Autism Spectrum DisorderNCT02695693
RCT of TeachTown in Autism Support Classrooms: Innovation and Exnovation
A study testing TeachTown, Discrete Trial Training and Pivotal Response Training in people with Autism Spectrum Disorder, run by University of Pennsylvania.
Trial summary
Computer assisted interventions are becoming very popular as an intervention strategy for students with autism. There is little data on how effective they are or how their implementation affects teachers' use of other evidence-based practices. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- TeachTown, Discrete Trial Training and Pivotal Response Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to 15 Jun 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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- educational classification of autism, receiving services in a kindergarten-through-second-grade autism support classroom in the School District of Philadelphia, with a teacher who has agreed to participate in the study, and parents speak English or Spanish
Who cannot join
- none
About this study
Computer assisted interventions are becoming very popular as an intervention strategy for students with autism. There is little data on how effective they are or how their implementation affects teachers' use of other evidence-based practices. The proposed study would be the first to examine these questions in a community setting.
Read the detailed description
This study comprises a randomized controlled trial to examine 1) the effectiveness of TeachTown: Basics, one of the only evidence-based computer-assisted intervention (CAI) packages for students with autism; 2) the extent to which teachers implement TeachTown the way it was designed; 3) the effects of its use on other evidence-based practices; and 4) organizational and teacher variables that mediate changes in the use of evidence-based practices when TeachTown is introduced. While there has been a rush to take advantage of CAI, there is little research on whether it will result in better outcomes for student with autism, and be feasible or sustainable in community settings. While CAI has the potential to increase instructional time for students with autism, it may result instead in teachers reducing their use of other evidence-based practices, including the amount of interpersonal (as opposed to computer) instruction students receive. While the related constructs of exnovation, de-implementation and de-adoption have been used to describe this phenomenon for more than 30 years, they rarely have been systematically studied. The proposed study takes advantage of an ongoing rollout of TeachTown in the School District of Philadelphia. TeachTown includes a computerized instruction component, combined with offline, interpersonal instruction between the student and teacher. It is not known whether public schools have the resources to implement programs like this, regardless of their efficacy, or whether or how teachers will incorporate them into the instructional day. An especially important question is whether existing evidence-based practices are exnovated as TeachTown is implemented. To address these questions, we rely on our longstanding collaboration with the School District of Philadelphia, the 8th largest school district in the US. At the beginning of the school year, we will inventory relevant technology and observe how it is used in the District's 83 kindergarten-through-second-grade autism support classrooms. We also will survey teachers and school administrators about expectations, support and rewards for using these technologies and attitudes, norms and self-efficacy regarding the use of these technologies. We then will use a waitlist-control randomized design to examine TeachTown's effects on student outcomes and use of other practices. We will unpack the impact of the implementation of TeachTown on existing evidence-based practices using direct observation and through qualitative interviews. The waitlist design allows the district to roll out the intervention to all classrooms, which is their intent. It also allows s to increase our sample to study moderators of sustainment of existing EBPs when a new technology is introduced. The proposed study would be one of the first to examine longitudinally the uptake of new technology for children with ASD in school settings, and the first to address use of CAI. Successful completion of this study will identify malleable targets for intervention to increase the use of CAI, should that appear warranted, while sustaining existing EBPs for children with autism in community settings.
- Conditions
- Autism Spectrum Disorder
- Being tested
- TeachTown, Discrete Trial Training, Pivotal Response Training, Teaching in Functional Routines
- 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.
