019), within an outpatient setting, as well as strategies that clinicians reported using to deliver and adapt Project ImPACT for minoritized families. Participants included 134 caregivers of a child 13 to 48 months with autism or other social communication differences and six clinicians delivering Project ImPACT. Findings suggest that caregivers experience barriers to participating in Project ImPACT and that these barriers are associated with caregivers' ability to complete the program. Although quantitative findings indicate that adaptation to Project ImPACT did not differ by caregiver and child background, qualitative findings highlighted that clinicians attempt to deliver Project ImPACT to respond to the needs of families from minoritized backgrounds by actively considering the family's culture, psychosocial experiences, goals, and specific barriers. Further, both qualitative and quantitative findings suggest that culturally responsive care and adaptations may support caregiver engagement, including rapport, trust, buy-in, and attendance. Approaches to center cultural alongside contextual/psychosocial considerations within family-centered care in the implementation of PMIs are also highlighted.

The Role of Maternal Anxiety in Treatment Response for Youth with ASD and Co-occurring Anxiety.

Anxiety disorders occur at higher rates in youth with ASD than in neurotypical youth. Although the efficacy of CBT for anxiety in children with ASD is widely supported, factors that influence treatment outcomes are not well understood. This study examined the role of maternal anxiety in treatment outcomes for youth with ASD. Youth with ASD and anxiety (ages 8 to 14), along with their mothers (n = 87), participated in a group CBT intervention. Results indicated that maternal anxiety did not improve over the course of treatment. However, findings suggest that high levels of maternal anxiety at pre-treatment predicted higher levels of youth anxiety post-treatment. Importantly, the relationship between parent anxiety and youth outcomes was moderated by child age. The findings of the present study may provide initial insight into the role that maternal anxiety plays in treatment outcomes for children with ASD and co-occurring anxiety, particularly when considering child age.

Self-Directed Telehealth Parent-Mediated Intervention for Children With Autism Spectrum Disorder: Examination of the Potential Reach and Utilization in Community Settings.

BACKGROUND: There is a significant need for strategies to increase access to evidence-based interventions for children with autism spectrum disorder (ASD). One novel approach is to train parents to use evidence-based interventions for their child with ASD via telehealth. Pilot work examining the efficacy of one such program, ImPACT Online, demonstrated a high rate of parent program engagement, low attrition, and associated gains in parent learning and child social communication. OBJECTIVE: The objective of this study was to conduct an open trial of ImPACT Online to better understand its dissemination potential. METHODS: We examined the reach and representativeness of families who registered (n=36) compared to families who were referred (n=139) to the open trial for one referral site. We then compared the demographics of all families who enrolled in the open trial (n=112) to families who enrolled in one of two controlled trials of the same program (n=50). We also examined metrics of program engagement for the open and controlled trials, the relationship between program engagement and changes in parents' intervention knowledge, and program evaluation for the participants in the open trial. RESULTS: In total, 25.8% (36/139) of the parents who were given information about the program at their child's diagnostic feedback session registered with the program. The parents who enrolled in the open (OT) and controlled trials (CT), respectively, were similar in gender (OT: 84.8% (95/112); CT: 88% (44/50), female), marital status (OT: 80.4% (90/112) ; CT: 69.6% (32/46), married), education (OT: 58.0% (65/112); CT: 54.0% (27/50), college degree or higher), and employment status (OT: 58.0% (65/112); CT: 65.3% (32/49), employed outside the home). The child participants were similar in terms of gender (OT: 83.0% (93/112); CT: 76.0% (38/50), male) and race and ethnicity (OT: 38.4% (43/112); CT: 24.0% (12/50), minority). However, the mean chronological age of the child participants in the open trial group was significantly higher (Mean=60.0 months) than in the controlled trial group (Mean=43.0 months), with t160=5.22, P<.001. Parents in the open trial engaged with the program at a significantly lower rate than the controlled trial, F3,81=21.14, P<.001. Program engagement was significantly associated with gains in parent intervention knowledge across both the groups, beta=.41, t=2.43, P=.02. Participants in the open access trial evaluated the program highly, but several barriers were noted. CONCLUSIONS: These data suggest that additional strategies may need to be developed to support families in using telehealth-based parent-mediated intervention in community settings.

Using Community Partnerships to Better Understand the Barriers to Using an Evidence-Based, Parent-Mediated Intervention for Autism Spectrum Disorder in a Medicaid System.

Service use disparities have been noted to impede under-resourced families' ability to access high-quality services for their child with autism spectrum disorder (ASD). These disparities are particularly relevant for parent-mediated interventions and may suggest a lack of fit between these interventions and the needs of under-resourced community settings. This study used Roger's Diffusion of Innovations theory to guide community partnerships aimed at understanding the perceived compatibility, complexity, and relative advantage of using an evidence-based, parent-mediated intervention (Project ImPACT) within a Medicaid system. Three focus groups were conducted with 16 Medicaid-eligible parents, and three focus groups were conducted with 16 ASD providers operating within a Medicaid system. Across all groups, parents and providers reported general interest in using Project ImPACT. However, primary themes emerged regarding the need to (a) reduce the complexity of written materials; (b) allow for a more flexible program delivery; (c) ensure a strong parent-therapist alliance; (d) involve the extended family; and (e) help families practice the intervention within their preexisting routines. Results are discussed as they relate to the design and fit of evidence-based, parent-mediated interventions for under-resourced community settings.

Considerations for effective dissemination of evidence-based early intervention approaches.

LAY ABSTRACT: Dissemination, or the widespread sharing of information, is important for moving research evidence into community practice. Early intervention programs for young autistic children have not yet been widely disseminated to the early childhood workforce. This letter describes factors that may support or prevent dissemination to community-based settings, such as packaging and branding early intervention approaches. We argue that an increased focus on dissemination research is needed.

Access to Part C, Early Intervention for children younger than 4 years evaluated for autism spectrum disorder.

LAY ABSTRACT: Health disparities are defined as preventable differences in the opportunities to achieve optimal health outcomes experienced by marginalized and underrepresented communities. For families with autistic children, health disparities limit accessing early intervention services-which have been found to improve quality of life and other outcomes. One specific early intervention service in the United States is Individuals with Disabilities Education Act, Part C Early Intervention programs, which are federally funded interventions for children birth-to-three with developmental delays. This study adds to this topic by examining which factors impact accessing Part C, Early Intervention services for children who were evaluated for autism. Results showed that only half of the sample received these services despite there being concerns about development for all children. In addition, results showed that those who identified as Black had decreased odds of having accessed Part C, Early Intervention compared to those who identified as White. These results suggest that there are disparities when it comes to accessing important early intervention services that may be negatively impacting the Black autistic community.

Implementing school-based cognitive behavior therapy for anxiety in students with autism or suspected autism via a train-the-trainer approach: Results from a clustered randomized trial.

LAY ABSTRACT: Autistic youth frequently experience anxiety that can negatively affect them at home, with friends, and at school. Autistic youth have difficulty accessing mental health care, and this is particularly true for youth from traditionally underserved backgrounds. Providing mental health programs in schools may increase access to care for autistic youth with anxiety. The purpose of the study was to train interdisciplinary school providers to deliver school-based Facing Your Fears, a cognitive behavior therapy program for anxiety in autistic youth. Seventy-seven interdisciplinary school providers across 25 elementary/middle schools were trained by their colleagues and members of the research (train-the-trainer approach). Eighty-one students with autism or suspected autism, ages 8-14 years, were randomly assigned to either school-based Facing Your Fears or usual care. Students in school-based Facing Your Fears showed significant reductions in anxiety compared to students in usual care according to caregiver and student report. Other measures involved examining change in provider cognitive behavior therapy knowledge after training and determining how well interdisciplinary school providers were able to deliver school-based Facing Your Fears. Results indicated that interdisciplinary school providers showed significant improvements in cognitive behavior therapy knowledge after training. Interdisciplinary school providers were able to deliver most of school-based Facing Your Fears activities and with good quality. The positive outcomes in this study are encouraging. Training interdisciplinary school providers to deliver school-based Facing Your Fears may increase access to care for anxious autistic students. Future directions and limitations are discussed.

Addressing disruptive behaviors within naturalistic developmental behavioral interventions: Clinical decision-making, intervention outcomes, and implications for practice.

LAY ABSTRACT: Naturalistic developmental behavioral interventions are a common and well-researched type of intervention for young autistic children that focus on supporting social communication. These interventions often do not include formal guidelines on how to address disruptive behaviors, even though they are common among autistic children. This study measured how often clinicians delivering a specific naturalistic developmental behavioral intervention, Project ImPACT, adapted how they delivered the program to address disruptive behavior, and how these adaptations related to children's social communication outcomes at the end of their participation in the intervention. We also spoke with clinicians about how they address disruptive behavior and emotion regulation during their sessions. In this study, clinicians adapted Project ImPACT to address disruptive behaviors in about one-third of all sessions. These adaptations did not affect children's social communication outcomes. Clinicians discussed how they felt social communication, disruptive behavior, and emotion regulation are linked to one another and that they often try to integrate intervention strategies to address each of these areas. However, they note that a clinicians' approach to addressing disruptive behavior might vary depending on their level of training and experience. These results indicate several future directions for supporting clinicians in addressing behavior and regulation effectively within these types of interventions.

Balancing Fidelity and Flexibility: Usual Care for Young Children With an Increased Likelihood of Having Autism Spectrum Disorder Within an Early Intervention System.

Naturalistic developmental behavioral interventions (NDBIs) are evidence-based interventions for young children with autism spectrum disorder. There has been growing interest in implementing manualized NDBIs within the early intervention (EI) system without a clear understanding of how these programs and the broader strategies encompassed within them are already used by EI providers. This study examined the use of manualized NDBI programs and broader NDBI strategies within an EI system and factors that impacted their use. Eighty-eight EI providers completed a measure of NDBI program and strategy use. Thirty-three providers participated in a supplemental focus group or interview. Overall, providers described using broader NDBI strategies and the need to adapt manualized NDBI programs. Provider-, intervention-, and organization-level factors impacted their use of NDBI programs and strategies.

Examining provider decisions around the delivery and adaptation of a parent-mediated intervention within an Early Intervention system.

LAY ABSTRACT: Parent-mediated interventions are an evidence-based practice for autism in which providers support caregivers in learning and applying strategies that support their child's development. Research has begun to study whether parent-mediated interventions can be effectively delivered in Part C Early Intervention systems. This research has been promising; however, it has been difficult to determine how Early Intervention providers deliver and adapt parent-mediated interventions to meet the needs of the families they serve. Examining how parent-mediated interventions are delivered and adapted may help us understand whether parent-mediated interventions are a good fit in these systems. The current study examined the delivery of an evidence-based parent-mediated intervention, Project ImPACT, when delivered by providers within an Early Intervention system. Results from 24 Early Intervention providers demonstrated that, on average, providers delivered Project ImPACT with higher quality during their time in training and consultation. However, there was also variability in how providers delivered Project ImPACT, with some delivering the program inconsistently, some increasing their quality throughout consultation, and others having consistently high-quality delivery. In addition, qualitative data demonstrated that a variety of events arose within Project ImPACT sessions that drove providers to adapt the program. Results suggest the importance of carefully examining how and why providers deliver evidence-based interventions within Early Intervention systems.

Partnering With Latino/a Caregivers and Community Stakeholders to Understand Priorities and Needs Prior to Implementing an Early Literacy Program.

PURPOSE: Latino/a children disproportionately experience academic vulnerabilities, including in reading. Caregiver-mediated interventions can be leveraged to support the bilingual language development of young Latino/a children to prevent these well-documented disparities in reading. However, in leveraging these programs, it is important to weigh Latino cultural values surrounding education, family connection, and learning alongside the barriers and inequities experienced by Latino families. In response to this need, this study used a community-partnered approach to (a) understand caregivers' needs related to the language and literacy development of their young children and (b) understand perspectives for how best to implement a culturally adapted and culturally responsive caregiver-mediated program. METHOD: A total of 101 caregivers completed a needs assessment of sociodemographic information, child development and needs, and family needs. Subsequently, nonprofit staff and caregivers completed semistructured interviews or focus groups about the development and implementation of a birth-to-5 program supporting early language development. RESULTS: Thirty-five percent of families reported having at least one child with delayed language. Furthermore, 60.3% of respondents reported desiring strategies to support their child's early reading. Deductive content analysis revealed that both staff and caregivers desired a birth-to-5, caregiver-mediated program. Staff described family-level characteristics to consider for an early language program, community strengths, specific inequities faced by Latino families, and suggestions about culturally responsive early language and literacy program content and structure. Caregivers described barriers and inequities that they have faced related to their children's learning and development and how a birth-to-5 program could be responsive to their needs and values. CONCLUSIONS: Staff and caregiver emphasized the resilience of Latino families and their strong values surrounding educational involvement. At the same time, participants also reported barriers and inequities rooted in systemic racism that have prevented families from being involved in certain aspects of the children's education. Together, these results revealed the importance of an early literacy program that is responsive to the structural inequities experienced by families.

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.

Examining adaptations necessary to support the implementation of a parent-mediated intervention for children with autism spectrum disorder and moderate feeding problems.

LAY ABSTRACT: Moderate feeding problems and disruptive mealtime behaviors are common in children with autism spectrum disorder. Although parent-mediated interventions are able to support feeding problems in autistic children, most research has occurred within specialty clinics when delivered by highly trained clinicians. Thus, the fit of these interventions within community settings is not clear. To address this limitation, this study explored adaptations to a parent-mediated intervention, Managing Eating Aversions and Limited Variety (i.e. MEAL Plan), to improve its fit and use within community settings. Participants were 14 multidisciplinary providers who attended one of the three intensive workgroups that included focus groups about the fit of MEAL Plan in their practice setting. Qualitative analysis was used to determine the main themes that came up within the focus groups. Specific themes included the appropriateness MEAL Plan for autistic and non-autistic children, how providers might adapt their delivery of MEAL Plan, billing and insurance considerations, administrator support for MEAL Plan, and the content and format of ongoing training and consultation. By proactively considering and responding to these factors, it may be possible to enhance MEAL Plan so that it is better able to be delivered and sustained within community practices that support autistic children.

A Survey of Community Providers on Feeding Problems in Autism Spectrum Disorder.

PURPOSE: Feeding problems, ranging from mild to severe, are common in children with autism spectrum disorder. We conducted a 15-item online survey of community providers to gather information on service demand and current treatment approaches for this clinical population. METHODS: Respondents, speech-language pathologists, occupational therapists, registered dietitians, and Board-Certified Behavior Analysts, were recruited via e-mail listservs, professional conferences, continuing education programs, social media and electronic newsletters. The survey included questions about professional discipline, years in practice, patient population served, feeding problem types, therapeutic approaches, and level of interest in parent-mediated interventions. RESULTS: A total of 541 community practitioners responded to the survey; 419 provided usable data. Across all providers, 97% (n = 406) reported seeing children with ASD and feeding problems. Of these, 90% (n = 367) offered treatment. Providers (n = 23) who did not treat feeding problems cited "insufficient training." Most common presenting problems included limited dietary variety, texture sensitivity, and disruptive mealtime behavior. Although treatment approaches varied across disciplines, 89.3% indicated openness to parent-mediated treatment. CONCLUSIONS: These results indicate a high demand for treatment of children with ASD and feeding problems across disciplines. Food selectivity was the most common problem. Treatment approaches varied across disciplines. Dissemination and implementation of evidence-based, parent-mediated intervention is warranted.

