Anorexia Nervosa, Atypical Anorexia Nervosa
Conditions
Keywords
Training, Eating disorders, Family based treatment, Medicaid, Community mental health, Children and adolescents, Mental health clinicians
Brief summary
This is a randomized controlled trial for mental health clinicians comparing two methods of training in family-based treatment (FBT) for restrictive eating disorders.
Detailed description
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.
Interventions
BEHAVIORALWeb-based training
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.
BEHAVIORALLive training
The live training will be delivered by two trainers over the course of two days via Zoom.
Sponsors
National Institute of Mental Health (NIMH)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 * Must treat patients with Medicaid insurance in a participating county
Exclusion criteria
\- Students (practicum students, interns, externs) or other learners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Complete 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) | Training completion will be the number of participants who complete the full course of training. |
| Family-Based Treatment Knowledge Assessment (FBT-KA) Score at Post-Training | Baseline and post-training (measured immediately following completion of 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Receive FBT Consultation at 12 Months | 12-month follow-up (measured at 12 months from the deadline for completion of training) | Providers will report on their receipt (yes/no) of FBT-specific consultation in the 12 months following completion of training. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 56 |
| 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. | 29 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 8 |
Baseline characteristics
| Characteristic | Online Training | Live Training | Total |
|---|---|---|---|
| Age, Continuous | 41.65 years STANDARD_DEVIATION 9.26 | 37.39 years STANDARD_DEVIATION 8.72 | 40.22 years STANDARD_DEVIATION 9.25 |
| Any prior eating disorder treatment experience | 29 Participants | 14 Participants | 43 Participants |
| Comfort with eating disorders | -0.18 units on a scale STANDARD_DEVIATION 1.16 | -0.25 units on a scale STANDARD_DEVIATION 0.93 | -0.20 units on a scale STANDARD_DEVIATION 1.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 14 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 15 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Family-Based Treatment Knowledge Assessment (FBT-KA) | 8.30 score on a scale STANDARD_DEVIATION 4.56 | 8.86 score on a scale STANDARD_DEVIATION 4.57 | 8.49 score on a scale STANDARD_DEVIATION 4.54 |
| Importance of eating disorders to organization | 1.42 units on a scale STANDARD_DEVIATION 0.93 | 1.23 units on a scale STANDARD_DEVIATION 0.97 | 1.36 units on a scale STANDARD_DEVIATION 0.94 |
| Importance of eating disorders to own practice | 1.36 units on a scale STANDARD_DEVIATION 0.9 | 1.23 units on a scale STANDARD_DEVIATION 0.81 | 1.32 units on a scale STANDARD_DEVIATION 0.87 |
| Level of training and/or experience in FBT | 2.45 units on a scale STANDARD_DEVIATION 1.21 | 2.03 units on a scale STANDARD_DEVIATION 1.02 | 2.31 units on a scale STANDARD_DEVIATION 1.16 |
| Licensure status (licensed) | 46 Participants | 20 Participants | 66 Participants |
| Modified Practice Attitudes Scale (MPAS) | 23.75 score on a scale STANDARD_DEVIATION 3.48 | 22.21 score on a scale STANDARD_DEVIATION 4.09 | 23.23 score on a scale STANDARD_DEVIATION 3.74 |
| Organizational Readiness for Change (ORC-D4) | 36.23 score on a scale STANDARD_DEVIATION 3.62 | 35.75 score on a scale STANDARD_DEVIATION 3.46 | 36.06 score on a scale STANDARD_DEVIATION 3.55 |
| Primary discipline Marriage/Family Therapy | 27 Participants | 10 Participants | 37 Participants |
| Primary discipline Other | 2 Participants | 0 Participants | 2 Participants |
| Primary discipline Psychiatry | 2 Participants | 0 Participants | 2 Participants |
| Primary discipline Psychology | 4 Participants | 3 Participants | 7 Participants |
| Primary discipline Social Work | 20 Participants | 15 Participants | 35 Participants |
| Primary discipline Unknown | 1 Participants | 1 Participants | 2 Participants |
| Provide services in language other than English | 33 Participants | 15 Participants | 48 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 4 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 8 Participants | 21 Participants |
| Race (NIH/OMB) White | 25 Participants | 13 Participants | 38 Participants |
| Region of Enrollment United States | 56 participants | 29 participants | 85 participants |
| Sex/Gender, Customized Cisgender female | 54 Participants | 23 Participants | 77 Participants |
| Sex/Gender, Customized Cisgender male | 2 Participants | 4 Participants | 6 Participants |
| Sex/Gender, Customized Gender non-binary or fluid | 0 Participants | 2 Participants | 2 Participants |
| Training Preference Live (moderate preference) | 4 Participants | 2 Participants | 6 Participants |
| Training Preference Live (slight preference) | 1 Participants | 1 Participants | 2 Participants |
| Training Preference Live (strong preference) | 22 Participants | 9 Participants | 31 Participants |
| Training Preference No preference | 8 Participants | 6 Participants | 14 Participants |
| Training Preference Online (moderate preference) | 7 Participants | 2 Participants | 9 Participants |
| Training Preference Online (slight preference) | 4 Participants | 2 Participants | 6 Participants |
| Training Preference Online (strong preference) | 10 Participants | 7 Participants | 17 Participants |
| Years clinical experience | 9.78 years STANDARD_DEVIATION 6.85 | 7.36 years STANDARD_DEVIATION 5.68 | 8.95 years STANDARD_DEVIATION 6.54 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 29 |
| other Total, other adverse events | 0 / 56 | 0 / 29 |
| serious Total, serious adverse events | 0 / 56 | 0 / 29 |
Outcome results
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.
Time frame: Baseline and post-training (measured immediately following completion of training)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Training | Family-Based Treatment Knowledge Assessment (FBT-KA) Score at Post-Training | 20.52 score on a scale | Standard Deviation 4.23 |
| Live Training | Family-Based Treatment Knowledge Assessment (FBT-KA) Score at Post-Training | 18.30 score on a scale | Standard Deviation 2.96 |
Comparison: 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.p-value: 0.2995% CI: [-3.618, 1.083]Regression, Linear
Primary
Number of Participants Who Complete Training
Training completion will be the number of participants who complete the full course of training.
Time frame: 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)
Population: Data on training completion were available for all participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Online Training | Number of Participants Who Complete Training | Did not complete training | 8 Participants |
| Online Training | Number of Participants Who Complete Training | Completed training | 48 Participants |
| Live Training | Number of Participants Who Complete Training | Completed training | 22 Participants |
| Live Training | Number of Participants Who Complete Training | Did not complete training | 7 Participants |
Comparison: 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.p-value: 0.4795% CI: [0.167, 2.283]Regression, Logistic
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.
Time frame: 12-month follow-up (measured at 12 months from the deadline for completion of training)
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Online Training | Number of Participants Who Receive FBT Consultation at 12 Months | Participating in FBT consultation | 28 Participants |
| Online Training | Number of Participants Who Receive FBT Consultation at 12 Months | Not participating in FBT consultation | 21 Participants |
| Online Training | Number of Participants Who Receive FBT Consultation at 12 Months | Unknown | 7 Participants |
| Live Training | Number of Participants Who Receive FBT Consultation at 12 Months | Participating in FBT consultation | 10 Participants |
| Live Training | Number of Participants Who Receive FBT Consultation at 12 Months | Not participating in FBT consultation | 11 Participants |
| Live Training | Number of Participants Who Receive FBT Consultation at 12 Months | Unknown | 8 Participants |
Comparison: 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.p-value: 0.9295% CI: [0.07, 19.293]Regression, Logistic