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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH136153 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Data Collection Only App (No Enhancements) | Active Comparator | A basic electronic platform for data collection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral economics strategies | Behavioral | Behavioral economics features designed to increase motivation to collect data and ease of data collection on the electronic platform. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Data collection completeness | intervals classified as complete or incomplete according to whether the aide collected their planned metrics as required by their agency (% goals targeted) | Assessed throughout 12-week trial |
| Youth Top Problems |
| Measure | Description | Time Frame |
|---|---|---|
| Intentions for Implementors | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heather J Nuske, PhD | Contact | (215) 746-6041 | heather.nuske@pennmedicine.upenn.edu | |
| David Mandell, Sc.D. | Contact | david.mandell@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Heather J Nuske, PhD | University of Pennsylvania | Principal Investigator |
| David Mandell, Sc.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35496358 | Background | 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. |
| Label | URL |
|---|---|
| Website which describes the development of this application and available features. | View source |
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fully powered, randomized, hybrid type 2, pragmatic effectiveness-implementation mixed-methods trial
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| Electronic platform | Device | Electronic platform to collect data |
|
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
| Assessed biweekly, at baseline through 12-week trial |
| Assessed biweekly, at baseline through 12-week trial |
| Attitudes for Implementors | 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. | Assessed biweekly, at baseline and through 12-week trial |
| Perceived Norms for Implementors | 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. | Assessed biweekly, at baseline through 12-week trial |
| Descriptive Norms for Implementors | 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. | Assessed biweekly, at baseline through 12-week trial |
| Self-Efficacy for Implementors | 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. | Assessed biweekly, at baseline through 12-week trial |
| System Usability Scale | 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.). | Assessed at post-trial (Week 12) |
| Supervisor <> Aide Communication | 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). | Assessed biweekly, at baseline through 12-week trial |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D000096865 | Oppositional Defiant Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
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