App for Strengthening Services In Specialized Therapeutic Support (ASSISTS)
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral economics strategies
Electronic platform
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Data collection, autism, Behavioral Health Technician (BHT), behavioral economics, implementation, implementation strategy, implementation science, Therapeutic Support Staff (TSS)
Eligibility Criteria
Inclusion Criteria:
- Participants must be working as a paraprofessionals or behavioral health technicians
- Currently providing individual support to children with autism
- Currently providing services in Philadelphia preschools, schools, day cares, or homes.
Exclusion Criteria:
- n/a
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Enhanced Electronic Platform
Electronic Platform Not Enhanced
Arm Description
A basic electronic platform for data collection that contains additional features designed to increase motivation to collect data and ease of data collection.
A basic electronic platform for data collection.
Outcomes
Primary Outcome Measures
The average difference in hourly data collection between groups across three weeks
Measure of frequency paraprofessionals collect hourly interval data with children during each school day, across a three week period.
Secondary Outcome Measures
Theory of Planned Behavior Questionnaire
Theory of Planned Behavior Questionnaire: A measure of participant's intentions to collect data as measured on a 7-point Likert scale from "strongly disagree" to "strongly agree". The questionnaire is 7 questions and measures intentions, attitude, perceived norms, and self-efficacy. There is no better or worse outcome measured by the scale, only intentions to implement the intervention.
System Usability Scale
System Usability Scale: A validated measure of the usability and satisfaction with a specific technology. Measured by answering 10 questions on a 5-point Likert scale from "strongly disagree" to "strongly agree". There is no better or worse outcome measured by the scale, only intentions to implement the intervention.
Full Information
NCT ID
NCT05207956
First Posted
November 24, 2021
Last Updated
July 27, 2022
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT05207956
Brief Title
App for Strengthening Services In Specialized Therapeutic Support
Acronym
ASSISTS
Official Title
App for Strengthening Services In Specialized Therapeutic Support
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
June 21, 2022 (Actual)
Study Completion Date
June 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In partnership with a digital health software company, the University research team created two versions of a mobile application to help behavioral health technicians (BHT's) who work with students with autism collect data. The first version comprises a basic electronic platform for data collection. The second version has the same basic electronic platform for data collection, plus additional features designed to increase motivation to collect data and ease the burden of data collection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Data collection, autism, Behavioral Health Technician (BHT), behavioral economics, implementation, implementation strategy, implementation science, Therapeutic Support Staff (TSS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After consenting to participate in the trial, participants will be randomized in pairs to one of the two study arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced Electronic Platform
Arm Type
Experimental
Arm Description
A basic electronic platform for data collection that contains additional features designed to increase motivation to collect data and ease of data collection.
Arm Title
Electronic Platform Not Enhanced
Arm Type
Active Comparator
Arm Description
A basic electronic platform for data collection.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral economics strategies
Intervention Description
Behavioral economics features designed to increase motivation to collect data and ease of data collection on the electronic platform.
Intervention Type
Other
Intervention Name(s)
Electronic platform
Intervention Description
Electronic platform to collect data
Primary Outcome Measure Information:
Title
The average difference in hourly data collection between groups across three weeks
Description
Measure of frequency paraprofessionals collect hourly interval data with children during each school day, across a three week period.
Time Frame
Three-week trial period
Secondary Outcome Measure Information:
Title
Theory of Planned Behavior Questionnaire
Description
Theory of Planned Behavior Questionnaire: A measure of participant's intentions to collect data as measured on a 7-point Likert scale from "strongly disagree" to "strongly agree". The questionnaire is 7 questions and measures intentions, attitude, perceived norms, and self-efficacy. There is no better or worse outcome measured by the scale, only intentions to implement the intervention.
Time Frame
Assessed at baseline and 3 weeks after enrollment
Title
System Usability Scale
Description
System Usability Scale: A validated measure of the usability and satisfaction with a specific technology. Measured by answering 10 questions on a 5-point Likert scale from "strongly disagree" to "strongly agree". There is no better or worse outcome measured by the scale, only intentions to implement the intervention.
Time Frame
Assessed at baseline and 3 weeks after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants must be working as a paraprofessionals or behavioral health technicians
Currently providing individual support to children with autism
Currently providing services in Philadelphia preschools, schools, day cares, or homes.
Exclusion Criteria:
n/a
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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App for Strengthening Services In Specialized Therapeutic Support
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