Autism Spectrum DisorderSAAGENCT03573128
Development and Pilot Testing of the Students With Autism Accessing General Education (SAAGE) Model
A study testing Students with Autism Accessing General Education and Enhanced Services As Usual in people with Autism Spectrum Disorder, run by University of Rochester at 1 site in United States.
Trial summary
Study personnel will use evidence based behavioral skills training procedures to coach educators to implement modules designed to increase the quality of educational services and access to inclusive settings in elementary school for students with Autism Spectrum Disorder. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Students with Autism Accessing General Education and Enhanced Services As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 28 Aug 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children subjects:
- Are enrolled in school grades kindergarten through 5th
- Have an IEP educational classification of Autism, confirmed by the Autism Diagnostic Observation Schedule, Second Edition, and DSM-5 checklist
- No planned changes in school placement or core team members during the school year of participation
- Adult subjects (teachers, para educators):
- Instructional personnel who currently support a participating child with ASD at school (e.g., teacher, instructional assistant, speech pathologist, occupational therapist)
- Letter from instructional personnel's district or school indicating agreement to take part in the research project
Who cannot join
- Children subjects • Diagnosis of (1) genetic disorders such as Fragile X, Down syndrome, or tuberous sclerosis; 2) profound vision or hearing loss; or (3) motor disabilities such as cerebral palsy (these multiple disabilities would prevent standard implementation of the intervention protocol).
- Adult subjects
- Instructional personnel whose written consent was not obtained
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Study personnel will use evidence based behavioral skills training procedures to coach educators to implement modules designed to increase the quality of educational services and access to inclusive settings in elementary school for students with Autism Spectrum Disorder.
Read the detailed description
This project brings together the expertise of investigators at three centers to develop and conduct a pilot test of a new comprehensive intervention to increase the quality of educational services and access to inclusive settings for students with autism spectrum disorder (ASD) in elementary school (kindergarten through 5th grade). The intervention model, Students with Autism Accessing General Education (SAAGE), integrates evidence-based strategies to teach skills to students with ASD in schools, best practices derived from this literature by the project investigators, a recent guidebook written by the principal investigator, and research on collaboration with community providers such as school teams to implement interventions efficaciously and sustainably. SAAGE begins with strategies to help a school form a cohesive team to oversee implementation of the model in the school. For each student, SAAGE uses a modular approach for identifying goals for a student, selecting appropriate teaching strategies, and systematically monitoring progress and trouble-shooting. The modules center on core and associated features of ASD. Study personnel will use well established behavioral skills training procedures to coach educators to implement the modules.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Students with Autism Accessing General Education, Enhanced Services As Usual
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Students with Autism Accessing General EducationBehavioural
With study team coach support, teacher implemented modules addressing student behavioral/academic goals.
Enhanced Services As UsualOther
Teaching staff access in-service presentations and print materials with no active study team coaching.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Students with Autism Accessing General Education (SAAGE). Teaching staff work with a study team coach to identify areas of concern for individual students, create goals and implement a modular behavioral intervention using an active teaching/feedback loop model. Receives: Behavioral: Students with Autism Accessing General Education |
| Enhanced Services As Usual | Active comparator | Teaching staff access in-service training sessions hosted by study team and are provided with print materials from which the modules for the active intervention were created. Receives: Other: Enhanced Services As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in student function as measured by the Developmental Disability-Clinical Global Assessment Scale
The Developmental Disability-Clinical Global Assessment Scale ranges from 1-100 with 100 indicating superior functioning. It assesses student function in a classroom setting.
Measured: baseline to end of school year (approx. 9 months)
Secondary outcomes (7)
Mean change in social communication and interaction as rated by child's teacher using the 30 item Social Skills Subscale of the Social Skills Improvement System
The Social Skills Improvement System, Social Skills Subscale is a 30 item measure of social communication and interaction using a 4 point Likert scale to rate the frequency of behaviors and a 3 point Likert scale to the the importance of each item.
Measured: baseline to end of school year (approx. 9 months)
Mean change in restricted and repetitive behavior as measured by the Children's Yale-Brown Obsessive-Compulsive Scales - PDD
The Children's Yale-Brown Obsessive-Compulsive Scales - PDD is a modified version of the Children's Yale-Brown Obsessive-Compulsive Scales which is adapted for use with children with ASD. It is a semi structured clinician rated scale designed to rate the current severity of repetitive behavior. Each item is scored on a 5 point scale from 0 to 4 with 4 being most symptomatic.
