Viewing Study NCT05389657


Ignite Creation Date: 2025-12-24 @ 6:36 PM
Ignite Modification Date: 2025-12-28 @ 12:29 AM
Study NCT ID: NCT05389657
Status: COMPLETED
Last Update Posted: 2025-08-07
First Post: 2022-05-18
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Optimizing Provider Training in Eating Disorders (OPTED)
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'erin.accurso@ucsf.edu', 'phone': '415-476-5139', 'title': 'Erin Accurso', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '15 months', 'description': 'No serious adverse events were expected in this trial given that it was low-risk (i.e., providing behavioral health training to mental health clinicians).', 'eventGroups': [{'id': 'EG000', 'title': 'Online Training', 'description': 'Online web-based training will provide online training primarily focused on family-based treatment and appropriate adaptations to the treatment model.\n\nOnline training: Online web-based training will be divided into training modules that will be completed by participants over the course of 6-8 weeks. Training will include didactic training videos, knowledge checks, example sessions, and a library of resources.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Live Training', 'description': 'Live training will include two days of expert-led live training (via zoom). The content of the training will be similar to that provided in web-based training, primarily focused on family-based treatment and appropriate adaptations to the treatment model.\n\nLive training: The live training will be delivered by two trainers over the course of two days via Zoom.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Complete Training', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Training', 'description': 'Online training will provide web-based training primarily focused on family-based treatment and appropriate adaptations to the treatment model.\n\nOnline training: Online training will be divided into training modules that will be completed by participants over the course of 6-8 weeks. Training will include didactic training videos, knowledge checks, example sessions, and a library of resources.'}, {'id': 'OG001', 'title': 'Live Training', 'description': 'Live training will include two days of expert-led live training (via zoom). The content of the training will be similar to that provided in web-based training, primarily focused on family-based treatment and appropriate adaptations to the treatment model.\n\nLive training: The live training will be delivered by two trainers over the course of two days via Zoom.'}], 'classes': [{'categories': [{'title': 'Completed training', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'Did not complete training', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.617', 'ciLowerLimit': '0.167', 'ciUpperLimit': '2.283', 'groupDescription': 'We used logistic multilevel models to examine the impact of training assignment (reference = live training) on training completion, with a random intercept at the agency level. Covariates included prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'multilevel logistic regression'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-training (measured at the time of planned completion, which will be 10 weeks from the start of web-based training, or on the second day of live training)', 'description': 'Training completion will be the number of participants who complete the full course of training.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on training completion were available for all participants.'}, {'type': 'PRIMARY', 'title': 'Family-Based Treatment Knowledge Assessment (FBT-KA) Score at Post-Training', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Training', 'description': 'Online training will provide web-based training primarily focused on family-based treatment and appropriate adaptations to the treatment model.\n\nOnline training: Online training will be divided into training modules that will be completed by participants over the course of 6-8 weeks. Training will include didactic training videos, knowledge checks, example sessions, and a library of resources.'}, {'id': 'OG001', 'title': 'Live Training', 'description': 'Live training will include two days of expert-led live training (via zoom). The content of the training will be similar to that provided in web-based training, primarily focused on family-based treatment and appropriate adaptations to the treatment model.\n\nLive training: The live training will be delivered by two trainers over the course of two days via Zoom.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.52', 'spread': '4.23', 'groupId': 'OG000'}, {'value': '18.30', 'spread': '2.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.29', 'groupIds': ['OG000', 'OG001'], 'paramType': 'adjusted group difference unstandardized', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.268', 'ciLowerLimit': '-3.618', 'ciUpperLimit': '1.083', 'groupDescription': 'We used linear multilevel models with restricted maximum likelihood (REML) estimation to examine the impact of training assignment (reference = live training) on knowledge acquisition at post-training, with a random intercept at the agency level. Covariates included baseline FBT-KA score, prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'multilevel linear regression with restricted maximum likelihood (REML) estimation'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-training (measured immediately following completion of training)', 'description': 'The FBT Knowledge Assessment (FBT-KA) is an 28-item multiple-choice test that measures knowledge about FBT. Scores range from 0 to 28, with higher scores indicating more knowledge.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on post-training knowledge were available for 70 participants (online: n = 50, live: n = 20). However, all participants were included in the analysis. We used multiple imputation to account for missingness.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Receive FBT Consultation at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Training', 'description': 'Online training will provide web-based training primarily focused on family-based treatment and appropriate adaptations to the treatment model.\n\nOnline training: Online training will be divided into training modules that will be completed by participants over the course of 6-8 weeks. Training will include didactic training videos, knowledge checks, example sessions, and a library of resources.'}, {'id': 'OG001', 'title': 'Live Training', 'description': 'Live training will include two days of expert-led live training (via zoom). The content of the training will be similar to that provided in web-based training, primarily focused on family-based treatment and appropriate adaptations to the treatment model.\n\nLive training: The live training will be delivered by two trainers over the course of two days via Zoom.'}], 'classes': [{'categories': [{'title': 'Participating in FBT consultation', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Not participating in FBT consultation', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.160', 'ciLowerLimit': '0.070', 'ciUpperLimit': '19.293', 'groupDescription': 'We used logistic multilevel models to examine the impact of training assignment (reference = live training) on engagement in FBT consultation at 12 months, with a random intercept at the agency level. Covariates included baseline intent to seek FBT consultation, prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'multilevel logistic regression'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12-month follow-up (measured at 12 months from the deadline for completion of training)', 'description': 'Providers will report on their receipt (yes/no) of FBT-specific consultation in the 12 months following completion of training.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on 12-month engagement in consultation were available for 70 participants (online: n = 49, live: n = 21). However, all participants were included in the analysis. We used multiple imputation to account for missingness.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Online Training', 'description': 'Online training will provide web-based training primarily focused on family-based treatment and appropriate adaptations to the treatment model. Interested participants who completed 100% of the online training were randomized to consultation groups (expert only vs. expert + peer consultation).\n\nOnline training: Online training will be divided into training modules that will be completed by participants over the course of 6-8 weeks. Training will include didactic training videos, knowledge checks, example sessions, and a library of resources.'}, {'id': 'FG001', 'title': 'Live Training', 'description': 'Live training will include two days of expert-led live training (via zoom). The content of the training will be similar to that provided in web-based training, primarily focused on family-based treatment and appropriate adaptations to the treatment model. Interested participants who completed 100% of the live training were randomized to consultation groups (expert only vs. expert + peer consultation).\n\nLive training: The live training will be delivered by two trainers over the course of two days via Zoom.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '16', 'numSubjects': '56'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '29'}]}, {'type': 'Enrollment in Consultation', 'achievements': [{'comment': 'Of the 33 online training participants who opted into consultation, 17 were assigned to expert consultation and 16 were assigned to expert + peer consultation.', 'groupId': 'FG000', 'numUnits': '11', 'numSubjects': '33'}, {'comment': 'Of the 10 online training participants who opted into consultation, all were assigned to expert consultation.', 'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '16', 'numSubjects': '49'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '7'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'typeUnitsAnalyzed': 'agency'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Online Training', 'description': 'Online training will provide web-based training primarily focused on family-based treatment and appropriate adaptations to the treatment model.\n\nOnline training: Online training will be divided into training modules that will be completed by participants over the course of 6-8 weeks. Training will include didactic training videos, knowledge checks, example sessions, and a library of resources.'}, {'id': 'BG001', 'title': 'Live Training', 'description': 'Live training will include two days of expert-led live training (via zoom). The content of the training will be similar to that provided in web-based training, primarily focused on family-based treatment and appropriate adaptations to the treatment model.\n\nLive training: The live training will be delivered by two trainers over the course of two days via Zoom.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41.65', 'spread': '9.26', 'groupId': 'BG000'}, {'value': '37.39', 'spread': '8.72', 'groupId': 'BG001'}, {'value': '40.22', 'spread': '9.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age was available for 83 participants (online: n = 55, live: n = 28).'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Cisgender female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Cisgender male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Gender non-binary or fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Primary discipline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Marriage/Family Therapy', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Social Work', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Psychology', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Psychiatry', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Provide services in language other than English', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Years clinical experience', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.78', 'spread': '6.85', 'groupId': 'BG000'}, {'value': '7.36', 'spread': '5.68', 'groupId': 'BG001'}, {'value': '8.95', 'spread': '6.