Autism Spectrum Disorder Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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).

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Heather J Nuske, PhD
heather.nuske@pennmedicine.upenn.edu
(215) 746-6041
Backup
David Mandell, Sc.D.
david.mandell@pennmedicine.upenn.edu
Time Frame
Start Date: 2026-04-08
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 200
Treatments
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.
Active_comparator: Data Collection Only App (No Enhancements)
A basic electronic platform for data collection.
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov