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Implementing FBT for Adolescent AN for Providers in Private Practice

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04428580
Enrollment
151
Registered
2020-06-11
Start date
2020-11-20
Completion date
2024-10-01
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Online Training for Therapists

Keywords

FBT, Training, Fidelity, Anorexia, Anorexia Nervosa

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.

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)

Sponsors

University of California, San Francisco
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Recruitment1 day (day of baseline assessment)Number of recruited subjects who provide full baseline data set at a rate of 50%
RetentionWeek 12 (1 day at end of training)Number of recruited subjects who provide full post training data set at a rate of 50%

Secondary

MeasureTime frameDescription
Exploring Association Between Fidelity and OutcomeBaseline and Follow-up (after supervision)A therapist fidelity questionnaire and reported patient weight outcomes (weight change from FBT session 1 to session 4).

Countries

United States

Participant flow

Pre-assignment details

1143 participants started the online screening process and 426 completed screening. 393 who completed the screen had sufficient information included in screening in order to assess eligibility. 151 participants signed informed consent, 123 were randomized.

Participants by arm

ArmCount
Online Training
Therapists receive enhanced online training in Family-Based Treatment (FBT)
61
Webinar Training
Therapists will receive online webinar training in Family-Based Treatment (FBT)
62
Total123

Baseline characteristics

CharacteristicOnline TrainingTotalWebinar Training
Age, Continuous36.4 years
STANDARD_DEVIATION 7.2
36.9 years
STANDARD_DEVIATION 8.8
37.5 years
STANDARD_DEVIATION 10.1
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants12 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
54 Participants111 Participants57 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
5 Participants8 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
55 Participants112 Participants57 Participants
Region of Enrollment
United States
61 Participants123 Participants62 Participants
Sex: Female, Male
Female
58 Participants119 Participants61 Participants
Sex: Female, Male
Male
3 Participants4 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 610 / 62
other
Total, other adverse events
0 / 610 / 62
serious
Total, serious adverse events
0 / 610 / 62

Outcome results

Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Online TrainingFeasibility of Recruitment61 Participants
Webinar TrainingFeasibility of Recruitment62 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Online TrainingRetention48 Participants
Webinar TrainingRetention51 Participants
Secondary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Online TrainingExploring Association Between Fidelity and Outcome7 Participants
Webinar TrainingExploring Association Between Fidelity and Outcome9 Participants

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026