Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-28 @ 4:44 AM
Study NCT ID:
NCT01822366
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2013-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Controlled Trial of Trauma-focused CBT in Tanzania and Kenya
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000066553', 'term': 'Problem Behavior'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002652', 'term': 'Child Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dorsey2@uw.edu', 'phone': '(206) 543-4527', 'title': 'Dr. Shannon Dorsey', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year, 3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care Comparison Condition', 'description': 'Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.', 'otherNumAtRisk': 640, 'deathsNumAtRisk': 640, 'otherNumAffected': 0, 'seriousNumAtRisk': 640, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Trauma-focused CBT Group Therapy', 'description': 'Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy', 'otherNumAtRisk': 640, 'deathsNumAtRisk': 640, 'otherNumAffected': 0, 'seriousNumAtRisk': 640, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Posttraumatic Stress Syndrome (PTSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}, {'value': '96', 'groupId': 'OG005'}, {'value': '64', 'groupId': 'OG006'}, {'value': '96', 'groupId': 'OG007'}, {'value': '64', 'groupId': 'OG008'}, {'value': '91', 'groupId': 'OG009'}, {'value': '63', 'groupId': 'OG010'}, {'value': '96', 'groupId': 'OG011'}, {'value': '64', 'groupId': 'OG012'}, {'value': '96', 'groupId': 'OG013'}, {'value': '64', 'groupId': 'OG014'}, {'value': '96', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzania Rural Comparison Child', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG001', 'title': 'Tanzania Urban Comparison Child', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG002', 'title': 'Tanzania Rural TF-CBT Child', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG003', 'title': 'Tanzania Urban TF-CBT Child', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG004', 'title': 'Kenya Rural Comparison Child', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG005', 'title': 'Kenya Urban Comparison Child', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG006', 'title': 'Kenya Rural TF-CBT Child', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG007', 'title': 'Kenya Urban TF-CBT Child', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG008', 'title': 'Tanzania Rural Comparison Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG009', 'title': 'Tanzania Urban Comparison Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG010', 'title': 'Tanzania Rural TF-CBT Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG011', 'title': 'Tanzania Urban TF-CBT Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG012', 'title': 'Kenya Rural Comparison Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG013', 'title': 'Kenya Urban Comparison Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG014', 'title': 'Kenya Rural TF-CBT Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG015', 'title': 'Kenya Urban TF-CBT Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}], 'classes': [{'title': 'Baseline Score', 'categories': [{'measurements': [{'value': '23.41', 'groupId': 'OG000', 'lowerLimit': '21.61', 'upperLimit': '25.21'}, {'value': '21.23', 'groupId': 'OG001', 'lowerLimit': '20.02', 'upperLimit': '22.44'}, {'value': '25.66', 'groupId': 'OG002', 'lowerLimit': '23.99', 'upperLimit': '27.32'}, {'value': '23.40', 'groupId': 'OG003', 'lowerLimit': '22.25', 'upperLimit': '24.54'}, {'value': '24.61', 'groupId': 'OG004', 'lowerLimit': '22.74', 'upperLimit': '26.47'}, {'value': '22.03', 'groupId': 'OG005', 'lowerLimit': '20.63', 'upperLimit': '23.43'}, {'value': '24.86', 'groupId': 'OG006', 'lowerLimit': '22.91', 'upperLimit': '26.81'}, {'value': '24.70', 'groupId': 'OG007', 'lowerLimit': '23.43', 'upperLimit': '25.96'}, {'value': '18.92', 'groupId': 'OG008', 'lowerLimit': '17.13', 'upperLimit': '20.72'}, {'value': '18.81', 'groupId': 'OG009', 'lowerLimit': '17.16', 'upperLimit': '20.46'}, {'value': '21.33', 'groupId': 'OG010', 'lowerLimit': '19.35', 'upperLimit': '23.31'}, {'value': '22.08', 'groupId': 'OG011', 'lowerLimit': '20.59', 'upperLimit': '23.58'}, {'value': '23.39', 'groupId': 'OG012', 'lowerLimit': '21.11', 'upperLimit': '25.67'}, {'value': '20.61', 'groupId': 'OG013', 'lowerLimit': '19.08', 'upperLimit': '22.15'}, {'value': '23.69', 'groupId': 'OG014', 'lowerLimit': '22.07', 'upperLimit': '25.30'}, {'value': '21.98', 'groupId': 'OG015', 'lowerLimit': '20.72', 'upperLimit': '23.24'}]}]}, {'title': 'Post-Treatment Score', 'categories': [{'measurements': [{'value': '8.98', 'groupId': 'OG000', 'lowerLimit': '7.40', 'upperLimit': '10.57'}, {'value': '12.78', 'groupId': 'OG001', 'lowerLimit': '11.17', 'upperLimit': '14.39'}, {'value': '10.17', 'groupId': 'OG002', 'lowerLimit': '8.26', 'upperLimit': '12.08'}, {'value': '10.82', 'groupId': 'OG003', 'lowerLimit': '9.26', 'upperLimit': '12.38'}, {'value': '22.44', 'groupId': 'OG004', 'lowerLimit': '20.06', 'upperLimit': '24.81'}, {'value': '15.92', 'groupId': 'OG005', 'lowerLimit': '14.57', 'upperLimit': '17.26'}, {'value': '14.00', 'groupId': 'OG006', 'lowerLimit': '12.59', 'upperLimit': '15.41'}, {'value': '12.82', 'groupId': 'OG007', 'lowerLimit': '11.52', 'upperLimit': '14.12'}, {'value': '6.94', 'groupId': 'OG008', 'lowerLimit': '5.77', 'upperLimit': '8.10'}, {'value': '9.75', 'groupId': 'OG009', 'lowerLimit': '8.43', 'upperLimit': '11.07'}, {'value': '5.56', 'groupId': 'OG010', 'lowerLimit': '4.83', 'upperLimit': '6.30'}, {'value': '7.80', 'groupId': 'OG011', 'lowerLimit': '6.69', 'upperLimit': '8.91'}, {'value': '23.06', 'groupId': 'OG012', 'lowerLimit': '21.08', 'upperLimit': '25.04'}, {'value': '14.71', 'groupId': 'OG013', 'lowerLimit': '13.29', 'upperLimit': '16.13'}, {'value': '10.77', 'groupId': 'OG014', 'lowerLimit': '9.20', 'upperLimit': '12.33'}, {'value': '9.94', 'groupId': 'OG015', 'lowerLimit': '8.90', 'upperLimit': '10.97'}]}]}, {'title': 'Mean Change in Score', 'categories': [{'measurements': [{'value': '-14.40', 'groupId': 'OG000', 'lowerLimit': '-16.55', 'upperLimit': '-12.24'}, {'value': '-8.39', 'groupId': 'OG001', 'lowerLimit': '-10.19', 'upperLimit': '-6.60'}, {'value': '-15.48', 'groupId': 'OG002', 'lowerLimit': '-17.43', 'upperLimit': '-13.54'}, {'value': '-12.53', 'groupId': 'OG003', 'lowerLimit': '-14.17', 'upperLimit': '-10.88'}, {'value': '-2.17', 'groupId': 'OG004', 'lowerLimit': '-5.14', 'upperLimit': '0.80'}, {'value': '-6.11', 'groupId': 'OG005', 'lowerLimit': '-7.76', 'upperLimit': '-4.47'}, {'value': '-10.86', 'groupId': 'OG006', 'lowerLimit': '-13.40', 'upperLimit': '-8.32'}, {'value': '-11.88', 'groupId': 'OG007', 'lowerLimit': '-13.41', 'upperLimit': '-10.34'}, {'value': '-11.81', 'groupId': 'OG008', 'lowerLimit': '-13.63', 'upperLimit': '-9.98'}, {'value': '-8.77', 'groupId': 'OG009', 'lowerLimit': '-10.56', 'upperLimit': '-6.98'}, {'value': '-15.77', 'groupId': 'OG010', 'lowerLimit': '-17.78', 'upperLimit': '-13.75'}, {'value': '-14.23', 'groupId': 'OG011', 'lowerLimit': '-16.07', 'upperLimit': '-12.39'}, {'value': '-0.33', 'groupId': 'OG012', 'lowerLimit': '-3.24', 'upperLimit': '2.58'}, {'value': '-5.91', 'groupId': 'OG013', 'lowerLimit': '-7.78', 'upperLimit': '-4.03'}, {'value': '-12.92', 'groupId': 'OG014', 'lowerLimit': '-15.19', 'upperLimit': '-10.65'}, {'value': '-12.04', 'groupId': 'OG015', 'lowerLimit': '-13.48', 'upperLimit': '-10.61'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'Measured using the Child PTSD Symptoms Scale (CPSS). Caregiver and Child reported separately. Scale range 0-57, with 57 representing extremely high PTSS symptomatology (worse outcome). 634 children and 634 caregivers (1268 total) analyzed at baseline and 3-month follow-up--includes all 1280 enrolled at baseline, minus 12 lost to follow-up.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)'}, {'type': 'PRIMARY', 'title': 'Childhood Traumatic Grief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}, {'value': '96', 'groupId': 'OG005'}, {'value': '64', 'groupId': 'OG006'}, {'value': '96', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzania Rural Comparison Child', 'description': 'Half of the participating children will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG001', 'title': 'Tanzania Urban Comparison Child', 'description': 'Half of the participating children will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG002', 'title': 'Tanzania Rural TF-CBT Child', 'description': 'Half of the participating children will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG003', 'title': 'Tanzania Urban TF-CBT Child', 'description': 'Half of the participating children will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG004', 'title': 'Kenya Rural Comparison Child', 'description': 'Half of the participating children will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG005', 'title': 'Kenya Urban Comparison Child', 'description': 'Half of the participating children will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG006', 'title': 'Kenya Rural TF-CBT Child', 'description': 'Half of the participating children will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG007', 'title': 'Kenya Urban TF-CBT Child', 'description': 'Half of the participating children will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}], 'classes': [{'title': 'Baseline Score', 'categories': [{'measurements': [{'value': '43.14', 'groupId': 'OG000', 'lowerLimit': '38.18', 'upperLimit': '48.10'}, {'value': '40.63', 'groupId': 'OG001', 'lowerLimit': '37.65', 'upperLimit': '43.61'}, {'value': '49.17', 'groupId': 'OG002', 'lowerLimit': '43.98', 'upperLimit': '54.37'}, {'value': '44.73', 'groupId': 'OG003', 'lowerLimit': '41.19', 'upperLimit': '48.26'}, {'value': '42.48', 'groupId': 'OG004', 'lowerLimit': '37.70', 'upperLimit': '47.27'}, {'value': '38.34', 'groupId': 'OG005', 'lowerLimit': '35.11', 'upperLimit': '41.58'}, {'value': '44.38', 'groupId': 'OG006', 'lowerLimit': '38.98', 'upperLimit': '49.77'}, {'value': '42.46', 'groupId': 'OG007', 'lowerLimit': '39.09', 'upperLimit': '45.83'}]}]}, {'title': 'Post-Treatment Score', 'categories': [{'measurements': [{'value': '13.44', 'groupId': 'OG000', 'lowerLimit': '9.93', 'upperLimit': '16.96'}, {'value': '22.90', 'groupId': 'OG001', 'lowerLimit': '19.09', 'upperLimit': '26.72'}, {'value': '16.00', 'groupId': 'OG002', 'lowerLimit': '11.07', 'upperLimit': '20.93'}, {'value': '18.97', 'groupId': 'OG003', 'lowerLimit': '15.75', 'upperLimit': '22.18'}, {'value': '38.13', 'groupId': 'OG004', 'lowerLimit': '32.74', 'upperLimit': '43.51'}, {'value': '25.19', 'groupId': 'OG005', 'lowerLimit': '22.13', 'upperLimit': '28.25'}, {'value': '21.09', 'groupId': 'OG006', 'lowerLimit': '18.17', 'upperLimit': '24.01'}, {'value': '20.32', 'groupId': 'OG007', 'lowerLimit': '17.25', 'upperLimit': '23.39'}]}]}, {'title': 'Mean Change in Score', 'categories': [{'measurements': [{'value': '-29.65', 'groupId': 'OG000', 'lowerLimit': '-35.42', 'upperLimit': '-23.88'}, {'value': '-17.25', 'groupId': 'OG001', 'lowerLimit': '-20.97', 'upperLimit': '-13.54'}, {'value': '-33.17', 'groupId': 'OG002', 'lowerLimit': '-38.20', 'upperLimit': '-28.15'}, {'value': '-25.77', 'groupId': 'OG003', 'lowerLimit': '-29.98', 'upperLimit': '-21.55'}, {'value': '-4.36', 'groupId': 'OG004', 'lowerLimit': '-11.12', 'upperLimit': '2.40'}, {'value': '-13.01', 'groupId': 'OG005', 'lowerLimit': '-17.15', 'upperLimit': '-8.88'}, {'value': '-23.28', 'groupId': 'OG006', 'lowerLimit': '-29.76', 'upperLimit': '-16.80'}, {'value': '-22.14', 'groupId': 'OG007', 'lowerLimit': '-26.06', 'upperLimit': '-18.21'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'Measured using the Inventory of Complicated Grief (ICG). Child report only. Scale range 0-112, with 112 representing extremely high grief symptomatology (worse outcome). 634 children and 634 caregivers (1268 total) analyzed at baseline and 3-month follow-up--includes all 1280 enrolled at baseline, minus 12 lost to follow-up.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Children from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)'}, {'type': 'SECONDARY', 'title': 'Behavioral Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}, {'value': '96', 'groupId': 'OG005'}, {'value': '64', 'groupId': 'OG006'}, {'value': '96', 'groupId': 'OG007'}, {'value': '64', 'groupId': 'OG008'}, {'value': '91', 'groupId': 'OG009'}, {'value': '63', 'groupId': 'OG010'}, {'value': '96', 'groupId': 'OG011'}, {'value': '64', 'groupId': 'OG012'}, {'value': '96', 'groupId': 'OG013'}, {'value': '64', 'groupId': 'OG014'}, {'value': '96', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzania Rural Comparison Child', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG001', 'title': 'Tanzania Urban Comparison Child', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG002', 'title': 'Tanzania Rural TF-CBT Child', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG003', 'title': 'Tanzania Urban TF-CBT Child', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG004', 'title': 'Kenya Rural Comparison Child', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG005', 'title': 'Kenya Urban Comparison Child', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG006', 'title': 'Kenya Rural TF-CBT Child', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG007', 'title': 'Kenya Urban TF-CBT Child', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG008', 'title': 'Tanzania Rural Comparison Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG009', 'title': 'Tanzania Urban Comparison Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG010', 'title': 'Tanzania Rural TF-CBT Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG011', 'title': 'Tanzania Urban TF-CBT Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG012', 'title': 'Kenya Rural Comparison Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG013', 'title': 'Kenya Urban Comparison Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG014', 'title': 'Kenya Rural TF-CBT Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG015', 'title': 'Kenya Urban TF-CBT Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}], 'classes': [{'title': 'Baseline Score', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.09'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.13'}, {'value': '0.11', 'groupId': 'OG002', 'lowerLimit': '0.08', 'upperLimit': '0.14'}, {'value': '0.11', 'groupId': 'OG003', 'lowerLimit': '0.09', 'upperLimit': '0.14'}, {'value': '0.13', 'groupId': 'OG004', 'lowerLimit': '0.09', 'upperLimit': '0.16'}, {'value': '0.15', 'groupId': 'OG005', 'lowerLimit': '0.12', 'upperLimit': '0.18'}, {'value': '0.18', 'groupId': 'OG006', 'lowerLimit': '0.13', 'upperLimit': '0.23'}, {'value': '0.21', 'groupId': 'OG007', 'lowerLimit': '0.17', 'upperLimit': '0.26'}, {'value': '0.15', 'groupId': 'OG008', 'lowerLimit': '0.12', 'upperLimit': '0.17'}, {'value': '0.16', 'groupId': 'OG009', 'lowerLimit': '0.14', 'upperLimit': '0.19'}, {'value': '0.12', 'groupId': 'OG010', 'lowerLimit': '0.10', 'upperLimit': '0.15'}, {'value': '0.17', 'groupId': 'OG011', 'lowerLimit': '0.14', 'upperLimit': '0.21'}, {'value': '0.14', 'groupId': 'OG012', 'lowerLimit': '0.10', 'upperLimit': '0.17'}, {'value': '0.18', 'groupId': 'OG013', 'lowerLimit': '0.15', 'upperLimit': '0.21'}, {'value': '0.13', 'groupId': 'OG014', 'lowerLimit': '0.09', 'upperLimit': '0.16'}, {'value': '0.25', 'groupId': 'OG015', 'lowerLimit': '0.21', 'upperLimit': '0.29'}]}]}, {'title': 'Post-Treatment Score', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.07'}, {'value': '0.09', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '0.10'}, {'value': '0.08', 'groupId': 'OG002', 'lowerLimit': '0.06', 'upperLimit': '0.09'}, {'value': '0.06', 'groupId': 'OG003', 'lowerLimit': '0.05', 'upperLimit': '0.08'}, {'value': '0.13', 'groupId': 'OG004', 'lowerLimit': '0.10', 'upperLimit': '0.16'}, {'value': '0.09', 'groupId': 'OG005', 'lowerLimit': '0.07', 'upperLimit': '0.12'}, {'value': '0.11', 'groupId': 'OG006', 'lowerLimit': '0.06', 'upperLimit': '0.16'}, {'value': '0.14', 'groupId': 'OG007', 'lowerLimit': '0.10', 'upperLimit': '0.18'}, {'value': '0.12', 'groupId': 'OG008', 'lowerLimit': '0.09', 'upperLimit': '0.15'}, {'value': '0.10', 'groupId': 'OG009', 'lowerLimit': '0.08', 'upperLimit': '0.12'}, {'value': '0.09', 'groupId': 'OG010', 'lowerLimit': '0.07', 'upperLimit': '0.10'}, {'value': '0.09', 'groupId': 'OG011', 'lowerLimit': '0.07', 'upperLimit': '0.10'}, {'value': '0.16', 'groupId': 'OG012', 'lowerLimit': '0.12', 'upperLimit': '0.21'}, {'value': '0.13', 'groupId': 'OG013', 'lowerLimit': '0.11', 'upperLimit': '0.16'}, {'value': '0.11', 'groupId': 'OG014', 'lowerLimit': '0.08', 'upperLimit': '0.15'}, {'value': '0.14', 'groupId': 'OG015', 'lowerLimit': '0.12', 'upperLimit': '0.17'}]}]}, {'title': 'Mean Change in Score', 'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.03', 'upperLimit': '0.01'}, {'value': '-0.02', 'groupId': 'OG001', 'lowerLimit': '-0.04', 'upperLimit': '-0.00'}, {'value': '-0.03', 'groupId': 'OG002', 'lowerLimit': '-0.07', 'upperLimit': '-0.00'}, {'value': '-0.05', 'groupId': 'OG003', 'lowerLimit': '-0.08', 'upperLimit': '-0.02'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '-0.04', 'upperLimit': '0.05'}, {'value': '-0.05', 'groupId': 'OG005', 'lowerLimit': '-0.09', 'upperLimit': '-0.02'}, {'value': '-0.07', 'groupId': 'OG006', 'lowerLimit': '-0.12', 'upperLimit': '-0.01'}, {'value': '-0.07', 'groupId': 'OG007', 'lowerLimit': '-0.13', 'upperLimit': '-0.01'}, {'value': '-0.03', 'groupId': 'OG008', 'lowerLimit': '-0.06', 'upperLimit': '0.01'}, {'value': '-0.07', 'groupId': 'OG009', 'lowerLimit': '-0.09', 'upperLimit': '-0.04'}, {'value': '-0.02', 'groupId': 'OG010', 'lowerLimit': '-0.06', 'upperLimit': '-0.01'}, {'value': '-0.09', 'groupId': 'OG011', 'lowerLimit': '-0.12', 'upperLimit': '-0.05'}, {'value': '0.03', 'groupId': 'OG012', 'lowerLimit': '-0.02', 'upperLimit': '0.07'}, {'value': '-0.05', 'groupId': 'OG013', 'lowerLimit': '-0.08', 'upperLimit': '-0.02'}, {'value': '-0.02', 'groupId': 'OG014', 'lowerLimit': '-0.05', 'upperLimit': '0.02'}, {'value': '-0.11', 'groupId': 'OG015', 'lowerLimit': '-0.15', 'upperLimit': '-0.08'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'Child report: Measured using the combined mean score of 1) the broadband externalizing scale of the Youth Self-Report (YSR) and 2) behavior-related items developed locally that are culturally specific. All items included are measured on a scale of 0-2, with 0 representing no behavioral difficulties (better) and 2 representing frequent behavioral difficulties (worse).\n\nCaregiver report: Measured using the combined mean score of 1) the broadband externalizing scale of the Child Behavior Checklist (CBCL) and 2) behavior-related items developed locally that are culturally specific. All items included are measured on a scale of 0-2, with 0 representing no behavioral difficulties (better) and 2 representing frequent behavioral difficulties (worse).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}, {'value': '96', 'groupId': 'OG005'}, {'value': '64', 'groupId': 'OG006'}, {'value': '96', 'groupId': 'OG007'}, {'value': '64', 'groupId': 'OG008'}, {'value': '91', 'groupId': 'OG009'}, {'value': '63', 'groupId': 'OG010'}, {'value': '96', 'groupId': 'OG011'}, {'value': '64', 'groupId': 'OG012'}, {'value': '96', 'groupId': 'OG013'}, {'value': '64', 'groupId': 'OG014'}, {'value': '96', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanzania Rural Comparison Child', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG001', 'title': 'Tanzania Urban Comparison Child', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG002', 'title': 'Tanzania Rural TF-CBT Child', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG003', 'title': 'Tanzania Urban TF-CBT Child', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG004', 'title': 'Kenya Rural Comparison Child', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG005', 'title': 'Kenya Urban Comparison Child', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG006', 'title': 'Kenya Rural TF-CBT Child', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG007', 'title': 'Kenya Urban TF-CBT Child', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG008', 'title': 'Tanzania Rural Comparison Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG009', 'title': 'Tanzania Urban Comparison Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG010', 'title': 'Tanzania Rural TF-CBT Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG011', 'title': 'Tanzania Urban TF-CBT Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG012', 'title': 'Kenya Rural Comparison Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG013', 'title': 'Kenya Urban Comparison Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'OG014', 'title': 'Kenya Rural TF-CBT Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'OG015', 'title': 'Kenya Urban TF-CBT Caregiver', 'description': 'Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}], 'classes': [{'title': 'Baseline Score', 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '0.29'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.13'}, {'value': '0.41', 'groupId': 'OG002', 'lowerLimit': '0.29', 'upperLimit': '0.53'}, {'value': '0.11', 'groupId': 'OG003', 'lowerLimit': '0.09', 'upperLimit': '0.14'}, {'value': '0.52', 'groupId': 'OG004', 'lowerLimit': '0.40', 'upperLimit': '0.63'}, {'value': '0.50', 'groupId': 'OG005', 'lowerLimit': '0.43', 'upperLimit': '0.57'}, {'value': '0.63', 'groupId': 'OG006', 'lowerLimit': '0.52', 'upperLimit': '0.74'}, {'value': '0.66', 'groupId': 'OG007', 'lowerLimit': '0.57', 'upperLimit': '0.74'}, {'value': '0.21', 'groupId': 'OG008', 'lowerLimit': '0.19', 'upperLimit': '0.24'}, {'value': '0.16', 'groupId': 'OG009', 'lowerLimit': '0.14', 'upperLimit': '0.19'}, {'value': '0.20', 'groupId': 'OG010', 'lowerLimit': '0.17', 'upperLimit': '0.24'}, {'value': '0.17', 'groupId': 'OG011', 'lowerLimit': '0.14', 'upperLimit': '0.21'}, {'value': '0.48', 'groupId': 'OG012', 'lowerLimit': '0.39', 'upperLimit': '0.56'}, {'value': '0.48', 'groupId': 'OG013', 'lowerLimit': '0.42', 'upperLimit': '0.54'}, {'value': '0.48', 'groupId': 'OG014', 'lowerLimit': '0.41', 'upperLimit': '0.55'}, {'value': '0.58', 'groupId': 'OG015', 'lowerLimit': '0.52', 'upperLimit': '0.64'}]}]}, {'title': 'Post-Treatment Score', 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.22'}, {'value': '0.09', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '0.10'}, {'value': '0.21', 'groupId': 'OG002', 'lowerLimit': '0.17', 'upperLimit': '0.25'}, {'value': '0.06', 'groupId': 'OG003', 'lowerLimit': '0.05', 'upperLimit': '0.08'}, {'value': '0.53', 'groupId': 'OG004', 'lowerLimit': '0.40', 'upperLimit': '0.63'}, {'value': '0.38', 'groupId': 'OG005', 'lowerLimit': '0.31', 'upperLimit': '0.45'}, {'value': '0.30', 'groupId': 'OG006', 'lowerLimit': '0.22', 'upperLimit': '0.38'}, {'value': '0.33', 'groupId': 'OG007', 'lowerLimit': '0.27', 'upperLimit': '0.39'}, {'value': '0.17', 'groupId': 'OG008', 'lowerLimit': '0.15', 'upperLimit': '0.19'}, {'value': '0.10', 'groupId': 'OG009', 'lowerLimit': '0.08', 'upperLimit': '0.12'}, {'value': '0.15', 'groupId': 'OG010', 'lowerLimit': '0.13', 'upperLimit': '0.17'}, {'value': '0.09', 'groupId': 'OG011', 'lowerLimit': '0.07', 'upperLimit': '0.10'}, {'value': '0.55', 'groupId': 'OG012', 'lowerLimit': '0.48', 'upperLimit': '0.62'}, {'value': '0.36', 'groupId': 'OG013', 'lowerLimit': '0.30', 'upperLimit': '0.41'}, {'value': '0.28', 'groupId': 'OG014', 'lowerLimit': '0.24', 'upperLimit': '0.32'}, {'value': '0.32', 'groupId': 'OG015', 'lowerLimit': '0.28', 'upperLimit': '0.36'}]}]}, {'title': 'Mean Change in Score', 'categories': [{'measurements': [{'value': '-0.05', 'groupId': 'OG000', 'lowerLimit': '-0.11', 'upperLimit': '0.01'}, {'value': '-0.02', 'groupId': 'OG001', 'lowerLimit': '-0.04', 'upperLimit': '-0.00'}, {'value': '-0.21', 'groupId': 'OG002', 'lowerLimit': '-0.32', 'upperLimit': '-0.10'}, {'value': '-0.05', 'groupId': 'OG003', 'lowerLimit': '-0.08', 'upperLimit': '-0.02'}, {'value': '0.01', 'groupId': 'OG004', 'lowerLimit': '-0.16', 'upperLimit': '0.18'}, {'value': '-0.11', 'groupId': 'OG005', 'lowerLimit': '-0.20', 'upperLimit': '-0.03'}, {'value': '-0.33', 'groupId': 'OG006', 'lowerLimit': '-0.48', 'upperLimit': '-0.19'}, {'value': '-0.32', 'groupId': 'OG007', 'lowerLimit': '-0.43', 'upperLimit': '-0.22'}, {'value': '-0.04', 'groupId': 'OG008', 'lowerLimit': '-0.08', 'upperLimit': '-0.01'}, {'value': '-0.07', 'groupId': 'OG009', 'lowerLimit': '-0.09', 'upperLimit': '-0.04'}, {'value': '-0.05', 'groupId': 'OG010', 'lowerLimit': '-0.09', 'upperLimit': '-0.02'}, {'value': '-0.09', 'groupId': 'OG011', 'lowerLimit': '-0.12', 'upperLimit': '-0.05'}, {'value': '0.07', 'groupId': 'OG012', 'lowerLimit': '-0.03', 'upperLimit': '0.18'}, {'value': '-0.12', 'groupId': 'OG013', 'lowerLimit': '-0.19', 'upperLimit': '-0.05'}, {'value': '-0.20', 'groupId': 'OG014', 'lowerLimit': '-0.28', 'upperLimit': '-0.13'}, {'value': '-0.26', 'groupId': 'OG015', 'lowerLimit': '-0.33', 'upperLimit': '-0.19'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'Child report: Measured using the combined mean score of 1) the broadband internalizing scale of the Youth Self-Report (YSR) and 2) depression-related items developed locally that are culturally specific. All items included are measured on a scale of 0-2, with 0 representing no depression (better) and 2 representing frequent signs of depression (worse).\n\nCaregiver report: Measured using the combined mean score of 1) the broadband internalizing scale of the Child Behavior Checklist (CBCL) and 2) depression-related items developed locally that are culturally specific. All items included are measured on a scale of 0-2, with 0 representing no depression (better) and 2 representing frequent signs of depression (worse).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Child Functioning', 'timeFrame': 'Baseline, 3 months', 'description': 'Locally developed tool used to measure functional impairment and improvement over time.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Child-Guardian Relationship', 'timeFrame': 'Baseline, 3 months', 'description': 'Measured using the Child-Parent Relationship Scale (CPRS)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care Comparison Condition - Children', 'description': 'Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'FG001', 'title': 'Trauma-focused CBT Group Therapy - Children', 'description': 'Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'FG002', 'title': 'Usual Care Comparison Condition - Caregivers', 'description': 'Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'FG003', 'title': 'Trauma-focused CBT Group Therapy - Caregivers', 'description': 'Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '320'}, {'groupId': 'FG001', 'numSubjects': '320'}, {'groupId': 'FG002', 'numSubjects': '320'}, {'groupId': 'FG003', 'numSubjects': '320'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '315'}, {'groupId': 'FG001', 'numSubjects': '298'}, {'groupId': 'FG002', 'numSubjects': '315'}, {'groupId': 'FG003', 'numSubjects': '298'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Partial Intervention Completion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}, {'value': '320', 'groupId': 'BG003'}, {'value': '1280', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care Comparison Condition - Children', 'description': 'Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'BG001', 'title': 'Trauma-focused CBT Group Therapy - Children', 'description': 'Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'BG002', 'title': 'Usual Care Comparison Condition - Caregivers', 'description': 'Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.'}, {'id': 'BG003', 'title': 'Trauma-focused CBT Group Therapy - Caregivers', 'description': 'Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.\n\nTrauma-focused Cognitive Behavioral Therapy'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}, {'value': '320', 'groupId': 'BG003'}, {'value': '1276', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '318', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '636', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '298', 'groupId': 'BG002'}, {'value': '292', 'groupId': 'BG003'}, {'value': '590', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Child age missing for 2 comparison and 2 intervention participants.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}, {'value': '320', 'groupId': 'BG003'}, {'value': '1276', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '10.68', 'spread': '1.66', 'groupId': 'BG000'}, {'value': '10.58', 'spread': '1.60', 'groupId': 'BG001'}, {'value': '45.10', 'spread': '13.34', 'groupId': 'BG002'}, {'value': '44.43', 'spread': '12.36', 'groupId': 'BG003'}, {'value': '27.75', 'spread': '19.38', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Child age missing for 2 comparison and 2 intervention participants.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}, {'value': '320', 'groupId': 'BG003'}, {'value': '1280', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '286', 'groupId': 'BG003'}, {'value': '894', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '386', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}, {'value': '320', 'groupId': 'BG003'}, {'value': '1280', 'groupId': 'BG004'}]}], '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'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '320', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}, {'value': '320', 'groupId': 'BG003'}, {'value': '1280', 'groupId': 'BG004'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}, {'value': '320', 'groupId': 'BG003'}, {'value': '1280', 'groupId': 'BG004'}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '320', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}, {'value': '320', 'groupId': 'BG003'}, {'value': '1280', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'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'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Tanzania', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}, {'value': '320', 'groupId': 'BG003'}, {'value': '1280', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}, {'value': '640', 'groupId': 'BG004'}]}]}, {'title': 'Kenya', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}, {'value': '320', 'groupId': 'BG003'}, {'value': '1280', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}, {'value': '640', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Caregivers and Children were treated as dyads for the study, but have been categorized separately here for the purpose of reporting results.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2011-05-03', 'size': 270463, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-31T16:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2013-03-25', 'resultsFirstSubmitDate': '2019-03-20', 'studyFirstSubmitQcDate': '2013-03-27', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-02', 'studyFirstPostDateStruct': {'date': '2013-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Depression', 'timeFrame': 'Baseline, 3 months', 'description': 'Child report: Measured using the combined mean score of 1) the broadband internalizing scale of the Youth Self-Report (YSR) and 2) depression-related items developed locally that are culturally specific. All items included are measured on a scale of 0-2, with 0 representing no depression (better) and 2 representing frequent signs of depression (worse).\n\nCaregiver report: Measured using the combined mean score of 1) the broadband internalizing scale of the Child Behavior Checklist (CBCL) and 2) depression-related items developed locally that are culturally specific. All items included are measured on a scale of 0-2, with 0 representing no depression (better) and 2 representing frequent signs of depression (worse).'}, {'measure': 'Child Functioning', 'timeFrame': 'Baseline, 3 months', 'description': 'Locally developed tool used to measure functional impairment and improvement over time.'}, {'measure': 'Child-Guardian Relationship', 'timeFrame': 'Baseline, 3 months', 'description': 'Measured using the Child-Parent Relationship Scale (CPRS)'}], 'primaryOutcomes': [{'measure': 'Posttraumatic Stress Syndrome (PTSS)', 'timeFrame': 'Baseline, 3 months', 'description': 'Measured using the Child PTSD Symptoms Scale (CPSS). Caregiver and Child reported separately. Scale range 0-57, with 57 representing extremely high PTSS symptomatology (worse outcome). 634 children and 634 caregivers (1268 total) analyzed at baseline and 3-month follow-up--includes all 1280 enrolled at baseline, minus 12 lost to follow-up.'}, {'measure': 'Childhood Traumatic Grief', 'timeFrame': 'Baseline, 3 months', 'description': 'Measured using the Inventory of Complicated Grief (ICG). Child report only. Scale range 0-112, with 112 representing extremely high grief symptomatology (worse outcome). 634 children and 634 caregivers (1268 total) analyzed at baseline and 3-month follow-up--includes all 1280 enrolled at baseline, minus 12 lost to follow-up.'}], 'secondaryOutcomes': [{'measure': 'Behavioral Difficulties', 'timeFrame': 'Baseline, 3 months', 'description': 'Child report: Measured using the combined mean score of 1) the broadband externalizing scale of the Youth Self-Report (YSR) and 2) behavior-related items developed locally that are culturally specific. All items included are measured on a scale of 0-2, with 0 representing no behavioral difficulties (better) and 2 representing frequent behavioral difficulties (worse).\n\nCaregiver report: Measured using the combined mean score of 1) the broadband externalizing scale of the Child Behavior Checklist (CBCL) and 2) behavior-related items developed locally that are culturally specific. All items included are measured on a scale of 0-2, with 0 representing no behavioral difficulties (better) and 2 representing frequent behavioral difficulties (worse).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Children', 'Adolescents', 'Trauma-focused Cognitive Behavioral Therapy (TF-CBT)', 'Low- and Middle-Income Countries (LMIC)', 'Randomized Controlled Trial (RCT)', 'Evidence-Based Practice (EBP)', 'Childhood Traumatic Grief (CTG)', 'Post-Traumatic Stress Disorder (PTSD)', 'Kenya', 'Tanzania', 'East Africa', 'Mental Health'], 'conditions': ['Childhood Traumatic Grief', 'Post Traumatic Stress', 'Post Traumatic Stress Disorder', 'Depressive Symptoms', 'Behavioral Problems', 'Child Overall Daily Functioning', 'Child and Guardian Relationship']}, 'referencesModule': {'references': [{'pmid': '31968059', 'type': 'DERIVED', 'citation': "Dorsey S, Lucid L, Martin P, King KM, O'Donnell K, Murray LK, Wasonga AI, Itemba DK, Cohen JA, Manongi R, Whetten K. Effectiveness of Task-Shifted Trauma-Focused Cognitive Behavioral Therapy for Children Who Experienced Parental Death and Posttraumatic Stress in Kenya and Tanzania: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):464-473. doi: 10.1001/jamapsychiatry.2019.4475."}], 'seeAlsoLinks': [{'url': 'http://depts.washington.edu/risemh/pamoja-tunaweza-together-we-can/', 'label': 'Pamoja Tunaweza (Together We Can)'}]}, 'descriptionModule': {'briefSummary': "The primary goal is to study the effectiveness of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in treating traumatic grief and traumatic stress for orphaned children and young adolescents in two East African sites with high prevalence HIV, Moshi, Tanzania (TZ) and Bungoma, Kenya (KE), through a randomized controlled trial (RCT). In a previous feasibility study of TF-CBT with orphans in Tanzania, the investigators have found a group-based TF-CBT intervention to be feasible and acceptable, with promising clinical outcomes. In the feasibility study, lay counselors with no prior mental health experience delivered the intervention with training and supervision by our team of mental health and TF-CBT experts.\n\nBuilding on this initial study, the investigators are conducting a RCT to test the effectiveness of TF-CBT for traumatic grief and traumatic stress compared to receipt of usual care orphan services in TZ and KE. The study involves collaboration with HIV/AIDS grassroots organizations and local Co-Investigators in TZ and KE, both of whom are longstanding collaborators with the investigators' US team and are located in mixed urban and rural areas, allowing examination of effectiveness in two countries and two settings (urban/rural). Using a task-shifting approach, in which lay individuals are trained as counselors, the investigators will train six counselors in each country, who deliver 20 groups in each site (8 rural, 12 urban), resulting in 320 children and adolescents (ages 7-13) who receive TF-CBT and 320 who receive usual care. Outcomes for children are assessed at 12-14 weeks (i.e., corresponding with the end of TF-CBT), 6-months post-treatment, and 12-months post-treatment. TF-CBT experts from the investigators' team partner with the lay counselors from the feasibility study (e.g., local trainers) to train the TZ and KE counselors, and these local trainers provide the TF-CBT supervision, while supervised themselves by the US-based TF-CBT and mental health experts. The investigators expect this trial to yield recommendations regarding an effective intervention for orphans that is acceptable, feasible, and includes local responsibility as a means to enhance potential sustainability in Low- and Middle-Income Countries (LMICs). Findings will inform other efforts to scale up mental health interventions to address the substantial mental health gap."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children ages 7-13 living in Moshi, Tanzania or Bungoma, Kenya who have had one or both parents die since they were 3 years old or older.\n* Children must have scores on study measures indicating they have symptoms of traumatic grief and/or traumatic stress.\n* Children must be living with an adult guardian who is willing to participate in 12 weekly group sessions.\n* Adult guardians of eligible children.\n\nExclusion Criteria:\n\n* Living in an institution (not with a guardian).\n* Parent(s) died before child was 3 years old.'}, 'identificationModule': {'nctId': 'NCT01822366', 'briefTitle': 'Randomized Controlled Trial of Trauma-focused CBT in Tanzania and Kenya', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Improving Health Outcomes by Preventing HIV/STD Risk', 'orgStudyIdInfo': {'id': 'Pro00039770'}, 'secondaryIdInfos': [{'id': 'R01MH096633', 'link': 'https://reporter.nih.gov/quickSearch/R01MH096633', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care Comparison Condition', 'description': 'Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.'}, {'type': 'EXPERIMENTAL', 'label': 'Trauma-focused CBT group therapy', 'description': 'Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.', 'interventionNames': ['Behavioral: Trauma-focused Cognitive Behavioral Therapy']}], 'interventions': [{'name': 'Trauma-focused Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Trauma-focused CBT group therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Department of Psychology', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Bungoma', 'country': 'Kenya', 'facility': 'Action in the Community Environment (ACE) Africa', 'geoPoint': {'lat': 0.5635, 'lon': 34.56055}}, {'city': 'Moshi', 'country': 'Tanzania', 'facility': 'Tanzania Women Research Foundation (TAWREF)', 'geoPoint': {'lat': -3.35, 'lon': 37.33333}}], 'overallOfficials': [{'name': 'Shannon Dorsey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Kate Whetten, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Tanzania Women Research Foundation (TAWREF)', 'class': 'UNKNOWN'}, {'name': 'Ace Africa', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}