Evaluating an eHealth Solution for Screening in Pediatric Care

Study Overview
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Brief Summary
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This study will evaluate the predictive validity of a game-based screening system based on child self-report measures. The core study hypotheses are that (1) in-game assessments will predict problematic recovery (child pain and posttraumatic stress symptoms [PTSS]) and (2) parents in the intervention group will report greater confidence in managing child recovery.

Detailed Description
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This study will evaluate the predictive validity of a game-based screening system based on child self-report measures. The core study hypotheses are that (1) in-game assessments will predict problematic recovery (child pain and PTSS) and (2) parents in the intervention group will report greater confidence in managing child recovery. Study Design: This study is a randomized controlled trial that will examine validity of eScreen measures (primary aim) and assess the impact of the eScreen system on parent confidence in managing child symptoms and recovery (secondary aim). At T1, after baseline assessment (questionnaires), children will be randomized to the usual care plus eScreen (eScreen) or usual care alone (Usual Care) groups. In the eScreen group, children will use the game-based screening component and parents the parent information component for 6 weeks. All participants will complete follow-up research assessments by phone, online, or mail at T2 (6 weeks) and T3 (12 weeks). Following their T3 research assessment, child participants in the Usual Care group will have the option to play and provide feedback on the game (with no in-game assessment and no parent information component).

Official Title
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Evaluating an eHealth Solution for Screening in Pediatric Care

Conditions
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Pain, Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Behavioral: eScreen system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child treated or admitted for injury or illness event that occurred within the past month Child has regular access to a compatible (IOS or Android) tablet at home Parent has an internet-capable smartphone and can receive text messages on that phone, OR has email account that can receive messages about child status Child and parent read or understand English well enough to consent / assent to participation and complete study tasks (e.g., checklists, use of screening system) Exclusion Criteria: Index medical event is due to family violence

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eScreen Group<br>After randomization at baseline, use eScreen system (child screening component and parent information component) for 6 weeks. | Behavioral: eScreen system<br>* The eScreen system is composed of a child screening component and a parent information component. The child screening component is delivered via a game-like interface and includes assessment of current pain, PTSS, and functional recovery. Children are asked to play the game at least 3x/week. The parent information component consists of text / email messages sent to parents at least weekly that summarize child ratings and include a link to an online dashboard with additional personalized information for parents.<br>|
| No Intervention: Usual Care Group<br>Treatment as usual from baseline. Optional access to the game only (no screening, no parent information component) after completion of T3 assessment ( 12 weeks) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive validity of eScreen pain measure for clinically significant pain severity at 6 weeks | Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen pain measure score (range 0-10) predicting presence of clinically significant pain intensity (score >=6 on the Numerical Rating Scale; NRSI) at 6 weeks. | 6 weeks | 
| Predictive validity of eScreen pain measure for clinically significant pain interference at 6 weeks | Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen pain measure score (range 0-10) predicting presence of clinically significant pain interference (T score >=65 on the PROMIS Pediatric Pain Interference scale - child report) at 6 weeks. | 6 weeks | 
| Predictive validity of eScreen posttraumatic stress measure for clinically significant posttraumatic stress symptoms at 6 weeks | Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen-administered posttraumatic stress measure (range 0-12) predicting presence of clinically significant posttraumatic stress symptoms at 6 weeks, scored from symptom count on the Child PTSD Symptom Scale for DSM-5 [CPSS-5]. | 6 weeks | 
| Predictive validity of eScreen posttraumatic stress measure for impairment from posttraumatic stress symptoms at 6 weeks | Evaluate predictive validity, measured as area under the curve (AUC) in receiver operating curve (ROC) analyses, for eScreen-administered posttraumatic stress measure (range 0-12) predicting presence of impairment from posttraumatic stress symptoms at 6 weeks, scored from impairment items on the Child PTSD Symptom Scale for DSM-5 [CPSS-5]. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of eScreen system on parent confidence in managing child symptoms and recovery | Examine difference between (randomly assigned) eScreen and usual care groups on a measure of parents' self-rated confidence in managing child symptoms and recovery. Effect size (Cohen's d) calculated as the between-group difference in summed ratings on the Parent Information / Confidence Questionnaire, standardized by the pooled standard deviation (SD) for the groups. | 6 weeks |