NCT07042347 · University of Pennsylvania
Testing a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health
(Footsteps)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Behavioral economics strategies
Behavioral economics features designed to increase motivation to collect data and ease of data collection on the electronic platform.
DEVICE
Electronic platform
Electronic platform to collect data
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Philadelphia, Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations