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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2024-04-30

Brief Summary

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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.

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Detailed Description

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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

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The investigator and diagnosticians for all measures will be kept blind to group assignment to treatment arm.

Study Groups

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Engagement Intervention

Family navigators will engage families to access resources and support when they first learn their child has signs of autism spectrum disorder (ASD) using an intervention that integrates motivational interviewing (MI) and problem-solving education (PSE). The family navigator will meet with parents for up to 6 individual MI+PSE sessions for each 3-month stage of intervention.

Group Type ACTIVE_COMPARATOR

Engagement Intervention

Intervention Type BEHAVIORAL

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.

Engagement + Coaching Intervention

Family navigators will engage families to access resources and support when they first learn their child has signs of autism spectrum disorder (ASD) using an intervention that integrates MI+PSE. Family navigators will also coach families to embed intervention strategies for toddlers with ASD in everyday activities using the Early Social Interaction (ESI) model. ESI teaches parents how to support their child's social communication, language, play and behaviors in everyday routines, activities, and places. The family navigator will meet with parents for 12 weekly home visits for each 3-month stage of intervention.

Group Type ACTIVE_COMPARATOR

Engagement + Coaching Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

12 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes