Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-27 @ 10:34 PM
Study NCT ID:
NCT04451161
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2020-06-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067073', 'term': 'Psychological Trauma'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012574', 'term': 'Schools'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D000072182', 'term': 'Non-Medical Public and Private Facilities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lyona@uw.edu', 'phone': '(206) 221-8604', 'title': 'Dr. Aaron Lyon', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months- Baseline (T1), 3-month follow up (T2), 6-month follow up (T3)', 'description': "Any adverse events (including serious ones) were only collected for students (none collected for providers). Identified through a CPSS-V item assessing self-harm (other adverse event). If a student scored \\>0 ('not at all') on this item, the protocol followed:\n\nNotifying the school mental health provider (provider participant) and the parent (with the student's consent). Based on the severity, escalating to the on-call study clinician to develop a safety plan.", 'eventGroups': [{'id': 'EG000', 'title': 'BASIS With TF-CBT (Student)', 'description': 'Students recruited by providers who received training for the interventions: implementation (BASIS) and clinical (TF-CBT).', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 3, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Attention Control With TF-CBT (Student)', 'description': 'Students recruited by providers who received control for the implementation intervention and training for TF-CBT for clinical intervention.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 4, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Enhanced Treatment as Usual (Student)', 'description': 'Students recruited by providers who received control for both implementation and clinical intervention.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 2, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'BASIS With TF-CBT (Provider)', 'description': 'Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'AC (Attention Control) With TF-CBT (Provider)', 'description': 'Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Enhanced Treatment as Usual (Provider)', 'description': 'Participants who received control for both implementation and clinical intervention.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Suicidal Ideation/ Self-harm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'TF-CBT Adoption and Penetration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BASIS With TF-CBT (Provider)', 'description': 'Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT.'}, {'id': 'OG001', 'title': 'AC (Attention Control) With TF-CBT (Provider)', 'description': 'Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention.'}, {'id': 'OG002', 'title': 'Enhanced Treatment as Usual (Provider)', 'description': 'Participants who received control for both implementation and clinical intervention.'}], 'classes': [{'title': 'Administered CPSS-V with at least one student.', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Started TF-CBT with at least one student.', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Completed TF-CBT with at least one student.', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.591', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student beginning of the active phase.', 'groupDescription': 'The primary TF-CBT adoption outcome (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student, or they did not at the beginning of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student by the end of the active phase.', 'groupDescription': 'The primary TF-CBT adoption outcome (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.054', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student by the end of the sustainment phase.', 'groupDescription': 'One of the primary TF-CBT adoption outcomes (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student at the end of the sustainment phase, or they did not. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.98', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student at the beginning of the active phase.', 'groupDescription': 'The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not at the beginning of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.068', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student by the end of the active phase.', 'groupDescription': 'The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.165', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student by the end of the sustainment phase.', 'groupDescription': 'The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the sustainment phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.191', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants completed TF-CBT with at least one student by the end of the active phase.', 'groupDescription': 'The primary TF-CBT adoption outcome (defined as completed TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants completed TF-CBT with at least one student at the end of the sustainment phase.', 'groupDescription': 'The primary TF-CBT adoption outcome (defined as completed TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the sustainment phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 Months- Active phase (timepoint 6 to 9); Sustainment phase (timepoint 10 to 12)', 'description': 'Participants provided data every 2-3 months for up to two years, reporting:\n\nHow many students received CPSS-V (PTSD screener)? With how many students was TF-CBT initiated? With how many students was it completed? This allowed for monitoring of both reach (screening) and implementation (initiation/completion) of TF-CBT.