Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

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.
    

Intervention name(s): Engagement Intervention; Engagement + Coaching Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study uses a 2-stage sequential multiple assignment randomized trial (SMART) design to optimize a menu of interventions by comparing the order and dose that best meet the needs of families. In stage 1, families will be randomly assigned to one of two study arms for 3 months. Stage 2 interventions will be for another 3 months and will be adapted based on the primary tailoring variable. Early responders will continue the same intervention and slow responders will be re-randomized to an adapted intervention for the next 3 months. The adaptations in stage 2 for slow responders include continuing the treatment arm, adding the other treatment arm, or increasing the dose of the treatment arm. Due to extenuating circumstances associated with COVID-19 from 2020-22, unplanned changes were necessary for slower recruitment than anticipated. Recruitment for the 2-stage SMART ended to allow completion of intervention and outcome measures. Recruitment continued for just stage 1 intervention.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Pediatrics; Social Communication; Family Navigators