<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/NCT04454736</url>
  </required_header>
  <id_info>
    <org_study_id>Grebosz-Haring SingingStudy</org_study_id>
    <nct_id>NCT04454736</nct_id>
  </id_info>
  <brief_title>Psychobiological Responses to Choral Singing in Mentally Ill and Healthy Children and Adolescents</brief_title>
  <official_title>Psychological and Biological Responses to Choral Singing in Mentally Ill, Socially Underprivileged and Privileged Healthy Children and Adolescents: An Open, Single-Arm, Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Salzburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universität Mozartuem Salzburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Salzburger Landeskliniken</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Paracelsus Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Vienna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Salzburg</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>
      Interventional, three-armed, open, monocentric, medium-term follow-up, pre-test-post-test&#xD;
      design, controlled, parallel group study to investigate the effects of a group singing&#xD;
      intervention on neuroendocrine (hair cortisol, salivary cortisol, salivary alpha amylase),&#xD;
      immune (salivary immunoglobulin A/s-IgA), and psychological (psychological stress, mood,&#xD;
      social contacts, emotional and social competence, self-esteem, and quality of life) responses&#xD;
      in mentally ill and healthy children and adolescents (N=135, age range 10 -18).&#xD;
&#xD;
      Additionally, the child and adolescent psychiatry group (age range 13-18) takes part in three&#xD;
      hour creative workshops every two weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Biopsychological responses to music-related activities (MRA) were examined in&#xD;
      various naturalistic settings in adults. Group singing in particular seems to be associated&#xD;
      with positive biopsychological outcomes. There is also an emerging view that MRA may play an&#xD;
      important role for youth with mental disorders. However, longitudinal research on&#xD;
      biopsychological responses to MRA in different clinical and healthy populations among&#xD;
      children and adolescents is lacking.&#xD;
&#xD;
      Method: Children and adolescents (age range 10-18) under psychiatric treatment at the&#xD;
      Department of Child and Adolescents Psychiatry in Salzburg (n=45), healthy children and&#xD;
      adolescents from a school in Salzburg (n=45), and members from the Vienna Boys Choir (n=45)&#xD;
      in Austria will be recruited to take part in the study. Subjective measures (mood, stress&#xD;
      experience) will be taken pre- and post singing sessions once a week throughout six months.&#xD;
      Additionally, salivary biomarkers (cortisol, alpha amylase and IgA), social contacts, and&#xD;
      quality of life are assessed. Emotional competence, social competence, self-esteem, and&#xD;
      chronic stress levels are measured at the beginning, after three months, at the end, and in a&#xD;
      follow-up of the study.&#xD;
&#xD;
      The group of child and adolescent psychiatry taking part in the creative workshops will be&#xD;
      additionally assessed via questionnaires regarding emotional regulation, self-esteem, and art&#xD;
      experience before and after every workshop. Furthermore, some individuals of the child and&#xD;
      adolescent psychiatry group will undergo fMRI evaluation of the brain before and after&#xD;
      completion of all creative interventions.&#xD;
&#xD;
      Conclusion: Singing and other creative activities are suggested to benefit mental and&#xD;
      physical health in children and adolescents. However, despite the current knowledge, the&#xD;
      researchers must better understand the biopsychological mechanisms underlying choral singing&#xD;
      in order to determine its full potential, particularly for vulnerable populations. This is&#xD;
      the first study to investigate this issue in this population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2021</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change Short-Term Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) from pre- to post singing session over six months</measure>
    <time_frame>every two weeks pre- and post singing sessions for six months</time_frame>
    <description>Biological Stress Marker: Salivary Cortisol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change Short-Term Immune Function from pre- to post singing session over six months</measure>
    <time_frame>every two weeks pre- and post singing sessions for six months</time_frame>
    <description>Biological Marker: Salivary Immunoglobulin A</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Chronic Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) at three and six months</measure>
    <time_frame>at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months</time_frame>
    <description>Biological Stress Marker: Hair Cortisol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change Short-Term Neuroendocrine Stress (Autonomic Nervous System) from pre- to post singing session over six months</measure>
    <time_frame>every two weeks pre- and post singing sessions for six months</time_frame>
    <description>Salivary Alpha-Amylase</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychological Stress</measure>
    <time_frame>at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months</time_frame>
    <description>Stress and Coping Questionnaire for Children and Adolescents (SSKJ 3-8 R; Lohaus, Eschenbeck, Kohlmann, &amp; Klein-Heßling, 2018)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>every week pre- and post singing sessions for six months</time_frame>
