Recruiting

Observational Study

Sponsor:

May Institute

Code:

NCT04533607

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Interventions

MAAPS

Study Details

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.

Conditions

Autism Spectrum Disorder

Study ID

NCT04533607

Start date

Nov 4, 2020

Status verified date

Mar, 2023

Completion date

Jun, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: MAAPS

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

no intervention: Waitlist control

Services as usual.

Interventions

MAAPS

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

Primary outcome measure

  • Change in score for Developmental Disability-Clinical Global Assessment Scale (DD-CGAS) [ Time Frame: Baseline, approximately 6 months after baseline, approximately 9 months after baseline ]
  • Change in rating for Teacher Nominated Target Problems (TNTP) [ Time Frame: Baseline, approximately 6 months after baseline, approximately 9 months after baseline ]
  • Change in score for Social Skills Improvement System (SSIS) [ Time Frame: Baseline, approximately 6 months after baseline, approximately 9 months after baseline ]
  • Change in score for Children's Communication Checklist, Second Edition (CCC-2) [ Time Frame: Baseline and approximately 9 months after baseline ]
  • Change in score for Children's Yale-Brown Obsessive-Compulsive Scales-ASD (CYBOCS-ASD) [ Time Frame: Baseline, approximately 6 months after baseline, approximately 9 months after baseline ]
  • Change in engaged time measured by Academic Engaged Time (AET) [ Time Frame: Baseline, approximately 6 months after baseline, approximately 9 months after baseline ]
  • Change in score for Adaptive Behavior Assessment System, Third Edition (ABAS-3) [ Time Frame: Baseline and approximately 9 months after baseline ]

Central Contacts and Locations

Central contacts

Kaitlin M Gould, PhD, BCBA-D

781-815-2748kgould1@mayinstitute.org

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Krystal Fontechia, MA, BCBA

813-974-0968kmcfee@usf.edu

Principal Investigator:

Rose Iovannone, PhD, BCBA-D

Kaitlin M Gould

Recruiting

Randolph, Massachusetts, United States, 02368

Contacts

Kait M Gould, PhD, BCBA-D

781-815-2748kgould1@mayinstitute.org

Principal Investigator:

Cynthia Anderson, PhD, BCBA-D

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Principal Investigator:

Suzannah Iadarola, PhD, BCBA-D

More Information

Sponsor

May Institute

Last update posted

Mar 16, 2023

Last verified

Mar, 2023

Keywords

  • Autism Spectrum Disorder
  • autism
  • ASD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by May Institute on 2023-03-16.