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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Electronic Platform | Experimental | A basic electronic platform for data collection that contains additional features designed to increase motivation to collect data and ease of data collection. |
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| Electronic Platform Not Enhanced | Active Comparator | A basic electronic platform for data collection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral economics strategies | Behavioral | Behavioral economics features designed to increase motivation to collect data and ease of data collection on the electronic platform. |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in Data Collection Consistency Between Groups Across Three Weeks | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intentions for Implementors | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 strategies: Behavioral economics features designed to increase motivation to collect data and ease of data collection on the electronic platform. Electronic platform: Electronic platform to collect data |
| FG001 | Electronic Platform Not Enhanced | A basic electronic platform for data collection. Electronic platform: Electronic platform to collect data |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 strategies: Behavioral economics features designed to increase motivation to collect data and ease of data collection on the electronic platform. Electronic platform: Electronic platform to collect data |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Difference in Data Collection Consistency Between Groups Across Three Weeks | 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. | 27 were enrolled (14 treatment, 13 control) and data complete for 23 | Posted | Mean | 95% Confidence Interval | percentage of intervals | Three-week trial period |
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Adverse event data was collected over the three week trial period for every participant.
The University of Pennsylvania IRB determined there was minimal risk to participate in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 strategies: Behavioral economics features designed to increase motivation to collect data and ease of data collection on the electronic platform. Electronic platform: Electronic platform to collect data |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Mandell | University of Pennsylvania | (215) 573 7494 | david.mandell@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2024 | Apr 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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After consenting to participate in the trial, participants will be randomized in pairs to one of the two study arms.
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| Electronic platform | Other | Electronic platform to collect data |
|
| Assessed at baseline and end of 3-week trial period |
| System Usability Scale | 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 | 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 | 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 | 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 | 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 |
| BG001 | Electronic Platform Not Enhanced | A basic electronic platform for data collection. Electronic platform: Electronic platform to collect data |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Work experience, Years | Mean | Standard Deviation | years |
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| OG001 | Electronic Platform Not Enhanced | A basic electronic platform for data collection. Electronic platform: Electronic platform to collect data |
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| Primary | The Difference in Data Collection Completion Between Groups Across Three Weeks | 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. | 27 were enrolled (14 treatment, 13 control) and data was complete for 23 | Posted | Mean | 95% Confidence Interval | percentage of intervals | Three-week trial period |
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| Primary | The Difference in Data Collection Timeliness Between Groups Across Three Weeks | 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. | 27 were enrolled (14 treatment, 13 control) and data was complete for 22 | Posted | Mean | 95% Confidence Interval | percentage of intervals | Three-week trial period |
|
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| Secondary | Intentions for Implementors | 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and end of 3-week trial period |
|
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|
| Secondary | System Usability Scale | 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.). | Posted | Mean | Standard Deviation | score on a scale | Three-week trial period |
|
|
|
| Secondary | Attitudes for Implementors | 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and end of 3-week trial period |
|
|
|
| Secondary | Perceived Norms for Implementors | 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and end of 3-week trial period |
|
|
|
| Secondary | Descriptive Norms for Implementors | 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and end of 3-week trial period |
|
|
|
| Secondary | Self-Efficacy for Implementors | 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and end of 3-week trial period |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Electronic Platform Not Enhanced | A basic electronic platform for data collection. Electronic platform: Electronic platform to collect data | 0 | 13 | 0 | 13 | 0 | 13 |
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