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the randomized participants, the overall number of participants analyzed was still active after the training period. The measure breaks down the number of providers who administered the screener with at least one student, and then adopted (started or completed) the trauma-informed intervention with at least one student.'}, {'type': 'PRIMARY', 'title': 'Child PTSD Symptom Scale for DSM-V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BASIS With TF-CBT (Student)', 'description': 'Students recruited by providers who received training for the interventions: implementation (BASIS) and clinical (TF-CBT).'}, {'id': 'OG001', 'title': 'Attention Control With TF-CBT (Student)', 'description': 'Students recruited by providers who received control for the implementation intervention and training for TF-CBT for clinical intervention.'}, {'id': 'OG002', 'title': 'Enhanced Treatment as Usual (Student)', 'description': 'Students recruited by providers who received control for both implementation and clinical intervention.'}], 'classes': [{'title': 'Baseline (T1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.7', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '39.3', 'spread': '18.7', 'groupId': 'OG001'}, {'value': '37.1', 'spread': '16.1', 'groupId': 'OG002'}]}]}, {'title': '3-month follow up (T2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.3', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '34.4', 'spread': '16.2', 'groupId': 'OG001'}, {'value': '28.1', 'spread': '17.4', 'groupId': 'OG002'}]}]}, {'title': '6-month follow up (T3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26.1', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '32.2', 'spread': '18.8', 'groupId': 'OG001'}, {'value': '19.4', 'spread': '16.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.425', 'ciLowerLimit': '-2.064', 'ciUpperLimit': '8.915', 'pValueComment': 'Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if BASIS+TF-CBT has a greater effect on decreasing trauma PTSD symptoms (measured using CPSS-V) over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.783', 'groupDescription': 'We compared the BASIS group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT reduced trauma-related PTSD symptoms over time, as measured by CPSS-V scores (higher scores indicate greater symptom severity).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.075', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.97', 'ciLowerLimit': '-.502', 'ciUpperLimit': '10.443', 'pValueComment': 'Mixed model analysis was used (the students were clustered under the providers who recruited them) to understand if AC+TF-CBT has a greater effect on decreasing trauma PTSD symptoms (measured using CPSS-V) over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.774', 'groupDescription': 'We compared the AC group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT reduced trauma-related PTSD symptoms over time, as measured by CPSS-V scores (higher scores indicate greater symptom severity).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3)', 'description': 'The Child PTSD Symptom Scale Self-Report for DSM-5 (CPSS-V) is a modified version of the original CPSS-SR adapted for DSM-5 criteria. The scale includes 20 PTSD symptom items scored on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("6 or more times a week / severe"), where higher scores indicate greater symptom severity. The scale includes 7 functioning items rated as "yes" or "no." The total score ranges from 0 to 80, with higher scores reflecting worse PTSD symptom severity.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the participants (students) who received trauma-informed intervention- TF-CBT or Enhanced treatment as usual.'}, {'type': 'PRIMARY', 'title': 'Mood and Feelings Questionnaire - Short', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BASIS With TF-CBT (Student)', 'description': 'Students recruited by providers who received training for the interventions: implementation (BASIS) and clinical (TF-CBT).'}, {'id': 'OG001', 'title': 'Attention Control With TF-CBT (Student)', 'description': 'Students recruited by providers who received control for the implementation intervention and training for TF-CBT for clinical intervention.'}, {'id': 'OG002', 'title': 'Enhanced Treatment as Usual (Student)', 'description': 'Students recruited by providers who received control for both implementation and clinical intervention.'