Autism Spectrum DisorderMAAPSNCT04533607
Modular Approach for Autism Programs in Schools
A study testing MAAPS in people with Autism Spectrum Disorder, run by May Institute at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- MAAPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Nov 2020to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Kaitlin M Gould
Randolph, Massachusetts, 02368
Kait M Gould, PhD, BCBA-D, 781-815-2748, kgould1@mayinstitute.org
Cynthia Anderson, PhD, BCBA-D
- Recruiting
University of Rochester
Rochester, New York, 14642
Samantha Hochheimer, 585-276-6465, samantha_hochheimer@urmc.rochester.edu
Suzannah Iadarola, PhD, BCBA-D
- Recruiting
University of South Florida
Tampa, Florida, 33612
Krystal Fontechia, MA, BCBA, 813-974-0968, kmcfee@usf.edu
Rose Iovannone, PhD, BCBA-D
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- MAAPS
- Keywords
- Autism Spectrum Disorder, autism, ASD
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAAPSBehavioural
Modular intervention system integrating evidence-based strategies to address core and associated features of ASD and ongoing coaching.
| Study group | Role | What they receive |
|---|---|---|
| MAAPS | Active comparator | Modular intervention system integrating evidence-based strategies to address core and associated features of ASD and ongoing coaching. Receives: Behavioral: MAAPS |
| Waitlist control | No intervention | Services as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and approximately 9 months after baseline
Secondary outcomes (1)
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.
Measured: Approximately 9 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start4 Nov 2020
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- May Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Florida, University of Rochester
- Responsible party
- Principal investigator, Cynthia Anderson, May Institute
- Investigators
- Cynthia Anderson, PhD, BCBA-D-D, Principal investigator, May Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533607
- Sponsor's protocol ID
- R324A200154
- Acronym
- MAAPS
- Status last verified
- Mar 2023
- First submitted
- 20 Aug 2020
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modular Approach for Autism Programs in Schools
- ClinicalTrials.gov ID
- NCT04533607
- Acronym / sponsor ID
- MAAPS / R324A200154
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, autism, ASD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- May InstituteUniversity, hospital or other
- Collaborators
- University of South Florida, University of Rochester
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MAAPS | Active comparator | Behavioral: MAAPSModular intervention system integrating evidence-based strategies to address core and associated features of ASD and ongoing coaching. |
| Waitlist control | No intervention | –Services as usual. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAAPSModular intervention system integrating evidence-based strategies to address core and associated features of ASD and ongoing coaching. | Behavioural | MAAPS |
Primary outcome
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
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)
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.
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.
Change in score for Children's Communication Checklist, Second Edition (CCC-2)
Time frame: Baseline and approximately 9 months after baseline
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)
Time frame: Baseline, approximately 6 months after baseline, approximately 9 months after baseline
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)
Time frame: Baseline, approximately 6 months after baseline, approximately 9 months after baseline
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)
Time frame: Baseline and approximately 9 months after baseline
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.
1 secondary outcome
Usage Rating Profile-Intervention, Revised (URP-IR)
Time frame: Approximately 9 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Anderson, PhD, BCBA-D-D principal investigator
May Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAAPS in people with Autism Spectrum Disorder, run by May Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kaitlin M Gould, PhD, BCBA-D (781-815-2748, kgould1@mayinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.