RCT of TeachTown in Autism Support Classrooms: Innovation and Exnovation

April 17, 2019 updated by: David Mandell, University of Pennsylvania
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TeachTown
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
Behavioral: TeachTown
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
Behavioral: Discrete Trial Training
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
Behavioral: Pivotal Response Training
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
Behavioral: Teaching in Functional Routines
Functional routines are sets of chained behaviors that students are taught that help them complete and manage specific activities in the classroom
Active Comparator: Control
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
Behavioral: Discrete Trial Training
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
Behavioral: Pivotal Response Training
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
Behavioral: Teaching in Functional Routines
Functional routines are sets of chained behaviors that students are taught that help them complete and manage specific activities in the classroom

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Differential Abilities Scale, 2nd Edition
Time Frame: 8 months
A nationally normed battery of cognitive and achievement tests.
8 months
Bracken School Readiness Assessment, 3rd Edition
Time Frame: 8 months
n individual cognitive test designed for children, pre-K through second grade
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
The School District of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MH106175 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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