}], 'classes': [{'title': 'Baseline (T1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.3', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '7.1', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '5.9', 'groupId': 'OG002'}]}]}, {'title': '3-month follow up (T2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '7.2', 'spread': '4.4', 'groupId': 'OG002'}]}]}, {'title': '6-month follow-up (T3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '10', 'spread': '7.3', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '4.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.284', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.024', 'ciLowerLimit': '-.855', 'ciUpperLimit': '2.904', 'pValueComment': 'Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if BASIS+TF-CBT has a greater effect on decreasing negative mood and feelings symptoms (measured using SMFQ) over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.952', 'groupDescription': "We compared the BASIS group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT decreased children's negative moods and feelings due to their trauma (higher score indicates more negative mood and feelings).", 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.046', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.908', 'ciLowerLimit': '.03', 'ciUpperLimit': '3.786', 'pValueComment': 'Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if AC+TF-CBT has a greater effect on decreasing negative mood and feelings symptoms (measured using SMFQ) over time.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.951', 'groupDescription': "We compared the AC group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT decreased children's negative moods and feelings due to their trauma (higher score indicates more negative mood and feelings).", 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3)', 'description': 'The Short Mood and Feelings Questionnaire (SMFQ) is a 13-item self-report measure assessing recent emotional and behavioral states. It consists of descriptive phrases rated based on how often they applied to the subject over the past two weeks: 0 ("not at all"), 1 ("sometimes"), or 2 ("most of the time"). The total score ranges from 0 to 26, with higher scores indicating greater severity of depressive symptoms (worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the participants (students) who received trauma-informed intervention- TF-CBT or Enhanced Treatment as Usual.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BASIS With TF-CBT (Provider)', 'description': 'Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT.'}, {'id': 'FG001', 'title': 'AC (Attention Control) With TF-CBT (Provider)', 'description': 'Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention.'}, {'id': 'FG002', 'title': 'Enhanced Treatment as Usual (Provider)', 'description': 'Participants who received control for both implementation and clinical intervention.'}, {'id': 'FG003', 'title': 'BASIS With TF-CBT (Students)', 'description': 'Students recruited by providers who received training for the interventions: implementation (BASIS) and clinical (TF-CBT).'}, {'id': 'FG004', 'title': 'AC (Attention Control) With TF-CBT (Student)', 'description': 'Students recruited by providers who received control for the implementation intervention and training for TF-CBT for clinical intervention.'}, {'id': 'FG005', 'title': 'Enhanced Treatment as Usual (Student)', 'description': 'Students recruited by providers who received control for both implementation and clinical intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '32'}, {'groupId': 'FG005', 'numSubjects': '35'}]}, {'type': 'End of Training Period (Provider)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'End of Active Phase of the Study (Provider)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': '3-month Follow up (Student)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '26'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'School districts across the United States were recruited to participate in the study, where the district leaders provided a list of potential eligible clinicians currently employed in schools in the district. The eligibility criteria for clinicians were a) provided school-based services for the participating school district; b) did not receive formal training in TF-CBT or CBT+; c) did not receive support to implement another trauma-focused intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '292', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'BASIS With TF-CBT (Provider)', 'description': 'Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT.'}, {'id': 'BG001', 'title': 'AC (Attention Control) With TF-CBT (Provider)', 'description': 'Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention.'}, {'id': 'BG002', 'title': 'Enhanced Treatment as Usual (Provider)', 'description': 'Participants who received control for both implementation and clinical intervention.'}, {'id': 'BG003', 'title': 'BASIS With TF-CBT (Students)', 'description': 'Students recruited by providers who received training for the interventions: implementation (BASIS) and clinical (TF-CBT).'}, {'id': 'BG004', 'title': 'AC (Attention Control) With TF-CBT (Student)', 'description': 'Students recruited by providers who received control for the implementation intervention and training for TF-CBT for clinical intervention.'