<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/NCT04450771</url>
  </required_header>
  <id_info>
    <org_study_id>56878</org_study_id>
    <secondary_id>R01MH121292</secondary_id>
    <nct_id>NCT04450771</nct_id>
  </id_info>
  <brief_title>Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight ARFID</brief_title>
  <official_title>Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight Avoidant/Restrictive Food Intake Disorder (ARFID)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</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>
      This study is examining the efficacy and mechanism of family therapy compared to usual care&#xD;
      for children between the ages of 6 and 12 who are diagnosed with Avoidant/Restrictive Food&#xD;
      Intake Disorder. Preliminary data suggest that family therapy is superior to usual care and&#xD;
      that improvement in parental self-efficacy related to feeding their children is the mechanism&#xD;
      of treatment. In addition, this study will attempt to identify specific patient groups who&#xD;
      respond to family therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Potential subjects aged 6 years to 12 years, 11 months old with DSM 5 ARFID, and weight equal&#xD;
      to or between 75 to 88% EBW who are medically stable for outpatient treatment and their&#xD;
      families will be recruited through Stanford University, pediatricians, mental health experts,&#xD;
      clinics treating EDs, and local parents' groups. Those eligible for the program will be&#xD;
      invited to read and sign informed consent forms and complete the baseline assessment.&#xD;
      Participants will then be randomized to FBT-ARFID with medical management for 14 sessions&#xD;
      provided over 4 months or manualized Non-Specific Care (NSC) with medical management for 4&#xD;
      months. NSC will consist of 14 sessions over 4 months.&#xD;
&#xD;
      There will be 5 major assessment time points: Baseline, 1 month, 2 months, End Of Treatment&#xD;
      (4 months), and 6-month post-treatment Follow-Up. Both the child and the parent will complete&#xD;
      measures at these time points. In addition, parents will complete short survey assessments&#xD;
      after each of the 14 treatment sessions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Expected Body Weight (EBW)</measure>
    <time_frame>Following 4 months of FBT-ARFID or NSC</time_frame>
    <description>Expected Body Weights (EBW) percentages used will be calculated using Center for Disease Control metrics in children and adolescents.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parents versus Avoidant/Restrictive Food Intake Disorder (ARFID)</measure>
    <time_frame>Following 4 months of FBT-ARFID or NSC</time_frame>
    <description>A modification of the Parents versus Anorexia Nervosa Scale, a measure of parental self-efficacy at changing eating behaviors. The modifications to the scale are minor and consisted of changing the name of the disorder named in the scale's questions from AN to ARFID. This is a 7 item 5 point scale where higher scores mean greater parental self-efficacy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parental Feeding Behavior Assessment</measure>
    <time_frame>After week 6 of either arm in all participants.</time_frame>
    <description>Meals at Baseline and Week 6 will be recorded and then coded for behaviors associated with successful re-feeding using a procedure developed for FBT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Pica, ARFID, Rumination Disorder Interview (PARDI)</measure>
    <time_frame>All assessment time points (BL, 1 month, 2 months, EOT, and 6-month follow-up)</time_frame>
    <description>The PARDI is a new measure designed to diagnose and evaluate symptom severity of ARFID putative subtypes. Data demonstrate the measure's validity and ability to distinguish ARFID patients from other clinical groups. Parents will be assessed using the PARDI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapy Suitability and Patient Expectancy (TSPE)</measure>
    <time_frame>At the end of session 1 and every two weeks during treatment and NSC.</time_frame>
    <description>The TSPE measures perceptions of the suitability and expectancy of the treatment provided and will be rated by parents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Style Questionnaire (PSQ)</measure>
    <time_frame>Completed at baseline and EOT</time_frame>
    <description>This questionnaire is a validated measure of parenting style related to authoritative and permissive style. This questionnaire will be completed parents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiological Studies Depression Scale for Children (CES-DC)</measure>
    <time_frame>Completed by children at all major assessment timepoints.</time_frame>
    <description>This is a validated measure of child depression that will be completed by children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revised Children's Manifest Anxiety Scale (RCMAS-2)</measure>
