Evaluating an eHealth Solution for Screening in Pediatric Care

NCT04506294 | Completed Results DMC

• 2 other identifiers: 20-017351R42HD087021
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pain; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Secondary Outcomes (1)

• Impact of eScreen System on Parent Confidence in Managing Child Symptoms and Recovery

  6 weeks

Study Arms (2)

eScreen Group

EXPERIMENTAL

After randomization at baseline, use eScreen system (child screening component and parent information component) for 6 weeks.

Behavioral: eScreen system

Usual Care Group

NO INTERVENTION

Treatment as usual from baseline. Optional access to the game only (no screening, no parent information component) after completion of T3 assessment (\~12 weeks)

Interventions

eScreen system BEHAVIORAL

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.

eScreen Group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Index medical event is due to family violence

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Kentucky: collaborator
• Radiant Creative Group, LLC: collaborator

Study Sites (2)

Kentucky Children's Hospital

Lexington, Kentucky, 40536, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (1)

• 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.

  PMID: 31275781 BACKGROUND

MeSH Terms

Conditions

Pain; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Nancy Kassam-Adams, PhD (Principal Investigator)
• Organization: Children's Hospital of Philadelphia

adamsn@chop.edu

215-590-3118

Study Officials

• Nancy Kassam-Adams, PhD

  Center for Injury Research & Prevention, Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: August 10, 2020
• Study Start: March 17, 2021
• Primary Completion: July 21, 2022
• Study Completion: July 21, 2022
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: As soon as possible after core study analyses are complete.
• Access Criteria: Qualified researchers.

Locations

US (2)