<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/NCT04421989</url>
  </required_header>
  <id_info>
    <org_study_id>R34MH115897</org_study_id>
    <secondary_id>R34MH115897</secondary_id>
    <nct_id>NCT04421989</nct_id>
  </id_info>
  <brief_title>Parent Emotion Coaching for Anorexia Nervosa</brief_title>
  <official_title>Emotion Coaching Skills as an Augmentation to Family Based Treatment for Adolescents With Anorexia Nervosa: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</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>
      Family based treatment (FBT) is the evidence based treatment for pediatric anorexia nervosa&#xD;
      (AN), but 50% of adolescents do not respond and the consequences for non-response are dire&#xD;
      (e.g., 11.5% mortality rate). Expressed emotion and parental warmth are significant&#xD;
      mechanisms of treatment outcome in adolescents with AN, which are not explicitly targeted by&#xD;
      FBT. The current proposal is a parent emotion coaching skills group designed to augment FBT&#xD;
      in the treatment of pediatric AN by arming high expressed emotion families with the skills&#xD;
      necessary to implement FBT and improve treatment outcomes (e.g., weight restoration).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pediatric anorexia nervosa (AN) affects 400,000 adolescents in the US with devastating&#xD;
      consequences including growth delay, bone density loss, bradycardia, and the highest&#xD;
      mortality rate of any psychiatric condition (11.5%), with half of all deaths due to suicide.&#xD;
      Early intervention in adolescents is life-saving, making pediatric AN treatment an important&#xD;
      public health concern. The goal of pediatric AN treatment is to restore the adolescent back&#xD;
      to a healthy weight and reverse the dangerous effects of malnutrition. Family based treatment&#xD;
      (FBT) is the gold standard of treatment for pediatric AN; however, 50% of patients do not&#xD;
      respond. The consequences of treatment non-response are dire, underscoring the importance of&#xD;
      improving treatment via augmentations to address non-response. One barrier to treatment&#xD;
      response in pediatric AN is expressed emotion (EE), which is defined as a family's response&#xD;
      to an ill patient that is characterized by hostility, critical comments, and emotional&#xD;
      overinvolvement. Several studies have highlighted that families with high EE undergoing&#xD;
      treatment for their adolescent with AN have poorer outcomes, including higher drop-out rates,&#xD;
      lack of weight restoration, and less improvement in eating disorder symptoms. Conversely,&#xD;
      parental warmth, a facet of EE, is associated with good outcomes in FBT. Recent parenting&#xD;
      interventions focused on emotion coaching (EC) to address high EE have demonstrated success&#xD;
      as adjuncts to evidence-based treatments in other pediatric populations (e.g., PTSD, ADHD)&#xD;
      but have not been applied to pediatric AN. Given the detrimental effects that high EE has on&#xD;
      the re-feeding process and the benefits of parental warmth, emotion coaching has the&#xD;
      potential to reduce high EE, increase parental warmth, and improve weight restoration in&#xD;
      adolescents with AN. The aim of this R34 pilot effectiveness trial is to evaluate the&#xD;
      effectiveness of a FBT + EC parent group intervention in families with high EE. In Stage 1&#xD;
      (Feasibility Stage; Year 1), the investigators will conduct preliminary feasibility and&#xD;
      acceptability testing of an EC parent group intervention in 6 patients with pediatric AN and&#xD;
      their families who exhibit elevated EE. The data from the Feasibility Stage will be used to&#xD;
      modify session content to improve treatment delivery and the uptake of EC skills. Once our&#xD;
      manual is refined and finalized, the investigators will conduct a randomized controlled&#xD;
      clinical trial (Stage 2) of 50 adolescents and their parents to compare FBT+EC parent group&#xD;
      (n=25) versus FBT+support (n=25). The FBT+support condition is a general parent support group&#xD;
      that is offered as part of standard care in the CCHMC Eating Disorders Program. FBT will be&#xD;
      identical in both the treatment and control conditions, with the EC parent group sessions and&#xD;
      parent support group sessions occurring separately from the FBT sessions. If the aims of the&#xD;
      project are achieved, this study would have a large impact on pediatric AN with the potential&#xD;
      to improve weight restoration outcomes by augmenting FBT for families high in EE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 24, 2020</start_date>
  <completion_date type="Actual">March 23, 2023</completion_date>
  <primary_completion_date type="Actual">December 30, 2022</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in expressed emotion</measure>
    <time_frame>baseline, 1-month, 3-months, and 6 months post-randomization</time_frame>
    <description>Change in expressed emotion will be assessed by the Five Minute Speech Sample. This is a recorded five-minute unstructured response that the parent gives when prompted to talk about their feelings about their child. Eligible families will be categorized as high EE using a modified version of the Family Affective Attitudes Rating Scale (FAARS), which was developed to code FMSS data in families with adolescents.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in percentage of median body mass index (%mBMI)</measure>
