- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04533607
Modular Approach for Autism Programs in Schools (MAAPS)
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kaitlin M Gould, PhD, BCBA-D
- Phone Number: 781-815-2748
- Email: kgould1@mayinstitute.org
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- Recruiting
- University of South Florida
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Massachusetts
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Randolph, Massachusetts, United States, 02368
- Recruiting
- Kaitlin M Gould
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Contact:
- Kait M Gould, PhD, BCBA-D
- Phone Number: 781-815-2748
- Email: kgould1@mayinstitute.org
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-
New York
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Rochester, New York, United States, 14642
- Recruiting
- University of Rochester
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: MAAPS
Modular intervention system integrating evidence-based strategies to address core and associated features of ASD and ongoing coaching.
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Modular intervention system integrating evidence-based strategies to address core and associated features of ASD and ongoing coaching.
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No Intervention: Waitlist control
Services as usual.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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).
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Baseline, approximately 6 months after baseline, approximately 9 months after baseline
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Change in rating for Teacher Nominated Target Problems (TNTP)
Time Frame: Baseline, approximately 6 months after baseline, approximately 9 months after baseline
|
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.
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Baseline, approximately 6 months after baseline, approximately 9 months after baseline
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Change in score for Social Skills Improvement System (SSIS)
Time Frame: Baseline, approximately 6 months after baseline, approximately 9 months after baseline
|
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.
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Baseline, approximately 6 months after baseline, approximately 9 months after baseline
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Change in score for Children's Communication Checklist, Second Edition (CCC-2)
Time Frame: Baseline and approximately 9 months after baseline
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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.
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Baseline and approximately 9 months after baseline
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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
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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.
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Baseline, approximately 6 months after baseline, approximately 9 months after baseline
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Change in engaged time measured by Academic Engaged Time (AET)
Time Frame: Baseline, approximately 6 months after baseline, approximately 9 months after baseline
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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.
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Baseline, approximately 6 months after baseline, approximately 9 months after baseline
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Change in score for Adaptive Behavior Assessment System, Third Edition (ABAS-3)
Time Frame: Baseline and approximately 9 months after baseline
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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.
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Baseline and approximately 9 months after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usage Rating Profile-Intervention, Revised (URP-IR)
Time Frame: Approximately 9 months after baseline
|
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.
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Approximately 9 months after baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cynthia Anderson, PhD, BCBA-D-D, May Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R324A200154
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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