Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2026-02-27 @ 11:59 PM
Study NCT ID:
NCT02723916
Status:
COMPLETED
Last Update Posted:
2020-12-31
First Post:
2016-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Parent Training in Pediatric Care: A Self Directed Tablet-Based Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'breitenstein.5@osu.edu', 'phone': '6146884614', 'title': 'Dr. Susie Breitenstein', 'organization': 'The Ohio State University, College of Nursing'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'No specific limitations related to the conduct of the study to report.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'No difference with definitions of adverse events and/or serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention: ezParent Program', 'description': 'ezParent Program: Tablet-based behavioral parent training program.', 'otherNumAtRisk': 144, 'deathsNumAtRisk': 144, 'otherNumAffected': 0, 'seriousNumAtRisk': 144, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control: Health-e Kids App', 'description': 'Health-e Kids Control App: Tablet based health promotion information App', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 0, 'seriousNumAtRisk': 143, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Parenting Behaviors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: ezParent Program', 'description': 'ezParent Program: Tablet-based behavioral parent training program.'}, {'id': 'OG001', 'title': 'Control: Health-e Kids App', 'description': 'Health-e Kids Control App: Tablet based health promotion information App'}], 'classes': [{'title': 'Parental Warmth (T1)', 'categories': [{'measurements': [{'value': '4.30', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.41', 'groupId': 'OG001'}]}]}, {'title': 'Parental Warmth (T2)', 'categories': [{'measurements': [{'value': '4.26', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '4.25', 'spread': '.41', 'groupId': 'OG001'}]}]}, {'title': 'Parental Warmth (T3)', 'categories': [{'measurements': [{'value': '4.29', 'spread': '.39', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '.44', 'groupId': 'OG001'}]}]}, {'title': 'Parental Warmth (T4)', 'categories': [{'measurements': [{'value': '4.27', 'spread': '.46', 'groupId': 'OG000'}, {'value': '4.34', 'spread': '.4', 'groupId': 'OG001'}]}]}, {'title': 'Parental Follow Through (T1)', 'categories': [{'measurements': [{'value': '3.46', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '3.37', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Parental Follow Through (T2)', 'categories': [{'measurements': [{'value': '3.47', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '3.49', 'spread': '.71', 'groupId': 'OG001'}]}]}, {'title': 'Parental Follow Through (T3)', 'categories': [{'measurements': [{'value': '3.58', 'spread': '.77', 'groupId': 'OG000'}, {'value': '3.52', 'spread': '.7', 'groupId': 'OG001'}]}]}, {'title': 'Parental Follow Through (T4)', 'categories': [{'measurements': [{'value': '3.64', 'spread': '.75', 'groupId': 'OG000'}, {'value': '3.59', 'spread': '.76', 'groupId': 'OG001'}]}]}, {'title': 'Corporal Punishment (T1)', 'categories': [{'measurements': [{'value': '1.43', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Corporal Punishment (T2)', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Corporal Punishment (T3)', 'categories': [{'measurements': [{'value': '1.44', 'spread': '.59', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '.57', 'groupId': 'OG001'}]}]}, {'title': 'Corporal Punishment (T4)', 'categories': [{'measurements': [{'value': '1.42', 'spread': '.58', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.', 'description': 'Measured by the Parent Questionnaire (PQ)\n\nScale scores reported:\n\nWarmth (scale range 1-5) - higher score indicates improvement Parent Follow Through (scale range 1-5) - higher score indicates improvement Corporal punishment (scale range 1-5) - lower score indicates improvement', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Parent Behaviors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: ezParent Program', 'description': 'ezParent Program: Tablet-based behavioral parent training program.'}, {'id': 'OG001', 'title': 'Control: Health-e Kids App', 'description': 'Health-e Kids Control App: Tablet based health promotion information App'}], 'classes': [{'title': 'Supporting Good Behavior (T1)', 'categories': [{'measurements': [{'value': '5.63', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '5.70', 'spread': '0.98', 'groupId': 'OG001'}]}]}, {'title': 'Supporting Good Behavior (T2)', 'categories': [{'measurements': [{'value': '5.36', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '5.65', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Supporting Good Behavior (T3)', 'categories': [{'measurements': [{'value': '5.54', 'spread': '.99', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'Supporting Good Behavior (T4)', 'categories': [{'measurements': [{'value': '5.53', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '5.85', 'spread': '.87', 'groupId': 'OG001'}]}]}, {'title': 'Setting Limits (T1)', 'categories': [{'measurements': [{'value': '5.17', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '5.24', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Setting Limits (T2)', 'categories': [{'measurements': [{'value': '5.14', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '5.23', 'spread': '1.06', 'groupId': 'OG001'}]}]}, {'title': 'Setting Limits (T3)', 'categories': [{'measurements': [{'value': '5.31', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '5.37', 'spread': '1.19', 'groupId': 'OG001'}]}]}, {'title': 'Setting Limits (T4)', 'categories': [{'measurements': [{'value': '5.41', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '5.52', 'spread': '1.12', 'groupId': 'OG001'}]}]}, {'title': 'Proactive Parenting (T1)', 'categories': [{'measurements': [{'value': '5.08', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '5.13', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Proactive Parenting (T2)', 'categories': [{'measurements': [{'value': '5.04', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '5.08', 'spread': '1.26', 'groupId': 'OG001'}]}]}, {'title': 'Proactive Parenting (T3)', 'categories': [{'measurements': [{'value': '5.2', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'Proactive Parenting (T4)', 'categories': [{'measurements': [{'value': '5.29', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '5.48', 'spread': '1.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.', 'description': 'Measured by the Parenting Young Children (PARYC) Reporting scales (scale range 1-7) (higher scores indicate more effective/improved parenting) Supporting good behavior Setting limits Proactive parenting', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Child Behavior Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: ezParent Program', 'description': 'ezParent Program: Tablet-based behavioral parent training program.'}, {'id': 'OG001', 'title': 'Control: Health-e Kids App', 'description': 'Health-e Kids Control App: Tablet based health promotion information App'}], 'classes': [{'title': 'Emotion (T1)', 'categories': [{'measurements': [{'value': '1.06', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': 'Emotion (T2)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'Emotion (T3)', 'categories': [{'measurements': [{'value': '1.02', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '.97', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': 'Emotion (T4)', 'categories': [{'measurements': [{'value': '1.03', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '.92', 'spread': '1.23', 'groupId': 'OG001'}]}]}, {'title': 'Conduct (T1)', 'categories': [{'measurements': [{'value': '1.93', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '1.77', 'groupId': 'OG001'}]}]}, {'title': 'Conduct (T2)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': 'Conduct (T3)', 'categories': [{'measurements': [{'value': '1.56', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '1.75', 'spread': '1.76', 'groupId': 'OG001'}]}]}, {'title': 'Conduct (T4)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': 'Hyper (T1)', 'categories': [{'measurements': [{'value': '3.50', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '3.38', 'spread': '2.28', 'groupId': 'OG001'}]}]}, {'title': 'Hyper (T2)', 'categories': [{'measurements': [{'value': '3.18', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '3.46', 'spread': '2.22', 'groupId': 'OG001'}]}]}, {'title': 'Hyper (T3)', 'categories': [{'measurements': [{'value': '3.09', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '2.91', 'spread': '2.14', 'groupId': 'OG001'}]}]}, {'title': 'Hyper (T4)', 'categories': [{'measurements': [{'value': '3.09', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '2.84', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Peer (T1)', 'categories': [{'measurements': [{'value': '1.62', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '1.52', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': 'Peer (T2)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'Peer (T3)', 'categories': [{'measurements': [{'value': '1.27', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '1.47', 'groupId': 'OG001'}]}]}, {'title': 'Peer (T4)', 'categories': [{'measurements': [{'value': '1.49', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Prosocial (T1)', 'categories': [{'measurements': [{'value': '8.01', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '8.26', 'spread': '1.74', 'groupId': 'OG001'}]}]}, {'title': 'Prosocial (T2)', 'categories': [{'measurements': [{'value': '8.43', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '8.24', 'spread': '1.96', 'groupId': 'OG001'}]}]}, {'title': 'Prosocial (T3', 'categories': [{'measurements': [{'value': '8.5', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'Prosocial (T4)', 'categories': [{'measurements': [{'value': '8.72', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '8.45', 'spread': '1.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.', 'description': 'Strengths and Difficulties Questionnaire (SDQ) scales (range 0-10) Emotional symptoms (higher scores indicate more difficulties) Conduct problems (higher scores indicate more difficulties) Hyperactivity/inattention (higher scores indicate more difficulties) Peer relationship problems (higher scores indicate more difficulties) Prosocial behavior (higher scores indicate more strengths)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Child Externalizing Behavior Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: ezParent Program', 'description': 'ezParent Program: Tablet-based behavioral parent training program.'}, {'id': 'OG001', 'title': 'Control: Health-e Kids App', 'description': 'Health-e Kids Control App: Tablet based health promotion information App'}], 'classes': [{'title': 'Problem Scale (T1)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Problem Scale (T2)', 'categories': [{'measurements': [{'value': '.14', 'spread': '.18', 'groupId': 'OG000'}, {'value': '.16', 'spread': '.19', 'groupId': 'OG001'}]}]}, {'title': 'Problem Scale (T3)', 'categories': [{'measurements': [{'value': '.14', 'spread': '.2', 'groupId': 'OG000'}, {'value': '.15', 'spread': '.19', 'groupId': 'OG001'}]}]}, {'title': 'Problem Scale (T4)', 'categories': [{'measurements': [{'value': '.12', 'spread': '.18', 'groupId': 'OG000'}, {'value': '.13', 'spread': '.19', 'groupId': 'OG001'}]}]}, {'title': 'Intensity Scale (T1)', 'categories': [{'measurements': [{'value': '2.80', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '2.84', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Intensity Scale (T2)', 'categories': [{'measurements': [{'value': '2.69', 'spread': '.85', 'groupId': 'OG000'}, {'value': '2.69', 'spread': '.72', 'groupId': 'OG001'}]}]}, {'title': 'Intensity Scale (T3)', 'categories': [{'measurements': [{'value': '2.64', 'spread': '.8', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '.75', 'groupId': 'OG001'}]}]}, {'title': 'Intensity Scale (T4)', 'categories': [{'measurements': [{'value': '2.64', 'spread': '.74', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.', 'description': 'Eyberg Child Behavior Inventory (ECBI) Problem scale (range 0-1) higher scores more problems Intensity scale (range 1-7) higher scores more intense problems', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Severity (intensity scale) 1 = never happens to 7 = always happening (higher scores more intense problems) - range is 1-7 Frequency (problem Scale of child behaviors. 0 = no; 1 = yes (higher scores more problems) Range 0-1\n\nT1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.'}, {'type': 'SECONDARY', 'title': 'Change in Parenting Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: ezParent Program', 'description': 'ezParent Program: Tablet-based behavioral parent training program.'