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RecruitingNCT07042347FootstepsUpdated May 8, 2026

Testing a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health

An interventional study of Behavioral economics strategies and Electronic platform in Autism, Challenging Behavior and ADHD, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-08.

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

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

The main questions it aims to answer are:

  1. Does the Footsteps app improve aides' data collection quality (i.e., consistency, timeliness, and completeness)?
  2. Does Footsteps use lead to improved youth behavioral health outcomes (e.g., SDQ, YTP scores)?
  3. 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
02

Conditions studied

  • Autism
  • Challenging Behavior
  • ADHD
  • Oppositional Defiant Disorder

Keywords

  • data collection
  • Behavioral Health Technician (BHT)
  • behavioral economics
  • implementation science
  • supervisory processes
03

In context

Autistic Disorder

1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.

This study's planned enrollment of 200 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

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

Study arms

  • Experimental
    Footsteps (Enhancements)

    An electronic platform for data collection ("Footsteps") that contains additional features designed to increase motivation to collect data and ease of data collection.

    Behavioral: Behavioral economics strategies · Device: Electronic platform

  • Active comparator
    Data Collection Only App (No Enhancements)

    A basic electronic platform for data collection.

    Device: 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.

  • DeviceElectronic platform

    Electronic platform to collect data

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Assessed monthly (Baseline; Weeks 4, 8, and 12)

  2. 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)

    Time frame: Assessed throughout 12-week trial

  3. Data collection timeliness

    for intervals in which data was entered, the time lag between occurrence and data entry

    Time frame: Assessed throughout 12-week trial

Secondary outcomes

  1. 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)

    Time frame: Assessed throughout 12-week trial

  2. 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

    Time frame: Assessed biweekly, at baseline through 12-week trial

Other outcomes

  1. Intentions for Implementors

    The investigators 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 biweekly, at baseline through 12-week trial

  2. Attitudes for Implementors

    The investigators 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 biweekly, at baseline and through 12-week trial

  3. Perceived Norms for Implementors

    The investigators 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 biweekly, at baseline through 12-week trial

  4. Descriptive Norms for Implementors

    The investigators 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 biweekly, at baseline through 12-week trial

  5. Self-Efficacy for Implementors

    The investigators 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 biweekly, at baseline through 12-week trial

  6. System Usability Scale

    The investigators 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). The investigators 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: Assessed at post-trial (Week 12)

  7. Supervisor <> Aide Communication

    The investigators will compare the groups on combined frequency and content of the communications by using a three-level ordinal response for each period (0=no communication, 1=communication, with discussion of client, 2=communication, discussion of client, and discussion of treatment strategy changes).

    Time frame: Assessed biweekly, at baseline through 12-week trial

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07042347
Responsible party
Sponsor
First posted
Jun 29, 2025
Start date
Apr 8, 2026
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
May 8, 2026

Study contacts

Heather J Nuske, PhD
Contact
heather.nuske@pennmedicine.upenn.edu
(215) 746-6041
David Mandell, Sc.D.
Contact
david.mandell@pennmedicine.upenn.edu
Heather J Nuske, PhD
principal investigator · University of Pennsylvania
David Mandell, Sc.D.
principal investigator · University of Pennsylvania

Oversight

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

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