xml: <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/NCT06001398</url>
    </required_header>
    <id_info>
      <org_study_id>00002540</org_study_id>
      <nct_id>NCT06001398</nct_id>
    </id_info>
    <brief_title>Parent Acceptance and Commitment Therapy (PACT) for Parents of Children With Pediatric Feeding Disorder</brief_title>
    <acronym>PACT</acronym>
    <official_title>Parent Acceptance and Commitment Therapy (PACT) for Parents of Children With Pediatric Feeding Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Mercy Hospital Kansas City</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Children's Mercy Hospital Kansas City</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a pilot study of randomized clinical trial of Parent Acceptance and Commitment&#xD;
        Therapy (PACT) vs. an attention-control condition (placebo) for improving the mental health&#xD;
        of parents of children with pediatric feeding disorder.&#xD;
  &#xD;
        The goal of this clinical trial is to compare two programs in parents of children with&#xD;
        pediatric feeding disorders.&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  PACT will result in clinically meaningful reductions in Mental Health(MH) problems among&#xD;
             parents of children with Pediatric Feed Disorder (PFD)&#xD;
  &#xD;
          -  Identify factors that impact the feasibility of PACT delivery&#xD;
  &#xD;
               -  Participants will asked to participate in one of two programs focused on parents of&#xD;
                  children with pediatric feeding disorders.&#xD;
  &#xD;
               -  The participants will also be asked to complete a battery of questionnaires at four&#xD;
                  timepoints during the study.&#xD;
  &#xD;
               -  The parents will be asked to video record a meal time twice during study.&#xD;
  &#xD;
        If there is a comparison group: Researchers will compare the PACT group with a control group&#xD;
        to see if PACT will result in clinically meaningful change in parent stress and anxiety, and&#xD;
        parent use of positive mealtime behaviors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this study is to advance the science of a brief parent mental health intervention&#xD;
        for parents of children with pediatric feeding disorder using Parent Acceptance and&#xD;
        Commitment Therapy (PACT-F). The ultimate goal of this research is to improve parent mental&#xD;
        health and child health and feeding outcomes through a parent-focused behavioral&#xD;
        intervention.&#xD;
  &#xD;
        PACT-F is a 2-session acceptance and commitment therapy (ACT) intervention guided by Brown&#xD;
        and Whittingham's ACT intervention for parents of children with neurodevelopmental&#xD;
        conditions. Intervention content is based on principles of ACT, an evidence-based treatment&#xD;
        for adult mental health problems. The intervention content is therefore broadly applicable to&#xD;
        all parents but was specifically tailored for the needs of parents of children with&#xD;
        neurodevelopmental conditions. In study phase 1 of this award, the investigators adapted&#xD;
        parent ACT for parents of children with pediatric feeding disorder (PACT-F) with consultation&#xD;
        from 2 parents of children with pediatric feeding disorder and 2 experts in parent ACT. The&#xD;
        investigators now have a complete treatment package that has been tailored for parents of&#xD;
        children with pediatric feeding disorder and is ready to be piloted.&#xD;
  &#xD;
        Thus, in this study the investigators will conduct a feasibility and proof-of-concept pilot&#xD;
        of a 2-session parent-focused ACT intervention tailored to meet the needs of parents of&#xD;
        children with pediatric feeding disorder (PACT-F). The goal of this pilot is to determine&#xD;
        factors that impact the success of recruitment, retention, assessment, and treatment delivery&#xD;
        for the PACT-F clinical trial and to test the intervention's proof of concept (i.e., does it&#xD;
        show a clinically meaningful signal of change in parent mental health). This study will be&#xD;
        conducted at a single site (Children's Mercy Hospital). The investigators will pilot the&#xD;
        clinical trial procedures and monitor feasibility success, and factors that may impact&#xD;
        feasibility success. Participants who meet inclusion criteria will be randomized to either&#xD;
        PACT-F or an attention control (control) condition. Participants will be blind to treatment&#xD;
        condition (single blind study). The aim of the feasibility analyses is to evaluate factors&#xD;
