Clinical trial NCT03575429: Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network
Official title: Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Pediatrics
Social Communication
Family Navigators
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Boston Medical Center
name: University of Miami
name: University of Massachusetts, Boston
name: Kaiser Permanente
name: Children's Hospital of Philadelphia
name: Boston University
First posted: 2018-07-02
Enrollment: 81
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Positive screen for autism by community provider in a primary care setting
* Child is between 12 and 24 months old
* Parent completes the Smart Early Screening for Autism and Communication Disorders (ESAC)
* Parent participates in the home observation to complete the Systematic Observation of Red Flags (SORF) of ASD
* Positive autism screen on the SORF
* Lives in the designated study region in Florida and Massachusetts

Exclusion Criteria:

* Parent/caregiver declines to participate in the study
* Child is already receiving early intervention services
* Child does not screen positive for autism on the ESAC and/or SORF
* Child is over 24 months old

Primary outcomes:
measure: Parent contingent responsiveness change over time
timeFrame: Baseline, 3, 6, 9, and 12 months after the start of intervention
measure: Observation of DSM-5 features of autism spectrum disorder change over time
timeFrame: Baseline, 3, 6, 9, and 12 months after the start of intervention
measure: Child social communication change over time
timeFrame: Baseline, 3, 6, 9, and 12 months after the start of intervention
Secondary outcomes:
measure: Autism Diagnostic Observation Schedule (ADOS)
timeFrame: 12 months after the start of intervention
measure: Mullen Scales of Early Learning (MSEL)
timeFrame: 12 months after the start of intervention
measure: Vineland Adaptive Behavior Scales (VABS-3)
timeFrame: 12 months after the start of intervention
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Tallahassee
country: United States
facility: Florida State University Autism Institute
state: Florida
city: Boston
country: United States
facility: Boston Medical Center Corporation
state: Massachusetts
Study officials:
affiliation: Florida State University Autism Institute
name: Amy Wetherby, PhD
role: PRINCIPAL_INVESTIGATOR
References: