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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04428580
Other study ID # 56548
Secondary ID R34MH123596
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 20, 2020
Est. completion date July 31, 2024

Study information

Verified date April 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 123
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Online FBT Training
Therapists will receive online training in Family-Based Treatment (FBT)
Webinar FBT Training
Therapists will receive webinar training in Family-Based Treatment (FBT)

Locations

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

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of recruitment number of recruited subjects who provide full baseline data set at a rate of 50% end of training (approximately 1.5 years after beginning training)
Primary Retention number of recruited subjects who provide full post training data set at a rate of 50% end of training (approximately 1.5 years after beginning training)
Secondary Change in Fidelity Weight change in patients treated pre and post training (Session 1-4 weight change in kilograms) at Baseline and End of Supervision end of supervision (approximately 2.5 years after starting training)
See also
  Status Clinical Trial Phase
Completed NCT02139462 - Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa N/A