- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05389657
Optimizing Provider Training in Eating Disorders (OPTED) (OPTED)
September 20, 2023 updated by: University of California, San Francisco
Dissemination and Implementation of Family-Based Treatment in Publicly-Funded Clinics: Optimizing Provider Training in Eating Disorders (OPTED)
This is a randomized controlled trial for mental health clinicians comparing two methods of training in family-based treatment (FBT) for restrictive eating disorders.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 web-based training (WBT) or live two-day training in FBT.
Data will be collected on the feasibility, acceptability, appropriateness, and effectiveness of the training (web-based 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.
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Francisco, California, United States, 94103
- University of California, San Francisco
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Web-based training
Web-based training will provide online training primarily focused on family-based treatment and appropriate adaptations to the treatment model.
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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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Active Comparator: 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.
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The live training will be delivered by two trainers over the course of two days via Zoom.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who complete 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)
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Training completion will be the number of participants who complete the full course of training.
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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)
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Change in Family-Based Treatment Knowledge Assessment (FBT-KA) Score at Post-Training
Time Frame: Baseline and post-training (measured immediately following completion of training)
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The FBT Knowledge Assessment (FBT-KA) is an 18-item multiple-choice test that measures knowledge about FBT.
Scores range from 0 to 18, with higher scores indicating more knowledge.
Change will be examined from baseline (pre-training) to post-training.
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Baseline and post-training (measured immediately following completion of training)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who receive FBT consultation at 12 months
Time Frame: 12-month follow-up
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Providers will report on their receipt (yes/no) of FBT-specific consultation in the 12 months following completion of training.
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12-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Erin C Accurso, PhD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 14, 2022
Primary Completion (Estimated)
February 28, 2024
Study Completion (Estimated)
February 28, 2024
Study Registration Dates
First Submitted
May 18, 2022
First Submitted That Met QC Criteria
May 24, 2022
First Posted (Actual)
May 25, 2022
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 20, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5K23MH120347 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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