Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT04506294
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2020-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating an eHealth Solution for Screening in Pediatric Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adamsn@chop.edu', 'phone': '215-590-3118', 'title': 'Nancy Kassam-Adams, PhD (Principal Investigator)', 'organization': "Children's Hospital of Philadelphia"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Adverse Event definition is same as clinicaltrials.gov definition', 'eventGroups': [{'id': 'EG000', 'title': 'eScreen Group', 'description': '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.\n\neScreen 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.', 'otherNumAtRisk': 214, 'deathsNumAtRisk': 214, 'otherNumAffected': 0, 'seriousNumAtRisk': 214, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care Group', 'description': '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.', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 0, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Severity at 6 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'eScreen Group', 'description': 'After randomization at baseline, child and parent each use the eScreen system (child: game with screening component; parent: information component) for 6 weeks.\n\neScreen 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.'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': '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.'}], 'timeFrame': '6 weeks', 'description': '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)\n\nPain 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.\n\nPain 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.', 'reportingStatus': 'POSTED', 'populationDescription': 'At 6 weeks no children reported NRSI \\>=6 (ie clinically significant pain, thus planned analyses could not be conducted.'}, {'type': 'PRIMARY', 'title': "Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Interference at 6 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'eScreen Group', 'description': 'After randomization at baseline, child and parent each use the eScreen system (child: game with screening component; parent: information component) for 6 weeks.\n\neScreen 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.'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '.756', 'groupId': 'OG000', 'lowerLimit': '.613', 'upperLimit': '.900'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': '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.\n\nPain 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.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome pertains only to children (not parents); only in the eScreen group.'}, {'type': 'PRIMARY', 'title': 'Validity of eScreen Posttraumatic Stress Screen as Predictor of Posttraumatic Stress at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'eScreen Group', 'description': 'After randomization at baseline, child and parent each use the eScreen system (child: game with screening component; parent: information component) for 6 weeks.\n\neScreen 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.'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '.822', 'groupId': 'OG000', 'lowerLimit': '.650', 'upperLimit': '.994'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': '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.\n\nChild 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.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome pertains only to child participants, and only to those in eScreen group.'}, {'type': 'PRIMARY', 'title': 'Validity of eScreen PTSS Screener as Predictor of Impairment From Posttraumatic Stress Symptoms at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'eScreen Group', 'description': 'After randomization at baseline, child and parent each use the eScreen system (child: game with screening component; parent: information component) for 6 weeks.\n\neScreen 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.'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '.691', 'groupId': 'OG000', 'lowerLimit': '.531', 'upperLimit': '.850'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': '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.\n\nChild 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.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome pertains only to child participants, and only to those in the eScreen group.'}, {'type': 'SECONDARY', 'title': 'Impact of eScreen System on Parent Confidence in Managing Child Symptoms and Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'eScreen Group', 'description': 'After randomization at baseline, child and parent each use the eScreen system (child: game with screening component; parent: information component) for 6 weeks.\n\neScreen 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.'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '38.9', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.536', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': "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.\n\nParent 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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome pertains only to parent participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'eScreen Group', 'description': '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.\n\neScreen 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.'}, {'id': 'FG001', 'title': 'Usual Care Group', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruited 320 participants (160 child/parent dyads) in two large academic medical centers, between March 2021 and April 2022.', 'preAssignmentDetails': 'No pre-assignment procedures other than baseline research assessment measures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'eScreen Group', 'description': '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.\n\neScreen 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.'}, {'id': 'BG001', 'title': 'Usual Care Group', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'age 8-17 (child participants)', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}, {'title': 'age 21-30 (parent participants)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'age 31-40 (parent participants)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'age 41-50 (parent participants)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': 'age 51-60 (parent participants)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'age 61-70 (parent participants)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'not reported (parent participants)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'female - child', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': 'female - parent / guardian', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}, {'title': 'male - child', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'male - parent / guardian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'other - child', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'other - parent / guardian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'not reported - child', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'not reported - parent / guardian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black / African American - child', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Black / African American - parent', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'White - child', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}, {'title': 'White - parent / guardian', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}, {'title': 'Asian - child', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Asian - parent / guardian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'American Indian / Alaska Native - child', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'American Indian / Alaska Native - parent / guardian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Multiple - child', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Multiple - parent / guardian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Other - child', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Other - parent / guardian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Not reported - child', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Not reported - parent / guardian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-03', 'size': 527623, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-04T08:52', 'hasProtocol': True}, {'date': '2022-02-03', 'size': 541118, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-04T08:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2020-07-15', 'resultsFirstSubmitDate': '2023-07-21', 'studyFirstSubmitQcDate': '2020-08-06', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-30', 'studyFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Severity at 6 Weeks", 'timeFrame': '6 weeks', 'description': '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)\n\nPain 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.\n\nPain 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.'}, {'measure': "Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Interference at 6 Weeks", 'timeFrame': '6 weeks', 'description': '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.\n\nPain 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.'}, {'measure': 'Validity of eScreen Posttraumatic Stress Screen as Predictor of Posttraumatic Stress at 6 Weeks', 'timeFrame': '6 weeks', 'description': '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.\n\nChild 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.'}, {'measure': 'Validity of eScreen PTSS Screener as Predictor of Impairment From Posttraumatic Stress Symptoms at 6 Weeks', 'timeFrame': '6 weeks', 'description': '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.\n\nChild 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.'}], 'secondaryOutcomes': [{'measure': 'Impact of eScreen System on Parent Confidence in Managing Child Symptoms and Recovery', 'timeFrame': '6 weeks', 'description': "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.\n\nParent 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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Stress Disorders, Post-Traumatic']}, 'referencesModule': {'references': [{'pmid': '31275781', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the predictive validity of a game-based screening system based on child self-report measures.\n\nThe 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.', 'detailedDescription': 'This study will evaluate the predictive validity of a game-based screening system based on child self-report measures.\n\nThe 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.\n\nStudy Design:\n\nThis 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).\n\nAt 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child treated or admitted for injury or illness event that occurred within the past month\n* Child has regular access to a compatible (IOS or Android) tablet at home\n* 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\n* 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)\n\nExclusion Criteria:\n\n* Index medical event is due to family violence'}, 'identificationModule': {'nctId': 'NCT04506294', 'briefTitle': 'Evaluating an eHealth Solution for Screening in Pediatric Care', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Evaluating an eHealth Solution for Screening in Pediatric Care', 'orgStudyIdInfo': {'id': '20-017351'}, 'secondaryIdInfos': [{'id': 'R42HD087021', 'link': 'https://reporter.nih.gov/quickSearch/R42HD087021', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eScreen Group', 'description': 'After randomization at baseline, use eScreen system (child screening component and parent information component) for 6 weeks.', 'interventionNames': ['Behavioral: eScreen system']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care Group', 'description': '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': [{'name': 'eScreen system', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['eScreen Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': "Kentucky Children's Hospital", 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '19146', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Nancy Kassam-Adams, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Center for Injury Research & Prevention, Children's Hospital of Philadelphia"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'As soon as possible after core study analyses are complete.', 'ipdSharing': 'YES', 'description': 'Will share de-identified individual participant data, at minimum including key variables relevant to describing participants and assessing primary and secondary outcomes.', 'accessCriteria': 'Qualified researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'University of Kentucky', 'class': 'OTHER'}, {'name': 'Radiant Creative Group, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}