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

NCT03575429 | Completed DMC

• 1 other identifier: R01HD093055
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 3

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.

Conditions

Autism Spectrum Disorder

Keywords

Pediatrics; Social Communication; Family Navigators

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Autism Diagnostic Observation Schedule (ADOS)

  12 months after the start of intervention

• Mullen Scales of Early Learning (MSEL)

  12 months after the start of intervention

• Vineland Adaptive Behavior Scales (VABS-3)

  12 months after the start of intervention

Study Arms (2)

Engagement Intervention

ACTIVE COMPARATOR

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.

Behavioral: Engagement Intervention

Engagement + Coaching Intervention

ACTIVE COMPARATOR

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.

Behavioral: Engagement + Coaching Intervention

Interventions

Engagement Intervention 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 Intervention

Engagement + Coaching Intervention 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.

Engagement + Coaching Intervention

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead
• Boston Medical Center: collaborator
• University of Miami: collaborator
• University of Massachusetts, Boston: collaborator
• Kaiser Permanente: collaborator
• Children's Hospital of Philadelphia: collaborator
• Boston University: collaborator

Study Sites (3)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Florida State University Autism Institute

Tallahassee, Florida, 32309, United States

Location

Boston Medical Center Corporation

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Communication

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Officials

• Amy Wetherby, PhD

  Florida State University Autism Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and diagnosticians for all measures will be kept blind to group assignment to treatment arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Research Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 2, 2018
• Study Start: August 1, 2019
• Primary Completion: January 31, 2024
• Study Completion: April 30, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (3)