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.

Enhancing stakeholder roles in autism early interventions in the United States: A stakeholder-driven research agenda.

LAY ABSTRACT: In this article, we outline a stakeholder-driven research agenda to guide future early intervention research for children with autism. Our research team collaborated with autism service providers, parents of individuals with autism, and autistic people to create this research agenda by (1) conducting workshops with community members and (2) distributing a survey to a larger number of community members around the country. The finalized research agenda includes (1) Guiding Principles for current and future research, (2) Research Priorities focused on early intervention for individuals with autism, and (3) Systems Implications to consider in future clinical, research, and policy efforts for early intervention. The full version of the research agenda is available in Supplemental Material. This article lists the main points of the research agenda and discusses unique themes highlighted by the community members. One main conclusion is that researchers need to include community members in decision-making and consultant positions throughout the research process to best meet the needs of the broader autism community. We have created a researcher workbook which we hope may facilitate these community consultation efforts. This workbook is available in Supplemental Material.

Characterizing Available Tools for Synchronous Virtual Assessment of Toddlers with Suspected Autism Spectrum Disorder: A Brief Report.

The COVID-19 pandemic, and associated social distancing mandates, has placed significant limitations on in-person health services, requiring creative solutions for supporting clinicians engaged in the diagnosis of autism spectrum disorder (ASD). This report describes the five virtual instruments available at the time of manuscript development for use by experienced clinicians making diagnostic determinations of ASD for toddlers across the 12- to 36-months age range. We focus on synchronous virtual assessments in which clinicians guide the child's caregiver through a range of assessment activities and observe spontaneous and elicited behaviors. Assessments are compared on dimensions of targeted behavioral domains, specific activities and presses employed, scoring approaches, and other key logistical considerations to guide instrument selection for use in varied clinical and research contexts.

Examining a stepped-care telehealth program for parents of young children with autism: a proof-of-concept trial.

BACKGROUND: Intervention during the first years of life for children with autism spectrum disorder (ASD) may have the strongest impact on long-term brain development and functioning. Yet, barriers such as a shortage of trained professionals contribute to significant delays in service. The goal of this proof-of-concept study was to explore strategies that support timely and equitable deployment of ASD-specific interventions. METHODS: This 15-week, randomized proof-of-concept study explored the acceptability of a digital parent mediated intervention online reciprocal imitation training (RIT; a naturalistic developmental behavioral intervention) and compared it to a treatment as usual (TAU) control on parent and child outcomes. Eligible children were between 18 and 60 months, met the cutoff for ASD on the Autism Diagnostic Observation Schedule-2nd Edition and demonstrate significant social imitation deficits. Primary outcomes include the acceptability of RIT (Scale of Treatment Perceptions) and the feasibility of the Online RIT digital intervention (online RIT attributes). Secondary outcomes included parent fidelity (RIT parent fidelity form) and parental self-efficacy (Early Intervention Parenting Self-Efficacy Scale). Exploratory outcome measures included child social communication (Social Communication Checklist), child imitation skills (Unstructured Imitation Assessment), and family quality of life (Beach Center Family Quality of Life Scale). RESULTS: Twenty participants were randomized in a 1:1 fashion. The acceptability and feasibility of RIT and the Online RIT digital intervention were rated highly. Among the secondary outcomes, there were significant group differences in parent fidelity (p < .001) and self-efficacy (p = .029). On exploratory outcomes, there were group differences in child social communication (p = .048). There were no significant group differences in imitation ability (p = .05) or family quality of life (p = .22). LIMITATIONS: There are several limitations with this study, including the small sample size as well as lack of data on enactment and website engagement. This study was not able to address questions related to which variables predict program engagement and treatment response, which will be critical for determining which families may benefit from such a stepped-care delivery model. CONCLUSIONS: Overall, the Online RIT program delivered in a stepped-care format shows strong acceptability and holds promise as an innovative delivery model. Trial registration ClinicalTrials.gov, NCT04467073. Registered 10 July 2020- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04467073.

