Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT04383327
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2020-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
School-Based Mental Health Effectiveness Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Keng-Yen.Huang@nyulangone.org', 'phone': '646-501-2879', 'title': 'Keng-Yen Huang, PhD, MPH', 'organization': 'NYU Langone Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Two years.', 'eventGroups': [{'id': 'EG000', 'title': 'ParentCorps-Professional Development (PD)', 'description': 'n = 6 Schools in Kampala, Uganda (Urban) - 89 Teachers, 325 Parent-Child Pairs\n\n\\+ n = 10 Schools in Hoima, Uganda (Rural) - 98 Teachers, 344 Parent-Child Pairs\n\nParentCorps-Professional Development (PD): Multi-component school-based intervention that promotes early childhood mental health and development. Teachers (pre-primary to 4th grade) will participate in a 3-day ParentCorps-PD training during the school term. They will also receive 8 sessions (8 hours) of face-to-face group-based coaching during after the training. Coaching sessions are to help teachers apply EBI strategies in their classrooms, engage families, and develop competencies.', 'otherNumAtRisk': 1525, 'deathsNumAtRisk': 1525, 'otherNumAffected': 0, 'seriousNumAtRisk': 1525, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness', 'description': 'n = 6 Schools in Kampala, Uganda (Urban) - 77 Teachers, 300 Parent-Child Pairs\n\n\\+ n = 10 Schools in Hoima, Uganda (Rural) - 80 Teachers, 329 Parent-Child Pairs\n\nParentCorps-Professional Development (PD): Multi-component school-based intervention that promotes early childhood mental health and development. Teachers (pre-primary to 4th grade) will participate in a 3-day ParentCorps-PD training during the school term. They will also receive 8 sessions (8 hours) of face-to-face group-based coaching during after the training. Coaching sessions are to help teachers apply EBI strategies in their classrooms, engage families, and develop competencies.\n\nT-Wellness: A brief teacher stress management psychoeducation package, adapted from EBIs including one-day workshop for common stress management and stress management, and three follow-up group support sessions (3 additional monthly 1-hr wellness sessions for teachers as a group that were integrated into the 3 of the 8 PD coaching sessions. A total 3 hours of coaching were included.', 'otherNumAtRisk': 1415, 'deathsNumAtRisk': 1415, 'otherNumAffected': 0, 'seriousNumAtRisk': 1415, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control', 'description': 'n = 6 Schools in Kampala, Uganda (Urban) - 73 Teachers, 316 Parent-Child Pairs\n\n\\+ n = 9 Schools in Hoima, Uganda (Rural) - 92 Teachers, 321 Parent-Child Pairs', 'otherNumAtRisk': 1439, 'deathsNumAtRisk': 1439, 'otherNumAffected': 0, 'seriousNumAtRisk': 1439, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Teacher Knowledge of Evidence-Based Practice (Knowledge Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Teacher: Urban and Rural', 'description': 'Teachers assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.68', 'spread': '14.46', 'groupId': 'OG000'}, {'value': '36.41', 'spread': '13.96', 'groupId': 'OG001'}, {'value': '35.18', 'spread': '11.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Teachers will complete a 10-item quiz assessing EBI knowledge. The total score is the number of correct responses and ranges from 0-100; higher scores indicate greater knowledge.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All teacher participants were analyzed.'}, {'type': 'PRIMARY', 'title': 'Teacher Knowledge of Evidence-Based Practice (Knowledge Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Teacher: Urban and Rural', 'description': 'Teachers assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.91', 'spread': '15.85', 'groupId': 'OG000'}, {'value': '45.12', 'spread': '14.12', 'groupId': 'OG001'}, {'value': '36.75', 'spread': '13.64', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'Teachers will complete a 10-item quiz assessing EBI knowledge. The total score is the number of correct responses and ranges from 0-100; higher scores indicate greater knowledge.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean values are reported based on the raw data using cases with the follow up data. However, effectiveness outcome analysis were conducted based on the entire sample using imputated data.'}, {'type': 'PRIMARY', 'title': 'Teacher EBI Practice Score-Emotion Support Strategies Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Teacher: Urban and Rural', 'description': 'Teachers assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.92', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '3.91', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '3.77', 'spread': '0.83', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "The Emotion Socialization Scale assesses teachers' practice in supporting students' management of negative emotions. Each of the scale items (6 items) are rated on a scale from 1 to 5. The total score is the average of responses and ranges from 1-5; lower scores indicate lower adherence to EBI practice.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All teacher participants were analyzed.'}, {'type': 'PRIMARY', 'title': 'Teacher EBI Practice Score-Emotion Support Strategies Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Teacher: Urban and Rural', 'description': 'Teachers assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.83', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '4.06', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '3.74', 'spread': '0.81', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': "The Emotion Socialization Scale assesses teachers' practice in supporting students' management of negative emotions. Each of the scale items (6 items) are rated on a scale from 1 to 5. The total score is the average of responses and ranges from 1-5; lower scores indicate lower adherence to EBI practice.