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

NCT ID: NCT07042347

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2028-06-30

Brief Summary

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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, GAS 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

Detailed Description

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Conditions

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Autism Challenging Behavior ADHD Oppositional Defiant Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

fully powered, randomized, hybrid type 2, pragmatic effectiveness-implementation mixed-methods trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Behavioral economics strategies

Intervention Type BEHAVIORAL

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

Electronic platform

Intervention Type DEVICE

Electronic platform to collect data

Data Collection Only App (No Enhancements)

A basic electronic platform for data collection.

Group Type ACTIVE_COMPARATOR

Electronic platform

Intervention Type DEVICE

Electronic platform to collect data

Interventions

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Behavioral economics strategies

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

Intervention Type BEHAVIORAL

Electronic platform

Electronic platform to collect data

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Aides must be employed by a community behavior health agency in Philadelphia or one of its surrounding counties
* and be working with at least one client in school who meets the following criteria: 1) between 4-17 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather J Nuske, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

David Mandell, Sc.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Heather J Nuske, PhD

Role: CONTACT

(215) 746-6041

David Mandell, Sc.D.

Role: CONTACT

Facility Contacts

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Heather J Nuske, PhD

Role: primary

215-746-6041

References

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Nuske HJ, Buck J, Ramesh B, Becker-Haimes EM, Zentgraf K, Mandell DS. Making Progress Monitoring Easier and More Motivating: Developing a Client Data Collection App Incorporating User-Centered Design and Behavioral Economics Insights. Soc Sci (Basel). 2022 Mar;11(3):106. doi: 10.3390/socsci11030106. Epub 2022 Mar 3.

Reference Type BACKGROUND
PMID: 35496358 (View on PubMed)

Related Links

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https://www.digitalmentalhealth.org/footsteps

Website which describes the development of this application and available features.

Other Identifiers

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R01MH136153

Identifier Type: NIH

Identifier Source: secondary_id

View Link

855228

Identifier Type: -

Identifier Source: org_study_id

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