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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03575429
• Other study ID #: R01HD093055
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Boston Medical Center Corporation	Boston	Massachusetts
United States	University of Miami	Coral Gables	Florida
United States	Florida State University Autism Institute	Tallahassee	Florida

Sponsors (7)

Lead Sponsor	Collaborator
Florida State University	Boston Medical Center, Boston University, Children's Hospital of Philadelphia, Kaiser Permanente, University of Massachusetts, Boston, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent contingent responsiveness change over time	Parent contingent responsiveness will be periodically assessed using the Measure of Active Engagement and Transactional Supports (MAETS). The MAETS is a rating of a video-recorded home observation of parent-child interaction during everyday activities. The MAETS includes 8 components: participation and a productive role; predictable activities; language that follows the child's focus of attention; child initiations; balance of communicative turns; messages to support child comprehension; verbal and nonverbal models; and appropriate expectations and demands. Each component is scored on a 4-point scale where 0 = Absent, 1 = Emerging, 2 = Practicing, and 3 = Mastery. Total scores range from 0 to 32 and higher scores indicate that the level of parent support is better.; Families assigned to the Engagement Intervention will be compared with families assigned to Engagement + Coaching Intervention at each time point.	Baseline, 3, 6, 9, and 12 months after the start of intervention
Primary	Observation of DSM-5 features of autism spectrum disorder change over time	Features of autism spectrum disorder (ASD) will be periodically measured using the Systematic Observation of Red Flags (SORF) of ASD. The SORF is measured from a home observation of everyday activities. The SORF includes 11 red flags in social communication and social interaction and 11 red flags in restricted and repetitive behaviors using the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) diagnostic features rated on a 3 point scale. The total number of red flags ranges from 0 to 22 and higher scores indicate more red flags of ASD. The total composite score ranges from 0 to 66 and higher scores indicate more diagnostic features of ASD.	Baseline, 3, 6, 9, and 12 months after the start of intervention
Primary	Child social communication change over time	Change in social communication skills will be periodically measured with the Communication and Symbolic Behavior Scales (CSBS) Behavior Sample. Interactions between the child and caregiver will be videotaped and later rated for social communication skills and converted into scores. The raw scores will be summed to form a social, speech, and symbolic composite. The social composite includes emotion and eye gaze and communication and gestures; and possible composite scores range from 0 to 64. The speech composite includes sounds and words, and possible composite scores range from 0 to 54. The symbolic composite includes understanding and object use, and possible scores for this composite range from 0 to 53. The total summed score for all 3 composites ranges from 0 to 171. Higher scores on the composites and total indicate better social communication skills.; Families assigned to the Engagement Intervention will be compared with families assigned to Engagement + Coaching Intervention.	Baseline, 3, 6, 9, and 12 months after the start of intervention
Secondary	Autism Diagnostic Observation Schedule (ADOS)	Autism symptoms will be measured with the Autism Diagnostic Observation Schedule (ADOS), Second Edition, the gold standard diagnostic measure of ASD. The revised algorithms forming Social-Affect and Restricted Repetitive Behavior ratings of autism symptoms will be used. Scores range from 1 to 10 and higher scores indicate more autism symptoms. A total of score of 1 to 3 indicates no signs of ASD, a score of 4 or 5 suggests that the child may have ASD, while a score of 6 to 10 is indicative of ASD.; Families assigned to the Engagement Intervention will be compared with families assigned to Engagement + Coaching Intervention.	12 months after the start of intervention
Secondary	Mullen Scales of Early Learning (MSEL)	This study will use four scales of the Mullen Scales of Early Learning (MSEL) to measure developmental level: Fine Motor; Visual Reception; Expressive Language; and Receptive Language. The average of the four cognitive scales forms an Early Learning Composite. The 4 cognitive scales are measured with T scores that range from 10 to 90 based on a mean T score of 50. A higher T score indicates a better developmental level for the child's age. The Early Learning Composite is measured with Standard scores that range from 40 to 160 based on a mean standard score of 100. A higher standard score indicates a better developmental level for the child's age.; Families assigned to the Engagement Intervention will be compared with families assigned to Engagement + Coaching Intervention.	12 months after the start of intervention
Secondary	Vineland Adaptive Behavior Scales (VABS-3)	Adaptive Behavior will be measured with the Vineland Adaptive Behavior Scales, 3rd edition (VABS-3). The VABS-3 provides a standard score in four domains: Communication, Daily Living Skills, Socialization, and Motor Skills. The domain scores are averaged to form an Adaptive Behavior Composite score. The domain and composite standard scores range from 40 to 160 based on a mean standard score of 100. A higher domain and composite standard score indicates a better adaptive behavior for the child's age.; Families assigned to the Engagement Intervention will be compared with families assigned to Engagement + Coaching Intervention.	12 months after the start of intervention