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean values are reported based on the raw data using cases with the follow up data. However, effectiveness outcome analysis were conducted based on the entire sample using imputated data.'}, {'type': 'PRIMARY', 'title': 'Teacher EBI Practice Score-Emotion Support Strategies Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Teacher: Urban and Rural', 'description': 'Teachers assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.14', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '4.19', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '3.98', 'spread': '0.77', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 18', 'description': "The Emotion Socialization Scale assesses teachers' practice in supporting students' management of negative emotions. Each of the scale items (6 items) are rated on a scale from 1 to 5. The total score is the average of responses and ranges from 1-5; lower scores indicate lower adherence to EBI practice.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean values are reported based on the raw data using cases with the follow up data. However, effectiveness outcome analysis were conducted based on the entire sample using imputated data.'}, {'type': 'PRIMARY', 'title': 'Teacher Stress Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Teacher: Urban and Rural', 'description': 'Teachers assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.98', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '2.05', 'spread': '0.66', 'groupId': 'OG001'}, {'value': '2.07', 'spread': '0.58', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Teachers complete a 5-item assessment of stress over the past month. Each item is rated on a scale from 1 to 4. The total score is the average of responses and ranges from 1-4. Higher scores indicate greater stress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All teacher participants were analyzed.'}, {'type': 'PRIMARY', 'title': 'Teacher Stress Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Teacher: Urban and Rural', 'description': 'Teachers assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.79', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '1.93', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'Teachers complete a 5-item assessment of stress over the past month. Each item is rated on a scale from 1 to 4. The total score is the average of responses and ranges from 1-4. Higher scores indicate greater stress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean values are reported based on the raw data using cases with the follow up data. However, effectiveness outcome analysis were conducted based on the entire sample using imputated data.'}, {'type': 'PRIMARY', 'title': 'Teacher Stress Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Teacher: Urban and Rural', 'description': 'Teachers assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.84', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.83', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '1.83', 'spread': '0.58', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 18', 'description': 'Teachers complete a 5-item assessment of stress over the past month. Each item is rated on a scale from 1 to 4. The total score is the average of responses and ranges from 1-4. Higher scores indicate greater stress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean values are reported based on the raw data using cases with the follow up data. However, effectiveness outcome analysis were conducted based on the entire sample using imputated data.'}, {'type': 'PRIMARY', 'title': "Child's Emotion Regulation Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}, {'value': '637', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Parents: Urban and Rural', 'description': 'Parents assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban and Rural', 'description': 'Parents assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Parents: Urban and Rural', 'description': 'Parents assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.33', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '2.42', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '2.39', 'spread': '0.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Parents answer 6 questions about their child's emotion regulation behavior over the past 7 days. Each item is rated on a Likert scale from 0 (not at all) to 4 (very well). The total score ranges from 0 to 4; higher scores indicate greater emotion regulation.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All parent participants' data are analyzed."}, {'type': 'PRIMARY', 'title': "Child's Emotion Regulation Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '441', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Parents: Urban and Rural', 'description': 'Parents assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban and Rural', 'description': 'Parents assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Parents: Urban and Rural', 'description': 'Parents assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.71', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '2.75', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '2.58', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': "Parents answer 6 questions about their child's emotion regulation behavior over the past 7 days. Each item is rated on a Likert scale from 0 (not at all) to 4 (very well). The total score ranges from 0 to 4; higher scores indicate greater emotion regulation.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean values are reported based on the raw data using cases with the follow up data. However, effectiveness outcome analysis were conducted based on the entire sample using imputated data.'