Clinical trial NCT04533607: Modular Approach for Autism Programs in Schools
Official title: Modular Approach for Autism Programs in Schools
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
autism
ASD
Lead sponsor: May Institute
Sponsor class: OTHER
Collaborators: name: University of South Florida
name: University of Rochester
First posted: 2020-08-31
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Schools will be randomized to either MAAPS or waitlist control with equal probability. Randomization at the school level will minimize the risk of spillover between MAAPS and the waitlist control group. Randomization will be conducted for each site to guarantee equal representation of treatment and control schools at each site. The project statistician will generate a randomization sequence that is concealed from the study team.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in score for Developmental Disability-Clinical Global Assessment Scale (DD-CGAS)
timeFrame: Baseline, approximately 6 months after baseline, approximately 9 months after baseline
measure: Change in rating for Teacher Nominated Target Problems (TNTP)
timeFrame: Baseline, approximately 6 months after baseline, approximately 9 months after baseline
measure: Change in score for Social Skills Improvement System (SSIS)
timeFrame: Baseline, approximately 6 months after baseline, approximately 9 months after baseline
measure: Change in score for Children's Communication Checklist, Second Edition (CCC-2)
timeFrame: Baseline and approximately 9 months after baseline
measure: Change in score for Children's Yale-Brown Obsessive-Compulsive Scales-ASD (CYBOCS-ASD)
timeFrame: Baseline, approximately 6 months after baseline, approximately 9 months after baseline
measure: Change in engaged time measured by Academic Engaged Time (AET)
timeFrame: Baseline, approximately 6 months after baseline, approximately 9 months after baseline
measure: Change in score for Adaptive Behavior Assessment System, Third Edition (ABAS-3)
timeFrame: Baseline and approximately 9 months after baseline
Secondary outcomes:
measure: Usage Rating Profile-Intervention, Revised (URP-IR)
timeFrame: Approximately 9 months after baseline
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Randolph
country: United States
facility: Kaitlin M Gould
state: Massachusetts
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: May Institute
name: Cynthia Anderson, PhD, BCBA-D-D
role: PRINCIPAL_INVESTIGATOR
References: