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OpenTrials
Completed

NCT Number: NCT04428580

Implementing FBT for Adolescent AN for Providers in Private Practice

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Online FBT Training

Other

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

Webinar FBT Training

Other

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

Primary outcomes

  1. Feasibility of Recruitment

    Time frame: 1 day (day of baseline assessment)

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

  2. Retention

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

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

Secondary outcomes

  1. Exploring Association Between Fidelity and Outcome

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

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of California, San Francisco

Registry information

Official study title

Implementing Family-Based Treatment for Adolescent Anorexia Nervosa for Providers in Private Practice: A Feasibility Study

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2020
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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