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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07042347
Acronym
Footsteps
Enrollment
200
Registered
2025-06-29
Start date
2026-04-08
Completion date
2028-06-30
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD, Autism, Challenging Behavior, Oppositional Defiant Disorder

Keywords

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

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

Interventions

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

Electronic platform to collect data

Sponsors

University of Pennsylvania
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Strengths and Difficulties Questionnaire total scoreAssessed 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 consistencyAssessed throughout 12-week trialan aggregate of the numbers of intervals scheduled, and the numbers of those intervals in which data was entered (% real time data)
Data collection timelinessAssessed throughout 12-week trialfor intervals in which data was entered, the time lag between occurrence and data entry

Secondary

MeasureTime frameDescription
Youth Top ProblemsAssessed biweekly, at baseline through 12-week trialTop problems identified during intake meeting. Severity of each problem is rated from 0 (not a problem) to 4 (a very big problem). Severity ratings can be tracked for each problem individually or as an overall mean severity score created by averaging ratings from the same informant at the same measurement occasion
Data collection completenessAssessed throughout 12-week trialintervals classified as complete or incomplete according to whether the aide collected their planned metrics as required by their agency (% goals targeted)

Countries

United States

Contacts

CONTACTHeather J Nuske, PhD
heather.nuske@pennmedicine.upenn.edu(215) 746-6041
CONTACTDavid Mandell, Sc.D.
david.mandell@pennmedicine.upenn.edu
PRINCIPAL_INVESTIGATORHeather J Nuske, PhD

University of Pennsylvania

PRINCIPAL_INVESTIGATORDavid Mandell, Sc.D.

University of Pennsylvania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026