- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05207956
App for Strengthening Services In Specialized Therapeutic Support (ASSISTS)
March 4, 2025 updated by: University of Pennsylvania
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Enhanced Electronic Platform
A basic electronic platform for data collection that contains additional features designed to increase motivation to collect data and ease of data collection.
|
Behavioral economics features designed to increase motivation to collect data and ease of data collection on the electronic platform.
Electronic platform to collect data
|
|
Active Comparator: Electronic Platform Not Enhanced
A basic electronic platform for data collection.
|
Electronic platform to collect data
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Difference in Data Collection Consistency Between Groups Across Three Weeks
Time Frame: Three-week trial period
|
Consistency was the percentage of intervals in which aides entered data per session with children during each school day, across a three week period.
These metrics were captured via web analytics in partnership with our digital health company.
|
Three-week trial period
|
|
The Difference in Data Collection Completion Between Groups Across Three Weeks
Time Frame: Three-week trial period
|
Consistency was the percentage of intervals in which aides entered data per session with children during each school day, across a three week period.
These metrics were captured via web analytics in partnership with our digital health company.
|
Three-week trial period
|
|
The Difference in Data Collection Timeliness Between Groups Across Three Weeks
Time Frame: Three-week trial period
|
Consistency was the percentage of intervals in which aides entered data per session with children during each school day, across a three week period.
These metrics were captured via web analytics in partnership with our digital health company.
|
Three-week trial period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intentions for Implementors
Time Frame: Assessed at baseline and end of 3-week trial period
|
We adapted scales to measure mechanisms affecting data collection, including intentions, using social psychology methods (Armitage & Connor, 2001).
The intentions measure had one item, which was rated from 1=strongly disagree to 7=strongly agree.
Strongly agree meant stronger intentions to take data.
Aides completed measures at baseline and post-trial (3 weeks).
Data reported are changes over time.
|
Assessed at baseline and end of 3-week trial period
|
|
System Usability Scale
Time Frame: Three-week trial period
|
We used the System Usability Scale (SUS; Brooke, 1996) to measure aides' reactions to various statements regarding the app's usability with 10 items that use a 5-point scale from (1) strongly disagree to (5) strongly agree.
The SUS has high internal consistent reliability (Cronbach's alpha = .91)
and demonstrated sensitivity to change (Lewis, 2018).
We adapted the original questionnaire to replace "system" with "app" across all items.
The SUS is calculated as a proportion score out of 100, with higher scores indicating higher usability (≥85 = Excellent; ≥71 = Good; ≥51 = Okay (Bangor et al.).
|
Three-week trial period
|
|
Attitudes for Implementors
Time Frame: Assessed at baseline and end of 3-week trial period
|
We adapted scales to measure mechanisms affecting data collection, including attitudes, using social psychology methods (Armitage & Connor, 2001).
The attitudes measure had one item, which was rated from 1=good to 7=bad (meaning that taking data would be bad).
Attitudes had 2 items.
These items were averaged to create the scale score which could range from 1 to 7 for each measure.
Aides completed measures at baseline and post-trial (3 weeks).
Data reported are changes over time.
|
Assessed at baseline and end of 3-week trial period
|
|
Perceived Norms for Implementors
Time Frame: Assessed at baseline and end of 3-week trial period
|
We adapted scales to measure mechanisms affecting data collection, including perceived norms, using social psychology methods (Armitage & Connor, 2001).
The perceived norms measure had one item, which was rated from 1=strongly disagree to 7=strongly agree.
Strongly agree meant stronger influence of norms on taking data.
Aides completed measures at baseline and post-trial (3 weeks).
Data reported are changes over time.
|
Assessed at baseline and end of 3-week trial period
|
|
Descriptive Norms for Implementors
Time Frame: Assessed at baseline and end of 3-week trial period
|
We adapted scales to measure mechanisms affecting data collection, including descriptive norms, using social psychology methods (Armitage & Connor, 2001).
The perceived norms measure had one item, which was rated from 1=strongly disagree to 7=strongly agree.
Strongly agree meant stronger influence of norms on taking data.
Aides completed measures at baseline and post-trial (3 weeks).
Data reported are changes over time.
|
Assessed at baseline and end of 3-week trial period
|
|
Self-Efficacy for Implementors
Time Frame: Assessed at baseline and end of 3-week trial period
|
We adapted scales to measure mechanisms affecting data collection, including self-efficacy, using social psychology methods (Armitage & Connor, 2001).
The self-efficacy measure had one item, which was rated from 1=strongly disagree to 7=strongly agree.
Strongly agree meant stronger self-efficacy about taking data.
Self-Efficacy had 2 items.
These items were averaged to create the scale score which could range from 1 to 7 for each measure.
Aides completed measures at baseline and post-trial (3 weeks).
Data reported are changes over time.
|
Assessed at baseline and end of 3-week trial period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 9, 2021
Primary Completion (Actual)
June 21, 2022
Study Completion (Actual)
June 21, 2022
Study Registration Dates
First Submitted
November 24, 2021
First Submitted That Met QC Criteria
January 11, 2022
First Posted (Actual)
January 26, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 4, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 849995
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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