University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
NCT Number: NCT07042347
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Behavioral economics features designed to increase motivation to collect data and ease of data collection on the electronic platform.
Electronic platform to collect data
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.
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)
Time frame: Assessed throughout 12-week trial
for intervals in which data was entered, the time lag between occurrence and data entry
Time frame: Assessed throughout 12-week trial
intervals classified as complete or incomplete according to whether the aide collected their planned metrics as required by their agency (% goals targeted)
Time frame: Assessed biweekly, at baseline through 12-week trial
Top 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
Time frame: Assessed biweekly, at baseline through 12-week trial
The investigators adapted scales to measure mechanisms affecting data collection, including intentions, using social psychology methods (Armitage & Connor, 2001). The intentions measure had one item, which was rated from 1=strongly disagree to 7=strongly agree. Strongly agree meant stronger intentions to take data. Aides completed measures at baseline and post-trial (3 weeks). Data reported are changes over time.
Time frame: Assessed biweekly, at baseline and through 12-week trial
The investigators adapted scales to measure mechanisms affecting data collection, including attitudes, using social psychology methods (Armitage & Connor, 2001). The attitudes measure had one item, which was rated from 1=good to 7=bad (meaning that taking data would be bad). Attitudes had 2 items. These items were averaged to create the scale score which could range from 1 to 7 for each measure. Aides completed measures at baseline and post-trial (3 weeks). Data reported are changes over time.
Time frame: Assessed biweekly, at baseline through 12-week trial
The investigators adapted scales to measure mechanisms affecting data collection, including perceived norms, using social psychology methods (Armitage & Connor, 2001). The perceived norms measure had one item, which was rated from 1=strongly disagree to 7=strongly agree. Strongly agree meant stronger influence of norms on taking data. Aides completed measures at baseline and post-trial (3 weeks). Data reported are changes over time.
Time frame: Assessed biweekly, at baseline through 12-week trial
The investigators adapted scales to measure mechanisms affecting data collection, including descriptive norms, using social psychology methods (Armitage & Connor, 2001). The perceived norms measure had one item, which was rated from 1=strongly disagree to 7=strongly agree. Strongly agree meant stronger influence of norms on taking data. Aides completed measures at baseline and post-trial (3 weeks). Data reported are changes over time.
Time frame: Assessed biweekly, at baseline through 12-week trial
The investigators adapted scales to measure mechanisms affecting data collection, including self-efficacy, using social psychology methods (Armitage & Connor, 2001). The self-efficacy measure had one item, which was rated from 1=strongly disagree to 7=strongly agree. Strongly agree meant stronger self-efficacy about taking data. Self-Efficacy had 2 items. These items were averaged to create the scale score which could range from 1 to 7 for each measure. Aides completed measures at baseline and post-trial (3 weeks). Data reported are changes over time.
Time frame: Assessed at post-trial (Week 12)
The investigators used the System Usability Scale (SUS; Brooke, 1996) to measure aides' reactions to various statements regarding the app's usability with 10 items that use a 5-point scale from (1) strongly disagree to (5) strongly agree. The SUS has high internal consistent reliability (Cronbach's alpha = .91) and demonstrated sensitivity to change (Lewis, 2018). The investigators adapted the original questionnaire to replace "system" with "app" across all items. The SUS is calculated as a proportion score out of 100, with higher scores indicating higher usability (≥85 = Excellent; ≥71 = Good; ≥51 = Okay (Bangor et al.).
Time frame: Assessed biweekly, at baseline through 12-week trial
The investigators will compare the groups on combined frequency and content of the communications by using a three-level ordinal response for each period (0=no communication, 1=communication, with discussion of client, 2=communication, discussion of client, and discussion of treatment strategy changes).
Contact information is provided by the study sponsor or research team.
David Mandell, Sc.D.
CONTACT
Heather J Nuske, PhD
CONTACT
University of Pennsylvania
Other
RCT of a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health
Acronym: Footsteps
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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