NCT07042347

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:

  • 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Jun 2028

First Submitted

Initial submission to the registry

June 12, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

March 26, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

June 12, 2025

Last Update Submit

April 27, 2026

Conditions

Keywords

data collectionBehavioral Health Technician (BHT)behavioral economicsimplementation sciencesupervisory processes

Outcome Measures

Primary Outcomes (3)

  • Strengths and Difficulties Questionnaire total score

    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.

    Assessed monthly (Baseline; Weeks 4, 8, and 12)

  • Data collection consistency

    an aggregate of the numbers of intervals scheduled, and the numbers of those intervals in which data was entered (% real time data)

    Assessed throughout 12-week trial

  • Data collection timeliness

    for intervals in which data was entered, the time lag between occurrence and data entry

    Assessed throughout 12-week trial

Secondary Outcomes (2)

  • Data collection completeness

    Assessed throughout 12-week trial

  • Youth Top Problems

    Assessed biweekly, at baseline through 12-week trial

Other Outcomes (7)

  • Intentions for Implementors

    Assessed biweekly, at baseline through 12-week trial

  • Attitudes for Implementors

    Assessed biweekly, at baseline and through 12-week trial

  • Perceived Norms for Implementors

    Assessed biweekly, at baseline through 12-week trial

  • +4 more other outcomes

Study Arms (2)

Footsteps (Enhancements)

EXPERIMENTAL

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

Behavioral: Behavioral economics strategiesDevice: Electronic platform

Data Collection Only App (No Enhancements)

ACTIVE COMPARATOR

A basic electronic platform for data collection.

Device: Electronic platform

Interventions

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

Footsteps (Enhancements)

Electronic platform to collect data

Data Collection Only App (No Enhancements)Footsteps (Enhancements)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35496358BACKGROUND

Related Links

MeSH Terms

Conditions

Autistic DisorderAttention Deficit Disorder with HyperactivityOppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersAttention Deficit and Disruptive Behavior Disorders

Study Officials

  • Heather J Nuske, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
  • David Mandell, Sc.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: fully powered, randomized, hybrid type 2, pragmatic effectiveness-implementation mixed-methods trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 29, 2025

Study Start

March 26, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations