Autism Spectrum DisorderNCT03079765
Training Educators to Conduct Functional Behavior Assessment Via Telehealth
A study testing Behavioral skills training and Protocol Only in people with Autism Spectrum Disorder, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study evaluates the effects of delivering training services via telehealth to educators in rural schools. The investigators hope to increase the accuracy with which educators implement functional behavior assessments in schools. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Behavioral skills training and Protocol Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 31 May 2019
- 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
- Must be an educator who conducts functional behavior assessment.
- Must be training to become a registered behavior technician.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Training Educators to Implement Behavioral Assessment and Treatment Procedures in School Settings Via Telehealth
This study evaluates the effects of delivering training services via telehealth to educators in rural schools. The investigators hope to increase the accuracy with which educators implement functional behavior assessments in schools. During the study, participants will receive training on functional behavior assessments at different periods. When one school is receiving training, other schools will not be receiving training. The purpose will be to show increased accuracy of functional behavior assessments only occur following training.
Read the detailed description
Training services for educators typically occurs in-vivo with experts providing immediate feedback and modeling to shape behavior. These types of training experiences may not be accessible for all educators though. The current study will evaluate delivering behavioral skills training (e.g., feedback and error correction) via telehealth for educators conducting functional behavior assessments. The components of the functional behavior assessment that will be targeted are open-ended interviews, stimulus preference assessments, direct observations of problem behavior, and a functional communication training program. With at least three different schools, the investigators will introduce training delivered via telehealth one at a time to show that increases in acquisition of the various components of the functional behavior assessment only occur following telehealth-based training.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Behavioral skills training, Protocol Only
- Keywords
- Telehealth, Functional behavior assessment
- 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.
Behavioral skills trainingBehavioural
Participants will receive feedback and error correction on their implementation of the assessment procedures. Feedback will take the form of the experimenter pointing out components of the assessment that are not being conducted accurately and error correction will take the form of the experimenter reviewing the correct way to implement that component of the assessment.
Protocol OnlyBehavioural
Participants will be given a written protocol describing how to conduct the target assessment procedure.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | Experimental | Participants will be given a written protocol for conducting the relevant assessment procedure (e.g., open-ended interview). Receives: Behavioral: Protocol Only |
| Telehealth Treatment | Active comparator | Participants will receive feedback and error correction on their implementation of the relevant assessment procedure to improve their performance. Receives: Behavioral: Behavioral skills training; Behavioral: Protocol Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased functional behavior assessment procedural fidelity
Will measure percentage of components of each assessment correctly implemented.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start1 Jan 2017
- Primary completion31 May 2019
- Study completion31 May 2019
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 Colorado, DenverThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Romani, Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079765
- Sponsor's protocol ID
- 16-1691
- Status last verified
- Mar 2020
- First submitted
- 8 Mar 2017
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will only be disseminated via professional meetings and peer-reviewed publications. Data will be de-identified to maintain confidentiality of participants. Data will not be shared with anyone else.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Educators to Implement Behavioral Assessment and Treatment Procedures in School Settings Via Telehealth
- ClinicalTrials.gov ID
- NCT03079765
- Acronym / sponsor ID
- 16-1691
- Conditions
- Autism Spectrum Disorder
- Keywords
- Telehealth, Functional behavior assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 14 Mar 2017 (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.
This study evaluates the effects of delivering training services via telehealth to educators in rural schools. The investigators hope to increase the accuracy with which educators implement functional behavior assessments in schools. During the study, participants will receive training on functional behavior assessments at different periods. When one school is receiving training, other schools will not be receiving training. The purpose will be to show increased accuracy of functional behavior assessments only occur following training.
Detailed description
Training services for educators typically occurs in-vivo with experts providing immediate feedback and modeling to shape behavior. These types of training experiences may not be accessible for all educators though. The current study will evaluate delivering behavioral skills training (e.g., feedback and error correction) via telehealth for educators conducting functional behavior assessments. The components of the functional behavior assessment that will be targeted are open-ended interviews, stimulus preference assessments, direct observations of problem behavior, and a functional communication training program. With at least three different schools, the investigators will introduce training delivered via telehealth one at a time to show that increases in acquisition of the various components of the functional behavior assessment only occur following telehealth-based training.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline | Experimental | Behavioral: Protocol OnlyParticipants will be given a written protocol for conducting the relevant assessment procedure (e.g., open-ended interview). |
| Telehealth Treatment | Active comparator | Behavioral: Behavioral skills training, Behavioral: Protocol OnlyParticipants will receive feedback and error correction on their implementation of the relevant assessment procedure to improve their performance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must be an educator who conducts functional behavior assessment.
- Must be training to become a registered behavior technician.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Behavioral skills trainingParticipants will receive feedback and error correction on their implementation of the assessment procedures. Feedback will take the form of the experimenter pointing out components of the assessment that are not being conducted accurately and error correction will take the form of the experimenter reviewing the correct way to implement that component of the assessment. | Behavioural | Telehealth Treatment |
| Protocol OnlyParticipants will be given a written protocol describing how to conduct the target assessment procedure. | Behavioural | Baseline, Telehealth Treatment |
Primary outcome
Increased functional behavior assessment procedural fidelity
Time frame: 1 hour
Will measure percentage of components of each assessment correctly implemented.
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 3 Mar 2020.
- Individual participant dataSharing planned: No. Individual participant data will only be disseminated via professional meetings and peer-reviewed publications. Data will be de-identified to maintain confidentiality of participants. Data will not be shared with anyone else.
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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.
Patrick Romani, Ph.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral skills training and Protocol Only in people with Autism Spectrum Disorder, run by University of Colorado, Denver 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 2 inclusion and 0 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 3 Mar 2020. 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?
Increased functional behavior assessment procedural fidelity (time frame: 1 hour). 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 3 Mar 2020.