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| ID | Type | Description | Link |
|---|---|---|---|
| R42HD087021 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| University of Kentucky | OTHER |
| Radiant Creative Group, LLC | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eScreen Group | Experimental | After randomization at baseline, use eScreen system (child screening component and parent information component) for 6 weeks. |
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| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Kassam-Adams, PhD | Center for Injury Research & Prevention, Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kentucky Children's Hospital | Lexington | Kentucky | 40536 | United States | ||
| Children's Hospital of Philadelphia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31275781 | Background | 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. |
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Will share de-identified individual participant data, at minimum including key variables relevant to describing participants and assessing primary and secondary outcomes.
As soon as possible after core study analyses are complete.
Qualified researchers.
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No pre-assignment procedures other than baseline research assessment measures.
Recruited 320 participants (160 child/parent dyads) in two large academic medical centers, between March 2021 and April 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | At 6 weeks no children reported NRSI >=6 (ie clinically significant pain, thus planned analyses could not be conducted. | Posted | 6 weeks |
12 weeks
Adverse Event definition is same as clinicaltrials.gov definition
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Kassam-Adams, PhD (Principal Investigator) | Children's Hospital of Philadelphia | 215-590-3118 | adamsn@chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2022 | Apr 4, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 3, 2022 | Apr 4, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D040921 | Stress Disorders, Traumatic |
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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 |
| 6 weeks |
| Philadelphia |
| Pennsylvania |
| 19146 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | eScreen Group | 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. |
| OG001 | Usual Care Group | 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. |
|
| 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. | This outcome pertains only to children (not parents); only in the eScreen group. | Posted | Number | 95% Confidence Interval | Probability | 6 weeks |
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|
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| 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. | This outcome pertains only to child participants, and only to those in eScreen group. | Posted | Number | 95% Confidence Interval | Probability | 6 weeks |
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| 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. | This outcome pertains only to child participants, and only to those in the eScreen group. | Posted | Number | 95% Confidence Interval | Probability | 6 weeks |
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| 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. | This outcome pertains only to parent participants. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
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| 0 |
| 214 |
| 0 |
| 214 |
| 0 |
| 214 |
| EG001 | 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. | 0 | 106 | 0 | 106 | 0 | 106 |
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| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |