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Completed

NCT Number: NCT04506294

Evaluating an eHealth Solution for Screening in Pediatric Care

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.

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Key information

Conditions

Pain Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kentucky Children's Hospital, Lexington, Kentucky, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Severity at 6 Weeks

    Time frame: 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.

  2. Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Interference at 6 Weeks

    Time frame: 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.

  3. Validity of eScreen Posttraumatic Stress Screen as Predictor of Posttraumatic Stress at 6 Weeks

    Time frame: 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.

  4. Validity of eScreen PTSS Screener as Predictor of Impairment From Posttraumatic Stress Symptoms at 6 Weeks

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Radiant Creative Group, LLC
  • University of Kentucky

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2020
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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