Implementing FBT for Adolescent AN for Providers in Private Practice

• ClinicalTrials.gov Identifier: NCT04428580
• Recruitment Status: Recruiting
• First Posted: June 11, 2020
• Last Update Posted: January 18, 2023
• Sponsor: Stanford University
• Collaborators: University of California, San Francisco; National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): James Dale Lock, Stanford University

Study Description

Brief Summary:

There is a critical need to disseminate efficacious psychosocial treatments for mental disorders as there is a significant gap between evidenced-based approaches and common clinical practice. One example of the need to improve dissemination and implementation of psychosocial treatments is for adolescent Anorexia Nervosa (AN), a serious mental disorder with an incidence rate of about 1% that can become life-threatening. Based on outcomes from a series of randomized clinical trials (RCTs), the first-line treatment for adolescent AN is Family-based Treatment (FBT); however, very few therapists are trained to use FBT for AN. Further, while approximately 45-50% of US mental health outpatient providers are in private practice, little attention has been paid to how best to train this group. Care for adolescent AN, in particular, is provided in private practice at high rates, because specialist programs in non-private settings are few and not readily accessible. Motivations, incentives, and rationale for learning evidence-based treatments (EBTs) differ in this group compared to therapists embedded in an organization or health care system. In this application, we propose to use an online training strategy to study the adoption of FBT to better understand factors that limit or enhance uptake and implementation of this treatment in private practice. We developed and piloted a self-directed enhanced online training (ET-FBT) aimed at improving therapist skills and knowledge related to key components of FBT for AN that predict patient outcome in a group of therapists of which 64% were in private practice. We propose to build on these findings to examine the feasibility of new methods to retain therapists during supervision, assess fidelity, and collect patient outcomes from clinicians in private practice. Thus, our specific aims are:

Aim 1: The overall aim of the study is to assess the feasibility of conducting a randomized clinical trial comparing two implementation strategies (online training vs webinar training) for training clinicians in private practice in FBT for AN. We predict that those randomized to online training will be retained, receive supervision, and provide patient data at higher rates than those who receive webinar training.

Aim 2: Patient outcomes (reflecting therapist effectiveness) will be assessed by comparing patient weight gain from session 1 to 4 of FBT before and after training (target for training effect) and compared between randomized groups. We predict a moderate efficacy signal difference favoring those who are received the online training. because of increased training in key components in the online training program.

Aim 3: Validate training effect by examining the association between therapist fidelity to FBT and patient outcomes. We predict that fidelity will be correlated (target validation) with patient outcome. The effects of therapeutic alliance, participation in supervision, and self-efficacy on both fidelity and patient outcome will be explored.

Aim 4: Explore BL factors associated with implementation processes (e.g. prior training, experience, family work).The primary significance of this study is its potential to increase the availability of FBT--the most effective treatment for adolescent AN. Increased availability of FBT will decrease cost, hospitalization, morbidity, mortality, and chronicity of the disorder.

Condition or disease	Intervention/treatment	Phase
Online Training for Therapists	Other: Online FBT Training; Other: Webinar FBT Training	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Implementing Family-Based Treatment for Adolescent Anorexia Nervosa for Providers in Private Practice: A Feasibility Study
• Actual Study Start Date: November 20, 2020
• Estimated Primary Completion Date: July 31, 2023
• Estimated Study Completion Date: July 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Online Training; 10 lectures that are self-paced with a maximum of three months to complete with each lecture bundle comprising of 5-8 short (about 4 minutes in length), didactic videos that discuss the treatment model and provide mock therapy session video clips (modeling FBT with a typical adolescent AN case), as well as supplementary readings and videotaped role-plays. Enrollees complete each lecture bundle and complete the assignments as they move through the training at their own pace, but to have completed all within the 3-month time frame. When the training is completed, therapists will proceed to schedule post-online supervision for a minimum of 1 case and a maximum of 2 cases over the course of 3 months.	Other: Online FBT Training; Therapists will receive online training in Family-Based Treatment (FBT)
Active Comparator: Webinar Training; 1-hour weekly webinar lectures that essentially is the FBT training that is conducted in person, just recorded. There will be lectures discussing the scientific evidence supporting FBT, how therapists set up treatment for FBT, main interventions used in FBT during each phase, and recorded role-plays illustrating interventions throughout the 3 phases. Enrollees watch each webinar video as it is released weekly over a 12 week (3 month period). When the training is completed, therapists will proceed to schedule post-online supervision for a minimum of 1 case and a maximum of 2 cases over the course of 3 months.	Other: Webinar FBT Training; Therapists will receive webinar training in Family-Based Treatment (FBT)

