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Modular Approach for Autism Programs in Schools (MAAPS)

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MAAPS
Sponsored by
May Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, autism, ASD

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South FloridaRecruiting
  • Kaitlin M GouldRecruiting
  • University of RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

MAAPS

Waitlist control

Arm Description

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

Services as usual.

Outcomes

Primary Outcome Measures

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).
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Usage Rating Profile-Intervention, Revised (URP-IR)
This measure will be used to measure social validity. The URP is a 29-item, 6-point rating scale with six factors: acceptability, understanding the intervention, home-school collaboration needed, feasibility, system climate and systems support needed for the intervention.

Full Information

First Posted
August 20, 2020
Last Updated
March 15, 2023
Sponsor
May Institute
Collaborators
University of South Florida, University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT04533607
Brief Title
Modular Approach for Autism Programs in Schools
Acronym
MAAPS
Official Title
Modular Approach for Autism Programs in Schools
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
May Institute
Collaborators
University of South Florida, University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, autism, ASD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MAAPS
Arm Type
Active Comparator
Arm Description
Modular intervention system integrating evidence-based strategies to address core and associated features of ASD and ongoing coaching.
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
Services as usual.
Intervention Type
Behavioral
Intervention Name(s)
MAAPS
Intervention Description
Modular intervention system integrating evidence-based strategies to address core and associated features of ASD and ongoing coaching.
Primary Outcome Measure Information:
Title
Change in score for Developmental Disability-Clinical Global Assessment Scale (DD-CGAS)
Description
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).
Time Frame
Baseline, approximately 6 months after baseline, approximately 9 months after baseline
Title
Change in rating for Teacher Nominated Target Problems (TNTP)
Description
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.
Time Frame
Baseline, approximately 6 months after baseline, approximately 9 months after baseline
Title
Change in score for Social Skills Improvement System (SSIS)
Description
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.
Time Frame
Baseline, approximately 6 months after baseline, approximately 9 months after baseline
Title
Change in score for Children's Communication Checklist, Second Edition (CCC-2)
Description
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.
Time Frame
Baseline and approximately 9 months after baseline
Title
Change in score for Children's Yale-Brown Obsessive-Compulsive Scales-ASD (CYBOCS-ASD)
Description
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.
Time Frame
Baseline, approximately 6 months after baseline, approximately 9 months after baseline
Title
Change in engaged time measured by Academic Engaged Time (AET)
Description
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.
Time Frame
Baseline, approximately 6 months after baseline, approximately 9 months after baseline
Title
Change in score for Adaptive Behavior Assessment System, Third Edition (ABAS-3)
Description
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.
Time Frame
Baseline and approximately 9 months after baseline
Secondary Outcome Measure Information:
Title
Usage Rating Profile-Intervention, Revised (URP-IR)
Description
This measure will be used to measure social validity. The URP is a 29-item, 6-point rating scale with six factors: acceptability, understanding the intervention, home-school collaboration needed, feasibility, system climate and systems support needed for the intervention.
Time Frame
Approximately 9 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaitlin M Gould, PhD, BCBA-D
Phone
781-815-2748
Email
kgould1@mayinstitute.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Anderson, PhD, BCBA-D-D
Organizational Affiliation
May Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krystal Fontechia, MA, BCBA
Phone
813-974-0968
Email
kmcfee@usf.edu
First Name & Middle Initial & Last Name & Degree
Rose Iovannone, PhD, BCBA-D
Facility Name
Kaitlin M Gould
City
Randolph
State/Province
Massachusetts
ZIP/Postal Code
02368
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kait M Gould, PhD, BCBA-D
Phone
781-815-2748
Email
kgould1@mayinstitute.org
First Name & Middle Initial & Last Name & Degree
Cynthia Anderson, PhD, BCBA-D
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Hochheimer
Phone
585-276-6465
Email
samantha_hochheimer@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Suzannah Iadarola, PhD, BCBA-D

12. IPD Sharing Statement

Plan to Share IPD
No

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Modular Approach for Autism Programs in Schools

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