NCT07042347 Testing a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health
| NCT ID | NCT07042347 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Autism |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-04-08 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-04-08 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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: * 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.
Contact & Investigator
Heather J Nuske, PhD
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT07042347 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07042347 currently recruiting?
Yes, NCT07042347 is actively recruiting participants. Contact the research team at heather.nuske@pennmedicine.upenn.edu for enrollment information.
Where is the NCT07042347 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT07042347 clinical trial?
NCT07042347 is sponsored by University of Pennsylvania. The principal investigator is Heather J Nuske, PhD at University of Pennsylvania. The trial plans to enroll 200 participants.