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/NCT06005181</url>
    </required_header>
    <id_info>
      <org_study_id>23-052</org_study_id>
      <nct_id>NCT06005181</nct_id>
    </id_info>
    <brief_title>The Synchrony Study: Examining Music Training for Children With FASD</brief_title>
    <acronym>Synchrony</acronym>
    <official_title>The Synchrony Study: A Randomized Controlled Trial of Music Training for Children With a Fetal Alcohol Spectrum Disorder (FASD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Mind Research Network</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of New Mexico</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The Mind Research Network</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>
        The goal of this clinical trial is to examine if music training improves behavioral or&#xD;
        cognitive performance in children with prenatal alcohol exposure who meet research criteria&#xD;
        for a fetal alcohol spectrum disorder. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Does music training improve behavioral regulation for children with an FASD&#xD;
  &#xD;
          -  Does music training improve cognitive performance (attention and working memory) for&#xD;
             children with an FASD.&#xD;
  &#xD;
        The study has two interventions for each participant: music listening and piano training.&#xD;
        Each participant will either practice piano daily for 12 weeks or listen to pre-selected&#xD;
        music daily for 12 weeks. The order of the interventions will be randomized across&#xD;
        participants. Assessment will occur before and after participation in each 12 week&#xD;
        intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Music training has been shown to alter brain function and structure in musicians relative to&#xD;
        nonmusicians. Music training requires a complex set of skills. By engaging in this activity,&#xD;
        music training may alter brain development in children and increase cortical connectivity&#xD;
        such that it provides improved self-regulation and cognitive performance. However, music&#xD;
        training has not been tested in children with a fetal alcohol spectrum disorder, despite&#xD;
        known behavioral and cognitive effects of prenatal alcohol exposure.&#xD;
  &#xD;
        The study will employ a randomized, cross-over design to examine the effects of piano&#xD;
        training versus music listening. Participants will be asked to attend two information&#xD;
        sessions prior to study enrollment. These will provide participants with detailed information&#xD;
        about the study expectations, complete study consent/assent, and train participants on use of&#xD;
        the devices for music listening/piano training. Participants will receive baseline&#xD;
        assessments which include cognitive testing, behavioral questionnaires and neuroimaging. Each&#xD;
        participant will be randomized to receive 12 weeks of either music listening or piano&#xD;
        training. After the initial 12 week intervention is completed, participants will receive an&#xD;
        intermediate assessment where the initial assessment battery will be repeated. The&#xD;
        participants will then engage in the other arm of the study (music listening or piano&#xD;
        training) for an additional 12 weeks. During the last week of the study, the initial&#xD;
        assessment battery will be repeated a third time.&#xD;
  &#xD;
        During music listening, the participant will be provided with a device that will allow the&#xD;
        participant to access study-selected music. Participants will be provided with one music&#xD;
        list/week for 12 weeks and will be asked to listen to music from the study-selected music for&#xD;
        at least 10 minutes per day. Participants will be required to check in with the study team&#xD;
        weekly to receive the next week's playlist and to ensure compliance.&#xD;
  &#xD;
        During piano training, the participant will be provided with an electronic keyboard that will&#xD;
        allow the participant to practice piano daily. Participants will attend weekly ½ hour piano&#xD;
        lessons which will follow a commercially-available beginner piano curriculum. Participants&#xD;
        will be assigned weekly homework with the requirement of practicing piano at least 10 minutes&#xD;
        per day. Progress will be checked at each weekly piano lesson to ensure compliance.&#xD;
  &#xD;
        All data will be either collected directly from the participants using COINS, an online&#xD;
        database and assessment tool, or will be double data entered into COINS with conflicts&#xD;
        resolved through consultation of the source material. Assessments will be transferred to the&#xD;
        National Institute on Alcohol Abuse and Alcoholism data archive (NIAAA-DA), which validates&#xD;
        data entry values relative to expected ranges. Any violations will be corrected within the&#xD;
        COINS database via consultation with source material and re-extracted for data upload to&#xD;
        NIAAA-DA. NIAAA-DA will maintain the source material. Missing data will be examined for any&#xD;
        systematic pattern of missingness. Mixed effects models are relatively insensitive to missing&#xD;
        data. If necessary, missing data will be replaced using standard statistical methods.&#xD;
  &#xD;
        Standard statistical analysis approaches will be employed to evaluate the data for violation&#xD;
        of assumptions of the statistical models. Transformations will be performed as necessary.&#xD;
        Outcome variables will be compared statistically between the music listening and piano&#xD;
        training arms using repeated measures analysis of variance (or covariance) or mixed effects&#xD;
        models depending on the amount of missing data. Working memory will be assessed using the&#xD;
        Wechsler Intelligence Scale for Children (WISC) Digit span and picture span subtests.&#xD;
        Attention will be assessed using the Conners Continuous Performance Test 3 (CPT3). Behavioral&#xD;
        regulation will be assessed using the Behavioral Rating Inventory of Executive Function 2&#xD;
        (BRIEF2). Age, socioeconomic status, and music experience will be included as covariates in&#xD;
        the model, as needed. Sex effects on outcome variables will also be examined.&#xD;
  &#xD;
        H1: Piano training will produce improvements in behavioral regulation (BRIEF2) relative to&#xD;
        music listening.&#xD;
  &#xD;
        H2: Piano training will produce improvements in attention (Conners CPT 3) relative to music&#xD;
        listening.&#xD;
  &#xD;
        H3: Piano training will produce improvements in working memory (WISC - Digit span) relative&#xD;
        to music listening.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2028</completion_date>
    <primary_completion_date type="Anticipated">September 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>Crossover Assignment</intervention_model>
      <intervention_model_description>This randomized cross-over design will employ two arms: music listening and piano training. Participants and outcomes assessor will be masked to which arm is active/passive.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Parents/participants will be masked to which condition is active/passive. The outcomes assessor will be masked to condition.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of behavioral regulation - Inhibit</measure>
      <time_frame>12 weeks</time_frame>
      <description>The inhibit subscale from the Behavior Rating Inventory of Executive Function - Second Edition (BRIEF 2) Inhibit subscale; min/max: t score: 35 - &gt;90; higher score means more impairment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of Attention using the Conners Continuous Performance Test</measure>
      <time_frame>12 weeks</time_frame>
      <description>Examine change in sustained attention based on the Conners Continuous Performance Test - Third Edition (CPT 3): Omission subscale; min/max: t score: &lt;40 - &gt;90; higher score means more impairment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of Working Memory using Wechsler Intelligence Scale for Children (WISC V)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Wechsler Intelligence Scale for Children - Fifth Edition (WISC V): Digit Span Backwards subtest, min/max: scaled score: 1 - 19; higher score means better performance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assessment of cognitive flexibility</measure>
      <time_frame>12 weeks</time_frame>
      <description>The Shift subscale from the Behavior Rating Inventory of Executive Function - Second Edition (BRIEF 2) Shift subscale; min/max: t score: 35 - &gt;90; higher score means more impairment</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Fetal Alcohol Spectrum Disorders</condition>
    <arm_group>
      <arm_group_label>Music listening then piano training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will listen to music for 10 minutes per day for 12 weeks. After one week of assessments, participants will practice piano for 10 minutes per day for 12 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Piano training then music listening</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will practice piano for 10 minutes per day for 12 weeks. After one week of assessments, participants will listen to music for 10 minutes per day for 12 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Music listening</intervention_name>
      <description>Daily music listening</description>
      <arm_group_label>Music listening then piano training</arm_group_label>
      <arm_group_label>Piano training then music listening</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Piano training</intervention_name>
      <description>Daily piano practice</description>
      <arm_group_label>Music listening then piano training</arm_group_label>
      <arm_group_label>Piano training then music listening</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children must receive a research designation of FASD&#xD;
  &#xD;
            -  Children must have confirmed prenatal alcohol exposure&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with other confirmed developmental disorders that are not deemed associated&#xD;
               with FASD (e.g. autism spectrum disorder, Down Syndrome). Children with attention&#xD;
               deficits (e.g. ADHD) are not excluded.&#xD;
  &#xD;
            -  Children with neurological disorders (epilepsy, cerebral palsy, etc.)&#xD;
  &#xD;
            -  Children who have experienced a traumatic brain injury with loss of consciousness &gt;10&#xD;
               minutes&#xD;
  &#xD;
            -  Children with intelligence quotient scores &lt;70&#xD;
  &#xD;
            -  Children who are, or become, a ward of the state; however children with a legal&#xD;
               representative who can consent on their behalf will not be excluded&#xD;
  &#xD;
            -  Children with ongoing music training outside of school or &gt;1 year of prior private&#xD;
               music lessons.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Julia M Stephen, PhD</last_name>
      <phone>505-272-5028</phone>
      <email>JSTEPHEN@MRN.ORG</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Mind Research Network</investigator_affiliation>
      <investigator_full_name>Julia Stephen</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>music training</keyword>
    <keyword>music listening</keyword>
    <keyword>piano training</keyword>
    <keyword>attention</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fetal Alcohol Spectrum Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data will be uploaded to the NIAAA-data archive.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Upon completion of the study</ipd_time_frame>
      <ipd_access_criteria>NIAAA-DA data sharing guidelines</ipd_access_criteria>
    </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/NCT06005181
  org study id: 23-052
  nct id: NCT06005181
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to examine if music training improves behavioral or
        cognitive performance in children with prenatal alcohol exposure who meet research criteria
        for a fetal alcohol spectrum disorder. The main questions it aims to answer are:
  