Outcome Measures

Primary Outcome Measures :

1. Feasibility of recruitment [ Time Frame: end of training (approximately 1.5 years after beginning training) ]
   number of recruited subjects who provide full baseline data set at a rate of 50%
2. Retention [ Time Frame: end of training (approximately 1.5 years after beginning training) ]
   number of recruited subjects who provide full post training data set at a rate of 50%

Secondary Outcome Measures :

1. Change in Fidelity [ Time Frame: end of supervision (approximately 2.5 years after starting training) ]
   Weight change in patients treated pre and post training (Session 1-4 weight change in kilograms) at Baseline and End of Supervision

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Therapists are eligible to participate if they have completed a masters or doctoral training in their field (psychology, psychiatry, family therapy, social work)
• Licensed in their respective state
• No reports of malpractice or loss of privileges at relevant clinical institutions
• Have computer/web access for online training and assessments
• No previous 2-day in-person workshop training in FBT
• Submit baseline data on fidelity rating and weight gain from week 1-4 from a previously treated adolescent with AN they have treated in the last 6 months or alternatively one that they treat within 3 months of the initial screening before starting the training.

Exclusion Criteria:

• Therapists who have had previous training in FBT are not eligible.
• Therapists who are unable to provide baseline data on fidelity rating and weight gain from week 1-4 from a previously treated adolescent with AN they have treated in the last 6 months or alternatively one that they treat within 3 months of the initial screening before starting the training will also be excluded.

Contacts and Locations

Locations

United States, California

University of California, San Francisco; Recruiting

San Francisco, California, United States, 94143

Contact: Madelyn Johnson, BA 415-476-0622 madelyn.johnson@ucsf.edu

Principal Investigator: Daniel Le Grange, PhD

Stanford University; Recruiting

Stanford, California, United States, 94305

Contact: Kyra Citron, BA 650-723-9182 kcitron@stanford.edu

Principal Investigator: James D Lock, MD, PhD

Sub-Investigator: Cara Bohon, PhD

Sponsors and Collaborators

Stanford University

University of California, San Francisco

National Institute of Mental Health (NIMH)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Citron K, Johnson M, Matheson BE, Onipede ZA, Yang HJ, Bohon C, Le Grange D, Lock J. Study protocol for training providers in private practice in family-based treatment for adolescents with anorexia nervosa: A randomized controlled feasibility trial. Contemp Clin Trials. 2022 Sep;120:106889. doi: 10.1016/j.cct.2022.106889. Epub 2022 Aug 20.

• Responsible Party: James Dale Lock, Professor of Child Psychiatry and Pediatrics in the Department of Psychiatry and Behavioral Sciences and Director of the Eating Disorder Program for Children and Adolescents, Stanford University
• ClinicalTrials.gov Identifier: NCT04428580
• Other Study ID Numbers: 56548; R34MH123596 ( U.S. NIH Grant/Contract )
• First Posted: June 11, 2020
• Last Update Posted: January 18, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James Dale Lock, Stanford University:

FBT; Training; Fidelity; Anorexia; Anorexia Nervosa

Additional relevant MeSH terms:

Anorexia; Anorexia Nervosa; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Mental Disorders