Modular Approach for Autism Programs in Schools

NCT ID: NCT04533607

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-04
• Study Completion Date: 2024-06-30

Brief Summary

The number of students aged 6-21 years with an educational classification of autism spectrum disorder (ASD) in the United States grew by about 19 times over a 19-year period-from 29,076 in 1995-6 to 545,198 in 2014-2015 (IDEA Data Center, 2018). Meeting the needs of this growing population of students is a significant concern for schools (Bowen, 2014). Investigators have described as many as 27 efficacious intervention strategies for teaching new skills to children with ASD (Wong et al., 2015). However, these strategies are only rarely implemented in schools. In a survey of 185 teachers across the state of Georgia working with at least one student with ASD, fewer than 5% reported using an evidence-based intervention (Hess, Morrier, Heflin, & Ivey, 2008). To address gaps in current practice for students with ASD, there is a need for (1) a process for selecting and implementing interventions that can address the multi-faceted needs of students with ASD and (2) a service-delivery system that is feasible, flexible, durable, effective, and sustainable in schools. The investigators hypothesize that The Modular Approach for Autism Programs in Schools (MAAPS), an individualized, comprehensive modular intervention system, will address this gap. MAAPS integrates evidence-based strategies to address core and associated features of autism spectrum disorders (ASD) to enhance the success of elementary students with ASD in schools. The primary aim is to evaluate whether, compared to services as usual, MAAPS improves teacher outcomes and subsequent student educational outcomes.

Detailed Description

Background: The number of students aged 6-21 years with an educational classification of autism spectrum disorder (ASD) in the United States grew by about 19 times over a 19-year period-from 29,076 in 1995-6 to 545,198 in 2014-2015 (IDEA Data Center, 2018). Meeting the needs of this growing population of students is a significant concern for schools (Bowen, 2014). Investigators have described as many as 27 efficacious intervention strategies for teaching new skills to children with ASD (Wong et al., 2015). However, these strategies are only rarely implemented in schools. In a survey of 185 teachers across the state of Georgia working with at least one student with ASD, fewer than 5% reported using an evidence-based intervention (Hess, Morrier, Heflin, & Ivey, 2008). The infrequent use of the wide range of evidence-based strategies that could improve outcomes for students with ASD is concerning and may at least partially explain why students with ASD receive large amounts of special education services (Brookman-Frazee et al., 2009) yet often continue to require extensive supports as adults (Howlin et al., 2004).

Objectives: The purpose of this project is to test the efficacy of the Modular Approach for Autism Programs in Schools (MAAPS). The Modular Approach for Autism Programs in Schools (MAAPS) is an individualized, comprehensive modular intervention system integrating evidence-based strategies to address core and associated features of autism spectrum disorders (ASD) to enhance the success of elementary students with ASD in schools.

Specific Aims: The primary aim is to evaluate whether, compared to services as usual, MAAPS improves teacher outcomes and subsequent student educational outcomes. The investigators also intend to explore the feasibility and acceptability of MAAPS, costs associated with MAAPS, and analyze any potential modifiers of intervention effects and the implementation process.

Design: 60 schools will be randomized to either MAAPS or waitlist control. 120 teacher-student dyads will be enrolled from these 60 schools. Schools will be recruited from three sites: May Institute, University of South Florida, and University of Rochester. Student outcome measures assess overall school functioning, improvements in teacher-nominated target behaviors, core and associated features of ASD. Teacher outcome measures assess feasibility, acceptability, and usability of MAAPS and teacher implementation fidelity.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MAAPS

Modular intervention system integrating evidence-based strategies to address core and associated features of ASD and ongoing coaching.

Group Type: ACTIVE_COMPARATOR

MAAPS

Intervention Type: BEHAVIORAL

Modular intervention system integrating evidence-based strategies to address core and associated features of ASD and ongoing coaching.

Waitlist control

Services as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MAAPS

Modular intervention system integrating evidence-based strategies to address core and associated features of ASD and ongoing coaching.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Educational classification of autism spectrum disorder
• Attending a public elementary school (K-6th grade)
• Attending school in person at least one day per week
• No planned changes in school placement or core team members in upcoming school year
• Parents/guardians able to participate in study-related activities (e.g., informed consent process and completion of study measures)
• Child's teacher consents to participate

Exclusion Criteria

• Profound vision or hearing loss
• Motor disabilities such as cerebral palsy
• Genetic disorder known to be associated with ASD such as Fragile X, Down Syndrome, tuberous sclerosis

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: collaborator

May Institute

OTHER

Sponsor Role: lead

Responsible Party

Cynthia Anderson

Senior Vice President of Applied Behavior Analysis and Director of the National Autism Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia Anderson, PhD, BCBA-D-D

Role: PRINCIPAL_INVESTIGATOR

May Institute

Locations

University of South Florida

Tampa, Florida, United States

Site Status: RECRUITING

Kaitlin M Gould

Randolph, Massachusetts, United States

Site Status: RECRUITING

University of Rochester

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kaitlin M Gould, PhD, BCBA-D

Role: CONTACT

kgould1@mayinstitute.org

781-815-2748

Facility Contacts

Krystal Fontechia, MA, BCBA

Role: primary

kmcfee@usf.edu

813-974-0968

Kait M Gould, PhD, BCBA-D

Role: primary

kgould1@mayinstitute.org

781-815-2748

Samantha Hochheimer

Role: primary

samantha_hochheimer@urmc.rochester.edu

585-276-6465

Other Identifiers

R324A200154

Identifier Type: -

Identifier Source: org_study_id