AutismFootstepsNCT07042347
Testing a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health
A study testing Behavioral economics strategies and Electronic platform in people with Autism and Challenging Behavior, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this clinical trial is to test whether a smartphone-based data collection and feedback application ("Footsteps") improves the quality of behavioral data collected by one-to-one aides and leads to better youth mental health outcomes in school-aged youth (ages 4-17) who receive one-to-one support in schools. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism, Challenging Behavior, ADHD
- What is being tested?
- Behavioral economics strategies and Electronic platform
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aides must be working with at least one client in school who meets the following criteria: 1) between 3-17 years, 2) has a diagnosis associated with a challenging behavior (e.g., autism spectrum disorder, attention deficit hyperactivity disorder, oppositional defiant disorder) as indicated on their treatment plan, and 3) receiving 1:1 aide support.
- Supervisors must be employed by a community behavior health agency and supervise a participating aide. The investigators will recruit supervisors in dyads and not triads (i.e., no supervisors with two [or more] aides) to ensure there are 30 supervisor-aide dyads in total).
Who cannot join
- Aides who participated in the pilot trial of the Footsteps will be excluded from participating to recruit a sample naïve to Footsteps and the control app.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
David Mandell, Sc.D. contact
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Heather J Nuske, PhD, 215-746-6041, heather.nuske@pennmedicine.upenn.edu
About this study
Official title: RCT of a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health
The goal of this clinical trial is to test whether a smartphone-based data collection and feedback application ("Footsteps") improves the quality of behavioral data collected by one-to-one aides and leads to better youth mental health outcomes in school-aged youth (ages 4-17) who receive one-to-one support in schools.
The main questions it aims to answer are:
Read more
- Does the Footsteps app improve aides' data collection quality (i.e., consistency, timeliness, and completeness)?
- Does Footsteps use lead to improved youth behavioral health outcomes (e.g., SDQ, YTP scores)?
- Does Footsteps improve communication and supervision processes between aides and clinical supervisors?
Researchers will compare aides using Footsteps to those using a "data collection only" control app to see if Footsteps leads to higher quality data collection, enhanced supervisory communication, and better youth outcomes.
Participants will:
- Use either Footsteps or a control app to record de-identified data on one client's behaviors and skills over 12 weeks
- Complete biweekly online surveys about data collection experiences, youth progress, and aide-supervisor communication
- Participate in a virtual intake and post-trial meeting
- (For a subset) Participate in a 30-45 minute qualitative interview about their experience using the app
- Conditions
- Autism, Challenging Behavior, ADHD, Oppositional Defiant Disorder
- Being tested
- Behavioral economics strategies, Electronic platform
- Keywords
- data collection, Behavioral Health Technician (BHT), behavioral economics, implementation science, supervisory processes
- Medical subject headings
- Autistic Disorder, Attention Deficit Disorder with Hyperactivity, Oppositional Defiant 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 platformDevice
Electronic platform to collect data
| Study group | Role | What they receive |
|---|---|---|
| Footsteps (Enhancements) | Experimental | An electronic platform for data collection ("Footsteps") that contains additional features designed to increase motivation to collect data and ease of data collection. Receives: Behavioral: Behavioral economics strategies; Device: Electronic platform |
| Data Collection Only App (No Enhancements) | Active comparator | A basic electronic platform for data collection. Receives: Device: Electronic platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strengths and Difficulties Questionnaire total score
A behavioral screening tool used to assess psychological attributes in children and adolescents, leading to a total score of 0 to 40. A higher total score indicates greater difficulties in emotional and behavioral functioning, while lower scores suggest fewer difficulties.
Measured: Assessed monthly (Baseline; Weeks 4, 8, and 12)
Data collection consistency
an aggregate of the numbers of intervals scheduled, and the numbers of those intervals in which data was entered (% real time data)
Measured: Assessed throughout 12-week trial
Data collection timeliness
for intervals in which data was entered, the time lag between occurrence and data entry
Measured: Assessed throughout 12-week trial
Secondary outcomes (2)
Data collection completeness
intervals classified as complete or incomplete according to whether the aide collected their planned metrics as required by their agency (% goals targeted)
Measured: Assessed throughout 12-week trial
Youth Top Problems
Top problems identified during intake meeting. Severity of each problem is rated from 0 (not a problem) to 4 (a very big problem). Severity ratings can be tracked for each problem individually or as an overall mean severity score created by averaging ratings from the same informant at the same measurement occasion
Measured: Assessed biweekly, at baseline through 12-week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start8 Apr 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies 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
- fully powered, randomized, hybrid type 2, pragmatic effectiveness-implementation mixed-methods trial
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Heather J Nuske, PhD, Principal investigator, University of PennsylvaniaDavid Mandell, Sc.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042347
- Sponsor's protocol ID
- 855228
- Other IDs
- R01MH136153
- Acronym
- Footsteps
- Status last verified
- May 2026
- First submitted
- 12 Jun 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nuske HJ, Buck J, Ramesh B, Becker-Haimes EM, Zentgraf K, Mandell DS. Making Progress Monitoring Easier and More Motivating: Developing a Client Data Collection App Incorporating User-Centered Design and Behavioral Economics Insights. Soc Sci (Basel). 2022 Mar;11(3):106. doi: 10.3390/socsci11030106. Epub 2022 Mar 3.