    <time_frame>baseline, 1-month, 3-months, and 6 months post-randomization</time_frame>
    <description>Change in %mBMI will be assessed at each time point. Weight and height will be assessed using a calibrated digital scale while wearing a hospital gown and post-void. Height will be recorded using a stadiometer. For individuals with anorexia nervosa, the %mBMI will be calculated as [current BMI] / [50th percentile BMI] x 100, using the 50th percentile BMI from the Centers for Disease Control charts for age and sex. For individuals with atypical anorexia nervosa, goal weight will be defined as change in % of return to pre-morbid weight.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in parental warmth</measure>
    <time_frame>baseline, 1-month, 3-months, and 6 months post-randomization</time_frame>
    <description>Change in parental warmth will be assessed by the Five Minute Speech Sample (see description above).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Anorexia Nervosa</condition>
  <condition>Atypical Anorexia Nervosa</condition>
  <arm_group>
    <arm_group_label>Emotion Coaching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to FBT + EC parent group condition will also receive FBT as part of their standard of care. In addition to FBT, they will receive 10 additional, weekly, parent group sessions (each session is 60 minutes, 6-8 group members), within a 3-month time frame to account for cancellations. The EC intervention is designed to reduce expressed emotion (e.g., critical comments) and increase parental warmth. The intervention includes emotional awareness and emotion regulation skills for parents, and emotion communication skills for parents to use with their teens undergoing FBT including active listening, emotion support, labeling emotions, and coping with emotions. The structure of EC parent group sessions will begin with review of homework as applicable, a didactic component to teach new skills, followed by role plays between parents in the group and interventionist, and live coaching and feedback from the interventionist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Support Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to FBT + Support parent group condition will also receive FBT as part of their standard of care. In addition to FBT, they will receive 10 additional, weekly, parent group sessions (each session is 60 minutes, 6-8 group members), within a 3-month time frame to account for cancellations. The parent support group facilitates parent discussion and support around a variety of topics central to treatment for pediatric AN including: understanding medical co-morbidities, levels of care for treatment, understanding expected body weight, navigating FMLA, and medications. The facilitator introduces each topic weekly and opens up discussion between parents. The facilitator's role is to ensure the group remains on topic and on time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Emotion Coaching</intervention_name>
    <description>Participants randomized to FBT + EC parent group condition will also receive FBT as part of their standard of care. In addition to FBT, they will receive 10 additional, weekly, parent group sessions (each session is 60 minutes, 6-8 group members), within a 3-month time frame to account for cancellations. The EC intervention is designed to reduce expressed emotion (e.g., critical comments) and increase parental warmth. The intervention includes emotional awareness and emotion regulation skills for parents, and emotion communication skills for parents to use with their teens undergoing FBT including active listening, emotion support, labeling emotions, and coping with emotions. The structure of EC parent group sessions will begin with review of homework as applicable, a didactic component to teach new skills, followed by role plays between parents in the group and interventionist, and live coaching and feedback from the interventionist.</description>
    <arm_group_label>Emotion Coaching</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Support Group</intervention_name>
    <description>Participants randomized to FBT + Support Group parent group condition will also receive FBT as part of their standard of care. In addition to FBT, they will receive 10 additional, weekly, parent group sessions (each session is 60 minutes, 6-8 group members), within a 3-month time frame to account for cancellations. The support group will have a facilitator introduce each topic weekly and parents will discuss. The facilitator's role is to ensure the group remains on topic and on time. Weekly discussion topics include: co-morbid medical diagnoses, understanding levels of care in treatment, taking time off from work, and medications.</description>
    <arm_group_label>Support Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Clinical diagnosis of AN or AAN&#xD;
&#xD;
          -  Must be able to read and speak English&#xD;
&#xD;
          -  Must have a caregiver participate who spends at least 50% time with participant&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Major medical conditions affecting metabolism and/or weight&#xD;
&#xD;
          -  Current substance abuse&#xD;
&#xD;
