Modular Approach for Autism Programs in Schools

NCT04533607 | Unknown

• 1 other identifier: R324A200154
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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

Keywords

Autism Spectrum Disorder; autism; ASD

Outcome Measures

Primary Outcomes (7)

• Change in score for Developmental Disability-Clinical Global Assessment Scale (DD-CGAS)

  This measure will be used to assess overall functioning. The DD-CGAS is a rating scale with scores from 1 (extreme and pervasive impairment) to 100 (superior functioning).

  Baseline, approximately 6 months after baseline, approximately 9 months after baseline

• Change in rating for Teacher Nominated Target Problems (TNTP)

  This measure represents the three most pressing, operationalized target problems for each student. Target problems are specified with specific descriptions of intensity/frequency at baseline. Following baseline, ratings of improvement are gathered for each target problem on a 7-point Likert scale, ranging from 1= very much improved, good functioning, minimal symptoms, substantial change to 7= very much worse, severe exacerbation of symptoms and loss of functioning.

  Baseline, approximately 6 months after baseline, approximately 9 months after baseline

• Change in score for Social Skills Improvement System (SSIS)

  This measure will be used to assess social communication and interaction and problem behavior and will be completed by the teacher. The SSIS has several subscales that use a 4-point Likert scale to rate the frequency of specified behaviors and a 3-point Likert rating the importance of each item. The 30-item Social Skills Subscale is a measure of social communication and interaction. The SSIS Problem Behaviors Scale will be used to assess problem behavior. This scale includes 18 items that can be interpreted independently of the SSIS composite score. This will be administered for students emitting challenging behavior.

  Baseline, approximately 6 months after baseline, approximately 9 months after baseline

• Change in score for Children's Communication Checklist, Second Edition (CCC-2)

  The CCC-2 is a 5-10-minute rating scale that assesses communication skills in the areas of pragmatic language, syntax, word formation, semantics, and overall speech. It yields an index that includes clinical cutoffs to indicate profiles consistent with ASD.

  Baseline and approximately 9 months after baseline

• Change in score for Children's Yale-Brown Obsessive-Compulsive Scales-ASD (CYBOCS-ASD)

  This measure will be used to assess restricted and repetitive behavior. The CYBOCS-ASD is a semi-structured clinician-rated scale designed to rate the current severity of repetitive behavior in children with ASD. A five-point Likert scale is used for rating with a 0 indicating less symptomatic to a 4 indicating most symptomatic. A total score is obtained ranging from 0-20.

  Baseline, approximately 6 months after baseline, approximately 9 months after baseline

• Change in engaged time measured by Academic Engaged Time (AET)

  This measure will be used to assess academic functioning. An independent data collector directly observes the student for two 15-minute instructional periods. A stopwatch is used to record the duration of time the student is preforming engaged behaviors. Two observations will be administered at the relevant timepoints.

  Baseline, approximately 6 months after baseline, approximately 9 months after baseline

• Change in score for Adaptive Behavior Assessment System, Third Edition (ABAS-3)

  The raw score from the 21-item Self Direction Scale will be used to measure school-related adaptive functioning. This subscale is a nationally normed, well-established, 15-minute questionnaire measuring school-related adaptive functioning. It is validated to use independent of the ABAS-3 total score.

  Baseline and approximately 9 months after baseline

Secondary Outcomes (1)

• Usage Rating Profile-Intervention, Revised (URP-IR)

  Approximately 9 months after baseline

Study Arms (2)

MAAPS

ACTIVE COMPARATOR

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

Behavioral: MAAPS

Waitlist control

NO INTERVENTION

Services as usual.

Interventions

MAAPS BEHAVIORAL

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

MAAPS

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• May Institute: lead
• University of South Florida: collaborator
• University of Rochester: collaborator

Study Sites (3)

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Kaitlin M Gould

Randolph, Massachusetts, 02368, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Cynthia Anderson, PhD, BCBA-D-D

  May Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaitlin M Gould, PhD, BCBA-D

CONTACT

781-815-2748; kgould1@mayinstitute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Vice President of Applied Behavior Analysis and Director of the National Autism Center

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 31, 2020
• Study Start: November 4, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)