<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/NCT03778216</url>
  </required_header>
  <id_info>
    <org_study_id>40043</org_study_id>
    <secondary_id>SPO 125881</secondary_id>
    <nct_id>NCT03778216</nct_id>
  </id_info>
  <brief_title>Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment</brief_title>
  <official_title>Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</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>
      Although Avoidant/Restrictive Food Intake Disorder (ARFID) was formally introduced in DSM-5,&#xD;
      no specialized intervention has yet been empirically studied. This randomized controlled&#xD;
      crossover trial (RCCT) will test the feasibility and acceptability of a novel intervention,&#xD;
      Family-Based Treatment of Avoidant/Restrictive Food Intake Disorder (FBT-ARFID) for patients&#xD;
      ages 5-12 years old.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Potential subjects aged 5 years to 12 years, 11 months old with anorexia nervosa (AN)&#xD;
      diagnosed with ARFID and their families will be recruited will be recruited through Stanford&#xD;
      University, pediatricians, mental health experts, clinics treating EDs, and local parents'&#xD;
      groups. Those eligible for the program will be invited to read and sign informed consent&#xD;
      forms and complete the baseline assessment. They will then be randomized to the FBT-ARFID&#xD;
      program either immediately after their screening or 3 months after assessment (i.e., to a&#xD;
      usual care group). FBT-ARFID consists of 22 sessions over a 6-month period.&#xD;
&#xD;
      There will be 3 major assessment time points for those in the FBT-ARFID Arm: Baseline, 3&#xD;
      months into treatment, and EOT. There will be 4 major assessment time points for those in&#xD;
      Usual Care: Baseline, transition to treatment (3 months after the usual care period is&#xD;
      complete), 3 months into treatment, and EOT. Both the child and the parent will complete&#xD;
      measures at these time points. In addition, patients and parents will participate in ongoing&#xD;
      qualitative assessments before treatment (BL), throughout treatment (every other session),&#xD;
      and at EOT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">March 7, 2019</completion_date>
  <primary_completion_date type="Actual">October 30, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Estimated Body Weight (EBW)</measure>
    <time_frame>following 6 months of treatment or 3 months of usual care</time_frame>
    <description>individual with ARFID's body weight at end of condition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptom Severity</measure>
    <time_frame>following 6 months of treatment or 3 months of usual care</time_frame>
    <description>individual with ARFID's symptom severity at end of condition according to the Pica, ARFID, and Rumination Disorder Interview (PARDI). The symptom severity subscale will be used where the higher the score, the greater the ARFID severity. A total of 17 items rated on a scale of 0 to 6 are included in this subscale and the average is reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Avoidant / Restrictive Food Intake Disorder</condition>
  <arm_group>
    <arm_group_label>FBT-ARFID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family Based Treatment of child ARFID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Continued usual care for ARFID with the exception of any Family Based Treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family Based Treatment</intervention_name>
    <arm_group_label>FBT-ARFID</arm_group_label>
    <other_name>FBT-ARFID</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children meeting DSM-V criteria for ARFID&#xD;
&#xD;
          -  children between the ages of 5 to 12 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any medical complications or severe mental disorder (psychosis, low-functioning&#xD;
             Autism) that may reduce compliance with the study procedures or require more intensive&#xD;
             care to manage the symptoms&#xD;
&#xD;
          -  a severe parental mental disorder (e.g., psychotic depression, psychosis, substance&#xD;
             dependence)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James D Lock, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</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>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Avoidant Restrictive Food Intake Disorder</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/NCT03778216
org study id: 40043
secondary id: SPO 125881
nct id: NCT03778216
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although Avoidant/Restrictive Food Intake Disorder (ARFID) was formally introduced in DSM-5,
      no specialized intervention has yet been empirically studied. This randomized controlled
      crossover trial (RCCT) will test the feasibility and acceptability of a novel intervention,
      Family-Based Treatment of Avoidant/Restrictive Food Intake Disorder (FBT-ARFID) for patients
      ages 5-12 years old.
Potential subjects aged 5 years to 12 years, 11 months old with anorexia nervosa (AN)
      diagnosed with ARFID and their families will be recruited will be recruited through Stanford
      University, pediatricians, mental health experts, clinics treating EDs, and local parents'
      groups. Those eligible for the program will be invited to read and sign informed consent
      forms and complete the baseline assessment. They will then be randomized to the FBT-ARFID
      program either immediately after their screening or 3 months after assessment (i.e., to a
      usual care group). FBT-ARFID consists of 22 sessions over a 6-month period.

      There will be 3 major assessment time points for those in the FBT-ARFID Arm: Baseline, 3
      months into treatment, and EOT. There will be 4 major assessment time points for those in
      Usual Care: Baseline, transition to treatment (3 months after the usual care period is
      complete), 3 months into treatment, and EOT. Both the child and the parent will complete
      measures at these time points. In addition, patients and parents will participate in ongoing
      qualitative assessments before treatment (BL), throughout treatment (every other session),
      and at EOT.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Estimated Body Weight (EBW)
time frame: following 6 months of treatment or 3 months of usual care
description: individual with ARFID's body weight at end of condition
measure: Symptom Severity
time frame: following 6 months of treatment or 3 months of usual care
description: individual with ARFID's symptom severity at end of condition according to the Pica, ARFID, and Rumination Disorder Interview (PARDI). The symptom severity subscale will be used where the higher the score, the greater the ARFID severity. A total of 17 items rated on a scale of 0 to 6 are included in this subscale and the average is reported.
arm group label: FBT-ARFID
arm group type: Experimental
description: Family Based Treatment of child ARFID
arm group label: Usual Care
arm group type: No Intervention
description: Continued usual care for ARFID with the exception of any Family Based Treatment
intervention type: Behavioral
intervention name: Family Based Treatment
arm group label: FBT-ARFID
other name: FBT-ARFID
criteria: 
gender: All
minimum age: 5 Years
maximum age: 12 Years
healthy volunteers: No
last name: James D Lock, MD, PhD
role: Principal Investigator
affiliation: Stanford University
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: James Dale Lock
investigator title: Principal Investigator
mesh term: Avoidant Restrictive Food Intake Disorder
sharing ipd: No