PubMed 35496358
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health
- ClinicalTrials.gov ID
- NCT07042347
- Acronym / sponsor ID
- Footsteps / 855228
- Conditions
- Autism, Challenging Behavior, ADHD, Oppositional Defiant Disorder
- Keywords
- data collection, Behavioral Health Technician (BHT), behavioral economics, implementation science, supervisory processes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test whether a smartphone-based data collection and feedback application ("Footsteps") improves the quality of behavioral data collected by one-to-one aides and leads to better youth mental health outcomes in school-aged youth (ages 4-17) who receive one-to-one support in schools.
The main questions it aims to answer are:
- Does the Footsteps app improve aides' data collection quality (i.e., consistency, timeliness, and completeness)?
- Does Footsteps use lead to improved youth behavioral health outcomes (e.g., SDQ, YTP scores)?
- Does Footsteps improve communication and supervision processes between aides and clinical supervisors?
Researchers will compare aides using Footsteps to those using a "data collection only" control app to see if Footsteps leads to higher quality data collection, enhanced supervisory communication, and better youth outcomes.
Participants will:
- Use either Footsteps or a control app to record de-identified data on one client's behaviors and skills over 12 weeks
- Complete biweekly online surveys about data collection experiences, youth progress, and aide-supervisor communication
- Participate in a virtual intake and post-trial meeting
- (For a subset) Participate in a 30-45 minute qualitative interview about their experience using the app
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- fully powered, randomized, hybrid type 2, pragmatic effectiveness-implementation mixed-methods trial
| Arm | Type | Receives |
|---|---|---|
| Footsteps (Enhancements) | Experimental | Behavioral: Behavioral economics strategies, Device: Electronic platformAn electronic platform for data collection ("Footsteps") that contains additional features designed to increase motivation to collect data and ease of data collection. |
| Data Collection Only App (No Enhancements) | Active comparator | Device: 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 (2 listed)
- Aides must be working with at least one client in school who meets the following criteria: 1) between 3-17 years, 2) has a diagnosis associated with a challenging behavior (e.g., autism spectrum disorder, attention deficit hyperactivity disorder, oppositional defiant disorder) as indicated on their treatment plan, and 3) receiving 1:1 aide support.
- Supervisors must be employed by a community behavior health agency and supervise a participating aide. The investigators will recruit supervisors in dyads and not triads (i.e., no supervisors with two [or more] aides) to ensure there are 30 supervisor-aide dyads in total).
Key exclusion criteria (1 listed)
- Aides who participated in the pilot trial of the Footsteps will be excluded from participating to recruit a sample naïve to Footsteps and the control app.
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 | Footsteps (Enhancements) |
| Electronic platformElectronic platform to collect data | Device | Data Collection Only App (No Enhancements), Footsteps (Enhancements) |
Primary outcome
Strengths and Difficulties Questionnaire total score
Time frame: Assessed monthly (Baseline; Weeks 4, 8, and 12)
A behavioral screening tool used to assess psychological attributes in children and adolescents, leading to a total score of 0 to 40. A higher total score indicates greater difficulties in emotional and behavioral functioning, while lower scores suggest fewer difficulties.
Data collection consistency
Time frame: Assessed throughout 12-week trial
an aggregate of the numbers of intervals scheduled, and the numbers of those intervals in which data was entered (% real time data)
Data collection timeliness
Time frame: Assessed throughout 12-week trial
for intervals in which data was entered, the time lag between occurrence and data entry
2 secondary outcomes
Data collection completeness
Time frame: Assessed throughout 12-week trial
Youth Top Problems
Time frame: Assessed biweekly, at baseline through 12-week trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 35496358Nuske HJ, Buck J, Ramesh B, Becker-Haimes EM, Zentgraf K, Mandell DS. Making Progress Monitoring Easier and More Motivating: Developing a Client Data Collection App Incorporating User-Centered Design and Behavioral Economics Insights. Soc Sci (Basel). 2022 Mar;11(3):106. doi: 10.3390/socsci11030106. Epub 2022 Mar 3.
- Website which describes the development of this application and available features.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
David Mandell, Sc.D. contact
Heather J Nuske, PhD principal investigator
University of Pennsylvania
David Mandell, Sc.D. principal investigator
University of Pennsylvania
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 and Challenging Behavior, 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 2 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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather J Nuske, PhD ((215) 746-6041, heather.nuske@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and Difficulties Questionnaire total score (time frame: Assessed monthly (Baseline; Weeks 4, 8, and 12)). 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?
On the ClinicalTrials.gov record for NCT07042347, which also lists 1 linked publication.
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 8 May 2026.