Early Intervention Provider-Reported NDBI Use and Relationships with Provider- to System-Level Implementation Determinants.

An expanding evidence base has advocated for delivery of naturalistic developmental behavioral interventions (NDBIs) within community systems, thus extending the reach of these practices to young autistic children. The current study examined provider-reported use of NBDIs within a Part C Early Intervention (EI) system and the extent to which provider background, attitudes, and perceived organizational support predicted NDBI use. Results from 100 EI providers representing multiple disciplines indicated reported use of NDBI strategies within their practice despite inconsistent reported competency with manualized NDBI programs. Although NDBI strategy use was not predicted by provider experiences or perceived organizational support, provider openness to new interventions predicted the reported use of NDBI strategies. Future directions include mixed methods data collection across and within EI systems to better understand NDBI use and ultimately facilitate NDBI implementation.

A systematic review of emotion regulation in parent-mediated interventions for autism spectrum disorder.

Autistic individuals are at elevated risk for difficulties with emotion regulation (ER) that emerge early in life and are associated with a range of internalizing and externalizing disorders. Existing interventions that support ER have focused on school-age autistic children and adolescents as well as adults. Proactive approaches to improving ER in early childhood are thus needed, as is understanding the approaches by which ER skills can be feasibly supported in this young population. This review summarizes how ER has been measured within parent-mediated interventions for children at or under the age of 6 years and the extent to which ER is measured concurrently with or distinctly from observable behaviors that have been referenced in existing literature as externalizing or challenging behavior. Using PsycInfo, EBSCOhost, and PubMed databases, we searched for peer-reviewed journal articles published through August 2021, that focused on the use of parent-mediated interventions targeting ER and/or challenging behavior. The systematic search resulted in 4,738 publications; following multi-stage screening, the search yielded 20 studies. Eighteen of 20 studies were designed to target challenging behavior using manualized curricula or behavior analytic methodologies and assessed child outcomes through validated caregiver rating scales and/or direct behavioral observation. One study measured changes in ER as secondary to the social communication skills that were targeted in the intervention. Only one study specifically supported ER skill development and measured changes in ER as the primary intervention outcome. Findings highlight the need for better assessment of ER outcomes within the context of parent-mediated interventions for toddlers and young autistic children.

Using evaluative frameworks to examine the implementation outcomes of a cognitive behavioral therapy program for autistic students with anxiety within public school settings.

LAY ABSTRACT: Cognitive behavioral therapy helps to treat anxiety symptoms in autistic youth, but it is difficult for families to access cognitive behavioral therapy in the community. Training school providers to deliver cognitive behavioral therapy may help autistic youth and their families to access these programs. Unfortunately, we do not know how cognitive behavioral therapy programs can be delivered by school providers and how these programs help the autistic students who access them. This study addressed this gap and was part of a larger study that looked at the effectiveness of Facing Your Fears-School-Based in 25 public schools. The study goals were to understand whether Facing Your Fears-School-Based helped students and the factors that made it easy or difficult to deliver Facing Your Fears-School-Based in schools. Thirty providers participated in interviews guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Participants shared information that fell into several major categories that included (1) delivering Facing Your Fears-School-Based to many different students; (2) the positive impact of Facing Your Fears-School-Based on students' school participation; and (3) plans to continue using Facing Your Fears-School-Based. School providers also shared that Facing Your Fears-School-Based was easy to use for non-mental health providers and reported adapting Facing Your Fears-School-Based to meet student needs. The results of this study suggest that Facing Your Fears-School-Based may help autistic students and highlight the importance of using mental health programs in schools that are flexible, able to be adapted, and that are able to be used by many different types of school providers.