    <time_frame>Completed by children at all major assessment timepoints.</time_frame>
    <description>This is a validated measure of childhood anxiety and will be completed by children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Helping Relationship Questionnaire (HRQ)</measure>
    <time_frame>Completed by parents bi-weekly and at all major assessment points except baseline.</time_frame>
    <description>The HRQ is an 11-item questionnaire that measures the quality of the therapist-patient relationship. The HRQ will be completed by parents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Schedule for Affective Disorders and Schizophrenia for School-Aged Children (6-18 years) (K-SADS)</measure>
    <time_frame>Completed by parents on behalf of their child at baseline.</time_frame>
    <description>The K-SADS-PL is a widely used semi-structured interview detecting psychiatric disorders in children and adolescents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strengths and Difficulties Questionnaire (SDQ)</measure>
    <time_frame>Completed by parents at all major assessment points.</time_frame>
    <description>The 25 items in the SDQ assess conduct, social, and peer behaviors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI)</measure>
    <time_frame>Completed by parents at BL and EOT.</time_frame>
    <description>The BDI is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. This measure also includes questions about suicidal ideation and intent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory (BAI)</measure>
    <time_frame>Completed by parents at BL and EOT.</time_frame>
    <description>A 21-item questionnaire about anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36-Item Short Form (SF-36)</measure>
    <time_frame>Completed by parents at BL.</time_frame>
    <description>A general measure of physical and mental health functioning. This assessment will be taken by the parents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bandura's General Self-Efficacy Scale (GSES)</measure>
    <time_frame>Completed by parents at all major assessments as well as after each of the 14 treatment sessions.</time_frame>
    <description>Measure of parental self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Sense of Competency Scale (PSOC)</measure>
    <time_frame>Completed by parents at all major assessments as well as after each of the 14 treatment sessions.</time_frame>
    <description>Measure of parental self-efficacy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Avoidant/Restrictive Food Intake Disorder</condition>
  <arm_group>
    <arm_group_label>Family-based Treatment for ARFID(FBT-ARFID)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FBT-ARFID is a manualized treatment based on the model of FBT that employs the same interventions as standard FBT for AN and BN: externalization, agnosticism, parental empowerment, a behavioral focus on changing eating behavior. Early sessions focus on inciting parents to make changes and include a family meal that allows therapists to observe &amp; consult directly to mealtime behaviors. FBT-ARFID for children 12 and under is manualized and consists of 2 phases. The first phase is focused on parents taking charge &amp; changing the eating behaviors of their child that are maintaining ARFID. The second phase focuses on the child taking up in an age-appropriate way managing their eating consistent with the changes the parents have employed in phase 1. Fourteen 1-hour sessions will be conducted approximately weekly over 4 months. Throughout medical monitoring and weekly dietary consultation are available to the family.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manualized Non-Specific Usual Care for ARFID(NSC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A manualized non-specific psycho-educational and motivational enhancement approach that is based on a supportive non-directive psychotherapy model that has been used in other RCTs with eating disorders as a comparison. NSC consists of sessions with the child alone and 5 parent-only meetings. Sessions are 1-hour. NSC matches FBT-ARFID for time and therapist attention. The focus of the NSC intervention is psychoeducation about health &amp; social impacts of restrictive eating and supporting parent &amp; child exploration of motivation to change eating patterns &amp; choices they make about changes to eating. The therapist does not initiate behavioral or cognitive interventions. Feelings about eating and making changes are explored in both the child and parent sessions. Medical and dietary advice are provided weekly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family-based Treatment for ARFID</intervention_name>
    <description>This treatment includes 14 1-hour sessions that will be conducted approximately weekly over a 4 month period. It is a manualized treatment based on the model of FBT that employs the same interventions as standard FBT for AN and BN: externalization, agnosticism, parental empowerment, a behavioral focus on changing eating behavior.</description>
