CClinicalTrials.gg
CompletedNCT05207956ASSISTSUpdated Mar 7, 2025Results posted

App for Strengthening Services In Specialized Therapeutic Support

An interventional study of Behavioral economics strategies and Electronic platform in Autism Spectrum Disorder, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • Data collection
  • autism
  • Behavioral Health Technician (BHT)
  • behavioral economics
  • implementation
  • implementation strategy
  • implementation science
  • Therapeutic Support Staff (TSS)
03

In context

Autism Spectrum Disorder

1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.

This study's enrollment of 27 is below the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • n/a
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • 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: Behavioral economics strategies · Other: Electronic platform

  • Active comparator
    Electronic Platform Not Enhanced

    A basic electronic platform for data collection.

    Other: Electronic platform

Interventions

  • BehavioralBehavioral economics strategies

    Behavioral economics features designed to increase motivation to collect data and ease of data collection on the electronic platform.

  • OtherElectronic platform

    Electronic platform to collect data

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Three-week trial period

  2. 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.

    Time frame: Three-week trial period

  3. 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.

    Time frame: Three-week trial period

Secondary outcomes

  1. 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.

    Time frame: Assessed at baseline and end of 3-week trial period

  2. 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.).

    Time frame: Three-week trial period

  3. 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.

    Time frame: Assessed at baseline and end of 3-week trial period

  4. 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.

    Time frame: Assessed at baseline and end of 3-week trial period

  5. 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.

    Time frame: Assessed at baseline and end of 3-week trial period

  6. 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.

    Time frame: Assessed at baseline and end of 3-week trial period

07

Results

Posted Mar 7, 2025

Participant flow

Participant flow — Overall Study
MilestoneEnhanced Electronic PlatformElectronic Platform Not Enhanced
Started1413
Completed1311
Not completed12
Withdrew: Lost to follow up12

Outcome measures

PrimaryThe 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.

Time frame:
Three-week trial period
Reported as:
Mean · percentage of intervals
The Difference in Data Collection Consistency Between Groups Across Three Weeks
percentage of intervalsEnhanced Electronic PlatformElectronic Platform Not Enhanced
The Difference in Data Collection Consistency Between Groups Across Three Weeks.66 (.51 to .80).44 (.19 to .70)
PrimaryThe 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.

Time frame:
Three-week trial period
Reported as:
Mean · percentage of intervals
The Difference in Data Collection Completion Between Groups Across Three Weeks
percentage of intervalsEnhanced Electronic PlatformElectronic Platform Not Enhanced
The Difference in Data Collection Completion Between Groups Across Three Weeks.81 (.67 to .96).98 (.96 to 1.00)
PrimaryThe 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.

Time frame:
Three-week trial period
Reported as:
Mean · percentage of intervals
The Difference in Data Collection Timeliness Between Groups Across Three Weeks
percentage of intervalsEnhanced Electronic PlatformElectronic Platform Not Enhanced
The Difference in Data Collection Timeliness Between Groups Across Three Weeks4.69 (1.76 to 7.62)71.87 (-9.32 to 153.05)
SecondaryIntentions 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.

Time frame:
Assessed at baseline and end of 3-week trial period
Reported as:
Mean · score on a scale
Intentions for Implementors
score on a scaleEnhanced Electronic PlatformElectronic Platform Not Enhanced
Intentions for Implementors5.31 ± 2.595.91 ± 2.07
SecondarySystem 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.).

Time frame:
Three-week trial period
Reported as:
Mean · score on a scale
System Usability Scale
score on a scaleEnhanced Electronic PlatformElectronic Platform Not Enhanced
System Usability Scale76.4 ± 15.267.7 ± 21.5
SecondaryAttitudes 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.

Time frame:
Assessed at baseline and end of 3-week trial period
Reported as:
Mean · score on a scale
Attitudes for Implementors
score on a scaleEnhanced Electronic PlatformElectronic Platform Not Enhanced
Attitudes for Implementors6.54 ± 1.036.68 ± 0.73
SecondaryPerceived 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.

Time frame:
Assessed at baseline and end of 3-week trial period
Reported as:
Mean · score on a scale
Perceived Norms for Implementors
score on a scaleEnhanced Electronic PlatformElectronic Platform Not Enhanced
Perceived Norms for Implementors5.62 ± 2.146.18 ± 1.83
SecondaryDescriptive 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.

Time frame:
Assessed at baseline and end of 3-week trial period
Reported as:
Mean · score on a scale
Descriptive Norms for Implementors
score on a scaleEnhanced Electronic PlatformElectronic Platform Not Enhanced
Descriptive Norms for Implementors6.08 ± 1.606.27 ± 1.27
SecondarySelf-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.

Time frame:
Assessed at baseline and end of 3-week trial period
Reported as:
Mean · score on a scale
Self-Efficacy for Implementors
score on a scaleEnhanced Electronic PlatformElectronic Platform Not Enhanced
Self-Efficacy for Implementors5.5 ± 1.724.91 ± 2.50

Adverse events

Collected over Adverse event data was collected over the three week trial period for every participant.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Enhanced Electronic Platform0/14 (0%)0/14 (0%)0/14 (0%)
Electronic Platform Not Enhanced0/13 (0%)0/13 (0%)0/13 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Enhanced Electronic PlatformElectronic Platform Not EnhancedTotal
Mean35.5 ± 10.241.6 ± 14.638.6 ± 12.4
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Enhanced Electronic PlatformElectronic Platform Not EnhancedTotal
Male639
Female71017
Non-binary/ third gender000
Prefer not to disclose101
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Enhanced Electronic PlatformElectronic Platform Not EnhancedTotal
Hispanic or Latino112
Not Hispanic or Latino131225
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Enhanced Electronic PlatformElectronic Platform Not EnhancedTotal
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American6612
White5712
More than one race101
Unknown or Not Reported101
Region of Enrollment
Region of Enrollment(participants)Enhanced Electronic PlatformElectronic Platform Not EnhancedTotal
United States141327
Work experience, Years
Work experience, Years(years)Enhanced Electronic PlatformElectronic Platform Not EnhancedTotal
Mean5.4 ± 4.57.4 ± 4.66.4 ± 4.55
08

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 11, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05207956
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Jan 26, 2022
Start date
Sep 9, 2021
Primary completion
Jun 21, 2022
Completion
Jun 21, 2022
Results posted
Mar 7, 2025
Last update
Mar 7, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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