Efficacy of low intensity, therapist-implemented Project ImPACT for increasing social communication skills in young children with ASD.

Project ImPACT is a Naturalistic Developmental Behavioral Intervention (NDBI) for young children with ASD. Preliminary research supports its feasibility and efficacy as a parent-mediated intervention; however, its efficacy as a low-intensity, therapist-implemented intervention is unclear. A single-case, multiple-baseline design evaluated the effect of 2 h per week of therapist-implemented Project ImPACT on social engagement, language, and play in nine children with ASD. Language and play skills were targeted separately for five children and together for four children. Children increased their rates of social engagement and language when language or play was the sole target and when language and play were targeted together; however, gains in play skills were evident only when they were targeted separately. This study provides support for the efficacy of the Project ImPACT when implemented by therapists at a low intensity and suggests the way in which skills are targeted can affect child learning.

Brief Report: The Preliminary Psychometric Properties of the Social Communication Checklist.

Despite the expansion of early intervention approaches for young children with ASD, investigators have struggled to identify measures capable of assessing social communication change in response to these interventions. Addressing recent calls for efficient, sensitive, and reliable social communication measures, the current paper outlines the refinement and validation of the Social Communication Checklist (SCC). We discuss two small studies exploring the psychometric properties of the SCC and the SCC-R (revised Social Communication Checklist), including sensitivity to change, inter-rater reliability, and test-retest reliability, in two samples of children with ASD and one sample of typically-developing children. Results indicate this measure is reliable, sensitive to change after a brief social communication intervention, and strongly related to well-established measures of social communicative functioning.

Remembering parents in parent-mediated early intervention: An approach to examining impact on parents and families.

The goal of this review is to advance the discussion regarding meaningful outcomes of early intervention for children with autism spectrum disorder. The rapid growth in the development and evaluation of early intervention approaches for autism spectrum disorder includes both therapist-driven and parent-mediated interventions. The majority of research on both approaches to early intervention focuses on promoting child outcomes (e.g. language acquisition) with less emphasis on family and parent outcomes (e.g. quality of life, self-efficacy). Given that parent buy-in is essential for parent-mediated interventions to be effective over time, increased attention to family outcomes that are of value to families and have the potential to be impacted positively by these interventions is needed to develop, disseminate, and sustain high-quality interventions in community settings. In this review, we draw from work on parent and family outcomes targeted in related fields (e.g. Part C early intervention, pediatric chronic illness, behavior management parent training) that we propose are particularly relevant for evaluating the impact of parent-mediated interventions in early intervention for autism spectrum disorder.

Comparison of a Self-Directed and Therapist-Assisted Telehealth Parent-Mediated Intervention for Children with ASD: A Pilot RCT.

This pilot RCT compared the effect of a self-directed and therapist-assisted telehealth-based parent-mediated intervention for young children with ASD. Families were randomly assigned to a self-directed or therapist-assisted program. Parents in both groups improved their intervention fidelity, self-efficacy, stress, and positive perceptions of their child; however, the therapist-assisted group had greater gains in parent fidelity and positive perceptions of child. Children in both groups improved on language measures, with a trend towards greater gains during a parent-child interaction for the therapist-assisted group. Only the children in the therapist-assisted group improved in social skills. Both models show promise for delivering parent-mediated intervention; however, therapist assistance provided an added benefit for some outcomes. A full-scale comparative efficacy trial is warranted.

A mixed-method evaluation of the feasibility and acceptability of a telehealth-based parent-mediated intervention for children with autism spectrum disorder.