}, {'id': 'OG001', 'title': 'Control: Health-e Kids App', 'description': 'Health-e Kids Control App: Tablet based health promotion information App'}], 'classes': [{'title': 'Parent Domain (T1)', 'categories': [{'measurements': [{'value': '26.06', 'spread': '9.58', 'groupId': 'OG000'}, {'value': '25.53', 'spread': '7.86', 'groupId': 'OG001'}]}]}, {'title': 'Parent Domain (T2)', 'categories': [{'measurements': [{'value': '25.9', 'spread': '9.26', 'groupId': 'OG000'}, {'value': '25.25', 'spread': '8.17', 'groupId': 'OG001'}]}]}, {'title': 'Parent Domain (T3)', 'categories': [{'measurements': [{'value': '25.39', 'spread': '10.04', 'groupId': 'OG000'}, {'value': '25.41', 'spread': '9.56', 'groupId': 'OG001'}]}]}, {'title': 'Parent Domain (T4)', 'categories': [{'measurements': [{'value': '25.3', 'spread': '9.72', 'groupId': 'OG000'}, {'value': '24.64', 'spread': '8.18', 'groupId': 'OG001'}]}]}, {'title': 'Parent-Child Domain (T1)', 'categories': [{'measurements': [{'value': '20.28', 'spread': '6.38', 'groupId': 'OG000'}, {'value': '19.76', 'spread': '6.05', 'groupId': 'OG001'}]}]}, {'title': 'Parent-Child Domain (T2)', 'categories': [{'measurements': [{'value': '19.62', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '20.02', 'spread': '5.79', 'groupId': 'OG001'}]}]}, {'title': 'Parent-Child Domain (T3)', 'categories': [{'measurements': [{'value': '19.62', 'spread': '6.53', 'groupId': 'OG000'}, {'value': '19.7', 'spread': '6.87', 'groupId': 'OG001'}]}]}, {'title': 'Parent-Child Domain (T4)', 'categories': [{'measurements': [{'value': '19.52', 'spread': '6.03', 'groupId': 'OG000'}, {'value': '19.62', 'spread': '6.07', 'groupId': 'OG001'}]}]}, {'title': 'Child Domain (T1)', 'categories': [{'measurements': [{'value': '24.72', 'spread': '8.02', 'groupId': 'OG000'}, {'value': '24.24', 'spread': '6.86', 'groupId': 'OG001'}]}]}, {'title': 'Child Domain (T2)', 'categories': [{'measurements': [{'value': '23.97', 'spread': '7.62', 'groupId': 'OG000'}, {'value': '24.34', 'spread': '7.29', 'groupId': 'OG001'}]}]}, {'title': 'Child Domain (T3)', 'categories': [{'measurements': [{'value': '23.37', 'spread': '7.45', 'groupId': 'OG000'}, {'value': '23.46', 'spread': '7.66', 'groupId': 'OG001'}]}]}, {'title': 'Child Domain (T4)', 'categories': [{'measurements': [{'value': '23.11', 'spread': '7.18', 'groupId': 'OG000'}, {'value': '23.18', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.', 'description': 'Parenting Stress Index-Short Form (PSI-SF) Scales (range 12-60): Higher scores indicate higher stress Parental distress Parent-child dysfunctional interaction Difficult child', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Parenting Self-efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: ezParent Program', 'description': 'ezParent Program: Tablet-based behavioral parent training program.'}, {'id': 'OG001', 'title': 'Control: Health-e Kids App', 'description': 'Health-e Kids Control App: Tablet based health promotion information App'}], 'classes': [{'title': 'Total Score (T1)', 'categories': [{'measurements': [{'value': '71.07', 'spread': '11.41', 'groupId': 'OG000'}, {'value': '71.28', 'spread': '10.62', 'groupId': 'OG001'}]}]}, {'title': 'Total Score (T2)', 'categories': [{'measurements': [{'value': '71.51', 'spread': '11.20', 'groupId': 'OG000'}, {'value': '70.94', 'spread': '10.7', 'groupId': 'OG001'}]}]}, {'title': 'Total Score (T3)', 'categories': [{'measurements': [{'value': '72.99', 'spread': '11.16', 'groupId': 'OG000'}, {'value': '71.73', 'spread': '12.24', 'groupId': 'OG001'}]}]}, {'title': 'Total Score (T4)', 'categories': [{'measurements': [{'value': '72.9', 'spread': '12.10', 'groupId': 'OG000'}, {'value': '72.1', 'spread': '11.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.', 'description': 'Parenting Sense of Competence Scale (PSOC) - Total Scale (Range 17-102) Higher scores indicate higher self efficacy', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention: ezParent Program', 'description': 'ezParent Program: Tablet-based behavioral parent training program.'}, {'id': 'FG001', 'title': 'Control: Health-e Kids App', 'description': 'Health-e Kids Control App: Tablet based health promotion information App'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Recruitment occurred from April 2016 - April 2018', 'preAssignmentDetails': 'No pre-assignment in study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention: ezParent Program', 'description': 'ezParent Program: Tablet-based behavioral parent training program.'