}, {'id': 'BG005', 'title': 'Enhanced Treatment as Usual (Student)', 'description': 'Students recruited by providers who received control for both implementation and clinical intervention.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '292', 'groupId': 'BG006'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '101', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '189', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '101', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '11', 'spread': '2.7', 'groupId': 'BG003'}, {'value': '12', 'spread': '3.2', 'groupId': 'BG004'}, {'value': '11.2', 'spread': '2.5', 'groupId': 'BG005'}, {'value': '11.4', 'spread': '2.8', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Students were recruited by providers who participated in the study. The students needed to be a) within the TF-CBT development range (age 8-19), b) experienced a traumatic event (e.g., exposure to violence), and c) have significant post-traumatic stress symptoms. Only categorical age was collected for provider participants; therefore, the mean and standard deviation cannot be calculated.'}, {'title': 'Sex/Gender, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '292', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '223', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '58', 'groupId': 'BG006'}]}, {'title': 'Transgender', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Non-binary', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}, {'title': 'Unknown or not reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '292', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}, {'value': '271', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '292', 'groupId': 'BG006'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '219', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '292', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '292', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The eligibility criteria for clinicians: a) provided school-based services for the participating school district; b) did not receive formal training in TF-CBT or CBT+; c) did not receive support to implement another trauma-focused intervention.\n\nEligible students recruited by participating providers: a) within the TF-CBT development age ( 8-19); b) experienced a traumatic event exposure (e.g., exposure to violence); and c) significant post-traumatic stress symptoms.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-05', 'size': 719473, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-25T13:45', 'hasProtocol': True}, {'date': '2021-09-21', 'size': 184383, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-25T13:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'The care provider is not masked to the intervention condition they are in (ie, TF-CBT vs TAU), but will be masked to the implementation strategy (ie, Attention Control vs. BASIS).'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2020-06-23', 'resultsFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2020-06-26', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-06-25', 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TF-CBT Adoption and Penetration', 'timeFrame': '18 Months- Active phase (timepoint 6 to 9); Sustainment phase (timepoint 10 to 12)', 'description': 'Participants provided data every 2-3 months for up to two years, reporting:\n\nHow many students received CPSS-V (PTSD screener)? With how many students was TF-CBT initiated? With how many students was it completed? This allowed for monitoring of both reach (screening) and implementation (initiation/completion) of TF-CBT.'}, {'measure': 'Child PTSD Symptom Scale for DSM-V', 'timeFrame': '6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3)', 'description': 'The Child PTSD Symptom Scale Self-Report for DSM-5 (CPSS-V) is a modified version of the original CPSS-SR adapted for DSM-5 criteria. The scale includes 20 PTSD symptom items scored on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("6 or more times a week / severe"), where higher scores indicate greater symptom severity. The scale includes 7 functioning items rated as "yes" or "no." The total score ranges from 0 to 80, with higher scores reflecting worse PTSD symptom severity.'}, {'measure': 'Mood and Feelings Questionnaire - Short', 'timeFrame': '6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3)', 'description': 'The Short Mood and Feelings Questionnaire (SMFQ) is a 13-item self-report measure assessing recent emotional and behavioral states. It consists of descriptive phrases rated based on how often they applied to the subject over the past two weeks: 0 ("not at all"), 1 ("sometimes"), or 2 ("most of the time"). The total score ranges from 0 to 26, with higher scores indicating greater severity of depressive symptoms (worse outcome).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Evidence-Based Practices', 'CBT', 'School Health Services', 'Trauma, Psychological']}, 'referencesModule': {'references': [{'pmid': '33413511', 'type': 'DERIVED', 'citation': 'Lyon AR, Pullmann MD, Dorsey S, Levin C, Gaias LM, Brewer SK, Larson M, Corbin CM, Davis C, Muse I, Joshi M, Reyes R, Jungbluth NJ, Barrett R, Hong D, Gomez MD, Cook CR. Protocol for a hybrid type 2 cluster randomized trial of trauma-focused cognitive behavioral therapy and a pragmatic individual-level implementation strategy. Implement Sci. 2021 Jan 7;16(1):3. doi: 10.1186/s13012-020-01064-1.'