    <description>Multidimensional Mood State Questionnaire (MDBF, short version; Steyer, Notz, Schwenkmezger, &amp; Eid, 1997)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional Skills</measure>
    <time_frame>at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months</time_frame>
    <description>Emotional Competence Questionnaire (EKF; Rindermann, 2009)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Esteem</measure>
    <time_frame>at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months</time_frame>
    <description>Selbstwertinventar für Kinder und Jugendliche (SEKJ; Schöne &amp; Stiensmeier-Pelster, 2016)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life Quality</measure>
    <time_frame>once a month for six months</time_frame>
    <description>Pediatric Quality of Life Inventory (PEDsQL; Varni, 2001)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance Anxiety</measure>
    <time_frame>once at the beginning of the study, once after 6 months</time_frame>
    <description>Das State-Trait-Angstinventar (STAI-T adapted; Laux, Glanzmann, Schaffner, &amp; Spielberger 1981)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Skills</measure>
    <time_frame>at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months</time_frame>
    <description>Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the choir session</measure>
    <time_frame>every week post singing sessions for six months</time_frame>
    <description>Liking of the session, liking of the songs, familiarity with the songs (5-point Likert scale; Higher scores mean a better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronical Stress</measure>
    <time_frame>at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months</time_frame>
    <description>Fragebogen zu chronischem Stress im Kindesalter (CSiK; Richartz, Hoffmann, &amp; Sallen, 2009)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress Perception</measure>
    <time_frame>every week pre- and post singing sessions for six months</time_frame>
    <description>Visual Analogue Scale (VAS; 0-100; higher score means a worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosocial Behavior</measure>
    <time_frame>every two weeks post singing sessions for six months</time_frame>
    <description>Social Network Map (Tracey &amp; Whittaker, 1990)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Stability (parents view)</measure>
    <time_frame>at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months</time_frame>
    <description>Child Behavior Checklist (CBCL; Achenbach &amp; Arbeitsgruppe Deutsche Child Behavior Checklist, 1994)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Stability (children view)</measure>
    <time_frame>at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months</time_frame>
    <description>Youth Self-Report (YSR; Achenbach &amp; Arbeitsgruppe Deutsche Child Behavior Checklist, 1994)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional Control</measure>
    <time_frame>at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months</time_frame>
    <description>Fragebogen zur Erhebung der Emotionsregulation bei Kindern und Jugendlichen (FEEL-KJ; Grob &amp; Smolenski, 2005)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specific personality and character traits such as curiosity, reward dependency, cooperativity, and self-steering ability</measure>
    <time_frame>At the beginning of creative workshops, and at a follow-up after three months in the group of children and adolescents with psychiatric disorders</time_frame>
    <description>JTCI Junior Temperament and Character Inventory in Children and Adolescents Psychiatry Group Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Current emotional state</measure>
    <time_frame>Pre and post every creative workshop in the group of children and adolescents with psychiatric disorders</time_frame>
    <description>Positive and negative affect schedule (PANAS)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">135</enrollment>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>SBGmentdis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children and adolescents with mental disorders at the Department of Child and Adolescents Psychiatry in Salzburg, Austria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SBGhealthy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy children and adolescents from schools in Salzburg, Austria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VIEhealthy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Members from the Vienna Boys Choir, Austria</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>&quot;Amateur&quot; Group Singing</intervention_name>
    <description>45-minute singing session led by a professional choirmaster without a therapeutic background once a week</description>
    <arm_group_label>SBGhealthy</arm_group_label>
    <arm_group_label>SBGmentdis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>&quot;Professional&quot; Group Singing</intervention_name>
    <description>120-minute singing session led by a professional choirmaster without a therapeutic background three times a week. Assessments take place twice a week.</description>
    <arm_group_label>VIEhealthy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Clinical N):&#xD;
&#xD;
          -  Written consent to study participation;&#xD;
&#xD;
          -  Gender: male, female, different;&#xD;
&#xD;
          -  Age: children and adolescents aged ≥ 10 and ≤ 18 years;&#xD;
&#xD;
          -  Diagnosis of a psychiatric disorder according to ICD-10;&#xD;
&#xD;