    <arm_group_label>Family-based Treatment for ARFID(FBT-ARFID)</arm_group_label>
    <other_name>FBT-ARFID</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Manualized Non-Specific Usual Care for ARFID</intervention_name>
    <description>This treatment is a manualized non-specific psycho-educational and motivational enhancement approach that is based on a supportive non-directive psychotherapy model. It consists of sessions with the child alone and 5 parent-only meetings, all of which are 1-hour over a 4 month period.</description>
    <arm_group_label>Manualized Non-Specific Usual Care for ARFID(NSC)</arm_group_label>
    <other_name>NSC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children meeting DSM-V criteria for ARFID&#xD;
&#xD;
          -  Children between the ages of 6 to 12 years old, living with their families&#xD;
&#xD;
          -  Medically stable for outpatient treatment according to the recommended thresholds of&#xD;
             the American Academy of Pediatrics and the Society of Adolescent Medicine.&#xD;
&#xD;
          -  Not engaging in another individual or family-based psychotherapy trial during the&#xD;
             duration of treatment sessions in the study.&#xD;
&#xD;
          -  Less than 4 sessions of FBT&#xD;
&#xD;
          -  If taking medication for co-morbid disorders, participants must be on a stable dose of&#xD;
             medication for 8 weeks (2 months) before participating. If the participant is on a new&#xD;
             medication at baseline, but is discontinuing the medication in order to start the&#xD;
             study, they must have discontinued the medication before beginning treatment.&#xD;
&#xD;
          -  EBW between 75% and 88%.&#xD;
&#xD;
          -  Able to fluently speak and read English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current physical, psychotic illness or other mental illness requiring hospitalization&#xD;
&#xD;
          -  Current psychotic illness or mental retardation or other mental illnesses that would&#xD;
             prohibit the use of psychotherapy&#xD;
&#xD;
          -  Current dependence on drugs or alcohol&#xD;
&#xD;
          -  Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or&#xD;
             weight&#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;
          -  4 or more sessions of FBT&#xD;
&#xD;
          -  Currently taking medication for co-morbid disorders that cannot be safely discontinued&#xD;
             or prescribed for less than 2 months&#xD;
&#xD;
          -  Medically unstable for outpatient treatment according to the recommended thresholds of&#xD;
             the American Academy of Pediatrics and the Society of Adolescent Medicine, defined as:&#xD;
             vital sign instability (heart rate less than 45 beats per minute), clinically&#xD;
             significant orthostatic blood pressure with changes usually greater than 35 points or&#xD;
             findings of gastrointestinal bleeding, dizziness, or syncope, IBW &lt;75%, hypothermia&#xD;
             (body temperature less than 36 degrees centigrade), clinically significant electrolyte&#xD;
             abnormalities, or prolonged QTc on electrocardiogram&#xD;
&#xD;
          -  Expected Body Weight (EBW) &lt;75% or &gt; 88%&#xD;
&#xD;
          -  Unable to fluently speak and read English&#xD;
&#xD;
          -  Parent excluded&#xD;
&#xD;
          -  Suicidal&#xD;
&#xD;
          -  In the case of patients with current, or a history of sexual or physical abuse by&#xD;
             family members, perpetrators of the abuse will be excluded from treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Eliza M Van Wye, B.A.</last_name>
    <phone>(650) 723-5521</phone>
    <email>evanwye@stanford.edu</email>
  </overall_contact>
  <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>
    <contact_backup>
      <last_name>Ayotola Onipede, BA</last_name>
      <phone>650-723-7885</phone>
      <email>zonipede@stanford.edu</email>
    </contact_backup>
    <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>January 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>January 16, 2023</last_update_submitted>
  <last_update_submitted_qc>January 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 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>Family Based Treatment</keyword>
  <keyword>ARFID</keyword>
  <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/NCT04450771
org study id: 56878
secondary id: R01MH121292
nct id: NCT04450771
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is examining the efficacy and mechanism of family therapy compared to usual care
      for children between the ages of 6 and 12 who are diagnosed with Avoidant/Restrictive Food
      Intake Disorder. Preliminary data suggest that family therapy is superior to usual care and
      that improvement in parental self-efficacy related to feeding their children is the mechanism
      of treatment. In addition, this study will attempt to identify specific patient groups who
      respond to family therapy.
