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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23MH120347 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This is a randomized controlled trial for mental health clinicians comparing two methods of training in family-based treatment (FBT) for restrictive eating disorders.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-based training | Experimental | Web-based training will provide online training primarily focused on family-based treatment and appropriate adaptations to the treatment model. |
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| Live training | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Complete Training | Training completion will be the number of participants who complete the full course of training. | 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) |
| Family-Based Treatment Knowledge Assessment (FBT-KA) Score at Post-Training | 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. | Baseline and post-training (measured immediately following completion of training) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Receive FBT Consultation at 12 Months | Providers will report on their receipt (yes/no) of FBT-specific consultation in the 12 months following completion of training. | 12-month follow-up (measured at 12 months from the deadline for completion of training) |
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Inclusion Criteria:
Exclusion criteria:
- Students (practicum students, interns, externs) or other learners
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| Name | Affiliation | Role |
|---|---|---|
| Erin C Accurso, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Online Training | 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). Online 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. |
| FG001 | Live Training | 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). Live training: The live training will be delivered by two trainers over the course of two days via Zoom. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Online Training | Online training will provide web-based training primarily focused on family-based treatment and appropriate adaptations to the treatment model. Online 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was available for 83 participants (online: n = 55, live: n = 28). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Complete Training | Training completion will be the number of participants who complete the full course of training. | Data on training completion were available for all participants. | Posted | Count of Participants | Participants | 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) |
|
15 months
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Online Training | Online web-based training will provide online training primarily focused on family-based treatment and appropriate adaptations to the treatment model. Online 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Accurso | University of California, San Francisco | 415-476-5139 | erin.accurso@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2025 | Jun 25, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 5, 2022 | Jun 23, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Live training | Behavioral | The live training will be delivered by two trainers over the course of two days via Zoom. |
|
| BG001 | Live Training | 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. Live training: The live training will be delivered by two trainers over the course of two days via Zoom. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary discipline | Count of Participants | Participants |
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| Provide services in language other than English | Count of Participants | Participants |
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| Years clinical experience | Clinical experience (years) was available for 82 participants (online: n = 54, live: n = 28). | Mean | Standard Deviation | years |
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| Licensure status (licensed) | Count of Participants | Participants |
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| Any prior eating disorder treatment experience | Count of Participants | Participants |
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| Level of training and/or experience in FBT | 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). | Mean | Standard Deviation | units on a scale |
|
| Training Preference | Count of Participants | Participants |
|
| Family-Based Treatment Knowledge Assessment (FBT-KA) | 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. | Mean | Standard Deviation | score on a scale |
|
| Modified Practice Attitudes Scale (MPAS) | 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. | MPAS data were available for 83 participants (online: n = 55, live: n = 28). | Mean | Standard Deviation | score on a scale |
|
| Organizational Readiness for Change (ORC-D4) | 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. | ORC-D4 data were available for 82 participants (online: n = 54, live: n = 28). | Mean | Standard Deviation | score on a scale |
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| Importance of eating disorders to organization | 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. | Data on the importance of eating disorders in one's organization were available for 72 participants (online: n = 50, live: n = 22). | Mean | Standard Deviation | units on a scale |
|
| Importance of eating disorders to own practice | 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. | Data on the importance of eating disorders in one's own practice were available for 72 participants (online: n = 50, live: n = 22). | Mean | Standard Deviation | units on a scale |
|
| Comfort with eating disorders | 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. | Data on comfort with eating disorders were available for 83 participants (online: n = 55, live: n = 28). | Mean | Standard Deviation | units on a scale |
|
| OG001 | Live Training | 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. Live training: The live training will be delivered by two trainers over the course of two days via Zoom. |
|
|
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| Primary | Family-Based Treatment Knowledge Assessment (FBT-KA) Score at Post-Training | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and post-training (measured immediately following completion of training) |
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| Secondary | Number of Participants Who Receive FBT Consultation at 12 Months | Providers will report on their receipt (yes/no) of FBT-specific consultation in the 12 months following completion of training. | 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. | Posted | Count of Participants | Participants | 12-month follow-up (measured at 12 months from the deadline for completion of training) |
|
|
|
|
| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Live Training | 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. Live training: The live training will be delivered by two trainers over the course of two days via Zoom. | 0 | 29 | 0 | 29 | 0 | 29 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Psychology |
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| Psychiatry |
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| Other |
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| Unknown |
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| Online (slight preference) |
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| No preference |
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| Live (slight preference) |
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| Live (moderate preference) |
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| Live (strong preference) |
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| Superiority |
| Unknown |
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