}]}, 'descriptionModule': {'briefSummary': 'This research project is a hybrid type 2 effectiveness-implementation trial that simultaneously examines (1) the effectiveness of a trauma-focused intervention for youth in the education sector and (2) the impact of a theory-driven pragmatic implementation strategy designed to increase the adoption, fidelity, and sustainment of evidence-based treatments (EBTs). This trial will include 120 clinicians and 480 students, and it is designed to test the cost effectiveness and impact of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in a new setting that increases access to mental health care - schools (Aim 1); test the cost effectiveness, immediate impact, and sustained impact of the Beliefs and Attitudes for Successful Implementation in Schools (BASIS) implementation strategy on proximal mechanisms and implementation outcomes (Aims 2a, 2b, 2d); and conduct sequential mixed-methods data collection to explain residuals (i.e., clinicians whose implementation behavior is unaccounted for by the mediation model) (Aim 2c).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Clinicians will be included if they (a) provide school-based services in a participating district; (b) have not previously received formal training in TF-CBT; and (c) are not actively receiving support to implement another trauma-focused intervention.\n\nStudents subjects will meet TF-CBT eligibility criteria, including (a) be within the TF-CBT developmental range (ages 8 to 19), (b) have traumatic event exposure (e.g., exposure to violence), and (c) significant post-traumatic stress symptoms.'}, 'identificationModule': {'nctId': 'NCT04451161', 'briefTitle': 'A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy', 'orgStudyIdInfo': {'id': 'STUDY00008401'}, 'secondaryIdInfos': [{'id': '1R01MH119148-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH119148-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'BASIS with TF-CBT', 'description': 'Implementation intervention: experimental arm (Beliefs and Attitudes for Successful Implementation in Schools)\n\nClinical Intervention: experimental arm (Trauma-Focused CBT)', 'interventionNames': ['Behavioral: Beliefs and Attitudes for Successful Implementation in Schools (BASIS)', 'Behavioral: Trauma-Focused Cognitive-Behavioral Therapy']}, {'type': 'OTHER', 'label': 'Attention Control (AC) with TF-CBT', 'description': 'Implementation intervention: control arm\n\nClinical Intervention: experimental arm (Trauma-Focused CBT)', 'interventionNames': ['Behavioral: Trauma-Focused Cognitive-Behavioral Therapy', 'Behavioral: Attention Control']}, {'type': 'OTHER', 'label': 'Enhanced Treatment as Usual', 'description': 'Implementation intervention: non-applicable\n\nClinical Intervention: control arm (Enhanced TAU)', 'interventionNames': ['Behavioral: Treatment as Usual']}], 'interventions': [{'name': 'Beliefs and Attitudes for Successful Implementation in Schools (BASIS)', 'type': 'BEHAVIORAL', 'description': 'BASIS blended (i.e., multifaceted and protocolized) implementation strategy, which occurs at the beginning of active implementation. BASIS is designed to facilitate observable implementation outcomes, including EBP adoption and intervention fidelity, via strategic education, motivational Interviewing, and social influence strategies.', 'armGroupLabels': ['BASIS with TF-CBT']}, {'name': 'Trauma-Focused Cognitive-Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'TF-CBT is an evidence-based treatment that helps children from elementary to high school to address the negative effects of trauma and promote greater emotion and behavior regulation, including processing their traumatic memories, overcoming problematic thoughts and behaviors, and developing effective coping and interpersonal skills. It also includes a treatment component for parents or other caregivers. Parents can learn skills related to stress management, positive parenting, behavior management, and effective communication.', 'armGroupLabels': ['Attention Control (AC) with TF-CBT', 'BASIS with TF-CBT']}, {'name': 'Treatment as Usual', 'type': 'BEHAVIORAL', 'description': 'Scaffolded intervention as usual. Includes: initial assessment of trauma symptoms, psychoeducation, follow-up planning and support.', 'armGroupLabels': ['Enhanced Treatment as Usual']}, {'name': 'Attention Control', 'type': 'BEHAVIORAL', 'description': 'Didactic presentation of implementation-related content (e.g., information about the importance of implementing, definitions of key terms, etc.) to control for facilitator, dose, information provided, and delivery platform', 'armGroupLabels': ['Attention Control (AC) with TF-CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98115', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Aaron Lyon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'University of Minnesota', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, School of Medicine: Psychiatry: Childrens Division', 'investigatorFullName': 'Aaron Lyon', 'investigatorAffiliation': 'University of Washington'}}}}