Measured: baseline to end of school year (approx. 9 months)
Change in teacher-nominated target behaviors
Teacher Nominated Target Behaviors
Measured: baseline to end of school year (approx. 9 months)
Change in on-task behavior during instruction
Academic Engaged Time
Measured: baseline to end of school year (approx. 9 months)
School-related adaptive functioning
Adaptive Behavior Assessment System, Self-Direction Scale
Measured: baseline to end of school year (approx. 9 months)
Social skills and behavior regulation
Social Skills Improvement System
Measured: baseline to end of school year (approx. 9 months)
Class placement
IEP review
Measured: baseline to end of school year (approx. 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start1 Aug 2017
- Primary completion28 Aug 2018
- Study completion28 Aug 2018
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.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- May Institute, University of South Florida
- Responsible party
- Principal investigator, Suzannah Iadarola, University of Rochester
- Investigators
- Tristram H Smith, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573128
- Sponsor's protocol ID
- R324A150032
- Acronym
- SAAGE
- Status last verified
- Nov 2018
- First submitted
- 6 Jun 2018
- Last updated
- 16 Nov 2018
- 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 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of the Students With Autism Accessing General Education (SAAGE) Model
- ClinicalTrials.gov ID
- NCT03573128
- Acronym / sponsor ID
- SAAGE / R324A150032
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- May Institute, University of South Florida
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 29 Jun 2018 (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.
Study personnel will use evidence based behavioral skills training procedures to coach educators to implement modules designed to increase the quality of educational services and access to inclusive settings in elementary school for students with Autism Spectrum Disorder.
Detailed description
This project brings together the expertise of investigators at three centers to develop and conduct a pilot test of a new comprehensive intervention to increase the quality of educational services and access to inclusive settings for students with autism spectrum disorder (ASD) in elementary school (kindergarten through 5th grade). The intervention model, Students with Autism Accessing General Education (SAAGE), integrates evidence-based strategies to teach skills to students with ASD in schools, best practices derived from this literature by the project investigators, a recent guidebook written by the principal investigator, and research on collaboration with community providers such as school teams to implement interventions efficaciously and sustainably. SAAGE begins with strategies to help a school form a cohesive team to oversee implementation of the model in the school. For each student, SAAGE uses a modular approach for identifying goals for a student, selecting appropriate teaching strategies, and systematically monitoring progress and trouble-shooting. The modules center on core and associated features of ASD. Study personnel will use well established behavioral skills training procedures to coach educators to implement the modules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Students with Autism Accessing General EducationStudents with Autism Accessing General Education (SAAGE). Teaching staff work with a study team coach to identify areas of concern for individual students, create goals and implement a modular behavioral intervention using an active teaching/feedback loop model. |
| Enhanced Services As Usual | Active comparator | Other: Enhanced Services As UsualTeaching staff access in-service training sessions hosted by study team and are provided with print materials from which the modules for the active intervention were created. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Are enrolled in school grades kindergarten through 5th
- Have an IEP educational classification of Autism, confirmed by the Autism Diagnostic Observation Schedule, Second Edition, and DSM-5 checklist
- No planned changes in school placement or core team members during the school year of participation
- Instructional personnel who currently support a participating child with ASD at school (e.g., teacher, instructional assistant, speech pathologist, occupational therapist)
- Letter from instructional personnel's district or school indicating agreement to take part in the research project
Key exclusion criteria (3 listed)
- Children subjects • Diagnosis of (1) genetic disorders such as Fragile X, Down syndrome, or tuberous sclerosis; 2) profound vision or hearing loss; or (3) motor disabilities such as cerebral palsy (these multiple disabilities would prevent standard implementation of the intervention protocol).
- Adult subjects
- Instructional personnel whose written consent was not obtained
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 |
|---|---|---|
| Students with Autism Accessing General EducationWith study team coach support, teacher implemented modules addressing student behavioral/academic goals. | Behavioural | Intervention |
| Enhanced Services As UsualTeaching staff access in-service presentations and print materials with no active study team coaching. | Other | Enhanced Services As Usual |
Primary outcome
Mean change in student function as measured by the Developmental Disability-Clinical Global Assessment Scale
Time frame: baseline to end of school year (approx. 9 months)
The Developmental Disability-Clinical Global Assessment Scale ranges from 1-100 with 100 indicating superior functioning. It assesses student function in a classroom setting.
7 secondary outcomes
Mean change in social communication and interaction as rated by child's teacher using the 30 item Social Skills Subscale of the Social Skills Improvement System
Time frame: baseline to end of school year (approx. 9 months)
Mean change in restricted and repetitive behavior as measured by the Children's Yale-Brown Obsessive-Compulsive Scales - PDD
Time frame: baseline to end of school year (approx. 9 months)
Change in teacher-nominated target behaviors
Time frame: baseline to end of school year (approx. 9 months)
Change in on-task behavior during instruction
Time frame: baseline to end of school year (approx. 9 months)
School-related adaptive functioning
Time frame: baseline to end of school year (approx. 9 months)
Social skills and behavior regulation
Time frame: baseline to end of school year (approx. 9 months)
Class placement
Time frame: baseline to end of school year (approx. 9 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- 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.
Tristram H Smith, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Students with Autism Accessing General Education and Enhanced Services As Usual in people with Autism Spectrum Disorder, run by University of Rochester at 1 site 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 7 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: finished, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in student function as measured by the Developmental Disability-Clinical Global Assessment Scale (time frame: baseline to end of school year (approx. 9 months)). 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 Nov 2018.