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/NCT05988138</url>
    </required_header>
    <id_info>
      <org_study_id>230616</org_study_id>
      <nct_id>NCT05988138</nct_id>
    </id_info>
    <brief_title>Prevention of Anhedonia in Children</brief_title>
    <official_title>Reward Responsiveness as a Prevention Target in Youth At Risk for Anhedonia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vanderbilt University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Nationwide Children's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Vanderbilt 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 trial will test the effects of a positive emotion-focused preventive intervention on&#xD;
        reward responsiveness in children of mothers with histories of depression and anhedonia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will test the effects of a dyadic preventive intervention, Family Promoting&#xD;
        Positive Emotion (F-PPE), for 8- to 12-year-old children of mothers with a history of major&#xD;
        depressive disorder (MDD) with anhedonia. The study will first test F-PPE effects on child&#xD;
        reward responsiveness (R61), and pending evidence of target engagement, effects on real-world&#xD;
        experience of interest/pleasure and clinical symptoms of anhedonia will be evaluated in a&#xD;
        second, larger clinical trial (R33). F-PPE was designed to increase child positive valence&#xD;
        systems function through mother-child training in behavioral and cognitive skills to increase&#xD;
        pleasant activities and attention towards/savoring the positive, individual and dyadic goals,&#xD;
        and skills practice. For the R61 phase, eligible child participants (N=60 intervention&#xD;
        completers) will complete an EEG assessment of neural reward responsiveness, as well as&#xD;
        halfway through the intervention (4 weeks) to determine dose effects. Children and their&#xD;
        biological mothers will be randomly assigned to 8 sessions of F-PPE or a psychoeducation&#xD;
        comparison condition (groups will be matched on child sex and baseline RewP). Both&#xD;
        interventions will be administered through individual telehealth sessions with a masters- or&#xD;
        doctoral-level clinician under the supervision of the PIs. To ensure treatment fidelity,&#xD;
        videotaped sessions will be reviewed for adherence to the protocol, clinicians will&#xD;
        participate in weekly group supervision, and supervisors will randomly review recorded&#xD;
        sessions for ratings of treatment adherence.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</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>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Neural responses to rewards measured by electroencephalogram (EEG) in a computerized guessing reward task (physiological measure)</measure>
      <time_frame>4 and 8 weeks</time_frame>
      <description>The reward positivity (RewP) component will be measured using EEG with an established computerized guessing reward task (&quot;Doors&quot; task). EEG data will be processed using best practices and the RewP component will be exported from the EEG data approximately 250-350 ms after feedback presentation at the electrode Cz. RewP scores will be quantified as the relative neural response to reward vs. loss feedback.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Anhedonia</condition>
    <condition>Depression</condition>
    <arm_group>
      <arm_group_label>Family Promoting Positive Emotions</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Psychoeducation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Family Promoting Positive Emotions</intervention_name>
      <description>An 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mothers</description>
      <arm_group_label>Family Promoting Positive Emotions</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Psychoeducation</intervention_name>
      <description>An 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources</description>
      <arm_group_label>Psychoeducation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Biological mothers with past or current MDD with anhedonia and their 8- to 12-year-old&#xD;
               children&#xD;
  &#xD;
            -  English-speaking mothers and children&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with past or current major depressive disorder (MDD) and/or anhedonia lasting&#xD;
               most of the day, nearly every day for at least 2 weeks based on semi-structured&#xD;
               interviews will be excluded&#xD;
  &#xD;
            -  A lifetime manic episode in mothers or children&#xD;
  &#xD;
            -  Mothers with current substance use disorders&#xD;
  &#xD;
            -  Mothers or children with intellectual or developmental disabilities&#xD;
  &#xD;
            -  Mothers or children with vision or hearing impairments that interfere with&#xD;
               participation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Vanderbilt University</investigator_affiliation>
      <investigator_full_name>Autumn Kujawa</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anhedonia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data will be shared through the National Institute of Mental Health Data Archive</ipd_description>
    </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/NCT05988138
  org study id: 230616
  nct id: NCT05988138
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This trial will test the effects of a positive emotion-focused preventive intervention on
        reward responsiveness in children of mothers with histories of depression and anhedonia.
  This study will test the effects of a dyadic preventive intervention, Family Promoting
        Positive Emotion (F-PPE), for 8- to 12-year-old children of mothers with a history of major
        depressive disorder (MDD) with anhedonia. The study will first test F-PPE effects on child
        reward responsiveness (R61), and pending evidence of target engagement, effects on real-world
        experience of interest/pleasure and clinical symptoms of anhedonia will be evaluated in a
        second, larger clinical trial (R33). F-PPE was designed to increase child positive valence
        systems function through mother-child training in behavioral and cognitive skills to increase
        pleasant activities and attention towards/savoring the positive, individual and dyadic goals,
        and skills practice. For the R61 phase, eligible child participants (N=60 intervention
        completers) will complete an EEG assessment of neural reward responsiveness, as well as
        halfway through the intervention (4 weeks) to determine dose effects. Children and their
        biological mothers will be randomly assigned to 8 sessions of F-PPE or a psychoeducation
        comparison condition (groups will be matched on child sex and baseline RewP). Both
        interventions will be administered through individual telehealth sessions with a masters- or
        doctoral-level clinician under the supervision of the PIs. To ensure treatment fidelity,
        videotaped sessions will be reviewed for adherence to the protocol, clinicians will
        participate in weekly group supervision, and supervisors will randomly review recorded
        sessions for ratings of treatment adherence.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Neural responses to rewards measured by electroencephalogram (EEG) in a computerized guessing reward task (physiological measure)
  time frame: 4 and 8 weeks
  description: The reward positivity (RewP) component will be measured using EEG with an established computerized guessing reward task ("Doors" task). EEG data will be processed using best practices and the RewP component will be exported from the EEG data approximately 250-350 ms after feedback presentation at the electrode Cz. RewP scores will be quantified as the relative neural response to reward vs. loss feedback.
  arm group label: Family Promoting Positive Emotions
  arm group type: Experimental
  arm group label: Psychoeducation
  arm group type: Active Comparator
  intervention type: Behavioral
  intervention name: Family Promoting Positive Emotions
  description: An 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mothers
  arm group label: Family Promoting Positive Emotions
  intervention type: Behavioral
  intervention name: Psychoeducation
  description: An 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources
  arm group label: Psychoeducation
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 12 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Vanderbilt University
  investigator full name: Autumn Kujawa
  investigator title: Associate Professor
  mesh term: Anhedonia
  sharing ipd: Yes
  ipd description: Data will be shared through the National Institute of Mental Health Data Archive