          -  Patients are admitted regardless of medication status and are allowed to the&#xD;
             medication will continue to be used during the study;&#xD;
&#xD;
          -  Additional therapies and medication are recorded and are not an exclusion criterion;&#xD;
&#xD;
          -  Musical skills or a certain musical background are not required&#xD;
&#xD;
        Inclusion Criteria (Healthy N):&#xD;
&#xD;
          -  Written consent to study participation;&#xD;
&#xD;
          -  Gender: male, female, different;&#xD;
&#xD;
          -  Age: children and adolescents aged ≥ 10 and ≤ 18 years;&#xD;
&#xD;
          -  Musical skills or a certain musical background are not required&#xD;
&#xD;
        Exclusion Criteria (Clinical N):&#xD;
&#xD;
          -  Age: children and adolescents aged &lt;10 years and &gt; 18 years;&#xD;
&#xD;
          -  Criteria that prevent an application: hearing loss, states of confusion, inability to&#xD;
             verbalize;&#xD;
&#xD;
          -  Patients with acute externalizing behavior or self-harm/suicidality;&#xD;
&#xD;
          -  Existing alcohol addiction or abuse of illegal drugs;&#xD;
&#xD;
        Exclusion Criteria (Healthy N):&#xD;
&#xD;
          -  Age: children and adolescents aged &lt;10 years and &gt; 18 years&#xD;
&#xD;
          -  Criteria that prevent an application: hearing loss, states of confusion, inability to&#xD;
             verbalize&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katarzyna Grebosz-Haring, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Mozarteum Salzburg, University of Salzburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leonhard Thun-Hohenstein, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Salzburger Landeskliniken Betriebsges.m.b.H.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Katarzyna Grebosz-Haring, Dr.</last_name>
    <phone>+43 - 662 - 8044 - 2370</phone>
    <email>katarzyna.grebosz-haring@sbg.ac.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>Salzburger Landeskliniken, Universitätsklinik für Kinder- und Jugendpsychiatrie</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leonhard Thun-Hohenstein, Prof.Dr.</last_name>
      <phone>+43 (0) 57255</phone>
      <phone_ext>34201</phone_ext>
      <email>l.thun-hohenstein@salk.at</email>
    </contact>
    <investigator>
      <last_name>Leonhard Thun-Hohenstein, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Mozarteum Salzburg/University of Salzburg</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katarzyna A Grebosz-Haring, Dr.</last_name>
      <phone>+43 - 662 - 8044 - 2370</phone>
      <email>katarzyna.grebosz-haring@sbg.ac.at</email>
    </contact>
    <investigator>
      <last_name>Katarzyna A Grebosz-Haring, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1010</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Urs M Nater, Prof. Dr.</last_name>
      <phone>+43 1 4277</phone>
      <phone_ext>47220</phone_ext>
      <email>urs.nater@univie.ac.at</email>
    </contact>
    <investigator>
      <last_name>Anja C Feneberg, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <reference>
    <citation>Grebosz-Haring K, Thun-Hohenstein L. Effects of group singing versus group music listening on hospitalized children and adolescents with mental disorders: A pilot study. Heliyon. 2018 Dec 17;4(12):e01014. doi: 10.1016/j.heliyon.2018.e01014. eCollection 2018 Dec.</citation>
    <PMID>30582039</PMID>
  </reference>
  <reference>
    <citation>Grebosz-Haring, K., Thun-Hohenstein, L. (2020). Singing for Health and Wellbeing in Children and Adolescents with Mental Disorders. In R. Heydon, D. Fancourt, A. Cohen (Eds.), The Routledge Companion to Interdisciplinary Studies in Singing: Vol 3 Wellbeing. London: Routledge.</citation>
  </reference>
  <reference>
    <citation>Linnemann, A., Schnersch, A., Nater, U. M. (2017). Testing the beneficial effects of singing in a choir on mood and stress in a longitudinal study: The role of social contacts. Musicae Scientiae, 21(2), 195-212.</citation>
  </reference>
  <reference>
    <citation>Ali N, Nater UM. Salivary Alpha-Amylase as a Biomarker of Stress in Behavioral Medicine. Int J Behav Med. 2020 Jun;27(3):337-342. doi: 10.1007/s12529-019-09843-x.</citation>
    <PMID>31900867</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>February 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>May 12, 2022</last_update_submitted>
  <last_update_submitted_qc>May 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Salzburg</investigator_affiliation>
    <investigator_full_name>Katarzyna Grebosz-Haring</investigator_full_name>
    <investigator_title>Senior Scientist, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Mental health</keyword>
  <keyword>Youth</keyword>
  <keyword>Singing</keyword>
  <keyword>Music</keyword>
  <keyword>Stress</keyword>
  <keyword>Cortisol</keyword>
  <keyword>Alpha Amylase</keyword>
  <keyword>Immunoglobulin A</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>July 2020-until the end of the study</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04454736
org study id: Grebosz-Haring SingingStudy
nct id: NCT04454736
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Interventional, three-armed, open, monocentric, medium-term follow-up, pre-test-post-test
      design, controlled, parallel group study to investigate the effects of a group singing
      intervention on neuroendocrine (hair cortisol, salivary cortisol, salivary alpha amylase),
      immune (salivary immunoglobulin A/s-IgA), and psychological (psychological stress, mood,
      social contacts, emotional and social competence, self-esteem, and quality of life) responses
      in mentally ill and healthy children and adolescents (N=135, age range 10 -18).

