App for Strengthening Services In Specialized Therapeutic Support

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05207956

Acronym

ASSISTS

Enrollment

Registered

2022-01-26

Start date

2021-09-09

Completion date

2022-06-21

Last updated

2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

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

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

After consenting to participate in the trial, participants will be randomized in pairs to one of the two study arms.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

* n/a

Design outcomes

Primary

Measure	Time frame	Description
The Difference in Data Collection Consistency Between Groups Across Three Weeks	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.
The Difference in Data Collection Completion Between Groups Across Three Weeks	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.
The Difference in Data Collection Timeliness Between Groups Across Three Weeks	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.

Secondary

Measure	Time frame	Description
Perceived Norms for Implementors	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.
Intentions for Implementors	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.
Self-Efficacy for Implementors	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.
Descriptive Norms for Implementors	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.
System Usability Scale	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.).
Attitudes for Implementors	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	14
Electronic Platform Not Enhanced A basic electronic platform for data collection. Electronic platform: Electronic platform to collect data	13
Total	27

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to follow up	1	2

Baseline characteristics

Characteristic	Enhanced Electronic Platform	Total	Electronic Platform Not Enhanced
Age, Continuous	35.5 Years STANDARD_DEVIATION 10.2	38.6 Years STANDARD_DEVIATION 12.4	41.6 Years STANDARD_DEVIATION 14.6
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	2 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants	25 Participants	12 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	6 Participants	12 Participants	6 Participants
Race (NIH/OMB) More than one race	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) White	5 Participants	12 Participants	7 Participants
Region of Enrollment United States	14 participants	27 participants	13 participants
Sex/Gender, Customized Female	7 Participants	17 Participants	10 Participants
Sex/Gender, Customized Male	6 Participants	9 Participants	3 Participants
Sex/Gender, Customized Non-binary/ third gender	0 Participants	0 Participants	0 Participants
Sex/Gender, Customized Prefer not to disclose	1 Participants	1 Participants	0 Participants
Work experience, Years	5.4 years STANDARD_DEVIATION 4.5	6.4 years STANDARD_DEVIATION 4.55	7.4 years STANDARD_DEVIATION 4.6

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 14	0 / 13
other Total, other adverse events	0 / 14	0 / 13
serious Total, serious adverse events	0 / 14	0 / 13

Outcome results

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.

Time frame: Three-week trial period

Population: 27 were enrolled (14 treatment, 13 control) and data was complete for 23

Arm	Measure	Value (MEAN)
Enhanced Electronic Platform	The Difference in Data Collection Completion Between Groups Across Three Weeks	.81 percentage of intervals
Electronic Platform Not Enhanced	The Difference in Data Collection Completion Between Groups Across Three Weeks	.98 percentage of intervals

Primary

The Difference in Data Collection Consistency Between Groups Across Three Weeks

Time frame: Three-week trial period

Population: 27 were enrolled (14 treatment, 13 control) and data complete for 23

Arm	Measure	Value (MEAN)
Enhanced Electronic Platform	The Difference in Data Collection Consistency Between Groups Across Three Weeks	.66 percentage of intervals
Electronic Platform Not Enhanced	The Difference in Data Collection Consistency Between Groups Across Three Weeks	.44 percentage of intervals

Primary

The Difference in Data Collection Timeliness Between Groups Across Three Weeks

Time frame: Three-week trial period

Population: 27 were enrolled (14 treatment, 13 control) and data was complete for 22

Arm	Measure	Value (MEAN)
Enhanced Electronic Platform	The Difference in Data Collection Timeliness Between Groups Across Three Weeks	4.69 percentage of intervals
Electronic Platform Not Enhanced	The Difference in Data Collection Timeliness Between Groups Across Three Weeks	71.87 percentage of intervals

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.