}, {'type': 'PRIMARY', 'title': "Child's Emotion Regulation Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Parents: Urban and Rural', 'description': 'Parents assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban and Rural', 'description': 'Parents assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Parents: Urban and Rural', 'description': 'Parents assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.56', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '2.47', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '2.53', 'spread': '0.64', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 18', 'description': "Parents answer 6 questions about their child's emotion regulation behavior over the past 7 days. Each item is rated on a Likert scale from 0 (not at all) to 4 (very well). The total score ranges from 0 to 4; higher scores indicate greater emotion regulation.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean values are reported based on the raw data using cases with the follow up data. However, effectiveness outcome analysis were conducted based on the entire sample using imputated data.'}, {'type': 'SECONDARY', 'title': 'Teacher Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Teacher: Urban and Rural', 'description': 'Teachers assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.74', 'spread': '5.62', 'groupId': 'OG000'}, {'value': '21.54', 'spread': '6.68', 'groupId': 'OG001'}, {'value': '20.55', 'spread': '5.81', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Teachers complete Kessler Psychological Distress Scale (K10), which assesses anxiety and depressive symptoms that teacher experiencing over the past month. Each item is rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0 to 40, where higher scores indicate greater psychological distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All teacher participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Teacher Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Teacher: Urban and Rural', 'description': 'Teachers assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.55', 'spread': '6.01', 'groupId': 'OG000'}, {'value': '18.84', 'spread': '5.17', 'groupId': 'OG001'}, {'value': '19.77', 'spread': '6.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'Teachers complete Kessler Psychological Distress Scale (K10), which assesses anxiety and depressive symptoms that teacher experiencing over the past month. Each item is rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0 to 40, where higher scores indicate greater psychological distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean values are reported based on the raw data using cases with the follow up data. However, effectiveness outcome analysis were conducted based on the entire sample using imputated data.'}, {'type': 'SECONDARY', 'title': 'Teacher Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban and Rural', 'description': 'Teachers assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Teacher: Urban and Rural', 'description': 'Teachers assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.79', 'spread': '5.96', 'groupId': 'OG000'}, {'value': '18.82', 'spread': '5.55', 'groupId': 'OG001'}, {'value': '19.32', 'spread': '5.94', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 18', 'description': 'Teachers complete Kessler Psychological Distress Scale (K10), which assesses anxiety and depressive symptoms that teacher experiencing over the past month. Each item is rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0 to 40, where higher scores indicate greater psychological distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean values are reported based on the raw data using cases with the follow up data. However, effectiveness outcome analysis were conducted based on the entire sample using imputated data.'}, {'type': 'SECONDARY', 'title': 'Child Mental Health- Conduct Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}, {'value': '637', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Parents: Urban and Rural', 'description': 'Parents assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban and Rural', 'description': 'Parents assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Parents: Urban and Rural', 'description': 'Parents assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.39', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '1.98', 'groupId': 'OG001'}, {'value': '2.44', 'spread': '2.09', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Conduct problem items (5 items) from the Strengths and Difficulties Questionnaire (SDQ) are rated by parents, which assesses child's conduct and non-compliant behaviors over the last six months. Each item is rated on a Likert scale from 0 (not true) to 2 (certainly true). The total score is the sum of responses and ranges from 0-10; higher scores indicate greater difficulties.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All parent participants are analyzed.'}, {'type': 'SECONDARY', 'title': 'Child Mental Health- Conduct Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '441', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Parents: Urban and Rural', 'description': 'Parents assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban and Rural', 'description': 'Parents assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Parents: Urban and Rural', 'description': 'Parents assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.96', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '1.90', 'groupId': 'OG001'}, {'value': '2.13', 'spread': '1.95', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': "Conduct problem items (5 items) from the Strengths and Difficulties Questionnaire (SDQ) are rated by parents, which assesses child's conduct and non-compliant behaviors over the last six months. Each item is rated on a Likert scale from 0 (not true) to 2 (certainly true). The total score is the sum of responses and ranges from 0-10; higher scores indicate greater difficulties.