Pain, Stress Disorders, Post-Traumatic
Conditions
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.
Detailed 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 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).
Interventions
BEHAVIORALeScreen system
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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Kentucky
Radiant Creative Group, LLC
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Severity at 6 Weeks | 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. |
| Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Interference at 6 Weeks | 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. |
| Validity of eScreen Posttraumatic Stress Screen as Predictor of Posttraumatic Stress at 6 Weeks | 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. |
| Validity of eScreen PTSS Screener as Predictor of Impairment From Posttraumatic Stress Symptoms at 6 Weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Impact of eScreen System on Parent Confidence in Managing Child Symptoms and Recovery | 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. |
Countries
United States
Participant flow
Recruitment details
Recruited 320 participants (160 child/parent dyads) in two large academic medical centers, between March 2021 and April 2022.
Pre-assignment details
No pre-assignment procedures other than baseline research assessment measures.
Participants by arm
| Arm | Count |
|---|---|
| eScreen Group Ill/injured child and one parent are enrolled in the study. After randomization at baseline, child and parent each use the eScreen system (child: game with screening component; parent: information component) for 6 weeks.
eScreen system: 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. | 214 |
| Usual Care Group Ill/injured child and one parent are enrolled in the study. Treatment as usual from baseline to 12 weeks. After completion of T3 assessment (\
12 weeks), child is given the option of accessing the game only (no screening). No parent information component is provided. | 106 |
| Total | 320 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 70 | 20 |
| Overall Study | Withdrawal by Subject | 16 | 2 |
Baseline characteristics
| Characteristic | eScreen Group | Total | Usual Care Group |
|---|---|---|---|
| Age, Customized age 21-30 (parent participants) | 6 Participants | 8 Participants | 2 Participants |
| Age, Customized age 31-40 (parent participants) | 36 Participants | 59 Participants | 23 Participants |
| Age, Customized age 41-50 (parent participants) | 45 Participants | 72 Participants | 27 Participants |
| Age, Customized age 51-60 (parent participants) | 13 Participants | 14 Participants | 1 Participants |
| Age, Customized age 61-70 (parent participants) | 2 Participants | 2 Participants | 0 Participants |
| Age, Customized age 8-17 (child participants) | 107 Participants | 160 Participants | 53 Participants |
| Age, Customized not reported (parent participants) | 5 Participants | 5 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian / Alaska Native - child | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian / Alaska Native - parent / guardian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian - child | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian - parent / guardian | 4 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Black / African American - child | 17 Participants | 30 Participants | 13 Participants |
| Race/Ethnicity, Customized Black / African American - parent | 17 Participants | 29 Participants | 12 Participants |
| Race/Ethnicity, Customized Multiple - child | 9 Participants | 11 Participants | 2 Participants |
| Race/Ethnicity, Customized Multiple - parent / guardian | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Not reported - child | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Not reported - parent / guardian | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Other - child | 7 Participants | 7 Participants | 0 Participants |
| Race/Ethnicity, Customized Other - parent / guardian | 6 Participants | 6 Participants | 0 Participants |
| Race/Ethnicity, Customized White - child | 70 Participants | 106 Participants | 36 Participants |
| Race/Ethnicity, Customized White - parent / guardian | 73 Participants | 111 Participants | 38 Participants |
| Sex/Gender, Customized female - child | 54 Participants | 80 Participants | 26 Participants |
| Sex/Gender, Customized female - parent / guardian | 97 Participants | 148 Participants | 51 Participants |
| Sex/Gender, Customized male - child | 53 Participants | 79 Participants | 26 Participants |
| Sex/Gender, Customized male - parent / guardian | 7 Participants | 9 Participants | 2 Participants |
| Sex/Gender, Customized not reported - child | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized not reported - parent / guardian | 3 Participants | 3 Participants | 0 Participants |
| Sex/Gender, Customized other - child | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized other - parent / guardian | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 214 | 0 / 106 |
| other Total, other adverse events | 0 / 214 | 0 / 106 |
| serious Total, serious adverse events | 0 / 214 | 0 / 106 |
Outcome results
Primary
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.
Time frame: 6 weeks
Population: This outcome pertains only to children (not parents); only in the eScreen group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eScreen Group | Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Interference at 6 Weeks | .756 Probability |
Primary
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.
Time frame: 6 weeks
Population: At 6 weeks no children reported NRSI \>=6 (ie clinically significant pain, thus planned analyses could not be conducted.
Primary
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.
Time frame: 6 weeks
Population: This outcome pertains only to child participants, and only to those in eScreen group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eScreen Group | Validity of eScreen Posttraumatic Stress Screen as Predictor of Posttraumatic Stress at 6 Weeks | .822 Probability |
Primary
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.
Time frame: 6 weeks
Population: This outcome pertains only to child participants, and only to those in the eScreen group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eScreen Group | Validity of eScreen PTSS Screener as Predictor of Impairment From Posttraumatic Stress Symptoms at 6 Weeks | .691 Probability |
Secondary
Impact of eScreen System on Parent Confidence in Managing Child Symptoms and Recovery
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.
Time frame: 6 weeks
Population: This outcome pertains only to parent participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| eScreen Group | Impact of eScreen System on Parent Confidence in Managing Child Symptoms and Recovery | 39.6 score on a scale | Standard Deviation 5.2 |
| Usual Care Group | Impact of eScreen System on Parent Confidence in Managing Child Symptoms and Recovery | 38.9 score on a scale | Standard Deviation 6.9 |
p-value: 0.536t-test, 2 sided