          -  Does music training improve behavioral regulation for children with an FASD
  
          -  Does music training improve cognitive performance (attention and working memory) for
             children with an FASD.
  
        The study has two interventions for each participant: music listening and piano training.
        Each participant will either practice piano daily for 12 weeks or listen to pre-selected
        music daily for 12 weeks. The order of the interventions will be randomized across
        participants. Assessment will occur before and after participation in each 12 week
        intervention.
  Music training has been shown to alter brain function and structure in musicians relative to
        nonmusicians. Music training requires a complex set of skills. By engaging in this activity,
        music training may alter brain development in children and increase cortical connectivity
        such that it provides improved self-regulation and cognitive performance. However, music
        training has not been tested in children with a fetal alcohol spectrum disorder, despite
        known behavioral and cognitive effects of prenatal alcohol exposure.
  
        The study will employ a randomized, cross-over design to examine the effects of piano
        training versus music listening. Participants will be asked to attend two information
        sessions prior to study enrollment. These will provide participants with detailed information
        about the study expectations, complete study consent/assent, and train participants on use of
        the devices for music listening/piano training. Participants will receive baseline
        assessments which include cognitive testing, behavioral questionnaires and neuroimaging. Each
        participant will be randomized to receive 12 weeks of either music listening or piano
        training. After the initial 12 week intervention is completed, participants will receive an
        intermediate assessment where the initial assessment battery will be repeated. The
        participants will then engage in the other arm of the study (music listening or piano
        training) for an additional 12 weeks. During the last week of the study, the initial
        assessment battery will be repeated a third time.
  
        During music listening, the participant will be provided with a device that will allow the
        participant to access study-selected music. Participants will be provided with one music
        list/week for 12 weeks and will be asked to listen to music from the study-selected music for
        at least 10 minutes per day. Participants will be required to check in with the study team
        weekly to receive the next week's playlist and to ensure compliance.
  
        During piano training, the participant will be provided with an electronic keyboard that will
        allow the participant to practice piano daily. Participants will attend weekly ½ hour piano
        lessons which will follow a commercially-available beginner piano curriculum. Participants
        will be assigned weekly homework with the requirement of practicing piano at least 10 minutes
        per day. Progress will be checked at each weekly piano lesson to ensure compliance.
  
