Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-29 @ 11:21 AM
Study NCT ID:
NCT04622969
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2020-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Healthy Child Development Program Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002652', 'term': 'Child Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lisaj@mailbox.sc.edu', 'phone': '8037777095', 'title': 'Director, Office of Research Compliance', 'organization': 'University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study:\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Child Behavior Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '132.8', 'spread': '35.5', 'groupId': 'OG000'}, {'value': '145.4', 'spread': '30.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, pre-intervention', 'description': 'Child behavior problems refers to the Eyberg Child Behavior Inventory Intensity Scale, which is the sum of parental report responses on 36 items. The minimum and maximum values on this measure are 36 and 252 respectively, with higher scores meaning a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Child Behavior Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '108.2', 'spread': '31.4', 'groupId': 'OG000'}, {'value': '139.1', 'spread': '30.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-21.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.157', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'six months after baseline assessment', 'description': 'Child behavior problems refers to the Eyberg Child Behavior Inventory Intensity Scale, which is the sum of parental report responses on 36 items. The minimum and maximum values on this measure are 36 and 252 respectively, with higher scores meaning a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Child Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.9', 'spread': '6.99', 'groupId': 'OG000'}, {'value': '92.9', 'spread': '6.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, pre-intervention', 'description': 'Child physical activity will be measured using an ActiGraph Link accelerometer to assess the number of minutes each day for each level of activity, to arrive at the average number of minutes per day the child spends engaging in moderate and vigorous physical activity.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Child Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'spread': '7.13', 'groupId': 'OG000'}, {'value': '82.5', 'spread': '7.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '7.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'six months after baseline assessment', 'description': 'Child physical activity will be measured using an ActiGraph Link accelerometer to assess the number of minutes each day for each level of activity, to arrive at the average number of minutes per day the child spends engaging in moderate and vigorous physical activity.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Child Screen Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.59', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '2.29', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, pre-intervention', 'description': 'Multi-day estimate of child screen time will be derived from parental log for the daily amount of child screen time at home.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Child Screen Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.35', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'six months after baseline assessment', 'description': 'Multi-day estimate of child screen time will be derived from parental log for the daily amount of child screen time at home.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Child Sleep Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, pre-intervention', 'description': 'Multi-day estimate of child sleep duration will be derived from parental log for the daily amount of child sleep duration at home.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Child Sleep Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.99', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0015', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.145', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'six months after baseline assessment', 'description': 'Multi-day estimate of child sleep duration will be derived from parental log for the daily amount of child sleep duration at home.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parenting Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.29', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '3.29', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, pre-intervention', 'description': 'Parenting difficulties refers to the Parenting Scale Total Score. The total score is the average of 30 items, with a minimum value of 1.0 and a maximum value of 7.0. Higher scores mean a worse outcome (i.e., greater parenting difficulties).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parenting Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.90', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '3.17', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.264', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.121', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'six months after baseline assessment', 'description': 'Parenting difficulties refers to the Parenting Scale Total Score. The total score is the average of 30 items, with a minimum value of 1.0 and a maximum value of 7.0. Higher scores mean a worse outcome (i.e., greater parenting difficulties).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parental Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '47.2', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, pre-intervention', 'description': 'Parental stress refers to the Parenting Daily Hassles Scale, which is the total of 20 items. The minimum and maximum values are 0 and 80 respectively, with higher scores meaning a worse outcome (i.e., greater parental stress).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parental Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.24', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '45.72', 'spread': '9.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-5.573', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.802', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'six months after baseline assessment', 'description': 'Parental stress refers to the Parenting Daily Hassles Scale, which is the total of 20 items. The minimum and maximum values are 0 and 80 respectively, with higher scores meaning a worse outcome (i.e., greater parental stress).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parental Confidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.3', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '71.6', 'spread': '9.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, pre-intervention', 'description': 'Parental confidence refers to the Parenting Sense of Competence scale. This scale, based on the sum of responses on 17 items, ranges from a minimum of 17 and a maximum of 102, with higher scores meaning a better outcome (i.e., greater parental confidence).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parental Confidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.96', 'spread': '10.48', 'groupId': 'OG000'}, {'value': '73.79', 'spread': '9.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=.062', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.509', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.842', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.78', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.047', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.170', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'six months after baseline assessment', 'description': 'Parental confidence refers to the Parenting Sense of Competence scale. This scale, based on the sum of responses on 17 items, ranges from a minimum of 17 and a maximum of 102, with higher scores meaning a better outcome (i.e., greater parental confidence).