}, {'id': 'BG001', 'title': 'Control: Health-e Kids App', 'description': 'Health-e Kids Control App: Tablet based health promotion information App'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'spread': '8.16', 'groupId': 'BG000'}, {'value': '32.9', 'spread': '7.70', 'groupId': 'BG001'}, {'value': '32.8', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-09-01', 'size': 351681, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-25T09:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-06', 'studyFirstSubmitDate': '2016-01-21', 'resultsFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2016-03-24', 'lastUpdatePostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-06', 'studyFirstPostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parenting Behaviors', 'timeFrame': 'T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.', 'description': 'Measured by the Parent Questionnaire (PQ)\n\nScale scores reported:\n\nWarmth (scale range 1-5) - higher score indicates improvement Parent Follow Through (scale range 1-5) - higher score indicates improvement Corporal punishment (scale range 1-5) - lower score indicates improvement'}], 'secondaryOutcomes': [{'measure': 'Change in Parent Behaviors', 'timeFrame': 'T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.', 'description': 'Measured by the Parenting Young Children (PARYC) Reporting scales (scale range 1-7) (higher scores indicate more effective/improved parenting) Supporting good behavior Setting limits Proactive parenting'}, {'measure': 'Change in Child Behavior Problems', 'timeFrame': 'T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.', 'description': 'Strengths and Difficulties Questionnaire (SDQ) scales (range 0-10) Emotional symptoms (higher scores indicate more difficulties) Conduct problems (higher scores indicate more difficulties) Hyperactivity/inattention (higher scores indicate more difficulties) Peer relationship problems (higher scores indicate more difficulties) Prosocial behavior (higher scores indicate more strengths)'}, {'measure': 'Change in Child Externalizing Behavior Problems', 'timeFrame': 'T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.', 'description': 'Eyberg Child Behavior Inventory (ECBI) Problem scale (range 0-1) higher scores more problems Intensity scale (range 1-7) higher scores more intense problems'}, {'measure': 'Change in Parenting Stress', 'timeFrame': 'T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.', 'description': 'Parenting Stress Index-Short Form (PSI-SF) Scales (range 12-60): Higher scores indicate higher stress Parental distress Parent-child dysfunctional interaction Difficult child'}, {'measure': 'Change in Parenting Self-efficacy', 'timeFrame': 'T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.', 'description': 'Parenting Sense of Competence Scale (PSOC) - Total Scale (Range 17-102) Higher scores indicate higher self efficacy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parents', 'Child', 'Preschool', 'eHealth'], 'conditions': ['Parent Training', 'Primary Care']}, 'referencesModule': {'references': [{'pmid': '27592122', 'type': 'BACKGROUND', 'citation': 'Breitenstein SM, Schoeny M, Risser H, Johnson T. A study protocol testing the implementation, efficacy, and cost effectiveness of the ezParent program in pediatric primary care. Contemp Clin Trials. 2016 Sep;50:229-37. doi: 10.1016/j.cct.2016.08.017. Epub 2016 Aug 31.'}, {'pmid': '31621349', 'type': 'RESULT', 'citation': 'Breitenstein SM, Laurent S, Pabalan L, Risser HJ, Roper P, Saba MT, Schoeny M. Implementation findings from an effectiveness-implementation trial of tablet-based parent training in pediatric primary care. Fam Syst Health. 2019 Dec;37(4):282-290. doi: 10.1037/fsh0000447. Epub 2019 Oct 17.'}, {'pmid': '35821979', 'type': 'RESULT', 'citation': 'Fehrenbacher C, Schoeny ME, Reed M, Shattell M, Breitenstein SM. Referral to Digital Parent Training in Primary Care: Facilitators and Barriers. Clin Pract Pediatr Psychol. 2020 Sep;8(3):268-277. doi: 10.1037/cpp0000367.'}, {'pmid': '33338496', 'type': 'DERIVED', 'citation': 'Breitenstein SM, Fehrenbacher C, Holod AF, Schoeny ME. A Randomized Trial of Digitally Delivered, Self-Administered Parent Training in Primary Care: Effects on Parenting and Child Behavior. J Pediatr. 