      Additionally, the child and adolescent psychiatry group (age range 13-18) takes part in three
      hour creative workshops every two weeks.
Background: Biopsychological responses to music-related activities (MRA) were examined in
      various naturalistic settings in adults. Group singing in particular seems to be associated
      with positive biopsychological outcomes. There is also an emerging view that MRA may play an
      important role for youth with mental disorders. However, longitudinal research on
      biopsychological responses to MRA in different clinical and healthy populations among
      children and adolescents is lacking.

      Method: Children and adolescents (age range 10-18) under psychiatric treatment at the
      Department of Child and Adolescents Psychiatry in Salzburg (n=45), healthy children and
      adolescents from a school in Salzburg (n=45), and members from the Vienna Boys Choir (n=45)
      in Austria will be recruited to take part in the study. Subjective measures (mood, stress
      experience) will be taken pre- and post singing sessions once a week throughout six months.
      Additionally, salivary biomarkers (cortisol, alpha amylase and IgA), social contacts, and
      quality of life are assessed. Emotional competence, social competence, self-esteem, and
      chronic stress levels are measured at the beginning, after three months, at the end, and in a
      follow-up of the study.

      The group of child and adolescent psychiatry taking part in the creative workshops will be
      additionally assessed via questionnaires regarding emotional regulation, self-esteem, and art
      experience before and after every workshop. Furthermore, some individuals of the child and
      adolescent psychiatry group will undergo fMRI evaluation of the brain before and after
      completion of all creative interventions.

      Conclusion: Singing and other creative activities are suggested to benefit mental and
      physical health in children and adolescents. However, despite the current knowledge, the
      researchers must better understand the biopsychological mechanisms underlying choral singing
      in order to determine its full potential, particularly for vulnerable populations. This is
      the first study to investigate this issue in this population.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change Short-Term Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) from pre- to post singing session over six months
time frame: every two weeks pre- and post singing sessions for six months
description: Biological Stress Marker: Salivary Cortisol
measure: Change Short-Term Immune Function from pre- to post singing session over six months
time frame: every two weeks pre- and post singing sessions for six months
description: Biological Marker: Salivary Immunoglobulin A
measure: Change from Baseline Chronic Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) at three and six months
time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
description: Biological Stress Marker: Hair Cortisol
measure: Change Short-Term Neuroendocrine Stress (Autonomic Nervous System) from pre- to post singing session over six months
time frame: every two weeks pre- and post singing sessions for six months
description: Salivary Alpha-Amylase
measure: Psychological Stress
time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
description: Stress and Coping Questionnaire for Children and Adolescents (SSKJ 3-8 R; Lohaus, Eschenbeck, Kohlmann, & Klein-Heßling, 2018)
measure: Mood
time frame: every week pre- and post singing sessions for six months
description: Multidimensional Mood State Questionnaire (MDBF, short version; Steyer, Notz, Schwenkmezger, & Eid, 1997)
measure: Emotional Skills
time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
description: Emotional Competence Questionnaire (EKF; Rindermann, 2009)
measure: Self-Esteem
time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
description: Selbstwertinventar für Kinder und Jugendliche (SEKJ; Schöne & Stiensmeier-Pelster, 2016)
measure: Life Quality
time frame: once a month for six months
description: Pediatric Quality of Life Inventory (PEDsQL; Varni, 2001)
measure: Performance Anxiety
time frame: once at the beginning of the study, once after 6 months
description: Das State-Trait-Angstinventar (STAI-T adapted; Laux, Glanzmann, Schaffner, & Spielberger 1981)
measure: Social Skills
time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
description: Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)
measure: Evaluation of the choir session
time frame: every week post singing sessions for six months