TeachTownBehavioural
TeachTown is an online program for students with autism that uses an applied behavior analysis framework to provide intervention in academic and pre-academic areas
Discrete Trial TrainingBehavioural
Discrete trial training is a one-on-one didactic behavioral intervention in which the teacher or therapist uses specific behavioral methods based on principles of operant conditioning, to help students gain skills
Pivotal Response TrainingBehavioural
Pivotal response training is a one-on-one child-lead behavioral intervention in which the teacher or therapist uses specific behavioral methods, leveraging the students interests, to help students gain skills
Teaching in Functional RoutinesBehavioural
Functional routines are sets of chained behaviors that students are taught that help them complete and manage specific activities in the classroom
| Study group | Role | What they receive |
|---|---|---|
| TeachTown | Experimental | Students in kindergarten-through-second-grade autism support classrooms in this arm receive access to TeachTown, an online academic and pre-academic intervention designed for students with autism. Their teachers also receive coaching in the use of TeachTown, as well as coaching in other evidence-based practices for students with autism, including discrete trial training, pivotal response training, and teaching in functional routines Receives: Behavioral: TeachTown; Behavioral: Discrete Trial Training; Behavioral: Pivotal Response Training; Behavioral: Teaching in Functional Routines |
| Control | Active comparator | Teachers in kindergarten-through-second-grade autism support classrooms in this arm receive coaching in evidence-based practices for students with autism, including discrete trial training, pivotal response training, and teaching in functional routines Receives: Behavioral: Discrete Trial Training; Behavioral: Pivotal Response Training; Behavioral: Teaching in Functional Routines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential Abilities Scale, 2nd Edition
A nationally normed battery of cognitive and achievement tests.
Measured: 8 months
Bracken School Readiness Assessment, 3rd Edition
n individual cognitive test designed for children, pre-K through second grade
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2017
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The School District of Philadelphia
- Responsible party
- Principal investigator, David Mandell, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695693
- Sponsor's protocol ID
- R01MH106175
- Other IDs
- R01MH106175
- Status last verified
- Apr 2019
- First submitted
- 24 Feb 2016
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Pellecchia M, Marcus SC, Spaulding C, Seidman M, Xie M, Rump K, Reisinger EM, Mandell DS. Randomized Trial of a Computer-Assisted Intervention for Children With Autism in Schools. J Am Acad Child Adolesc Psychiatry. 2020 Mar;59(3):373-380. doi: 10.1016/j.jaac.2019.03.029. Epub 2019 Apr 3.
PubMed 30953731Pellecchia M, Beidas RS, Marcus SC, Fishman J, Kimberly JR, Cannuscio CC, Reisinger EM, Rump K, Mandell DS. Study protocol: implementation of a computer-assisted intervention for autism in schools: a hybrid type II cluster randomized effectiveness-implementation trial. Implement Sci. 2016 Nov 25;11(1):154. doi: 10.1186/s13012-016-0513-4.
PubMed 27884169
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of TeachTown in Autism Support Classrooms: Innovation and Exnovation
- ClinicalTrials.gov ID
- NCT02695693
- Acronym / sponsor ID
- R01MH106175
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The School District of Philadelphia
- Study start
- Apr 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 1 Mar 2016 (estimated)
- 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.
Computer assisted interventions are becoming very popular as an intervention strategy for students with autism. There is little data on how effective they are or how their implementation affects teachers' use of other evidence-based practices. The proposed study would be the first to examine these questions in a community setting.
Detailed description
This study comprises a randomized controlled trial to examine 1) the effectiveness of TeachTown: Basics, one of the only evidence-based computer-assisted intervention (CAI) packages for students with autism; 2) the extent to which teachers implement TeachTown the way it was designed; 3) the effects of its use on other evidence-based practices; and 4) organizational and teacher variables that mediate changes in the use of evidence-based practices when TeachTown is introduced. While there has been a rush to take advantage of CAI, there is little research on whether it will result in better outcomes for student with autism, and be feasible or sustainable in community settings. While CAI has the potential to increase instructional time for students with autism, it may result instead in teachers reducing their use of other evidence-based practices, including the amount of interpersonal (as opposed to computer) instruction students receive. While the related constructs of exnovation, de-implementation and de-adoption have been used to describe this phenomenon for more than 30 years, they rarely have been systematically studied. The proposed study takes advantage of an ongoing rollout of TeachTown in the School District of Philadelphia. TeachTown includes a computerized instruction component, combined with offline, interpersonal instruction between the student and teacher. It is not known whether public schools have the resources to implement programs like this, regardless of their efficacy, or whether or how teachers