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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05389657
Other study ID # 5K23MH120347
Secondary ID 5K23MH120347
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 14, 2022
Est. completion date February 28, 2024

Study information

Verified date September 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 85
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Web-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.
Live training
The live training will be delivered by two trainers over the course of two days via Zoom.

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary Change in Family-Based Treatment Knowledge Assessment (FBT-KA) Score at Post-Training 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. Baseline and post-training (measured immediately following completion of training)
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. 12-month follow-up
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