          -  Moderate-profound intellectual disabilities&#xD;
&#xD;
          -  Active psychosis&#xD;
&#xD;
          -  Bipolar disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Insulin dependent diabetes Thyroid disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire M Aarnio-Peterson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>March 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 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>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>family based treatment</keyword>
  <keyword>expressed emotion</keyword>
  <keyword>parent coaching</keyword>
  <keyword>adolescents</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>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT04421989/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04421989
org study id: R34MH115897
secondary id: R34MH115897
nct id: NCT04421989
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Family based treatment (FBT) is the evidence based treatment for pediatric anorexia nervosa
      (AN), but 50% of adolescents do not respond and the consequences for non-response are dire
      (e.g., 11.5% mortality rate). Expressed emotion and parental warmth are significant
      mechanisms of treatment outcome in adolescents with AN, which are not explicitly targeted by
      FBT. The current proposal is a parent emotion coaching skills group designed to augment FBT
      in the treatment of pediatric AN by arming high expressed emotion families with the skills
      necessary to implement FBT and improve treatment outcomes (e.g., weight restoration).
Pediatric anorexia nervosa (AN) affects 400,000 adolescents in the US with devastating
      consequences including growth delay, bone density loss, bradycardia, and the highest
      mortality rate of any psychiatric condition (11.5%), with half of all deaths due to suicide.
      Early intervention in adolescents is life-saving, making pediatric AN treatment an important
      public health concern. The goal of pediatric AN treatment is to restore the adolescent back
      to a healthy weight and reverse the dangerous effects of malnutrition. Family based treatment
      (FBT) is the gold standard of treatment for pediatric AN; however, 50% of patients do not
      respond. The consequences of treatment non-response are dire, underscoring the importance of
      improving treatment via augmentations to address non-response. One barrier to treatment
      response in pediatric AN is expressed emotion (EE), which is defined as a family's response
      to an ill patient that is characterized by hostility, critical comments, and emotional
      overinvolvement. Several studies have highlighted that families with high EE undergoing
      treatment for their adolescent with AN have poorer outcomes, including higher drop-out rates,
      lack of weight restoration, and less improvement in eating disorder symptoms. Conversely,
      parental warmth, a facet of EE, is associated with good outcomes in FBT. Recent parenting
      interventions focused on emotion coaching (EC) to address high EE have demonstrated success
      as adjuncts to evidence-based treatments in other pediatric populations (e.g., PTSD, ADHD)
      but have not been applied to pediatric AN. Given the detrimental effects that high EE has on
      the re-feeding process and the benefits of parental warmth, emotion coaching has the
      potential to reduce high EE, increase parental warmth, and improve weight restoration in
      adolescents with AN. The aim of this R34 pilot effectiveness trial is to evaluate the
      effectiveness of a FBT + EC parent group intervention in families with high EE. In Stage 1
      (Feasibility Stage; Year 1), the investigators will conduct preliminary feasibility and
      acceptability testing of an EC parent group intervention in 6 patients with pediatric AN and
      their families who exhibit elevated EE. The data from the Feasibility Stage will be used to
      modify session content to improve treatment delivery and the uptake of EC skills. Once our
      manual is refined and finalized, the investigators will conduct a randomized controlled
      clinical trial (Stage 2) of 50 adolescents and their parents to compare FBT+EC parent group
      (n=25) versus FBT+support (n=25). The FBT+support condition is a general parent support group
      that is offered as part of standard care in the CCHMC Eating Disorders Program. FBT will be
      identical in both the treatment and control conditions, with the EC parent group sessions and
      parent support group sessions occurring separately from the FBT sessions. If the aims of the
      project are achieved, this study would have a large impact on pediatric AN with the potential
      to improve weight restoration outcomes by augmenting FBT for families high in EE.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in expressed emotion
time frame: baseline, 1-month, 3-months, and 6 months post-randomization
description: Change in expressed emotion will be assessed by the Five Minute Speech Sample. This is a recorded five-minute unstructured response that the parent gives when prompted to talk about their feelings about their child. Eligible families will be categorized as high EE using a modified version of the Family Affective Attitudes Rating Scale (FAARS), which was developed to code FMSS data in families with adolescents.