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean values are reported based on the raw data using cases with the follow up data. However, effectiveness outcome analysis were conducted based on the entire sample using imputated data.'}, {'type': 'SECONDARY', 'title': 'Child Mental Health- Conduct Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ParentCorps-Professional Development (PD) - Parents: Urban and Rural', 'description': 'Parents assigned to the PD-only group.'}, {'id': 'OG001', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban and Rural', 'description': 'Parents assigned to the PD+T wellness group.'}, {'id': 'OG002', 'title': 'Control - Parents: Urban and Rural', 'description': 'Parents assigned to the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.76', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '1.69', 'groupId': 'OG001'}, {'value': '1.77', 'spread': '1.64', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 18', 'description': "Conduct problem items (5 items) from the Strengths and Difficulties Questionnaire (SDQ) are rated by parents, which assesses child's conduct and non-compliant behaviors over the last six months. Each item is rated on a Likert scale from 0 (not true) to 2 (certainly true). The total score is the sum of responses and ranges from 0-10; higher scores indicate greater difficulties.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean values are reported based on the raw data using cases with the follow up data. However, effectiveness outcome analysis were conducted based on the entire sample using imputated data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ParentCorps-Professional Development (PD) - Parent + Child: Urban', 'description': 'Parents + Children assigned to the PD-only group in an urban setting.'}, {'id': 'FG001', 'title': 'ParentCorps-Professional Development (PD) - Teachers: Urban', 'description': 'Teachers assigned to the PD-only group in an urban setting.'}, {'id': 'FG002', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Parent + Child: Urban', 'description': 'Parents + Children assigned to the PD+T wellness group in an urban setting.'}, {'id': 'FG003', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban', 'description': 'Teachers assigned to the PD+T wellness group in an urban setting.'}, {'id': 'FG004', 'title': 'Control - Parent + Child: Urban', 'description': 'Parents + Children assigned to the control group in an urban setting.'}, {'id': 'FG005', 'title': 'Control - Teacher: Urban', 'description': 'Teachers assigned to the control group in an urban setting.'}, {'id': 'FG006', 'title': 'ParentCorps-Professional Development (PD) - Parent + Child: Rural', 'description': 'Parents + Children assigned to the PD-only group in a rural setting.'}, {'id': 'FG007', 'title': 'ParentCorps-Professional Development (PD) - Teachers: Rural', 'description': 'Teachers assigned to the PD-only group in a rural setting.'}, {'id': 'FG008', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Parent + Child: Rural', 'description': 'Parents + Children assigned to the PD+T wellness group in a rural setting.'}, {'id': 'FG009', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Rural', 'description': 'Teachers assigned to the PD+T wellness group in a rural setting.'}, {'id': 'FG010', 'title': 'Control - Parent + Child: Rural', 'description': 'Parents + Children assigned to the control group in a rural setting.'}, {'id': 'FG011', 'title': 'Control - Teacher: Rural', 'description': 'Teachers assigned to the control group in a rural setting.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The number of participants represents the total number of parents + children; n = 325 dyads started the study.', 'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '650'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '89'}, {'comment': 'The number of participants represents the total number of parents + children; n = 300 dyads started the study.', 'groupId': 'FG002', 'numUnits': '6', 'numSubjects': '600'}, {'groupId': 'FG003', 'numUnits': '6', 'numSubjects': '77'}, {'comment': 'The number of participants represents the total number of parents + children; n = 316 dyads started the study.', 'groupId': 'FG004', 'numUnits': '6', 'numSubjects': '632'}, {'groupId': 'FG005', 'numUnits': '6', 'numSubjects': '73'}, {'comment': 'The number of participants represents the total number of parents + children; n = 344 dyads started the study.', 'groupId': 'FG006', 'numUnits': '10', 'numSubjects': '688'}, {'groupId': 'FG007', 'numUnits': '10', 'numSubjects': '98'}, {'comment': 'The number of participants represents the total number of parents + children; n = 329 dyads started the study.', 'groupId': 'FG008', 'numUnits': '10', 'numSubjects': '658'}, {'groupId': 'FG009', 'numUnits': '10', 'numSubjects': '80'}, {'comment': 'The number of participants represents the total number of parents + children; n = 321 dyads started the study.', 'groupId': 'FG010', 'numUnits': '9', 'numSubjects': '642'}, {'groupId': 'FG011', 'numUnits': '9', 'numSubjects': '92'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'The number of participants represents the total number of parents + children; n = 269 dyads completed the study.', 'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '538'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '75'}, {'comment': 'The number of participants represents the total number of parents + children; n = 261 dyads completed the study.', 'groupId': 'FG002', 'numUnits': '6', 'numSubjects': '522'}, {'groupId': 'FG003', 'numUnits': '6', 'numSubjects': '64'}, {'comment': 'The number of participants represents the total number of parents + children; n = 261 dyads completed the study.', 'groupId': 'FG004', 'numUnits': '6', 'numSubjects': '522'}, {'groupId': 'FG005', 'numUnits': '6', 'numSubjects': '60'}, {'comment': 'The number of participants represents the total number of parents + children; n = 307 dyads completed the study.', 'groupId': 'FG006', 'numUnits': '10', 'numSubjects': '614'}, {'groupId': 'FG007', 'numUnits': '10', 'numSubjects': '85'}, {'comment': 'The number of participants represents the total number of parents + children; n = 290 dyads completed the study.', 'groupId': 'FG008', 'numUnits': '10', 'numSubjects': '580'}, {'groupId': 'FG009', 'numUnits': '10', 'numSubjects': '70'}, {'comment': 'The number of participants represents the total number of parents + children; n = 241 dyads completed the study.', 'groupId': 'FG010', 'numUnits': '9', 'numSubjects': '482'}, {'groupId': 'FG011', 'numUnits': '9', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '112'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '14'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '78'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '13'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '110'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '13'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '74'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '13'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '78'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '10'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '160'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '78'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '110'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '74'}, {'groupId': 'FG007', 'numSubjects': '13'}, {'groupId': 'FG008', 'numSubjects': '78'}, {'groupId': 'FG009', 'numSubjects': '10'}, {'groupId': 'FG010', 'numSubjects': '160'}, {'groupId': 'FG011', 'numSubjects': '13'}]}]}], 'typeUnitsAnalyzed': 'Schools', 'preAssignmentDetails': 'While parents + children were enrolled as dyads, only the parent participants provided consent. The participant flow information provides the total number of parents AND children. The baseline characteristic information provides data on parents only, as only parents had baseline characteristic data collected. Further, all child-related assessments were completed by the parent participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '316', 'groupId': 'BG004'}, {'value': '73', 'groupId': 'BG005'}, {'value': '344', 'groupId': 'BG006'}, {'value': '98', 'groupId': 'BG007'}, {'value': '329', 'groupId': 'BG008'}, {'value': '80', 'groupId': 'BG009'}, {'value': '321', 'groupId': 'BG010'}, {'value': '92', 'groupId': 'BG011'}, {'value': '2444', 'groupId': 'BG012'}]}], 'groups': [{'id': 'BG000', 'title': 'ParentCorps-Professional Development (PD) - Parents Urban', 'description': 'Parents of school children assigned to the PD-only group in an urban setting.'}, {'id': 'BG001', 'title': 'ParentCorps-Professional Development (PD) - Teachers: Urban', 'description': 'Teachers assigned to the PD-only group in an urban setting.'}, {'id': 'BG002', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Parents: Urban', 'description': 'Parents of school children assigned to the PD+T wellness group in an urban setting.'}, {'id': 'BG003', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Urban', 'description': 'Teachers assigned to the PD+T wellness group in an urban setting.'}, {'id': 'BG004', 'title': 'Control - Parents: Urban', 'description': 'Parents of school children assigned to the control group in an urban setting.'}, {'id': 'BG005', 'title': 'Control - Teacher: Urban', 'description': 'Teachers assigned to the control group in an urban setting.'}, {'id': 'BG006', 'title': 'ParentCorps-Professional Development (PD) - Parents: Rural', 'description': 'Parents of school children assigned to the PD-only group in a rural setting.'}, {'id': 'BG007', 'title': 'ParentCorps-Professional Development (PD) - Teachers: Rural', 'description': 'Teachers assigned to the PD-only group in a rural setting.'}, {'id': 'BG008', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Parents: Rural', 'description': 'Parents of school children assigned to the PD+T wellness group in a rural setting.'}, {'id': 'BG009', 'title': 'ParentCorps-Professional Development (PD) + T-Wellness - Teachers: Rural', 'description': 'Teachers assigned to the PD+T wellness group in a rural setting.'}, {'id': 'BG010', 'title': 'Control - Parents: Rural', 'description': 'Parents of school children assigned to the control group in a rural setting.'}, {'id': 'BG011', 'title': 'Control - Teacher: Rural', 'description': 'Teachers assigned to the control group in a rural setting.'}, {'id': 'BG012', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.04', 'spread': '9.65', 'groupId': 'BG000'}, {'value': '40.9', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '36.54', 'spread': '10.17', 'groupId': 'BG002'}, {'value': '40.2', 'spread': '12.3', 'groupId': 'BG003'}, {'value': '35.83', 'spread': '8.86', 'groupId': 'BG004'}, {'value': '42.7', 'spread': '11.3', 'groupId': 'BG005'}, {'value': '38.07', 'spread': '10.63', 'groupId': 'BG006'}, {'value': '40.8', 'spread': '9.7', 'groupId': 'BG007'}, {'value': '38.05', 'spread': '9.46', 'groupId': 'BG008'}, {'value': '40.8', 'spread': '11.8', 'groupId': 'BG009'}, {'value': '38.33', 'spread': '11.49', 'groupId': 'BG010'}, {'value': '38.4', 'spread': '9.9', 'groupId': 'BG011'}, {'value': '38.88', 'spread': '10.59', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '245', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '237', 'groupId': 'BG004'}, {'value': '50', 'groupId': 'BG005'}, {'value': '232', 'groupId': 'BG006'}, {'value': '74', 'groupId': 'BG007'}, {'value': '239', 'groupId': 'BG008'}, {'value': '64', 'groupId': 'BG009'}, {'value': '211', 'groupId': 'BG010'}, {'value': '63', 'groupId': 'BG011'}, {'value': '1782', 'groupId': 'BG012'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '112', 'groupId': 'BG006'}, {'value': '24', 'groupId': 'BG007'}, {'value': '90', 