Potential subjects aged 6 years to 12 years, 11 months old with DSM 5 ARFID, and weight equal
      to or between 75 to 88% EBW who are medically stable for outpatient treatment and their
      families 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.
      Participants will then be randomized to FBT-ARFID with medical management for 14 sessions
      provided over 4 months or manualized Non-Specific Care (NSC) with medical management for 4
      months. NSC will consist of 14 sessions over 4 months.

      There will be 5 major assessment time points: Baseline, 1 month, 2 months, End Of Treatment
      (4 months), and 6-month post-treatment Follow-Up. Both the child and the parent will complete
      measures at these time points. In addition, parents will complete short survey assessments
      after each of the 14 treatment sessions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Expected Body Weight (EBW)
time frame: Following 4 months of FBT-ARFID or NSC
description: Expected Body Weights (EBW) percentages used will be calculated using Center for Disease Control metrics in children and adolescents.
measure: Parents versus Avoidant/Restrictive Food Intake Disorder (ARFID)
time frame: Following 4 months of FBT-ARFID or NSC
description: A modification of the Parents versus Anorexia Nervosa Scale, a measure of parental self-efficacy at changing eating behaviors. The modifications to the scale are minor and consisted of changing the name of the disorder named in the scale's questions from AN to ARFID. This is a 7 item 5 point scale where higher scores mean greater parental self-efficacy.
measure: Parental Feeding Behavior Assessment
time frame: After week 6 of either arm in all participants.
description: Meals at Baseline and Week 6 will be recorded and then coded for behaviors associated with successful re-feeding using a procedure developed for FBT.
measure: The Pica, ARFID, Rumination Disorder Interview (PARDI)
time frame: All assessment time points (BL, 1 month, 2 months, EOT, and 6-month follow-up)
description: The PARDI is a new measure designed to diagnose and evaluate symptom severity of ARFID putative subtypes. Data demonstrate the measure's validity and ability to distinguish ARFID patients from other clinical groups. Parents will be assessed using the PARDI.
measure: Therapy Suitability and Patient Expectancy (TSPE)
time frame: At the end of session 1 and every two weeks during treatment and NSC.
description: The TSPE measures perceptions of the suitability and expectancy of the treatment provided and will be rated by parents
measure: Parenting Style Questionnaire (PSQ)
time frame: Completed at baseline and EOT
description: This questionnaire is a validated measure of parenting style related to authoritative and permissive style. This questionnaire will be completed parents.
measure: Center for Epidemiological Studies Depression Scale for Children (CES-DC)
time frame: Completed by children at all major assessment timepoints.
description: This is a validated measure of child depression that will be completed by children.
measure: Revised Children's Manifest Anxiety Scale (RCMAS-2)
time frame: Completed by children at all major assessment timepoints.
description: This is a validated measure of childhood anxiety and will be completed by children.
measure: Helping Relationship Questionnaire (HRQ)
time frame: Completed by parents bi-weekly and at all major assessment points except baseline.
description: The HRQ is an 11-item questionnaire that measures the quality of the therapist-patient relationship. The HRQ will be completed by parents.
measure: Schedule for Affective Disorders and Schizophrenia for School-Aged Children (6-18 years) (K-SADS)
time frame: Completed by parents on behalf of their child at baseline.
