Measurement Feedback App for Autism Spectrum Disorder

(Footsteps Trial)

Overseen By Heather J Nuske, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Pilot trial participants

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app called Footsteps to determine if it helps aides collect better behavioral data and improve mental health outcomes for school-aged children with challenging behaviors, such as autism. The study compares Footsteps to a basic app to assess which one more effectively improves data quality and communication between aides and their supervisors. Aides working for behavioral health agencies in the Philadelphia area who support children aged 4-17 with conditions like autism are well-suited for this trial. Participants will use one of the apps for 12 weeks and share their experiences through online surveys and interviews. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance support for children with challenging behaviors.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems focused on using an app for data collection, so it's unlikely that medication changes are required.

What prior data suggests that the Footsteps app is safe for use in schools?

Research has shown that people generally have a good experience using the Footsteps app. In an earlier study, 90% of users found the app easy to use, rating it as good or excellent. No major problems have been reported from using the app. The app aids users by sending reminders and feedback to ensure accurate and timely data collection, enhancing the user experience. Although the study did not specifically examine safety, the positive feedback and absence of negative reports suggest that the app is safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Footsteps app for Autism Spectrum Disorder because it introduces new features that make data collection more engaging and user-friendly. Unlike standard treatments that typically involve in-person evaluations or basic data collection tools, Footsteps offers enhancements designed to boost motivation and simplify the process. By integrating these features, the app aims to improve the quality and consistency of data collected from users, potentially leading to more accurate insights and better personalized care for individuals with autism.

What evidence suggests that the Footsteps app is effective for improving behavioral data collection and youth mental health outcomes?

Research shows that the Footsteps app might improve data collection and support the mental health of children with autism. In this trial, participants will use either the basic Data Collection Only App or the enhanced Footsteps app. The enhanced Footsteps app assists aides in gathering information on their devices and provides reminders and feedback to ensure timely and accurate data collection. Consistent and high-quality data collection is crucial for understanding and tracking a child's progress. While direct evidence on Footsteps' effectiveness is still being gathered, the app aims to simplify and motivate data collection, which is key to improving mental health outcomes. ^{1 2 6 7 8}

Who Is on the Research Team?

Heather J Nuske, PhD

Principal Investigator

University of Pennsylvania

David Mandell, Sc.D.

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for school-aged youth (4-17 years) with behavioral challenges such as Autism, ADHD, ODD, or ASD who receive one-to-one support in schools. Aides and clinical supervisors involved in their care are also participants. The study excludes details on specific inclusion and exclusion criteria.

Inclusion Criteria

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.

I work for a community health agency in Philadelphia or nearby, with a client in school who has challenging behavior.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants use either the Footsteps app or a control app to record data on one client's behaviors and skills

12 weeks

Biweekly online surveys

Follow-up

Participants are monitored for data collection quality and youth behavioral health outcomes

4 weeks

1 post-trial meeting (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Footsteps

Trial Overview The 'Footsteps' smartphone app is being tested against a control app to see if it improves data collection quality by aides, enhances communication with supervisors, and leads to better mental health outcomes for the youth over a 12-week period.

How Is the Trial Designed?

Group I: Footsteps (Enhancements) Experimental Treatment 2 Interventions

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

Group II: Data Collection Only App (No Enhancements) Active Control 1 Intervention

A basic electronic platform for data collection.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07042347

Testing a Measurement Feedback App to Improve Data ... The goal of this clinical trial is to test whether a smartphone-based data collection and feedback application ("Footsteps") improves the quality of behavioral ...

2. digitalmentalhealth.org digitalmentalhealth.org/footsteps

Footsteps App The app allows aides to collect data on their phone or tablet and provides reminders and feedback to increase accurate and timely progress monitoring. While ...

3. withpower.com withpower.com/trial/phase-challenging-behavior-7-2025-02bef

Measurement Feedback App for Autism Spectrum Disorder ... The goal of this clinical trial is to test whether a smartphone-based data collection and feedback application ("Footsteps") improves the quality of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8043993/

Prediction in Autism Spectrum Disorder: A Systematic Review ... We review results from 47 studies. These studies suggest that ASD may be associated with differences in the learning of predictive pairings.

5. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-6-2023-8be7b

Online Work Chat Program for Autism · Info for Participants The study involved 40 children aged 9 to 15 with autism spectrum disorder, comparing a communication app to the Picture Exchange Communication System (PECS) for ...

6. mdpi.com mdpi.com/2076-0760/11/3/106

Making Progress Monitoring Easier and More Motivating Of the participants that tested the app, 90% rated usability as good or excellent. Results support continuing to develop Footsteps and testing its impact in a ...

7. researchgate.net researchgate.net/figure/Footsteps-app-basic-data-collection-and-behavioral-economics-features_tbl1_359011671

basic data collection and behavioral economics features. The purpose of this study was to learn the opinion and perception of professionals who work with people with autism on the functionality and applicability of ...

8. acamh.org acamh.org/blog/validation-of-a-mobile-app-for-remote-autism-screening-in-toddlers/

Validation of a Mobile App for Remote Autism Screening in ... Among 620 toddlers aged 16–40 months, the app showed high accuracy in identifying autism, performing comparably to established screeners. The ...