        critical to success, rather than evaluating whether the intervention is &quot;feasible or not&#xD;
        feasible&quot;. The aim of the proof-of-concept analyses is to determine if this intervention has&#xD;
        promise and warrants a larger efficacy trial.&#xD;
  &#xD;
        Parents randomized to PACT-F will complete two 90-minute PACT-F sessions individually with a&#xD;
        study interventionist, 2 weeks apart. Parents randomized to the control group will complete&#xD;
        two 90-minute sessions individually with a study interventionist, 2-weeks apart (focused on&#xD;
        nutrition education). The control intervention will be parallel to the ACT intervention in&#xD;
        all ways, including interactive components and the face-to-face time with health&#xD;
        professionals (interventionists). The control condition intervention has already been&#xD;
        developed by Dr. Davis's research team and covers a range of nutrition and healthy lifestyle&#xD;
        topics including the United States Department of Agriculture's (USDA) MyPlate. An attention&#xD;
        control condition was selected to mimic the interpersonal benefits that may come from meeting&#xD;
        individually with a caring professional. The control condition intervention content (healthy&#xD;
        lifestyles) was specifically chosen as it most closely reflects the types of information that&#xD;
        parents would learn from healthcare professionals about the type of nutrition that their&#xD;
        child needs. However, this type of intervention should not impact parent mental health.&#xD;
  &#xD;
        Interventionists for both conditions will be individuals with at least master's degree&#xD;
        training in mental health or a related field. The interventions will take via tele-video&#xD;
        conferencing to allow participants to participate from home without needing transportation to&#xD;
        and from the hospital. Both arms of the intervention will be manualized and interventionists&#xD;
        in both arms will be trained using didactics and role playing with the Principle&#xD;
        Investigator(PI). Intervention fidelity will be monitored by audio/video recording all&#xD;
        sessions. The PI (Dr. Bakula) will review recordings each week and conduct separate 1-hour&#xD;
        weekly supervision of study interventionists for each arm of the study (PACT-F &amp; control).&#xD;
  &#xD;
        Strategies will be used to promote fidelity in line with recommendations from the NIH&#xD;
        Behavior Change Consortium. A fidelity checklist will be developed in line with adaptations&#xD;
        to the intervention and will be piloted with study interventionists. The fidelity checklist&#xD;
        will be refined during research team meetings. The fidelity checklist will be reviewed by the&#xD;
        PI during supervision.&#xD;
  &#xD;
        Hypothesis testing: The investigators will test the hypothesis that PACT-F results in&#xD;
        clinically meaningful change using the Reliable Change Index (RCI; success defined as RCI &gt;&#xD;
        1.96). The investigators anticipate that these procedures will be feasible, with feasibility&#xD;
        success defined as recruitment rate above 60%, and retention, assessment completion, and&#xD;
        intervention completion rate above 80%. Mixed methods data collection will identify factors&#xD;
        that impact 1) recruitment rate (qualitative interviews, % meeting inclusion criteria, # of&#xD;
        contact attempts), 2) retention rates (qualitative interviews, baseline characteristics;&#xD;
        treatment group), 3) assessment completion rate (qualitative interviews, measure type), and&#xD;
        4) treatment completion rate (qualitative interviews, scheduling, treatment location).&#xD;
  &#xD;
        The proposed study is an important first step towards developing an evidence-based treatment&#xD;
        that can be used with parents of children with pediatric feeding disorder. This intervention&#xD;
        has the potential to improve parent mental health, as well as child health, and therefore has&#xD;
        the potential to have broad public health impact.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 27, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 1, 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>Other</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
      <time_frame>Baseline, 2 weeks post-intervention completion, 3-months post-intervention</time_frame>
      <description>A 9-item self-report measure of depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>General Anxiety Disorder Screener (GAD-7)</measure>