description: The K-SADS-PL is a widely used semi-structured interview detecting psychiatric disorders in children and adolescents.
measure: Strengths and Difficulties Questionnaire (SDQ)
time frame: Completed by parents at all major assessment points.
description: The 25 items in the SDQ assess conduct, social, and peer behaviors.
measure: Beck Depression Inventory (BDI)
time frame: Completed by parents at BL and EOT.
description: The BDI is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. This measure also includes questions about suicidal ideation and intent.
measure: Beck Anxiety Inventory (BAI)
time frame: Completed by parents at BL and EOT.
description: A 21-item questionnaire about anxiety.
measure: 36-Item Short Form (SF-36)
time frame: Completed by parents at BL.
description: A general measure of physical and mental health functioning. This assessment will be taken by the parents.
measure: Bandura's General Self-Efficacy Scale (GSES)
time frame: Completed by parents at all major assessments as well as after each of the 14 treatment sessions.
description: Measure of parental self-efficacy.
measure: Parental Sense of Competency Scale (PSOC)
time frame: Completed by parents at all major assessments as well as after each of the 14 treatment sessions.
description: Measure of parental self-efficacy.
arm group label: Family-based Treatment for ARFID(FBT-ARFID)
arm group type: Experimental
description: FBT-ARFID is a manualized treatment based on the model of FBT that employs the same interventions as standard FBT for AN and BN: externalization, agnosticism, parental empowerment, a behavioral focus on changing eating behavior. Early sessions focus on inciting parents to make changes and include a family meal that allows therapists to observe & consult directly to mealtime behaviors. FBT-ARFID for children 12 and under is manualized and consists of 2 phases. The first phase is focused on parents taking charge & changing the eating behaviors of their child that are maintaining ARFID. The second phase focuses on the child taking up in an age-appropriate way managing their eating consistent with the changes the parents have employed in phase 1. Fourteen 1-hour sessions will be conducted approximately weekly over 4 months. Throughout medical monitoring and weekly dietary consultation are available to the family.
arm group label: Manualized Non-Specific Usual Care for ARFID(NSC)
arm group type: Active Comparator
description: A manualized non-specific psycho-educational and motivational enhancement approach that is based on a supportive non-directive psychotherapy model that has been used in other RCTs with eating disorders as a comparison. NSC consists of sessions with the child alone and 5 parent-only meetings. Sessions are 1-hour. NSC matches FBT-ARFID for time and therapist attention. The focus of the NSC intervention is psychoeducation about health & social impacts of restrictive eating and supporting parent & child exploration of motivation to change eating patterns & choices they make about changes to eating. The therapist does not initiate behavioral or cognitive interventions. Feelings about eating and making changes are explored in both the child and parent sessions. Medical and dietary advice are provided weekly.
intervention type: Behavioral
intervention name: Family-based Treatment for ARFID
description: This treatment includes 14 1-hour sessions that will be conducted approximately weekly over a 4 month period. It is a manualized treatment based on the model of FBT that employs the same interventions as standard FBT for AN and BN: externalization, agnosticism, parental empowerment, a behavioral focus on changing eating behavior.
arm group label: Family-based Treatment for ARFID(FBT-ARFID)
other name: FBT-ARFID
intervention type: Behavioral
intervention name: Manualized Non-Specific Usual Care for ARFID
description: This treatment is a manualized non-specific psycho-educational and motivational enhancement approach that is based on a supportive non-directive psychotherapy model. It consists of sessions with the child alone and 5 parent-only meetings, all of which are 1-hour over a 4 month period.
arm group label: Manualized Non-Specific Usual Care for ARFID(NSC)
other name: NSC
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Eliza M Van Wye, B.A.
phone: (650) 723-5521
email: evanwye@stanford.edu
facility: 
status: Recruiting
contact: 
contact backup: 
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: Avoidant Restrictive Food Intake Disorder
sharing ipd: No