measure: Change in percentage of median body mass index (%mBMI)
time frame: baseline, 1-month, 3-months, and 6 months post-randomization
description: Change in %mBMI will be assessed at each time point. Weight and height will be assessed using a calibrated digital scale while wearing a hospital gown and post-void. Height will be recorded using a stadiometer. For individuals with anorexia nervosa, the %mBMI will be calculated as [current BMI] / [50th percentile BMI] x 100, using the 50th percentile BMI from the Centers for Disease Control charts for age and sex. For individuals with atypical anorexia nervosa, goal weight will be defined as change in % of return to pre-morbid weight.
measure: Change in parental warmth
time frame: baseline, 1-month, 3-months, and 6 months post-randomization
description: Change in parental warmth will be assessed by the Five Minute Speech Sample (see description above).
arm group label: Emotion Coaching
arm group type: Experimental
description: Participants randomized to FBT + EC parent group condition will also receive FBT as part of their standard of care. In addition to FBT, they will receive 10 additional, weekly, parent group sessions (each session is 60 minutes, 6-8 group members), within a 3-month time frame to account for cancellations. The EC intervention is designed to reduce expressed emotion (e.g., critical comments) and increase parental warmth. The intervention includes emotional awareness and emotion regulation skills for parents, and emotion communication skills for parents to use with their teens undergoing FBT including active listening, emotion support, labeling emotions, and coping with emotions. The structure of EC parent group sessions will begin with review of homework as applicable, a didactic component to teach new skills, followed by role plays between parents in the group and interventionist, and live coaching and feedback from the interventionist.
arm group label: Support Group
arm group type: Active Comparator
description: Participants randomized to FBT + Support parent group condition will also receive FBT as part of their standard of care. In addition to FBT, they will receive 10 additional, weekly, parent group sessions (each session is 60 minutes, 6-8 group members), within a 3-month time frame to account for cancellations. The parent support group facilitates parent discussion and support around a variety of topics central to treatment for pediatric AN including: understanding medical co-morbidities, levels of care for treatment, understanding expected body weight, navigating FMLA, and medications. The facilitator introduces each topic weekly and opens up discussion between parents. The facilitator's role is to ensure the group remains on topic and on time.
intervention type: Behavioral
intervention name: Emotion Coaching
description: Participants randomized to FBT + EC parent group condition will also receive FBT as part of their standard of care. In addition to FBT, they will receive 10 additional, weekly, parent group sessions (each session is 60 minutes, 6-8 group members), within a 3-month time frame to account for cancellations. The EC intervention is designed to reduce expressed emotion (e.g., critical comments) and increase parental warmth. The intervention includes emotional awareness and emotion regulation skills for parents, and emotion communication skills for parents to use with their teens undergoing FBT including active listening, emotion support, labeling emotions, and coping with emotions. The structure of EC parent group sessions will begin with review of homework as applicable, a didactic component to teach new skills, followed by role plays between parents in the group and interventionist, and live coaching and feedback from the interventionist.
arm group label: Emotion Coaching
intervention type: Other
intervention name: Support Group
description: Participants randomized to FBT + Support Group parent group condition will also receive FBT as part of their standard of care. In addition to FBT, they will receive 10 additional, weekly, parent group sessions (each session is 60 minutes, 6-8 group members), within a 3-month time frame to account for cancellations. The support group will have a facilitator introduce each topic weekly and parents will discuss. The facilitator's role is to ensure the group remains on topic and on time. Weekly discussion topics include: co-morbid medical diagnoses, understanding levels of care in treatment, taking time off from work, and medications.
arm group label: Support Group
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Claire M Aarnio-Peterson, PhD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Anorexia Nervosa
sharing ipd: No
provided document: 