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'FG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention\n\nHealthy Child Development Program: The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.'}, {'id': 'BG001', 'title': 'Wait List Control', 'description': 'Not provide the Healthy Child Development Program during study\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.03', 'spread': '0.66', 'groupId': 'BG000'}, {'value': '3.98', 'spread': '0.79', 'groupId': 'BG001'}, {'value': '4.01', 'spread': '0.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Child Gender', 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '57', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Outcome Measure Child Behavior Problems', 'classes': [{'categories': [{'measurements': [{'value': '132.8', 'spread': '35.5', 'groupId': 'BG000'}, {'value': '145.4', 'spread': '30.9', 'groupId': 'BG001'}, {'value': '139.2', 'spread': '33.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-04-16', 'size': 103404, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-17T13:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2020-10-24', 'resultsFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-17', 'studyFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child Behavior Problems', 'timeFrame': 'baseline, pre-intervention', 'description': 'Child behavior problems refers to the Eyberg Child Behavior Inventory Intensity Scale, which is the sum of parental report responses on 36 items. The minimum and maximum values on this measure are 36 and 252 respectively, with higher scores meaning a worse outcome.'}, {'measure': 'Child Behavior Problems', 'timeFrame': 'six months after baseline assessment', 'description': 'Child behavior problems refers to the Eyberg Child Behavior Inventory Intensity Scale, which is the sum of parental report responses on 36 items. The minimum and maximum values on this measure are 36 and 252 respectively, with higher scores meaning a worse outcome.'}, {'measure': 'Child Physical Activity', 'timeFrame': 'baseline, pre-intervention', 'description': 'Child physical activity will be measured using an ActiGraph Link accelerometer to assess the number of minutes each day for each level of activity, to arrive at the average number of minutes per day the child spends engaging in moderate and vigorous physical activity.'}, {'measure': 'Child Physical Activity', 'timeFrame': 'six months after baseline assessment', 'description': 'Child physical activity will be measured using an ActiGraph Link accelerometer to assess the number of minutes each day for each level of activity, to arrive at the average number of minutes per day the child spends engaging in moderate and vigorous physical activity.'}, {'measure': 'Child Screen Time', 'timeFrame': 'baseline, pre-intervention', 'description': 'Multi-day estimate of child screen time will be derived from parental log for the daily amount of child screen time at home.'}, {'measure': 'Child Screen Time', 'timeFrame': 'six months after baseline assessment', 'description': 'Multi-day estimate of child screen time will be derived from parental log for the daily amount of child screen time at home.'}, {'measure': 'Child Sleep Duration', 'timeFrame': 'baseline, pre-intervention', 'description': 'Multi-day estimate of child sleep duration will be derived from parental log for the daily amount of child sleep duration at home.'}, {'measure': 'Child Sleep Duration', 'timeFrame': 'six months after baseline assessment', 'description': 'Multi-day estimate of child sleep duration will be derived from parental log for the daily amount of child sleep duration at home.'}], 'secondaryOutcomes': [{'measure': 'Parenting Difficulties', 'timeFrame': 'baseline, pre-intervention', 'description': 'Parenting difficulties refers to the Parenting Scale Total Score. The total score is the average of 30 items, with a minimum value of 1.0 and a maximum value of 7.0. Higher scores mean a worse outcome (i.e., greater parenting difficulties).'}, {'measure': 'Parenting Difficulties', 'timeFrame': 'six months after baseline assessment', 'description': 'Parenting difficulties refers to the Parenting Scale Total Score. The total score is the average of 30 items, with a minimum value of 1.0 and a maximum value of 7.0. Higher scores mean a worse outcome (i.e., greater parenting difficulties).'}, {'measure': 'Parental Stress', 'timeFrame': 'baseline, pre-intervention', 'description': 'Parental stress refers to the Parenting Daily Hassles Scale, which is the total of 20 items. The minimum and maximum values are 0 and 80 respectively, with higher scores meaning a worse outcome (i.e., greater parental stress).'}, {'measure': 'Parental Stress', 'timeFrame': 'six months after baseline assessment', 'description': 'Parental stress refers to the Parenting Daily Hassles Scale, which is the total of 20 items. The minimum and maximum values are 0 and 80 respectively, with higher scores meaning a worse outcome (i.e., greater parental stress).'}, {'measure': 'Parental Confidence', 'timeFrame': 'baseline, pre-intervention', 'description': 'Parental confidence refers to the Parenting Sense of Competence scale. This scale, based on the sum of responses on 17 items, ranges from a minimum of 17 and a maximum of 102, with higher scores meaning a better outcome (i.e., greater parental confidence).'}, {'measure': 'Parental Confidence', 'timeFrame': 'six months after baseline assessment', 'description': 'Parental confidence refers to the Parenting Sense of Competence scale. This scale, based on the sum of responses on 17 items, ranges from a minimum of 17 and a maximum of 102, with higher scores meaning a better outcome (i.e., greater parental confidence).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Child Behavior', 'Child Health', 'Child, Preschool', 'Parents']}, 'descriptionModule': {'briefSummary': 'This study conducts a preliminary test of an intervention program delivered in the home to assist families of preschool-age children with social, emotional, and behavioral development, and the acquisition of healthy lifestyle behaviors.', 'detailedDescription': 'Utilizing referrals from community-based organizations serving high-risk families, this study addresses both health and behavioral domains through a family-based intervention. The home-delivered prevention intervention includes content on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices. Families engage in practical skill building and have the opportunity to practice these skills and receive feedback.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parent has primary custody of the child\n* one or more children in the home is in the 3 to 4 year old age range\n* English-speaking parent\n* parent stated an interest to participate in the program\n* parent completes informed consent process\n* family experiencing economic disadvantage\n* parenting challenges due to child behavior\n\nExclusion Criteria:\n\n* an open Child Protective Services maltreatment case on the family\n* parent receiving inpatient treatment or enrolled in an institutional-residential treatment program'}, 'identificationModule': {'nctId': 'NCT04622969', 'briefTitle': 'The Healthy Child Development Program Study', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'Targeting Behavioral Adjustment and Healthy Lifestyle in Preschool-age Children Using an Integrated Family-Based Intervention', 'orgStudyIdInfo': {'id': 'Pro00091502'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Provide the 15-week Healthy Child Development Program intervention', 'interventionNames': ['Behavioral: Healthy Child Development Program']}, {'type': 'NO_INTERVENTION', 'label': 'Wait list control', 'description': 'Not provide the Healthy Child Development Program during study:\n\nIndividuals in this condition do not participate in the intervention program until after the study period is completed.'}], 'interventions': [{'name': 'Healthy Child Development Program', 'type': 'BEHAVIORAL', 'description': 'The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29204', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'Kristen D Seay, Ph.D., MSW', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ron Prinz, PhD', 'investigatorAffiliation': 'University of South Carolina'}}}}