        All data will be either collected directly from the participants using COINS, an online
        database and assessment tool, or will be double data entered into COINS with conflicts
        resolved through consultation of the source material. Assessments will be transferred to the
        National Institute on Alcohol Abuse and Alcoholism data archive (NIAAA-DA), which validates
        data entry values relative to expected ranges. Any violations will be corrected within the
        COINS database via consultation with source material and re-extracted for data upload to
        NIAAA-DA. NIAAA-DA will maintain the source material. Missing data will be examined for any
        systematic pattern of missingness. Mixed effects models are relatively insensitive to missing
        data. If necessary, missing data will be replaced using standard statistical methods.
  
        Standard statistical analysis approaches will be employed to evaluate the data for violation
        of assumptions of the statistical models. Transformations will be performed as necessary.
        Outcome variables will be compared statistically between the music listening and piano
        training arms using repeated measures analysis of variance (or covariance) or mixed effects
        models depending on the amount of missing data. Working memory will be assessed using the
        Wechsler Intelligence Scale for Children (WISC) Digit span and picture span subtests.
        Attention will be assessed using the Conners Continuous Performance Test 3 (CPT3). Behavioral
        regulation will be assessed using the Behavioral Rating Inventory of Executive Function 2
        (BRIEF2). Age, socioeconomic status, and music experience will be included as covariates in
        the model, as needed. Sex effects on outcome variables will also be examined.
  
        H1: Piano training will produce improvements in behavioral regulation (BRIEF2) relative to
        music listening.
  
        H2: Piano training will produce improvements in attention (Conners CPT 3) relative to music
        listening.
  
        H3: Piano training will produce improvements in working memory (WISC - Digit span) relative
        to music listening.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: This randomized cross-over design will employ two arms: music listening and piano training. Participants and outcomes assessor will be masked to which arm is active/passive.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Parents/participants will be masked to which condition is active/passive. The outcomes assessor will be masked to condition.
  measure: Assessment of behavioral regulation - Inhibit
  time frame: 12 weeks
  description: The inhibit subscale from the Behavior Rating Inventory of Executive Function - Second Edition (BRIEF 2) Inhibit subscale; min/max: t score: 35 - >90; higher score means more impairment
  measure: Assessment of Attention using the Conners Continuous Performance Test
  time frame: 12 weeks
  description: Examine change in sustained attention based on the Conners Continuous Performance Test - Third Edition (CPT 3): Omission subscale; min/max: t score: <40 - >90; higher score means more impairment
  measure: Assessment of Working Memory using Wechsler Intelligence Scale for Children (WISC V)
  time frame: 12 weeks
  description: Wechsler Intelligence Scale for Children - Fifth Edition (WISC V): Digit Span Backwards subtest, min/max: scaled score: 1 - 19; higher score means better performance.
  measure: Assessment of cognitive flexibility
  time frame: 12 weeks
  description: The Shift subscale from the Behavior Rating Inventory of Executive Function - Second Edition (BRIEF 2) Shift subscale; min/max: t score: 35 - >90; higher score means more impairment
  arm group label: Music listening then piano training
  arm group type: Experimental
  description: Participants will listen to music for 10 minutes per day for 12 weeks. After one week of assessments, participants will practice piano for 10 minutes per day for 12 weeks.
  arm group label: Piano training then music listening
  arm group type: Experimental
  description: Participants will practice piano for 10 minutes per day for 12 weeks. After one week of assessments, participants will listen to music for 10 minutes per day for 12 weeks.
  intervention type: Behavioral
  intervention name: Music listening
  description: Daily music listening
  arm group label: Music listening then piano training
  arm group label: Piano training then music listening
  intervention type: Behavioral
  intervention name: Piano training
  description: Daily piano practice
  arm group label: Music listening then piano training
  arm group label: Piano training then music listening
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 16 Years
  healthy volunteers: No
  last name: Julia M Stephen, PhD
  phone: 505-272-5028
  email: JSTEPHEN@MRN.ORG
  responsible party type: Principal Investigator
  investigator affiliation: The Mind Research Network
  investigator full name: Julia Stephen
  investigator title: Professor
  mesh term: Fetal Alcohol Spectrum Disorders
  sharing ipd: Yes
  ipd description: The data will be uploaded to the NIAAA-data archive.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Upon completion of the study
  ipd access criteria: NIAAA-DA data sharing guidelines