Recruiting

Footsteps

Sponsor:

University of Pennsylvania

Code:

NCT07042347

Conditions

Autism

Challenging Behavior

ADHD

Oppositional Defiant Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Behavioral economics strategies

Electronic platform

Study Details

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

Conditions

Autism

Challenging Behavior

ADHD

Oppositional Defiant Disorder

Study ID

NCT07042347

Start date

Apr 8, 2026

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

active comparator: Data Collection Only App (No Enhancements)

A basic electronic platform for data collection.

Interventions

Behavioral economics strategies

Behavioral economics features designed to increase motivation to collect data and ease of data collection on the electronic platform.

Electronic platform

Electronic platform to collect data

Primary outcome measure

  • Strengths and Difficulties Questionnaire total score [ Time Frame: Assessed monthly (Baseline; Weeks 4, 8, and 12) ]
  • Data collection consistency [ Time Frame: Assessed throughout 12-week trial ]
  • Data collection timeliness [ Time Frame: Assessed throughout 12-week trial ]

Central Contacts and Locations

Central contacts

Heather J Nuske, PhD

(215) 746-6041heather.nuske@pennmedicine.upenn.edu

David Mandell, Sc.D.

david.mandell@pennmedicine.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Heather J Nuske, PhD

215-746-6041heather.nuske@pennmedicine.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-05-08.