Trial Outcomes & Findings for App for Strengthening Services In Specialized Therapeutic Support (NCT NCT05207956)
NCT ID: NCT05207956
Last Updated: 2025-03-07
Results Overview
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.
COMPLETED
NA
27 participants
Three-week trial period
2025-03-07
Participant Flow
Participant milestones
| Measure |
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
|
Electronic Platform Not Enhanced
A basic electronic platform for data collection.
Electronic platform: Electronic platform to collect data
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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
|
Electronic Platform Not Enhanced
A basic electronic platform for data collection.
Electronic platform: Electronic platform to collect data
|
|---|---|---|
|
Overall Study
Lost to follow up
|
1
|
2
|
Baseline Characteristics
App for Strengthening Services In Specialized Therapeutic Support
Baseline characteristics by cohort
| Measure |
Enhanced Electronic Platform
n=14 Participants
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
|
Electronic Platform Not Enhanced
n=13 Participants
A basic electronic platform for data collection.
Electronic platform: Electronic platform to collect data
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.5 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
41.6 Years
STANDARD_DEVIATION 14.6 • n=7 Participants
|
38.6 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-binary/ third gender
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Prefer not to disclose
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Work experience, Years
|
5.4 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
7.4 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
6.4 years
STANDARD_DEVIATION 4.55 • n=5 Participants
|
PRIMARY outcome
Timeframe: Three-week trial periodPopulation: 27 were enrolled (14 treatment, 13 control) and data complete for 23
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.
Outcome measures
| Measure |
Enhanced Electronic Platform
n=13 Participants
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
|
Electronic Platform Not Enhanced
n=11 Participants
A basic electronic platform for data collection.
Electronic platform: Electronic platform to collect data
|
|---|---|---|
|
The Difference in Data Collection Consistency Between Groups Across Three Weeks
|
.66 percentage of intervals
Interval 0.51 to 0.8
|
.44 percentage of intervals
Interval 0.19 to 0.7
|
PRIMARY outcome
Timeframe: Three-week trial periodPopulation: 27 were enrolled (14 treatment, 13 control) and data was complete for 23
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.
Outcome measures
| Measure |
Enhanced Electronic Platform
n=13 Participants
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
|
Electronic Platform Not Enhanced
n=10 Participants
A basic electronic platform for data collection.
Electronic platform: Electronic platform to collect data
|
|---|---|---|
|
The Difference in Data Collection Completion Between Groups Across Three Weeks
|
.81 percentage of intervals
Interval 0.67 to 0.96
|
.98 percentage of intervals
Interval 0.96 to 1.0
|
PRIMARY outcome
Timeframe: Three-week trial periodPopulation: 27 were enrolled (14 treatment, 13 control) and data was complete for 22
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.
Outcome measures
| Measure |
Enhanced Electronic Platform
n=12 Participants
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
|
Electronic Platform Not Enhanced
n=10 Participants
A basic electronic platform for data collection.
Electronic platform: Electronic platform to collect data
|
|---|---|---|
|
The Difference in Data Collection Timeliness Between Groups Across Three Weeks
|
4.69 percentage of intervals
Interval 1.76 to 7.62
|
71.87 percentage of intervals
Interval -9.32 to 153.05
|
SECONDARY outcome
Timeframe: Assessed at baseline and end of 3-week trial periodWe 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.
Outcome measures
| Measure |
Enhanced Electronic Platform
n=13 Participants
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
|
Electronic Platform Not Enhanced
n=11 Participants
A basic electronic platform for data collection.
Electronic platform: Electronic platform to collect data
|
|---|---|---|
|
Intentions for Implementors
|
5.31 score on a scale
Standard Deviation 2.59
|
5.91 score on a scale
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: Three-week trial periodWe 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.).
Outcome measures
| Measure |
Enhanced Electronic Platform
n=13 Participants
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
|
Electronic Platform Not Enhanced
n=11 Participants
A basic electronic platform for data collection.
Electronic platform: Electronic platform to collect data
|
|---|---|---|
|
System Usability Scale
|
76.4 score on a scale
Standard Deviation 15.2
|
67.7 score on a scale
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: Assessed at baseline and end of 3-week trial periodWe 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.
Outcome measures
| Measure |
Enhanced Electronic Platform
n=13 Participants
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
|
Electronic Platform Not Enhanced
n=11 Participants
A basic electronic platform for data collection.
Electronic platform: Electronic platform to collect data
|
|---|---|---|
|
Attitudes for Implementors
|
6.54 score on a scale
Standard Deviation 1.03
|
6.68 score on a scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Assessed at baseline and end of 3-week trial periodWe 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.
Outcome measures
| Measure |
Enhanced Electronic Platform
n=13 Participants
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
|
Electronic Platform Not Enhanced
n=11 Participants
A basic electronic platform for data collection.
Electronic platform: Electronic platform to collect data
|
|---|---|---|
|
Perceived Norms for Implementors
|
5.62 score on a scale
Standard Deviation 2.14
|
6.18 score on a scale
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: Assessed at baseline and end of 3-week trial periodWe 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.
Outcome measures
| Measure |
Enhanced Electronic Platform
n=13 Participants
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
|
Electronic Platform Not Enhanced
n=11 Participants
A basic electronic platform for data collection.
Electronic platform: Electronic platform to collect data
|
|---|---|---|
|
Descriptive Norms for Implementors
|
6.08 score on a scale
Standard Deviation 1.60
|
6.27 score on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Assessed at baseline and end of 3-week trial periodWe 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.
Outcome measures
| Measure |
Enhanced Electronic Platform
n=13 Participants
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
|
Electronic Platform Not Enhanced
n=11 Participants
A basic electronic platform for data collection.
Electronic platform: Electronic platform to collect data
|
|---|---|---|
|
Self-Efficacy for Implementors
|
5.5 score on a scale
Standard Deviation 1.72
|
4.91 score on a scale
Standard Deviation 2.50
|
Adverse Events
Enhanced Electronic Platform
Electronic Platform Not Enhanced
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place