'groupId': 'BG008'}, {'value': '16', 'groupId': 'BG009'}, {'value': '110', 'groupId': 'BG010'}, {'value': '29', 'groupId': 'BG011'}, {'value': '662', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '325', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '316', 'groupId': 'BG004'}, {'value': '73', 'groupId': 'BG005'}, {'value': '344', 'groupId': 'BG006'}, {'value': '98', 'groupId': 'BG007'}, {'value': '329', 'groupId': 'BG008'}, {'value': '80', 'groupId': 'BG009'}, {'value': '321', 'groupId': 'BG010'}, {'value': '92', 'groupId': 'BG011'}, {'value': '2444', 'groupId': 'BG012'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'title': 'Black or African American', 'measurements': [{'value': '325', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '316', 'groupId': 'BG004'}, {'value': '73', 'groupId': 'BG005'}, {'value': '344', 'groupId': 'BG006'}, {'value': '98', 'groupId': 'BG007'}, {'value': '329', 'groupId': 'BG008'}, {'value': '80', 'groupId': 'BG009'}, {'value': '321', 'groupId': 'BG010'}, {'value': '92', 'groupId': 'BG011'}, {'value': '2444', 'groupId': 'BG012'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Uganda', 'categories': [{'measurements': [{'value': '325', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '316', 'groupId': 'BG004'}, {'value': '73', 'groupId': 'BG005'}, {'value': '344', 'groupId': 'BG006'}, {'value': '98', 'groupId': 'BG007'}, {'value': '329', 'groupId': 'BG008'}, {'value': '80', 'groupId': 'BG009'}, {'value': '321', 'groupId': 'BG010'}, {'value': '92', 'groupId': 'BG011'}, {'value': '2444', 'groupId': 'BG012'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Note that only parent participants in the parent + child dyads were consented and had baseline characteristic data collected.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-10', 'size': 1350797, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-30T11:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Research staff performing outcome assessment will be blind to the study conditions.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A cluster randomized controlled trial (cRCT), single blind and mixed-methods design will be applied'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2444}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2020-04-16', 'resultsFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2020-05-07', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-22', 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Teacher Knowledge of Evidence-Based Practice (Knowledge Score)', 'timeFrame': 'Baseline', 'description': 'Teachers will complete a 10-item quiz assessing EBI knowledge. The total score is the number of correct responses and ranges from 0-100; higher scores indicate greater knowledge.'}, {'measure': 'Teacher Knowledge of Evidence-Based Practice (Knowledge Score)', 'timeFrame': 'Month 6', 'description': 'Teachers will complete a 10-item quiz assessing EBI knowledge. The total score is the number of correct responses and ranges from 0-100; higher scores indicate greater knowledge.'}, {'measure': 'Teacher EBI Practice Score-Emotion Support Strategies Use', 'timeFrame': 'Baseline', 'description': "The Emotion Socialization Scale assesses teachers' practice in supporting students' management of negative emotions. Each of the scale items (6 items) are rated on a scale from 1 to 5. The total score is the average of responses and ranges from 1-5; lower scores indicate lower adherence to EBI practice."}, {'measure': 'Teacher EBI Practice Score-Emotion Support Strategies Use', 'timeFrame': 'Month 6', 'description': "The Emotion Socialization Scale assesses teachers' practice in supporting students' management of negative emotions. Each of the scale items (6 items) are rated on a scale from 1 to 5. The total score is the average of responses and ranges from 1-5; lower scores indicate lower adherence to EBI practice."}, {'measure': 'Teacher EBI Practice Score-Emotion Support Strategies Use', 'timeFrame': 'Month 18', 'description': "The Emotion Socialization Scale assesses teachers' practice in supporting students' management of negative emotions. Each of the scale items (6 items) are rated on a scale from 1 to 5. The total score is the average of responses and ranges from 1-5; lower scores indicate lower adherence to EBI practice."}, {'measure': 'Teacher Stress Score', 'timeFrame': 'Baseline', 'description': 'Teachers complete a 5-item assessment of stress over the past month. Each item is rated on a scale from 1 to 4. The total score is the average of responses and ranges from 1-4. Higher scores indicate greater stress.'}, {'measure': 'Teacher Stress Score', 'timeFrame': 'Month 6', 'description': 'Teachers complete a 5-item assessment of stress over the past month. Each item is rated on a scale from 1 to 4. The total score is the average of responses and ranges from 1-4. Higher scores indicate greater stress.'}, {'measure': 'Teacher Stress Score', 'timeFrame': 'Month 18', 'description': 'Teachers complete a 5-item assessment of stress over the past month. Each item is rated on a scale from 1 to 4. The total score is the average of responses and ranges from 1-4. Higher scores indicate greater stress.'}, {'measure': "Child's Emotion Regulation Score", 'timeFrame': 'Baseline', 'description': "Parents answer 6 questions about their child's emotion regulation behavior over the past 7 days. Each item is rated on a Likert scale from 0 (not at all) to 4 (very well). The total score ranges from 0 to 4; higher scores indicate greater emotion regulation."}, {'measure': "Child's Emotion Regulation Score", 'timeFrame': 'Month 6', 'description': "Parents answer 6 questions about their child's emotion regulation behavior over the past 7 days. Each item is rated on a Likert scale from 0 (not at all) to 4 (very well). The total score ranges from 0 to 4; higher scores indicate greater emotion regulation."