2021 Apr;231:207-214.e4. doi: 10.1016/j.jpeds.2020.12.016. Epub 2020 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'High quality and effective parenting in the preschool years is connected with long term positive child behavior and mental health outcomes. The purpose of the study, "Parent Training in Pediatric Primary Care: A Self-directed Tablet-based Approach," is to test the outcomes and implementation of a tablet-based parent training program in Pediatric Primary Care. Testing and evaluating the implementation of digitally delivered programs is important to increase the ease, reach, sustainability, and integration of mental health prevention into primary care settings.', 'detailedDescription': "One in four young children in the United States faces poverty-associated risks that make her or him more likely to have mental health and behavior problems. These problems, left untreated, can have long-term social, emotional, and behavioral consequences. High-quality parenting in the preschool years can substantially buffer the negative effects of socioeconomic adversity on children's mental health and behavior. However, most parent training programs use face-to-face delivery models resulting in barriers to participation and limited reach to those most in need. Testing the efficacy and implementation of alternative delivery models is needed to (a) increase the reach and sustainability of parent training interventions and (b) address the barriers to parent participation and implementation of such programs, specifically in primary health care settings. The parent training program proposed in this study is a digital adaptation (tablet-based) of the evidence-based based Chicago Parent Program (CPP) called the ezParent Program. The purpose of this study is to evaluate the efficacy, cost-effectiveness, and implementation process of delivering the ezParent in pediatric primary care sites serving low-income, urban families. The specific aims of the study are: (1) Test the direct effects of the 6-module ezParent Program on parenting outcomes (parenting behavior, parenting self-efficacy, and parenting stress) and child outcomes (child problem and prosocial behavior) compared to an enhanced usual care control condition among low-income parents with young children seen in primary care settings; (2) Compare the cost-effectiveness of the ezParent intervention relative to the control condition for the parenting and child outcomes; and (3) Quantify the levels of program implementation of the ezParent Program in primary care using the RE-AIM framework. The efficacy of the ezParent Program will be tested using a randomized clinical trial design with 312 parents of 2- to 5-year-old children from pediatric primary care settings. Data on parenting and child behavior outcomes will be obtained from all participants at baseline, and 3, 6, and 12 months post baseline. A descriptive design guided by the RE-AIM framework and cost-effectiveness analysis will evaluate the implementation of the ezParent Program in the pediatric primary care sites.\n\nIntegrating and evaluating the implementation of the ezParent Program is an innovative opportunity to promote parenting with potential for universal access to the preschool (2- to 5-year-olds) population and potential for low cost by building on existing infrastructure. Findings from this study will lay the foundation for full-scale implementation of the ezParent Program in pediatric primary care settings and subsequent implementation and dissemination research."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parent, legal guardian, or primary caregiver for the target child,\n* target child is 2-5 years old,\n* child receives care at the primary practice implementation site,\n* parent can speak and read English.\n\nExclusion Criteria:\n\n* Only one parent per family\n* Parent does not meet inclusion criteria.\n* Parent previously used the ezPARENT program.'}, 'identificationModule': {'nctId': 'NCT02723916', 'briefTitle': 'Parent Training in Pediatric Care: A Self Directed Tablet-Based Approach', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Parent Training in Pediatric Care: A Self Directed Tablet-Based Approach', 'orgStudyIdInfo': {'id': 'ORA# 15012705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention: ezParent Program', 'interventionNames': ['Behavioral: ezParent Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control: Health-e Kids App', 'interventionNames': ['Behavioral: Health-e Kids Control App']}], 'interventions': [{'name': 'ezParent Program', 'type': 'BEHAVIORAL', 'otherNames': ['previously called eCPP'], 'description': 'Tablet-based behavioral parent training program.', 'armGroupLabels': ['Intervention: ezParent Program']}, {'name': 'Health-e Kids Control App', 'type': 'BEHAVIORAL', 'description': 'Tablet based health promotion information App', 'armGroupLabels': ['Control: Health-e Kids App']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Susie Breitenstein', 'investigatorAffiliation': 'Ohio State University'}}}}