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Clinical experience (years) was available for 82 participants (online: n = 54, live: n = 28).'}, {'title': 'Licensure status (licensed)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Any prior eating disorder treatment experience', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Level of training and/or experience in FBT', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.45', 'spread': '1.21', 'groupId': 'BG000'}, {'value': '2.03', 'spread': '1.02', 'groupId': 'BG001'}, {'value': '2.31', 'spread': '1.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Clinicians reported on the extent to which they had been exposed to or received training in FBT using a five-point scale (1 = no formal training or exposure, 2 = no formal training but some exposure, 3 = very little training, 4= moderate training, 5 = extensive training).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Training Preference', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Online (strong preference)', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Online (moderate preference)', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Online (slight preference)', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'No preference', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Live (slight preference)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Live (moderate preference)', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Live (strong preference)', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Family-Based Treatment Knowledge Assessment (FBT-KA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.30', 'spread': '4.56', 'groupId': 'BG000'}, {'value': '8.86', 'spread': '4.57', 'groupId': 'BG001'}, {'value': '8.49', 'spread': '4.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Family-Based Treatment Knowledge Assessment (FBT-KA) is an 28-item measure that assesses knowledge about FBT for anorexia nervosa and atypical anorexia nervosa. The assessment focuses on general knowledge about FBT (e.g., contraindications, treatment phases), key principles (e.g., externalization, agnosticism, clinician as consultant), and key procedures (e.g., taking regular open weights). Scores range from 0 to 28, with higher scores indicating more knowledge.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Modified Practice Attitudes Scale (MPAS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23.75', 'spread': '3.48', 'groupId': 'BG000'}, {'value': '22.21', 'spread': '4.09', 'groupId': 'BG001'}, {'value': '23.23', 'spread': '3.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Modified Practice Attitudes Scale (MPAS) is an eight-item measure with good reliability and validity that assesses clinician attitudes towards evidence-based treatments. Scores range from 0 to 32, with higher scores indicating more positive attitudes towards evidence-based practice.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'MPAS data were available for 83 participants (online: n = 55, live: n = 28).'}, {'title': 'Organizational Readiness for Change (ORC-D4)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.23', 'spread': '3.62', 'groupId': 'BG000'}, {'value': '35.75', 'spread': '3.46', 'groupId': 'BG001'}, {'value': '36.06', 'spread': '3.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Organizational Readiness for Change (ORC-D4) measure is a 30-item measure with acceptable reliability and validity that assesses attitudes, barriers, and facilitators within the working environment (e.g., collaboration and trust amongst peers, openness to change, management effectiveness). Scores range from 10 to 50, with higher scores indicating greater organizational capacity to implement a change.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'ORC-D4 data were available for 82 participants (online: n = 54, live: n = 28).'}, {'title': 'Importance of eating disorders to organization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.93', 'groupId': 'BG000'}, {'value': '1.23', 'spread': '0.97', 'groupId': 'BG001'}, {'value': '1.36', 'spread': '0.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "A five-item scale (extremely unimportant to extremely important) with a neutral mid-point was used to rank the extent to which eating disorders were perceived to be of importance to clinicians' organization (e.g., agency). Scores range from -2 to 2, with higher scores indicating greater importance.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "Data on the importance of eating disorders in one's organization were available for 72 participants (online: n = 50, live: n = 22)."}, {'title': 'Importance of eating disorders to own practice', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.36', 'spread': '0.90', 'groupId': 'BG000'}, {'value': '1.23', 'spread': '0.81', 'groupId': 'BG001'}, {'value': '1.32', 'spread': '0.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "A five-item scale (extremely unimportant to extremely important) with a neutral mid-point was used to rank the extent to which eating disorders were important to clinicians' own practice. Scores range from -2 to 2, with higher scores indicating greater importance.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "Data on the importance of eating disorders in one's own practice were available for 72 participants (online: n = 50, live: n = 22)."}, {'title': 'Comfort with eating disorders', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '-0.18', 'spread': '1.16', 'groupId': 'BG000'}, {'value': '-0.25', 'spread': '0.93', 'groupId': 'BG001'}, {'value': '-0.20', 'spread': '1.