NCT04506294

Evaluating an eHealth Solution for Screening in Pediatric Care

Completed NA Results posted Last updated 26 June 2024

What this trial tests

NA trial testing eScreen system in Pain in 320 participants. Completed in 21 July 2022.

Timeline

17 March 2021

Primary endpoint
21 July 2022

21 July 2022

Quick facts

Lead sponsor	Children's Hospital of Philadelphia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	screening
Enrollment	320
Start date	17 March 2021
Primary completion	21 July 2022
Estimated completion	21 July 2022
Sites	2 locations across United States

Drugs / interventions tested

• eScreen system

Conditions studied

• Pain — all drugs for Pain →
• Stress Disorders, Post-Traumatic — all drugs for Stress Disorders, Post-Traumatic →

Sponsor

Children's Hospital of Philadelphia

Who can join

Adults 8 to 17, any sex, with Pain or Stress Disorders, Post-Traumatic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Interference at 6 Weeks Primary · 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 sho

Group	Value	95% CI
eScreen Group	.756	.613 – .900

Validity of eScreen Posttraumatic Stress Screen as Predictor of Posttraumatic Stress at 6 Weeks Primary · 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 (P

Group	Value	95% CI
eScreen Group	.822	.650 – .994

Validity of eScreen PTSS Screener as Predictor of Impairment From Posttraumatic Stress Symptoms at 6 Weeks Primary · 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 o

Group	Value	95% CI
eScreen Group	.691	.531 – .850

Impact of eScreen System on Parent Confidence in Managing Child Symptoms and Recovery Secondary · 6 weeks

Examine difference between eScreen and usual care groups on parents' self-rated confidence (at 6 weeks) related to managing child symptoms and recovery after discharge. Parent Confidence Scale - 9 Likert-scale items in which parents rate (from 1 to 5) the extent to which they have felt prepared to manage their ill or injured child's symptoms and recovery after hospital or clinic discharge. Summed total scores range from 5 to 45, higher scores indicate greater confidence.

Group	Value	95% CI
eScreen Group	39.6	± 5.2
Usual Care Group	38.9	± 6.9

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.