}, {'measure': "Child's Emotion Regulation Score", 'timeFrame': 'Month 18', 'description': "Parents answer 6 questions about their child's emotion regulation behavior over the past 7 days. Each item is rated on a Likert scale from 0 (not at all) to 4 (very well). The total score ranges from 0 to 4; higher scores indicate greater emotion regulation."}], 'secondaryOutcomes': [{'measure': 'Teacher Mental Health', 'timeFrame': 'Baseline', 'description': 'Teachers complete Kessler Psychological Distress Scale (K10), which assesses anxiety and depressive symptoms that teacher experiencing over the past month. Each item is rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0 to 40, where higher scores indicate greater psychological distress.'}, {'measure': 'Teacher Mental Health', 'timeFrame': 'Month 6', 'description': 'Teachers complete Kessler Psychological Distress Scale (K10), which assesses anxiety and depressive symptoms that teacher experiencing over the past month. Each item is rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0 to 40, where higher scores indicate greater psychological distress.'}, {'measure': 'Teacher Mental Health', 'timeFrame': 'Month 18', 'description': 'Teachers complete Kessler Psychological Distress Scale (K10), which assesses anxiety and depressive symptoms that teacher experiencing over the past month. Each item is rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0 to 40, where higher scores indicate greater psychological distress.'}, {'measure': 'Child Mental Health- Conduct Problem', 'timeFrame': 'Baseline', 'description': "Conduct problem items (5 items) from the Strengths and Difficulties Questionnaire (SDQ) are rated by parents, which assesses child's conduct and non-compliant behaviors over the last six months. Each item is rated on a Likert scale from 0 (not true) to 2 (certainly true). The total score is the sum of responses and ranges from 0-10; higher scores indicate greater difficulties."}, {'measure': 'Child Mental Health- Conduct Problem', 'timeFrame': 'Month 6', 'description': "Conduct problem items (5 items) from the Strengths and Difficulties Questionnaire (SDQ) are rated by parents, which assesses child's conduct and non-compliant behaviors over the last six months. Each item is rated on a Likert scale from 0 (not true) to 2 (certainly true). The total score is the sum of responses and ranges from 0-10; higher scores indicate greater difficulties."}, {'measure': 'Child Mental Health- Conduct Problem', 'timeFrame': 'Month 18', 'description': "Conduct problem items (5 items) from the Strengths and Difficulties Questionnaire (SDQ) are rated by parents, which assesses child's conduct and non-compliant behaviors over the last six months. Each item is rated on a Likert scale from 0 (not true) to 2 (certainly true). The total score is the sum of responses and ranges from 0-10; higher scores indicate greater difficulties."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Child Development']}, 'referencesModule': {'references': [{'pmid': '35718782', 'type': 'DERIVED', 'citation': 'Huang KY, Nakigudde J, Kisakye EN, Sentongo H, Dennis-Tiwary TA, Tozan Y, Park H, Brotman LM. Advancing scalability and impacts of a teacher training program for promoting child mental health in Ugandan primary schools: protocol for a hybrid-type II effectiveness-implementation cluster randomized trial. Int J Ment Health Syst. 2022 Jun 20;16(1):28. doi: 10.1186/s13033-022-00538-7.'}]}, 'descriptionModule': {'briefSummary': 'This study involves efforts to advance the science of prevention in early childhood mental health in low-resource communities. Investigators will assess the effectiveness, practical implementation strategies, and underlying mechanisms of the evidence-based intervention, ParentCorps-Professional Development, in urban and rural Uganda. Two implementation approaches, with and without the teacher stress management package, T-Wellness, will be compared for efficacy.', 'detailedDescription': "Promoting child mental health in low-resource or low-income country settings faces numerous challenges in global health research. Although efforts have been made to improve mental health interventions and services for young children, evidence-based interventions (EBIs) for children in low-and middle-income countries (LMICs) are limited. Most mental health EBIs in LMICs have not been scaled widely, and do not focus on early childhood. Mechanisms of action and effectiveness are not well understood. Additionally, most EBIs in LMICs rely on community health workers (CHWs) or a task-shifting approach of implementation because of resource barriers and shortage of mental health professionals (MHPs). However, challenges related to task-shifting (e.g., CHW stress and job burnout) have rarely been studied. For task-shifting to be successful, strategies to overcome challenges faced by CHWs and understanding mechanisms to conduct effective task-shifting are paramount. The overall goal of this study is to address these EBI effectiveness and implementation knowledge gaps by providing a preventive EBI (ParentCorps-Professional Development; PD) that utilizes a task-shifting and a scalable implementation model to promote early childhood students' mental health in a LMIC-Uganda. PD is a school-based EBI and preventive mental health service provision model that supports teachers and school personnel to apply EBI strategies to promote young children's mental health. The PD approach represents a task-shifting model of mental healthcare by shifting mental health preventive duties from professionals to teachers to optimize school children's mental health. Therefore, teachers are considered as CHWs. This study examines impacts and cost-effectiveness of the EBI/PD on teachers and students, as well as examines underlying mechanisms (or theories of change) that contribute to intervention effect. In addition, considering most Ugandan teachers (or CHWs) experience occupational stress that threatens PD uptake, effectiveness, and sustainment, this study will also test a teacher stress management package (T-Wellness, adapted from EBIs) as an enhancement to PD. This study will investigate whether PD + T-Wellness (PDT) is more effective for CHWs/teachers than PD alone."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. The inclusion criteria for the school staff (teachers, head teachers) are: they must be in the recruited study schools and teaching in Pre-Primary to Primary 4 classrooms or holding the head teachers/administration leadership position in school. The inclusion criteria for Parent Leaders are: they must be at least 18 years old and have served as a Parent-Teacher-Association member or Parent Leader in the school for at least 1 year.\n2. The inclusion criteria for the PD/PDT program implementers are: they must have current employment with eligible partners (i.e., medical/mental health institutions, Teacher Training Colleges), with professional experiences in teacher training or mental health training.\n3. The inclusion criteria for parents are: caregivers must be at least 18 years old, their children must be enrolled in Pre-Primary or Primary 1 to 4 classes (or between 3 to 10 years old) in the recruited schools, and willing to have their child to be assessed by research staff. Parents and children will have diverse characteristics (e.g., randomly selected from school student lists). About 10% families will be randomly selected from the student lists. The proposed study will be open to both men and women caregivers\n\nExclusion Criteria\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study.\n2. Minors (age \\<18) will also be excluded. Additional criteria should be included as appropriate for the study design and risk.'}, 'identificationModule': {'nctId': 'NCT04383327', 'briefTitle': 'School-Based Mental Health Effectiveness Study', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Effectiveness and Implementation of an Early Childhood School-Based Mental Health Intervention in Low-Resource Communities', 'orgStudyIdInfo': {'id': '20-00117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ParentCorps-Professional Development (PD)', 'description': 'n = 6 Schools in Kampala, Uganda (Urban) - 89 Teachers, 325 Parent-Child Pairs\n\n\\+ n = 10 Schools in Hoima, Uganda (Rural) - 98 Teachers, 344 Parent-Child Pairs', 'interventionNames': ['Behavioral: ParentCorps-Professional Development (PD)']}, {'type': 'EXPERIMENTAL', 'label': 'ParentCorps-Professional Development (PD) + T-Wellness', 'description': 'n = 6 Schools in Kampala, Uganda (Urban) - 77 Teachers, 300 Parent-Child Pairs\n\n\\+ n = 10 Schools in Hoima, Uganda (Rural) - 80 Teachers, 329 Parent-Child Pairs', 'interventionNames': ['Behavioral: ParentCorps-Professional Development (PD)', 'Behavioral: T-Wellness']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'n = 6 Schools in Kampala, Uganda (Urban) - 73 Teachers, 316 Parent-Child Pairs\n\n\\+ n = 9 Schools in Hoima, Uganda (Rural) - 92 Teachers, 321 Parent-Child Pairs'}], 'interventions': [{'name': 'ParentCorps-Professional Development (PD)', 'type': 'BEHAVIORAL', 'description': 'Multi-component school-based intervention that promotes early childhood mental health and development. Teachers (pre-primary to 4th grade) will participate in a 3-day ParentCorps-PD training during the school term. They will also receive 8 sessions (8 hours) of face-to-face group-based coaching during after the training. Coaching sessions are to help teachers apply EBI strategies in their classrooms, engage families, and develop competencies.', 'armGroupLabels': ['ParentCorps-Professional Development (PD)', 'ParentCorps-Professional Development (PD) + T-Wellness']}, {'name': 'T-Wellness', 'type': 'BEHAVIORAL', 'description': 'A brief teacher stress management psychoeducation package, adapted from EBIs including one-day workshop for common stress management and stress management, and three follow-up group support sessions (3 additional monthly 1-hr wellness sessions for teachers as a group that were integrated into the 3 of the 8 PD coaching sessions. A total 3 hours of coaching were included.', 'armGroupLabels': ['ParentCorps-Professional Development (PD) + T-Wellness']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hoima', 'country': 'Uganda', 'facility': 'Hoima School', 'geoPoint': {'lat': 1.43314, 'lon': 31.35241}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'Kampala School', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'overallOfficials': [{'name': 'Keng-Yen Huang, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Analyzed data file and final trial data will be share at the end of the study via the National Databased of Clinical Trials (NDCT) related to Mental Illness (the NIMH recommended format). There will be no end date for data sharing.', 'ipdSharing': 'YES', 'description': 'The de-identified participant data from the final research datasets (defined below) will be shared via the National Databased of Clinical Trials (NDCT) related to Mental Illness. The proposed cluster RCT study will be carried out in Uganda. It will collect data on 540 school staff (i.e., teachers), and 1,980 parent-child pairs from 36 schools. Child and teacher/school effectiveness outcome data and demographic data collected from teachers, schools, and families across all three assessment time points will be released for sharing. In addition, implementation context data will also be released. These data will be share via the NDCT related to Mental Illness. Implementation fidelity data will not be shared through NDCT, but can be requested from the PI Keng-Yen Huang directly beginning 9 months following article publication or at the end of the study.', 'accessCriteria': 'Requests should be directed to PI Keng-Yen Huang at huangk01@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}