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A five-item scale (extremely uncomfortable to extremely comfortable) with a neutral mid-point was used to rank the degree to which clinicians feel comfortable treating EDs. Scores range from -2 to 2, with higher scores indicating greater comfort.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data on comfort with eating disorders were available for 83 participants (online: n = 55, live: n = 28).'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-25', 'size': 290334, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-25T19:58', 'hasProtocol': True}, {'date': '2022-07-05', 'size': 224863, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-23T13:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2022-05-18', 'resultsFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2022-05-24', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-17', 'studyFirstPostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Complete Training', 'timeFrame': 'Post-training (measured at the time of planned completion, which will be 10 weeks from the start of web-based training, or on the second day of live training)', 'description': 'Training completion will be the number of participants who complete the full course of training.'}, {'measure': 'Family-Based Treatment Knowledge Assessment (FBT-KA) Score at Post-Training', 'timeFrame': 'Baseline and post-training (measured immediately following completion of training)', 'description': 'The FBT Knowledge Assessment (FBT-KA) is an 28-item multiple-choice test that measures knowledge about FBT. Scores range from 0 to 28, with higher scores indicating more knowledge.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Receive FBT Consultation at 12 Months', 'timeFrame': '12-month follow-up (measured at 12 months from the deadline for completion of training)', 'description': 'Providers will report on their receipt (yes/no) of FBT-specific consultation in the 12 months following completion of training.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Training', 'Eating disorders', 'Family based treatment', 'Medicaid', 'Community mental health', 'Children and adolescents', 'Mental health clinicians'], 'conditions': ['Anorexia Nervosa', 'Atypical Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial for mental health clinicians comparing two methods of training in family-based treatment (FBT) for restrictive eating disorders.', 'detailedDescription': 'This is a randomized controlled trial for mental health clinicians comparing two methods of training in family-based treatment (FBT) for restrictive eating disorders. Clinicians who treat youth and accept Medicaid insurance within a predetermined group of participating California counties will be randomized to receive either online training or live two-day training in FBT. Data will be collected on the feasibility, acceptability, appropriateness, and effectiveness of the training (online vs. live). Following training, a subset of clinicians may opt into group consultation for one year. Consultation groups will be kept separate by training condition. Data will also be collected from clinicians on the extent to which they perceive the treatment itself (i.e., FBT) as feasible, acceptable, and appropriate for Medicaid-insured youth. In addition to implementation outcomes, de-identified clinical data will be collected from providers about their cases up to one year following the initial training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mental health provider licensed to practice in the state of California, or unlicensed mental health providers in California who are formally employed by their agency/clinic and have a licensed clinical supervisor who agrees to take legal responsibility for any cases treated with FBT\n* Must treat patients with Medicaid insurance in a participating county\n\nExclusion criteria:\n\n\\- Students (practicum students, interns, externs) or other learners'}, 'identificationModule': {'nctId': 'NCT05389657', 'acronym': 'OPTED', 'briefTitle': 'Optimizing Provider Training in Eating Disorders (OPTED)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Dissemination and Implementation of Family-Based Treatment in Publicly-Funded Clinics: Optimizing Provider Training in Eating Disorders (OPTED)', 'orgStudyIdInfo': {'id': '5K23MH120347', 'link': 'https://reporter.nih.gov/quickSearch/5K23MH120347', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '5K23MH120347', 'link': 'https://reporter.nih.gov/quickSearch/5K23MH120347', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Web-based training', 'description': 'Web-based training will provide online training primarily focused on family-based treatment and appropriate adaptations to the treatment model.', 'interventionNames': ['Behavioral: Web-based training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Live training', 'description': 'Live training will include two days of expert-led live training (via zoom). The content of the training will be similar to that provided in web-based training, primarily focused on family-based treatment and appropriate adaptations to the treatment model.', 'interventionNames': ['Behavioral: Live training']}], 'interventions': [{'name': 'Web-based training', 'type': 'BEHAVIORAL', 'description': 'Web-based training will be divided into training modules that will be completed by participants over the course of 6-8 weeks. Training will include didactic training videos, knowledge checks, example sessions, and a library of resources.', 'armGroupLabels': ['Web-based training']}, {'name': 'Live training', 'type': 'BEHAVIORAL', 'description': 'The live training will be delivered by two trainers over the course of two days via Zoom.', 'armGroupLabels': ['Live training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94103', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Erin C Accurso, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}