NCT04506294|CompletedResultsDMC
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Sponsor study identifier
Secondary identifiers
NIH
interventional
320
1 country
2
Study Start
March 17, 2021
Actual (reported)Primary Completion
July 21, 2022
Actual (reported)Study Completion
July 21, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 21, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 15, 2020
Actual (reported)August 10, 2020
Actual (reported)March 17, 2021
Actual (reported)July 21, 2022
Actual (reported)July 21, 2022
Actual (reported)June 26, 2024
Actual (reported)Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Severity at 6 Weeks
Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen Pain Measure score predicting rating \>= 6 on 6-week Numerical Rating Scale for Pain Intensity (NRSI) Pain at baseline: eScreen Pain Measure score (0-10) On-screen visual analog 'slider' - width \& color intensity increase from bottom to top, face of child's avatar (selected by child in eScreen system) anchors lower \& upper ends of slider with validated 'no pain' and 'most pain' facial expressions. On-screen instructions: "The bottom of this scale is no pain, and the top is the most pain you can imagine. Slide the marker to show how much pain you feel right now." Child uses touch screen to slide virtual marker, system derives score from 0.000 to 10.000 based on marker location. Pain severity at 6 weeks: NRSI \>= 6 Verbally-administered, child rates pain by choosing integer from 0 to 10 "where 0 = no pain or hurt and 10 = the most or worst pain/hurt" Rating \>=6 validated as clinically significant.
6 weeks
Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Interference at 6 Weeks
Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen Pain Measure score predicting T score \>= 65 on 6-wk PROMIS Pain Interference scale Pain at baseline: eScreen Pain Measure score (0-10) On-screen visual analog 'slider' - width \& color intensity increase from bottom to top, face of child's avatar (selected by child in eScreen system) anchors lower \& upper ends of slider with validated 'no pain' and 'most pain' facial expressions. On-screen instructions: "The bottom of this scale is no pain, and the top is the most pain you can imagine. Slide the marker to show how much pain you feel right now." Child uses touch screen to slide virtual marker, system derives score from 0.000 to 10.000 based on marker location. Pain interference at 6 weeks: PROMIS Pediatric Pain Interference T score \>=65 Brief questionnaire - Child rates pain interference with daily activities over past 7 days. Ratings lead to normed T scores where \>=65 = significant interference.
6 weeks
Impact of eScreen System on Parent Confidence in Managing Child Symptoms and Recovery
6 weeks
After randomization at baseline, use eScreen system (child screening component and parent information component) for 6 weeks.
Treatment as usual from baseline. Optional access to the game only (no screening, no parent information component) after completion of T3 assessment (\~12 weeks)
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kentucky Children's Hospital
Lexington, Kentucky, 40536, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146, United States
Kassam-Adams N, Kohser KL, McLaughlin J, Winston F, Marsac ML. Evaluating the Acceptability and Validity of Assessing Pain and Posttraumatic Stress Symptoms in an Adaptable eHealth System for School-Age Children. Clin Pract Pediatr Psychol. 2019 Mar;7(1):9-19. doi: 10.1037/cpp0000261.
Nancy Kassam-Adams, PhD
Center for Injury Research & Prevention, Children's Hospital of Philadelphia
320 participants (actual enrollment reported by the registry).
First Submitted
July 15, 2020
First Posted
August 10, 2020
Study Start
March 17, 2021
Actual (reported)Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress
Testing a Self-Management App for Symptoms of Posttraumatic Stress
Validity of eScreen Posttraumatic Stress Screen as Predictor of Posttraumatic Stress at 6 Weeks
Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen PTSS Screener score predicting whether child meets symptom criteria for posttraumatic stress disorder (PTSD) on 6-wk Child PTSD Symptom Scale for DSM-5 \[CPSS-5\] eScreen PTSS Screener eScreen uses the Acute Stress Checklist for Children 6-item Short Form (ASC-6) to screen for posttraumatic stress symptoms (PTSS). Scores range from 0 to 12; higher scores indicate greater PTSS severity. Child PTSD Symptom Scale for DSM-5 (CPSS-5) 20-item questionnaire assesses DSM-5 criteria for posttraumatic stress disorder (PTSD), scored here to determine whether child meets symptom criteria for PTSD at 6 wks.
6 weeks
Validity of eScreen PTSS Screener as Predictor of Impairment From Posttraumatic Stress Symptoms at 6 Weeks
Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen PTSS Screener score predicting whether or not child reports impairment from posttraumatic stress symptoms (PTSS) on 6-wk Child PTSD Symptom Scale for DSM-5 \[CPSS-5\] eScreen PTSS Screener eScreen uses the Acute Stress Checklist for Children 6-item Short Form (ASC-6) to screen for posttraumatic stress symptoms (PTSS). Scores range from 0 to 12; higher scores indicate greater PTSS severity. Child PTSD Symptom Scale for DSM-5 (CPSS-5) 7 items in the CPSS questionnaire assess impairment (in social/interpersonal or academic functioning or daily activities) related to posttraumatic stress symptoms. Impairment scored as present if child endorses impairment on any item at 6 wks.
6 weeks
Contact the study team to confirm eligibility.
Primary Completion
July 21, 2022
Actual (reported)Study Completion
July 21, 2022
Actual (reported)Last Updated
June 26, 2024
Results First Posted
June 26, 2024
Record last verified: 2024-05
Will share de-identified individual participant data, at minimum including key variables relevant to describing participants and assessing primary and secondary outcomes.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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