Co-Principal Investigators: Woods, Juliann; Stapel-Wax, Jennifer

Purpose: The purpose of this study is to test the efficacy of a technology-supported version of the Early Social Interaction (ESI) model, an intervention designed to coach families to use evidence-based interventions for toddlers with early signs of autism spectrum disorder (ASD). Early ASD diagnosis and intervention can have a significant impact on children's later outcomes, making it critical to identify evidence-based interventions that are feasible to deliver in community- and home-based settings. The ESI model is a comprehensive intervention that teaches parents of toddlers with ASD to incorporate evidence-based intervention strategies to support social communication, language, play, and adaptive behaviors within everyday activities. In a prior efficacy trial, this research team found that the ESI model led to improvements in children's social communication, developmental functioning, and adaptive behavior. The current study will replicate the prior study using a more efficient and sustainable mode of delivery. Specifically, the research team will evaluate the efficacy of a technology-supported version of the ESI model that involves early intervention providers (EIPs) as coaches. The research team will investigate whether this version of the ESI model shows efficacy for improving children's active engagement, social communication, developmental level, adaptive behavior, and early signs of ASD. They will also investigate whether children's active engagement and the level of support parents provide to their children mediate the impact of ESI on child outcomes and whether family and child characteristics, as well as intensity of the intervention, moderate its impact.

Project Activities: The research team will evaluate the efficacy of the technology-supported ESI model using a randomized controlled trial design. In Years 1 and 2, providers will be recruited, enrolled, and randomly assigned to the intervention or control group. Each provider will recruit three children and their families, one at a time, to participate in the 9-month intervention or business-as usual services. Researchers will collect data at baseline, after the intervention, and 9 months following the completion of the intervention period to determine the effects of the intervention.

Products: The products of this project will include evidence of the efficacy of the technology-supported version of the ESI model with EIPs as coaches on child outcomes, peer-reviewed publications, and presentations.

Structured Abstract

Setting: The research will take place in homes and community settings in urban, suburban, and rural communities in Florida and Georgia.

Sample: Approximately 40 EIPs, 120 toddlers ages 18-24 months (approximately 3 per provider) who show signs of ASD and meet eligibility criteria for Part C intervention services, and the children's families will participate in the study.

Intervention: As part of the technology-supported ESI model, EIPs will be trained to coach parents on the ESI model, an intervention in which parents of young children with ASD learn to embed evidence-based strategies to support social communication, language, play, and adaptive behaviors within every day activities. ESI training for the providers is comprised of a 30-hour online course and associated resources (e.g., video illustrations, print documents, learning assessments, interactive webinars) addressing early detection, family collaboration, developmental perspectives, evidence-based intervention strategies, and strategies to address challenging behaviors. ESI for families consists of individual and group weekly sessions over 9 months. The 30 individual sessions include coaching and specific feedback for parents on the use of evidence-based strategies. Coaching sessions will begin in the home and eventually move to community settings. The parents in the ESIgroup access both an online course and 24 weekly group meetings by video conferencing to discuss the topics covered in the online course, including social communication, emotion regulation, play development, and behavioral challenges.

Research Design and Methods: This study will use a cluster randomized controlled trial with families nested within providers. In Years 1 and 2 of the study, the team will recruit providers and randomly assign them to the ESI or control group. Each provider will recruit three families sequentially. Prior to beginning coaching with families, providers will receive the online training. Each provider will then work with one family at a time to provide 9 months of intervention. When they complete intervention with one family, they will begin intervention with the next so that they work with the 3 families over a span of 27 months. Child outcomes will be assessed at baseline, post-test, and at 9-month follow up. Mediator variables (i.e., child active engagement and parents' level of support to their child) will be assessed at baseline and monthly until the end of the intervention.

Control Condition: Toddlers and their families in the control group will receive business-as-usual early intervention services.

Key Measures: The research team will use the Smart Early Screening for Autism and Communication Disorders to screen children for ASD. Additional screening measures include the Communication and Symbolic Behavior Scales(CSBS) Behavior Sample to assess social communication and the Systematic Observation of Red Flags of Autism Spectrum Disorder (SORF) checklist to assess early signs of ASD. Child outcomes will be measured using the CSBS Behavior Sample (social communication), the SORF checklist (early signs of ASD), the Mullen Scales of Early Learning (developmental level) and the Vineland Adaptive Behavior Scales (adaptive behavior). The mediators of child engagement and parent support will be assessed from video-recorded observations of parent-child interactions using the Measure of Active Engagement and Transactional Supports(MAETS). The following moderator variables will also be assessed: parents' buy-in to treatment (parent-reported Caregiver Diaryand provider-reported Caregiver Involvement Scale),demographic information, hours spent on ESI and other interventions (parent log of hours, provider count of sessions), and family functioning (parent-reported Family Impact Questionnaire, Family Resource Scale, Parenting Daily Hassles, Parenting Sense of Competence, and Parenting Stress Index, as well as aform to document how many activities the parent participates in and how their child with ASD impacts their participation). Fidelity of the providers' delivery will be measured through observational ratings by master coaches. Fidelity of intervention delivery will be assessed using the Caregiver Diary and Caregiver Involvement Scaleand hours spent on ESI and on other interventions. Fidelity of parents' implementation will be measured from the monthly home observation using the MAETS. Parent satisfaction will also be measured using a family evaluation survey.

Data Analytic Strategy: Growth curve modeling will be used to determine the difference in effects between the intervention group and the control group on active engagement, social communication, developmental level, adaptive behavior, and early signs of autism. Models will take into account the nested structure of the data (families nested within providers). Effect size estimates will also be calculated. Moderation will be explored through interactions, and mediation will be tested within the multilevel growth curve models.