Research within the autism spectrum disorder field has called for the use of service delivery models that are able to more efficiently disseminate evidence-based practices into community settings. This study employed telehealth methods in order to deliver an Internet-based, parent training intervention for autism spectrum disorder, ImPACT Online. This study used mixed-methods analysis to create a more thorough understanding of parent experiences likely to influence the adoption and implementation of the program in community settings. Specific research questions included (1) What are parents' perceptions of the online program? (2) How does ImPACT Online compare to other services that parents are accessing for their children? And (3) Do parents' experience in, and perceptions of, the program differ based on whether they received a therapist-assisted version of the program? Results from 28 parents of a child with autism spectrum disorder indicate that parents saw improvements in their child's social communication skills and their own competence during the course of the program, regardless of whether they received therapist assistance. However, qualitative interviews indicate that parents who received therapist assistance were more likely endorse the acceptability and observability of the program. These findings support the potential for Internet-based service delivery to more efficiently disseminate evidence-based parent training interventions for autism spectrum disorder.

Increasing Access to an ASD Imitation Intervention Via a Telehealth Parent Training Program.

Systematic research focused on developing and improving strategies for the dissemination and implementation of effective ASD services is essential. An innovative and promising area of research is the use of telehealth programs to train parents of children with ASD in intervention techniques. A hybrid telehealth program, combining self-directed internet-based instruction with remote coaching, was created to introduce parents of children with ASD to an imitation intervention. A single-subject multiple-baseline design study evaluated the effect of the program on changes in parent and child behavior. Parents improved in their use of the intervention techniques and their children demonstrated concurrent increases in spontaneous imitation skills. Parents also indicated that the intervention and telehealth service delivery model were acceptable, useable, and effective. Results suggest that this hybrid telehealth program has the potential to increase access to ASD services.

The broader autism phenotype and friendships in non-clinical dyads.

The broader autism phenotype (BAP) is a set of subclinical traits qualitatively similar to those observed in autism spectrum disorders. The current study sought to elucidate the association between self- and informant-reports of the BAP and friendships, in a non-clinical sample of college student dyads. Self-informant agreement of the BAP and friendship similarity was evaluated, and the Actor-Partner Interdependence Model was used to test how both friends' BAP characteristics jointly and uniquely contribute to the experiences of friendships. Results suggest self-informant agreement about the BAP, friendship closeness, quality, and conflict. Actor effects were observed for the BAP and friendship values, quality, conflict, and loneliness. Findings suggest that the BAP relates in meaningful ways to self-perceptions of friendship variables in the general population.

Disseminating ASD interventions: a pilot study of a distance learning program for parents and professionals.

There is a need for the adaptation of training in evidence-based interventions to non-traditional methods, particularly for individuals working with children with autism spectrum disorders (ASD). An internet-based self-directed distance learning program was created to teach reciprocal imitation training, a naturalistic behavioral intervention aimed at increasing imitation in children with ASD. A single-subject multiple-baseline design study evaluated the effect of the program on changes in therapist (sample 1) and parent (sample 2) knowledge and behavior, and changes in child behavior. Adult participants improved their knowledge and use of the intervention techniques, and child participants improved their rates of imitation. Results suggest that a self-directed distance learning program may be effective for disseminating evidence-based practices to individuals working with children with ASD.

Pilot study of a school-based parent training program for preschoolers with ASD.

This study investigated the feasibility and preliminary effectiveness of a parenting training program designed for early intervention and early childhood special education (EI/ESCE) programs serving students with autistic spectrum disorders. Thirteen teachers representing three intermediate school districts implemented the intervention with 27 students and their parents. Eighty-nine percent of families completed the program. From pre- to post-intervention parents improved their use of the treatment strategies and children increased their rate of language during a parent-child interaction in their home. Parents and teachers reported significant gains in child mastery of social-communication skills and teachers, but not parents, reported a significant decrease in social impairment. Parents reported a significant decrease in parenting stress. Both groups rated the intervention highly in regard to treatment acceptability, perceived effectiveness, and usability. Findings suggest that this intervention can be feasibly implemented in public EI/ECSE settings, filling an important gap in services for intervention programs serving children with autistic spectrum disorders.