<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04428580</url>
  </required_header>
  <id_info>
    <org_study_id>56548</org_study_id>
    <secondary_id>R34MH123596</secondary_id>
    <nct_id>NCT04428580</nct_id>
  </id_info>
  <brief_title>Implementing FBT for Adolescent AN for Providers in Private Practice</brief_title>
  <official_title>Implementing Family-Based Treatment for Adolescent Anorexia Nervosa for Providers in Private Practice: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a critical need to disseminate efficacious psychosocial treatments for mental&#xD;
      disorders as there is a significant gap between evidenced-based approaches and common&#xD;
      clinical practice. One example of the need to improve dissemination and implementation of&#xD;
      psychosocial treatments is for adolescent Anorexia Nervosa (AN), a serious mental disorder&#xD;
      with an incidence rate of about 1% that can become life-threatening. Based on outcomes from a&#xD;
      series of randomized clinical trials (RCTs), the first-line treatment for adolescent AN is&#xD;
      Family-based Treatment (FBT); however, very few therapists are trained to use FBT for AN.&#xD;
      Further, while approximately 45-50% of US mental health outpatient providers are in private&#xD;
      practice, little attention has been paid to how best to train this group. Care for adolescent&#xD;
      AN, in particular, is provided in private practice at high rates, because specialist programs&#xD;
      in non-private settings are few and not readily accessible. Motivations, incentives, and&#xD;
      rationale for learning evidence-based treatments (EBTs) differ in this group compared to&#xD;
      therapists embedded in an organization or health care system. In this application, we propose&#xD;
      to use an online training strategy to study the adoption of FBT to better understand factors&#xD;
      that limit or enhance uptake and implementation of this treatment in private practice. We&#xD;
      developed and piloted a self-directed enhanced online training (ET-FBT) aimed at improving&#xD;
      therapist skills and knowledge related to key components of FBT for AN that predict patient&#xD;
      outcome in a group of therapists of which 64% were in private practice. We propose to build&#xD;
      on these findings to examine the feasibility of new methods to retain therapists during&#xD;
      supervision, assess fidelity, and collect patient outcomes from clinicians in private&#xD;
      practice. Thus, our specific aims are:&#xD;
&#xD;
      Aim 1: The overall aim of the study is to assess the feasibility of conducting a randomized&#xD;
      clinical trial comparing two implementation strategies (online training vs webinar training)&#xD;
      for training clinicians in private practice in FBT for AN. We predict that those randomized&#xD;
      to online training will be retained, receive supervision, and provide patient data at higher&#xD;
      rates than those who receive webinar training.&#xD;
&#xD;
      Aim 2: Patient outcomes (reflecting therapist effectiveness) will be assessed by comparing&#xD;
      patient weight gain from session 1 to 4 of FBT before and after training (target for training&#xD;
      effect) and compared between randomized groups. We predict a moderate efficacy signal&#xD;
      difference favoring those who are received the online training. because of increased training&#xD;
      in key components in the online training program.&#xD;
&#xD;
      Aim 3: Validate training effect by examining the association between therapist fidelity to&#xD;
      FBT and patient outcomes. We predict that fidelity will be correlated (target validation)&#xD;
      with patient outcome. The effects of therapeutic alliance, participation in supervision, and&#xD;
      self-efficacy on both fidelity and patient outcome will be explored.&#xD;
&#xD;
      Aim 4: Explore BL factors associated with implementation processes (e.g. prior training,&#xD;
      experience, family work).The primary significance of this study is its potential to increase&#xD;
      the availability of FBT--the most effective treatment for adolescent AN. Increased&#xD;
      availability of FBT will decrease cost, hospitalization, morbidity, mortality, and chronicity&#xD;
      of the disorder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 20, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of recruitment</measure>
    <time_frame>end of training (approximately 1.5 years after beginning training)</time_frame>
    <description>number of recruited subjects who provide full baseline data set at a rate of 50%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention</measure>
    <time_frame>end of training (approximately 1.5 years after beginning training)</time_frame>
    <description>number of recruited subjects who provide full post training data set at a rate of 50%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Fidelity</measure>