description: Liking of the session, liking of the songs, familiarity with the songs (5-point Likert scale; Higher scores mean a better outcome)
measure: Chronical Stress
time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
description: Fragebogen zu chronischem Stress im Kindesalter (CSiK; Richartz, Hoffmann, & Sallen, 2009)
measure: Stress Perception
time frame: every week pre- and post singing sessions for six months
description: Visual Analogue Scale (VAS; 0-100; higher score means a worse outcome)
measure: Prosocial Behavior
time frame: every two weeks post singing sessions for six months
description: Social Network Map (Tracey & Whittaker, 1990)
measure: Psychological Stability (parents view)
time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
description: Child Behavior Checklist (CBCL; Achenbach & Arbeitsgruppe Deutsche Child Behavior Checklist, 1994)
measure: Psychological Stability (children view)
time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
description: Youth Self-Report (YSR; Achenbach & Arbeitsgruppe Deutsche Child Behavior Checklist, 1994)
measure: Emotional Control
time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
description: Fragebogen zur Erhebung der Emotionsregulation bei Kindern und Jugendlichen (FEEL-KJ; Grob & Smolenski, 2005)
measure: Specific personality and character traits such as curiosity, reward dependency, cooperativity, and self-steering ability
time frame: At the beginning of creative workshops, and at a follow-up after three months in the group of children and adolescents with psychiatric disorders
description: JTCI Junior Temperament and Character Inventory in Children and Adolescents Psychiatry Group Questionnaire
measure: Current emotional state
time frame: Pre and post every creative workshop in the group of children and adolescents with psychiatric disorders
description: Positive and negative affect schedule (PANAS)
arm group label: SBGmentdis
arm group type: Experimental
description: Children and adolescents with mental disorders at the Department of Child and Adolescents Psychiatry in Salzburg, Austria
arm group label: SBGhealthy
arm group type: Experimental
description: Healthy children and adolescents from schools in Salzburg, Austria
arm group label: VIEhealthy
arm group type: Experimental
description: Members from the Vienna Boys Choir, Austria
intervention type: Behavioral
intervention name: "Amateur" Group Singing
description: 45-minute singing session led by a professional choirmaster without a therapeutic background once a week
arm group label: SBGhealthy
arm group label: SBGmentdis
intervention type: Behavioral
intervention name: "Professional" Group Singing
description: 120-minute singing session led by a professional choirmaster without a therapeutic background three times a week. Assessments take place twice a week.
arm group label: VIEhealthy
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Katarzyna Grebosz-Haring, Dr.
role: Principal Investigator
affiliation: University Mozarteum Salzburg, University of Salzburg
last name: Leonhard Thun-Hohenstein, Prof. Dr.
role: Principal Investigator
affiliation: Salzburger Landeskliniken Betriebsges.m.b.H.
last name: Katarzyna Grebosz-Haring, Dr.
phone: +43 - 662 - 8044 - 2370
email: katarzyna.grebosz-haring@sbg.ac.at
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Austria
citation: Grebosz-Haring K, Thun-Hohenstein L. Effects of group singing versus group music listening on hospitalized children and adolescents with mental disorders: A pilot study. Heliyon. 2018 Dec 17;4(12):e01014. doi: 10.1016/j.heliyon.2018.e01014. eCollection 2018 Dec.
PMID: 30582039
citation: Grebosz-Haring, K., Thun-Hohenstein, L. (2020). Singing for Health and Wellbeing in Children and Adolescents with Mental Disorders. In R. Heydon, D. Fancourt, A. Cohen (Eds.), The Routledge Companion to Interdisciplinary Studies in Singing: Vol 3 Wellbeing. London: Routledge.
citation: Linnemann, A., Schnersch, A., Nater, U. M. (2017). Testing the beneficial effects of singing in a choir on mood and stress in a longitudinal study: The role of social contacts. Musicae Scientiae, 21(2), 195-212.
citation: Ali N, Nater UM. Salivary Alpha-Amylase as a Biomarker of Stress in Behavioral Medicine. Int J Behav Med. 2020 Jun;27(3):337-342. doi: 10.1007/s12529-019-09843-x.
PMID: 31900867
responsible party type: Principal Investigator
investigator affiliation: University of Salzburg
investigator full name: Katarzyna Grebosz-Haring
investigator title: Senior Scientist, Principal Investigator
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: July 2020-until the end of the study