CClinicalTrials.gg
CompletedNCT04428580Updated Aug 29, 2025Results posted

Implementing FBT for Adolescent AN for Providers in Private Practice

An interventional study of Online FBT Training and Webinar FBT Training in Online Training for Therapists, sponsored by Stanford University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by Stanford University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
151
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Online Training for Therapists

Keywords

  • FBT
  • Training
  • Fidelity
  • Anorexia
  • Anorexia Nervosa
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In context

Anorexia

411 studies on the registry are indexed under Anorexia; 67 are open to participants now.

This study's enrollment of 151 is above the median of 41 across 287 interventional studies indexed under Anorexia.

Browse Anorexia studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
151 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherOnline FBT Training

    Therapists will receive online training in Family-Based Treatment (FBT)

  • OtherWebinar FBT Training

    Therapists will receive webinar training in Family-Based Treatment (FBT)

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What researchers measure

Primary outcomes

  1. Feasibility of Recruitment

    Number of recruited subjects who provide full baseline data set at a rate of 50%

    Time frame: 1 day (day of baseline assessment)

  2. Retention

    Number of recruited subjects who provide full post training data set at a rate of 50%

    Time frame: Week 12 (1 day at end of training)

Secondary outcomes

  1. Exploring Association Between Fidelity and Outcome

    A therapist fidelity questionnaire and reported patient weight outcomes (weight change from FBT session 1 to session 4).

    Time frame: Baseline and Follow-up (after supervision)

07

Results

Posted Aug 29, 2025

Participant flow

Participant flow — Overall Study
MilestoneOnline TrainingWebinar Training
Started6162
Started training6162
Finished training5859
Started clinical case consultation2628
Completed clinical case consultation2027
Completed6162
Not completed00

Outcome measures

PrimaryFeasibility of Recruitment

Number of recruited subjects who provide full baseline data set at a rate of 50%

Time frame:
1 day (day of baseline assessment)
Reported as:
Count of participants · Participants
Feasibility of Recruitment
ParticipantsOnline TrainingWebinar Training
Feasibility of Recruitment6162
PrimaryRetention

Number of recruited subjects who provide full post training data set at a rate of 50%

Time frame:
Week 12 (1 day at end of training)
Reported as:
Count of participants · Participants
Retention
ParticipantsOnline TrainingWebinar Training
Retention4851
SecondaryExploring Association Between Fidelity and Outcome

A therapist fidelity questionnaire and reported patient weight outcomes (weight change from FBT session 1 to session 4).

Time frame:
Baseline and Follow-up (after supervision)
Reported as:
Count of participants · Participants
Exploring Association Between Fidelity and Outcome
ParticipantsOnline TrainingWebinar Training
Exploring Association Between Fidelity and Outcome79

Adverse events

Collected over Average approximately 6 months (12 weeks of training plus up to 12 weeks for supervision). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Online Training0/61 (0%)0/61 (0%)0/61 (0%)
Webinar Training0/62 (0%)0/62 (0%)0/62 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Online TrainingWebinar TrainingTotal
Mean36.4 ± 7.237.5 ± 10.136.9 ± 8.8
Sex: Female, Male
Sex: Female, Male(Participants)Online TrainingWebinar TrainingTotal
Female5861119
Male314
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Online TrainingWebinar TrainingTotal
Hispanic or Latino7512
Not Hispanic or Latino5457111
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Online TrainingWebinar TrainingTotal
American Indian or Alaska Native000
Asian112
Native Hawaiian or Other Pacific Islander000
Black or African American011
White5557112
More than one race538
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Online TrainingWebinar TrainingTotal
United States6162123
08

Study locations

2 sites
  • University of California, San Francisco
    San Francisco, California 94143, United States
  • Stanford University
    Stanford, California 94305, United States
09

References and documents

Publications

  • 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. PubMed 35998767 ↗

Study documents

  • Study protocol · Jun 9, 2020
  • Statistical analysis plan · Jun 9, 2020
  • Informed consent form · Mar 19, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04428580
Lead sponsor
Stanford University
Collaborators
University of California, San Francisco, National Institute of Mental Health (NIMH)
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) — Principal investigator
First posted
Jun 11, 2020
Start date
Nov 20, 2020
Primary completion
Aug 2, 2024
Completion
Oct 1, 2024
Results posted
Aug 29, 2025
Last update
Aug 29, 2025

Study contacts

James Lock, MD, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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