      <time_frame>Baseline, 2 weeks post-intervention, 3-months post-intervention</time_frame>
      <description>A 7-item self-report measure of anxious symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Impact of Event Scale - Revised (IES-R)</measure>
      <time_frame>Baseline, 2 weeks post-intervention, 3-months post-intervention</time_frame>
      <description>A 22-item self-report measure of posttraumatic stress symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived Stress Scale (PSS)</measure>
      <time_frame>Baseline, 2 weeks post-intervention, 3-months post-intervention</time_frame>
      <description>A 10-item self-report measure of perceived stress</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Acceptance and Action Questionnaire (AAQ-2)</measure>
      <time_frame>Baseline, 2 weeks post-intervention, 3-months post-intervention</time_frame>
      <description>A 7-item self-report measure of psychological flexibility and experiential avoidance</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pediatric Quality of Life Inventory (PedsQL)</measure>
      <time_frame>Baseline, 2 weeks post-intervention, 3-months post-intervention</time_frame>
      <description>A 23-item parent-proxy measure of child quality of life, with versions specific to child age (2-4 years, 5-7 years) that each result in standardized total scores and domain-specific scores of physical functioning, emotional functioning, social functioning, and school functioning</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Behavioral Pediatrics Feeding Assessment Scale (BPFAS)</measure>
      <time_frame>Baseline, 2 weeks post-intervention, 3-months post-intervention</time_frame>
      <description>A 35-item parent-proxy report of child mealtime and feeding behavior</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Pediatric Feeding Disorder, Chronic</condition>
    <condition>Pediatric Feeding Dysfunction, Acute</condition>
    <arm_group>
      <arm_group_label>Parent Acceptance and Commitment Therapy (PACT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>PACT-F is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Parent Acceptance and Commitment Therapy (PACT)</intervention_name>
      <description>PACT is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature</description>
      <arm_group_label>Parent Acceptance and Commitment Therapy (PACT)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Control</intervention_name>
      <description>The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1) Must be a parent aged 18+ (primary caregiver) of 2-6-year-old child with PFD&#xD;
  &#xD;
            -  2) Child must be receiving outpatient PFD treatment at Children's Mercy Hospital (CMH)&#xD;
  &#xD;
            -  3) The parent must have a clinically significant elevation on at least one measure of&#xD;
               parent MH (using established clinical cutoffs). Parents will be included regardless of&#xD;
               whether the child has a new diagnosis or established diagnoses&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1) Parent has significant cognitive impairments&#xD;
  &#xD;
            -  2) Parent does not speak English&#xD;
  &#xD;
            -  Parent unable to obtain high speed internet at home&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dana Bakula, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Children's Mercy Hosptial</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Corey R Schurman, MA</last_name>
      <phone>816-302-3076</phone>
      <email>crschurman@cmh.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Children's Mercy Hospitals and Clinics</name>
        <address>
          <city>Kansas City</city>
          <state>Missouri</state>
          <zip>64108</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Corey Schurman, MA</last_name>
        <phone>816-302-3076</phone>
        <email>crschurman@cmh.edu</email>
      </contact>
      <contact_backup>
        <last_name>Dana Bakula, Phd</last_name>
        <phone>816-234-3016</phone>
      </contact_backup>
      <investigator>
        <last_name>Dana Bakula, Phd</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Children's Mercy Hospital Kansas City</investigator_affiliation>
      <investigator_full_name>Dana Bakula</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>Feeding and Eating Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06001398
  org study id: 00002540
  nct id: NCT06001398
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a pilot study of randomized clinical trial of Parent Acceptance and Commitment
        Therapy (PACT) vs. an attention-control condition (placebo) for improving the mental health
        of parents of children with pediatric feeding disorder.
  
        The goal of this clinical trial is to compare two programs in parents of children with
        pediatric feeding disorders.
  
        The main question[s] it aims to answer are:
  
          -  PACT will result in clinically meaningful reductions in Mental Health(MH) problems among
             parents of children with Pediatric Feed Disorder (PFD)
  
          -  Identify factors that impact the feasibility of PACT delivery
  
               -  Participants will asked to participate in one of two programs focused on parents of
                  children with pediatric feeding disorders.
  
               -  The participants will also be asked to complete a battery of questionnaires at four
                  timepoints during the study.
  
               -  The parents will be asked to video record a meal time twice during study.
  
        If there is a comparison group: Researchers will compare the PACT group with a control group
        to see if PACT will result in clinically meaningful change in parent stress and anxiety, and
        parent use of positive mealtime behaviors.
  The goal of this study is to advance the science of a brief parent mental health intervention
        for parents of children with pediatric feeding disorder using Parent Acceptance and
        Commitment Therapy (PACT-F). The ultimate goal of this research is to improve parent mental
        health and child health and feeding outcomes through a parent-focused behavioral
        intervention.
  
        PACT-F is a 2-session acceptance and commitment therapy (ACT) intervention guided by Brown
        and Whittingham's ACT intervention for parents of children with neurodevelopmental
        conditions. Intervention content is based on principles of ACT, an evidence-based treatment
        for adult mental health problems. The intervention content is therefore broadly applicable to
        all parents but was specifically tailored for the needs of parents of children with
        neurodevelopmental conditions. In study phase 1 of this award, the investigators adapted
        parent ACT for parents of children with pediatric feeding disorder (PACT-F) with consultation
        from 2 parents of children with pediatric feeding disorder and 2 experts in parent ACT. The
        investigators now have a complete treatment package that has been tailored for parents of
        children with pediatric feeding disorder and is ready to be piloted.
  
        Thus, in this study the investigators will conduct a feasibility and proof-of-concept pilot
        of a 2-session parent-focused ACT intervention tailored to meet the needs of parents of
        children with pediatric feeding disorder (PACT-F). The goal of this pilot is to determine
        factors that impact the success of recruitment, retention, assessment, and treatment delivery
        for the PACT-F clinical trial and to test the intervention's proof of concept (i.e., does it
        show a clinically meaningful signal of change in parent mental health). This study will be
        conducted at a single site (Children's Mercy Hospital). The investigators will pilot the
        clinical trial procedures and monitor feasibility success, and factors that may impact
        feasibility success. Participants who meet inclusion criteria will be randomized to either
        PACT-F or an attention control (control) condition. Participants will be blind to treatment
        condition (single blind study). The aim of the feasibility analyses is to evaluate factors
        critical to success, rather than evaluating whether the intervention is "feasible or not
        feasible". The aim of the proof-of-concept analyses is to determine if this intervention has
        promise and warrants a larger efficacy trial.
  
        Parents randomized to PACT-F will complete two 90-minute PACT-F sessions individually with a
        study interventionist, 2 weeks apart. Parents randomized to the control group will complete
        two 90-minute sessions individually with a study interventionist, 2-weeks apart (focused on
        nutrition education). The control intervention will be parallel to the ACT intervention in
        all ways, including interactive components and the face-to-face time with health
        professionals (interventionists). The control condition intervention has already been
        developed by Dr. Davis's research team and covers a range of nutrition and healthy lifestyle
        topics including the United States Department of Agriculture's (USDA) MyPlate. An attention
        control condition was selected to mimic the interpersonal benefits that may come from meeting
        individually with a caring professional. The control condition intervention content (healthy
        lifestyles) was specifically chosen as it most closely reflects the types of information that
        parents would learn from healthcare professionals about the type of nutrition that their
        child needs. However, this type of intervention should not impact parent mental health.
  
        Interventionists for both conditions will be individuals with at least master's degree
        training in mental health or a related field. The interventions will take via tele-video
        conferencing to allow participants to participate from home without needing transportation to
        and from the hospital. Both arms of the intervention will be manualized and interventionists
        in both arms will be trained using didactics and role playing with the Principle
        Investigator(PI). Intervention fidelity will be monitored by audio/video recording all
        sessions. The PI (Dr. Bakula) will review recordings each week and conduct separate 1-hour
        weekly supervision of study interventionists for each arm of the study (PACT-F & control).
  