will incorporate them into the instructional day. An especially important question is whether existing evidence-based practices are exnovated as TeachTown is implemented. To address these questions, we rely on our longstanding collaboration with the School District of Philadelphia, the 8th largest school district in the US. At the beginning of the school year, we will inventory relevant technology and observe how it is used in the District's 83 kindergarten-through-second-grade autism support classrooms. We also will survey teachers and school administrators about expectations, support and rewards for using these technologies and attitudes, norms and self-efficacy regarding the use of these technologies. We then will use a waitlist-control randomized design to examine TeachTown's effects on student outcomes and use of other practices. We will unpack the impact of the implementation of TeachTown on existing evidence-based practices using direct observation and through qualitative interviews. The waitlist design allows the district to roll out the intervention to all classrooms, which is their intent. It also allows s to increase our sample to study moderators of sustainment of existing EBPs when a new technology is introduced. The proposed study would be one of the first to examine longitudinally the uptake of new technology for children with ASD in school settings, and the first to address use of CAI. Successful completion of this study will identify malleable targets for intervention to increase the use of CAI, should that appear warranted, while sustaining existing EBPs for children with autism in community settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TeachTown | Experimental | Behavioral: TeachTown, Behavioral: Discrete Trial Training, Behavioral: Pivotal Response Training, Behavioral: Teaching in Functional RoutinesStudents in kindergarten-through-second-grade autism support classrooms in this arm receive access to TeachTown, an online academic and pre-academic intervention designed for students with autism. Their teachers also receive coaching in the use of TeachTown, as well as coaching in other evidence-based practices for students with autism, including discrete trial training, pivotal response training, and teaching in functional routines |
| Control | Active comparator | Behavioral: Discrete Trial Training, Behavioral: Pivotal Response Training, Behavioral: Teaching in Functional RoutinesTeachers in kindergarten-through-second-grade autism support classrooms in this arm receive coaching in evidence-based practices for students with autism, including discrete trial training, pivotal response training, and teaching in functional routines |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- educational classification of autism, receiving services in a kindergarten-through-second-grade autism support classroom in the School District of Philadelphia, with a teacher who has agreed to participate in the study, and parents speak English or Spanish
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| TeachTownTeachTown is an online program for students with autism that uses an applied behavior analysis framework to provide intervention in academic and pre-academic areas | Behavioural | TeachTown |
| Discrete Trial TrainingDiscrete trial training is a one-on-one didactic behavioral intervention in which the teacher or therapist uses specific behavioral methods based on principles of operant conditioning, to help students gain skills | Behavioural | Control, TeachTown |
| Pivotal Response TrainingPivotal response training is a one-on-one child-lead behavioral intervention in which the teacher or therapist uses specific behavioral methods, leveraging the students interests, to help students gain skills | Behavioural | Control, TeachTown |
| Teaching in Functional RoutinesFunctional routines are sets of chained behaviors that students are taught that help them complete and manage specific activities in the classroom | Behavioural | Control, TeachTown |
Primary outcome
Differential Abilities Scale, 2nd Edition
Time frame: 8 months
A nationally normed battery of cognitive and achievement tests.
Bracken School Readiness Assessment, 3rd Edition
Time frame: 8 months
n individual cognitive test designed for children, pre-K through second grade
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 18 Apr 2019.
- Derived from this study: PubMed 30953731Pellecchia M, Marcus SC, Spaulding C, Seidman M, Xie M, Rump K, Reisinger EM, Mandell DS. Randomized Trial of a Computer-Assisted Intervention for Children With Autism in Schools. J Am Acad Child Adolesc Psychiatry. 2020 Mar;59(3):373-380. doi: 10.1016/j.jaac.2019.03.029. Epub 2019 Apr 3.
- Derived from this study: PubMed 27884169Pellecchia M, Beidas RS, Marcus SC, Fishman J, Kimberly JR, Cannuscio CC, Reisinger EM, Rump K, Mandell DS. Study protocol: implementation of a computer-assisted intervention for autism in schools: a hybrid type II cluster randomized effectiveness-implementation trial. Implement Sci. 2016 Nov 25;11(1):154. doi: 10.1186/s13012-016-0513-4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TeachTown, Discrete Trial Training and Pivotal Response Training in people with Autism Spectrum Disorder, run by University of Pennsylvania.
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 1 inclusion and 1 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 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Differential Abilities Scale, 2nd Edition (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02695693, which also lists 2 linked publications.
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 18 Apr 2019.