NCT05207956: ASSISTS

App for Strengthening Services In Specialized Therapeutic Support

Completed NA Results posted Last updated 7 March 2025

What this trial tests

NA trial testing Behavioral economics strategies in Autism Spectrum Disorder in 27 participants. Completed in 21 June 2022.

Timeline

9 September 2021

Primary endpoint
21 June 2022

21 June 2022

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	9 September 2021
Primary completion	21 June 2022
Estimated completion	21 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Behavioral economics strategies
• Electronic platform

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

University of Pennsylvania

Who can join

18 and older, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Difference in Data Collection Consistency Between Groups Across Three Weeks Primary · 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.

Group	Value	95% CI
Enhanced Electronic Platform	.66	.51 – .80
Electronic Platform Not Enhanced	.44	.19 – .70

The Difference in Data Collection Completion Between Groups Across Three Weeks Primary · 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.

Group	Value	95% CI
Enhanced Electronic Platform	.81	.67 – .96
Electronic Platform Not Enhanced	.98	.96 – 1.00

The Difference in Data Collection Timeliness Between Groups Across Three Weeks Primary · 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.

Group	Value	95% CI
Enhanced Electronic Platform	4.69	1.76 – 7.62
Electronic Platform Not Enhanced	71.87	-9.32 – 153.05

Intentions for Implementors Secondary · 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.

Group	Value	95% CI
Enhanced Electronic Platform	5.31	± 2.59
Electronic Platform Not Enhanced	5.91	± 2.07

System Usability Scale Secondary · 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.).

Group	Value	95% CI
Enhanced Electronic Platform	76.4	± 15.2
Electronic Platform Not Enhanced	67.7	± 21.5

Attitudes for Implementors Secondary · 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.

Group	Value	95% CI
Enhanced Electronic Platform	6.54	± 1.03
Electronic Platform Not Enhanced	6.68	± 0.73

Perceived Norms for Implementors Secondary · 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.

Group	Value	95% CI
Enhanced Electronic Platform	5.62	± 2.14
Electronic Platform Not Enhanced	6.18	± 1.83

Descriptive Norms for Implementors Secondary · 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.

Group	Value	95% CI
Enhanced Electronic Platform	6.08	± 1.60
Electronic Platform Not Enhanced	6.27	± 1.27

Self-Efficacy for Implementors Secondary · 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.

Group	Value	95% CI
Enhanced Electronic Platform	5.5	± 1.72
Electronic Platform Not Enhanced	4.91	± 2.50

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.