        Strategies will be used to promote fidelity in line with recommendations from the NIH
        Behavior Change Consortium. A fidelity checklist will be developed in line with adaptations
        to the intervention and will be piloted with study interventionists. The fidelity checklist
        will be refined during research team meetings. The fidelity checklist will be reviewed by the
        PI during supervision.
  
        Hypothesis testing: The investigators will test the hypothesis that PACT-F results in
        clinically meaningful change using the Reliable Change Index (RCI; success defined as RCI >
        1.96). The investigators anticipate that these procedures will be feasible, with feasibility
        success defined as recruitment rate above 60%, and retention, assessment completion, and
        intervention completion rate above 80%. Mixed methods data collection will identify factors
        that impact 1) recruitment rate (qualitative interviews, % meeting inclusion criteria, # of
        contact attempts), 2) retention rates (qualitative interviews, baseline characteristics;
        treatment group), 3) assessment completion rate (qualitative interviews, measure type), and
        4) treatment completion rate (qualitative interviews, scheduling, treatment location).
  
        The proposed study is an important first step towards developing an evidence-based treatment
        that can be used with parents of children with pediatric feeding disorder. This intervention
        has the potential to improve parent mental health, as well as child health, and therefore has
        the potential to have broad public health impact.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Participant, Outcomes Assessor)
  measure: Patient Health Questionnaire-9 (PHQ-9)
  time frame: Baseline, 2 weeks post-intervention completion, 3-months post-intervention
  description: A 9-item self-report measure of depressive symptoms
  measure: General Anxiety Disorder Screener (GAD-7)
  time frame: Baseline, 2 weeks post-intervention, 3-months post-intervention
  description: A 7-item self-report measure of anxious symptoms
  measure: Impact of Event Scale - Revised (IES-R)
  time frame: Baseline, 2 weeks post-intervention, 3-months post-intervention
  description: A 22-item self-report measure of posttraumatic stress symptoms
  measure: Perceived Stress Scale (PSS)
  time frame: Baseline, 2 weeks post-intervention, 3-months post-intervention
  description: A 10-item self-report measure of perceived stress
  measure: The Acceptance and Action Questionnaire (AAQ-2)
  time frame: Baseline, 2 weeks post-intervention, 3-months post-intervention
  description: A 7-item self-report measure of psychological flexibility and experiential avoidance
  measure: Pediatric Quality of Life Inventory (PedsQL)
  time frame: Baseline, 2 weeks post-intervention, 3-months post-intervention
  description: A 23-item parent-proxy measure of child quality of life, with versions specific to child age (2-4 years, 5-7 years) that each result in standardized total scores and domain-specific scores of physical functioning, emotional functioning, social functioning, and school functioning
  measure: Behavioral Pediatrics Feeding Assessment Scale (BPFAS)
  time frame: Baseline, 2 weeks post-intervention, 3-months post-intervention
  description: A 35-item parent-proxy report of child mealtime and feeding behavior
  arm group label: Parent Acceptance and Commitment Therapy (PACT)
  arm group type: Experimental
  description: PACT-F is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature.
  arm group label: Control
  arm group type: Active Comparator
  description: The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate.
  intervention type: Behavioral
  intervention name: Parent Acceptance and Commitment Therapy (PACT)
  description: PACT is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature
  arm group label: Parent Acceptance and Commitment Therapy (PACT)
  intervention type: Behavioral
  intervention name: Control
  description: The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Dana Bakula, PhD
  role: Principal Investigator
  affiliation: Children's Mercy Hosptial
  last name: Corey R Schurman, MA
  phone: 816-302-3076
  email: crschurman@cmh.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Children's Mercy Hospital Kansas City
  investigator full name: Dana Bakula
  investigator title: Principal Investigator
  mesh term: Feeding and Eating Disorders
  sharing ipd: No