NCT03575429

Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Florida State University · Academic / Other
• Sex: All
• Age: 12 Months – 24 Months
• Healthy volunteers: Accepted

Summary

The Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network-a new interdisciplinary network of 6 institutions-will blend clinical effectiveness and implementation research designs to study individual and combined effects of 2 evidence-based interventions in real world settings. The first is to engage families to access resources and support when they first learn their child has signs of ASD using an evidence-based intervention that integrates motivational interviewing and problem-solving education (MI+PSE). The second is to coach families to embed evidence-based intervention strategies for toddlers with ASD in everyday activities using the Early Social Interaction (ESI) model. In Phase 1, investigators will compare the effectiveness of adaptive interventions that use MI+PSE with and without ESI on parent and child outcomes in 3 sites in Florida and Massachusetts using a 2-stage Sequential Multiple Assignment Randomized Trial (SMART) design. In Phase 2, investigators will construct an adaptive intervention to optimize the effects and study the feasibility of implementation in new sites in California. This research network can build the capacity of community-based systems to provide earlier and widespread access to cost-efficient, community-viable treatment and be ready for immediate and rapid implementation across the US.

Detailed description

Research shows that a stable diagnosis of autism spectrum disorder (ASD) can be made by trained professionals at 18-24 months and yet the median age of diagnosis in the US is 4-5 years of age. Lower income, minority, and rural families receive a diagnosis up to 1.5 years later and more likely miss the window of opportunity for early intervention (EI). One of the greatest challenges researchers face, in spite of scientific advances and investments, is how to bridge the healthcare science-to-service gap and address health disparities in access to evidence-based EI for children with ASD. Doing this would be the best solution to improve lifelong outcomes, reduce costs to society, and change the landscape of autism. The Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network-a new interdisciplinary network of 6 institutions-will blend clinical effectiveness and implementation research designs to study individual and combined effects of 2 evidence-based interventions in real world settings: 1) engage families to access resources and support when they first learn their child has signs of ASD using an evidence-based intervention that integrates motivational interviewing and problem solving education (MI+PSE); and 2) coach families to embed evidence-based intervention strategies for toddlers with ASD in everyday activities using the Early Social Interaction (ESI) model. Building on existing infrastructure, the Network will infuse mobile technology using the Autism Navigator® collection of web-based courses and tools. Families will be recruited by screening in community-based primary care and EI systems in 3 diverse regions in 2 states: Florida and Massachusetts. In Phase 1, investigators will compare the effectiveness of adaptive interventions that use MI+PSE with and without ESI in a 2-stage Sequential Multiple Assignment Randomized Trial (SMART) design on family engagement in EI, parent use of intervention strategies in everyday activities, and child outcomes of social communication, active engagement, autism symptoms, developmental level, and adaptive behavior. In Phase 2, investigators will construct an adaptive intervention to optimize the effects of MI+PSE with ESI based on the SMART and study the feasibility of implementation in two new service systems in California: Kaiser Permanente Healthcare System and the National Black Church Initiative. The ACTION Network brings a unique interdisciplinary team with expertise spanning early detection, maternal mental health, clinical trials, health disparities, implementation science, and policy. Using dynamic technology platform the Network has ambitious dissemination aims of informing a community of change agents committed to impact at the population level. This research network can build the capacity of community-based systems to provide earlier and widespread access to cost-efficient, community-viable treatment and be ready for immediate and rapid implementation across the US. Findings will advance science by providing researchers with a method for rapidly deploying evidence-based practices, enabling research at younger ages-accelerating genetic, neuroscience, and intervention research-and lead to transformative changes in workforce development and healthcare delivery.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Engagement Intervention	Family navigators will use MI to engage families to decrease resistance and build motivation and commitment to challenging behavior changes by eliciting and reflecting broader goals and values, linking those values to specific behavior change, and negotiating a "menu" of options for change based on individual preferences. PSE will be used by the Family Navigators to guide families in selecting an objective, measurable problem, then proceed through a series of steps that involve goal setting, brainstorming and evaluating solutions, choosing a solution, and action planning.
BEHAVIORAL	Engagement + Coaching Intervention	ESI program planning entails identifying goals and objectives for the child and teaching strategies and supports for parents. Each session includes the following components: 1) setting the stage to develop that visit's agenda and gather updates; 2) intervention implementation that must include the following steps to coach the parent: a) review the objective, b) use modeling, guided/caregiver practice, or video review to teach the strategy, c) provide specific feedback to the parent, and d) problem solving and plan for next time; steps a-d are repeated for 3-5 activities per session; and 3) summarize plans for parent implementation between sessions. Families are invited to Autism Navigator How-To Guide for Families, a self-guided web-based course, with an online weekly group meeting.

Timeline

• Start date: 2019-08-01
• Primary completion: 2024-01-31
• Completion: 2024-04-30
• First posted: 2018-07-02
• Last updated: 2024-05-16

Locations

3 sites across 1 country: United States