    <time_frame>end of supervision (approximately 2.5 years after starting training)</time_frame>
    <description>Weight change in patients treated pre and post training (Session 1-4 weight change in kilograms) at Baseline and End of Supervision</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Online Training for Therapists</condition>
  <arm_group>
    <arm_group_label>Online Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Webinar Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Online FBT Training</intervention_name>
    <description>Therapists will receive online training in Family-Based Treatment (FBT)</description>
    <arm_group_label>Online Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Webinar FBT Training</intervention_name>
    <description>Therapists will receive webinar training in Family-Based Treatment (FBT)</description>
    <arm_group_label>Webinar Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Therapists are eligible to participate if they have completed a masters or doctoral&#xD;
             training in their field (psychology, psychiatry, family therapy, social work)&#xD;
&#xD;
          -  Licensed in their respective state&#xD;
&#xD;
          -  No reports of malpractice or loss of privileges at relevant clinical institutions&#xD;
&#xD;
          -  Have computer/web access for online training and assessments&#xD;
&#xD;
          -  No previous 2-day in-person workshop training in FBT&#xD;
&#xD;
          -  Submit baseline data on fidelity rating and weight gain from week 1-4 from a&#xD;
             previously treated adolescent with AN they have treated in the last 6 months or&#xD;
             alternatively one that they treat within 3 months of the initial screening before&#xD;
             starting the training.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Therapists who have had previous training in FBT are not eligible.&#xD;
&#xD;
          -  Therapists who are unable to provide baseline data on fidelity rating and weight gain&#xD;
             from week 1-4 from a previously treated adolescent with AN they have treated in the&#xD;
             last 6 months or alternatively one that they treat within 3 months of the initial&#xD;
             screening before starting the training will also be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Madelyn Johnson, BA</last_name>
      <phone>415-476-0622</phone>
      <email>madelyn.johnson@ucsf.edu</email>
    </contact>
    <investigator>
      <last_name>Daniel Le Grange, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kyra Citron, BA</last_name>
      <phone>650-723-9182</phone>
      <email>kcitron@stanford.edu</email>
    </contact>
    <investigator>
      <last_name>James D Lock, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cara Bohon, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>James Dale Lock</investigator_full_name>
    <investigator_title>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</investigator_title>
  </responsible_party>
  <keyword>FBT</keyword>
  <keyword>Training</keyword>
  <keyword>Fidelity</keyword>
  <keyword>Anorexia</keyword>
  <keyword>Anorexia Nervosa</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anorexia</mesh_term>
    <mesh_term>Anorexia Nervosa</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04428580
org study id: 56548
secondary id: R34MH123596
nct id: NCT04428580
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Feasibility of recruitment
time frame: end of training (approximately 1.5 years after beginning training)
description: number of recruited subjects who provide full baseline data set at a rate of 50%
measure: Retention
time frame: end of training (approximately 1.5 years after beginning training)
description: number of recruited subjects who provide full post training data set at a rate of 50%
measure: Change in Fidelity
time frame: end of supervision (approximately 2.5 years after starting training)
description: Weight change in patients treated pre and post training (Session 1-4 weight change in kilograms) at Baseline and End of Supervision
arm group label: Online Training
arm group type: Experimental
description: 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.
arm group label: Webinar Training
arm group type: Active Comparator
description: 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.
intervention type: Other
intervention name: Online FBT Training
description: Therapists will receive online training in Family-Based Treatment (FBT)
arm group label: Online Training
intervention type: Other
intervention name: Webinar FBT Training
description: Therapists will receive webinar training in Family-Based Treatment (FBT)
arm group label: Webinar Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: James Dale Lock
investigator title: 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
mesh term: Anorexia
mesh term: Anorexia Nervosa
sharing ipd: No