Autism Spectrum DisorderASSISTSNCT05207956
App for Strengthening Services In Specialized Therapeutic Support
A study testing Behavioral economics strategies and Electronic platform in people with Autism Spectrum Disorder, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Behavioral economics strategies and Electronic platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2021to 21 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Behavioral economics strategies, Electronic platform
- Keywords
- Data collection, autism, Behavioral Health Technician (BHT), behavioral economics, implementation, implementation strategy, implementation science, Therapeutic Support Staff (TSS)
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral economics strategiesBehavioural
Behavioral economics features designed to increase motivation to collect data and ease of data collection on the electronic platform.
Electronic platformOther
Electronic platform to collect data
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral economics strategies; Other: Electronic platform |
| Electronic Platform Not Enhanced | Active comparator | A basic electronic platform for data collection. Receives: Other: Electronic platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Three-week trial period
Secondary outcomes (6)
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.
Measured: 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.).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at baseline and end of 3-week trial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start9 Sep 2021
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After consenting to participate in the trial, participants will be randomized in pairs to one of the two study arms.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207956
- Sponsor's protocol ID
- 849995
- Acronym
- ASSISTS
- Status last verified
- Mar 2025
- First submitted
- 24 Nov 2021
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App for Strengthening Services In Specialized Therapeutic Support
- ClinicalTrials.gov ID
- NCT05207956
- Acronym / sponsor ID
- ASSISTS / 849995
- Conditions
- Autism Spectrum Disorder
- Keywords
- Data collection, autism, Behavioral Health Technician (BHT), behavioral economics, implementation, implementation strategy, implementation science, Therapeutic Support Staff (TSS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After consenting to participate in the trial, participants will be randomized in pairs to one of the two study arms.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Electronic Platform | Experimental | Behavioral: Behavioral economics strategies, Other: Electronic platformA basic electronic platform for data collection that contains additional features designed to increase motivation to collect data and ease of data collection. |
| Electronic Platform Not Enhanced | Active comparator | Other: Electronic platformA basic electronic platform for data collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral economics strategiesBehavioral economics features designed to increase motivation to collect data and ease of data collection on the electronic platform. | Behavioural | Enhanced Electronic Platform |
| Electronic platformElectronic platform to collect data | Other | Electronic Platform Not Enhanced, Enhanced Electronic Platform |
Primary outcome
The Difference in Data Collection Consistency Between Groups Across Three Weeks
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
Intentions for Implementors
Time frame: Assessed at baseline and end of 3-week trial period
System Usability Scale
Time frame: Three-week trial period
Attitudes for Implementors
Time frame: Assessed at baseline and end of 3-week trial period
Perceived Norms for Implementors
Time frame: Assessed at baseline and end of 3-week trial period
Descriptive Norms for Implementors
Time frame: Assessed at baseline and end of 3-week trial period
Self-Efficacy for Implementors
Time frame: Assessed at baseline and end of 3-week trial period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral economics strategies and Electronic platform in people with Autism Spectrum Disorder, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Difference in Data Collection Consistency Between Groups Across Three Weeks (time frame: Three-week trial period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.