Psychobiological Responses to Choral Singing in Mentally Ill and Healthy Children and Adolescents

• ClinicalTrials.gov Identifier: NCT04454736
• Recruitment Status: Recruiting
• First Posted: July 1, 2020
• Last Update Posted: May 19, 2022
• Sponsor: University of Salzburg
• Collaborators: Universität Mozartuem Salzburg; Salzburger Landeskliniken; Paracelsus Medical University; University of Vienna
• Information provided by (Responsible Party): Katarzyna Grebosz-Haring, University of Salzburg

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Stress	Behavioral: "Amateur" Group Singing; Behavioral: "Professional" Group Singing	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 135 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: August 1, 2021
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: July 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: SBGmentdis; Children and adolescents with mental disorders at the Department of Child and Adolescents Psychiatry in Salzburg, Austria	Behavioral: "Amateur" Group Singing; 45-minute singing session led by a professional choirmaster without a therapeutic background once a week
Experimental: SBGhealthy; Healthy children and adolescents from schools in Salzburg, Austria	Behavioral: "Amateur" Group Singing; 45-minute singing session led by a professional choirmaster without a therapeutic background once a week
Experimental: VIEhealthy; Members from the Vienna Boys Choir, Austria	Behavioral: "Professional" Group Singing; 120-minute singing session led by a professional choirmaster without a therapeutic background three times a week. Assessments take place twice a week.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   Biological Stress Marker: Salivary Cortisol
2. 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 ]
   Biological Marker: Salivary Immunoglobulin A
3. 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 ]
   Biological Stress Marker: Hair Cortisol
4. 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 ]
   Salivary Alpha-Amylase

Secondary Outcome Measures :

1. 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 ]
   Stress and Coping Questionnaire for Children and Adolescents (SSKJ 3-8 R; Lohaus, Eschenbeck, Kohlmann, & Klein-Heßling, 2018)
2. Mood [ Time Frame: every week pre- and post singing sessions for six months ]
   Multidimensional Mood State Questionnaire (MDBF, short version; Steyer, Notz, Schwenkmezger, & Eid, 1997)
3. 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 ]
   Emotional Competence Questionnaire (EKF; Rindermann, 2009)
4. 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 ]
   Selbstwertinventar für Kinder und Jugendliche (SEKJ; Schöne & Stiensmeier-Pelster, 2016)
5. Life Quality [ Time Frame: once a month for six months ]
   Pediatric Quality of Life Inventory (PEDsQL; Varni, 2001)
6. Performance Anxiety [ Time Frame: once at the beginning of the study, once after 6 months ]
   Das State-Trait-Angstinventar (STAI-T adapted; Laux, Glanzmann, Schaffner, & Spielberger 1981)
7. 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 ]
   Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)
8. Evaluation of the choir session [ Time Frame: every week post singing sessions for six months ]
   Liking of the session, liking of the songs, familiarity with the songs (5-point Likert scale; Higher scores mean a better outcome)
9. 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 ]
   Fragebogen zu chronischem Stress im Kindesalter (CSiK; Richartz, Hoffmann, & Sallen, 2009)
10. Stress Perception [ Time Frame: every week pre- and post singing sessions for six months ]
    Visual Analogue Scale (VAS; 0-100; higher score means a worse outcome)
11. Prosocial Behavior [ Time Frame: every two weeks post singing sessions for six months ]
    Social Network Map (Tracey & Whittaker, 1990)
12. 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 ]
    Child Behavior Checklist (CBCL; Achenbach & Arbeitsgruppe Deutsche Child Behavior Checklist, 1994)
13. 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 ]
    Youth Self-Report (YSR; Achenbach & Arbeitsgruppe Deutsche Child Behavior Checklist, 1994)
14. 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 ]
    Fragebogen zur Erhebung der Emotionsregulation bei Kindern und Jugendlichen (FEEL-KJ; Grob & Smolenski, 2005)
15. 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 ]
    JTCI Junior Temperament and Character Inventory in Children and Adolescents Psychiatry Group Questionnaire
16. Current emotional state [ Time Frame: Pre and post every creative workshop in the group of children and adolescents with psychiatric disorders ]
    Positive and negative affect schedule (PANAS)

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria (Clinical N):

• Written consent to study participation;
• Gender: male, female, different;
• Age: children and adolescents aged ≥ 10 and ≤ 18 years;
• Diagnosis of a psychiatric disorder according to ICD-10;
• Patients are admitted regardless of medication status and are allowed to the medication will continue to be used during the study;
• Additional therapies and medication are recorded and are not an exclusion criterion;
• Musical skills or a certain musical background are not required

Inclusion Criteria (Healthy N):

• Written consent to study participation;
• Gender: male, female, different;
• Age: children and adolescents aged ≥ 10 and ≤ 18 years;
• Musical skills or a certain musical background are not required

Exclusion Criteria (Clinical N):

• Age: children and adolescents aged <10 years and > 18 years;
• Criteria that prevent an application: hearing loss, states of confusion, inability to verbalize;
• Patients with acute externalizing behavior or self-harm/suicidality;
• Existing alcohol addiction or abuse of illegal drugs;

Exclusion Criteria (Healthy N):

• Age: children and adolescents aged <10 years and > 18 years
• Criteria that prevent an application: hearing loss, states of confusion, inability to verbalize

Contacts and Locations

Contacts

Contact: Katarzyna Grebosz-Haring, Dr.; +43 - 662 - 8044 - 2370; katarzyna.grebosz-haring@sbg.ac.at

Locations

Austria

Salzburger Landeskliniken, Universitätsklinik für Kinder- und Jugendpsychiatrie; Recruiting

Salzburg, Austria, 5020

Contact: Leonhard Thun-Hohenstein, Prof.Dr. +43 (0) 57255 ext 34201 l.thun-hohenstein@salk.at

Principal Investigator: Leonhard Thun-Hohenstein, Prof. Dr.

University Mozarteum Salzburg/University of Salzburg; Recruiting

Salzburg, Austria, 5020

Contact: Katarzyna A Grebosz-Haring, Dr. +43 - 662 - 8044 - 2370 katarzyna.grebosz-haring@sbg.ac.at

Principal Investigator: Katarzyna A Grebosz-Haring, Dr.

University of Vienna; Recruiting

Vienna, Austria, 1010

Contact: Urs M Nater, Prof. Dr. +43 1 4277 ext 47220 urs.nater@univie.ac.at

Sub-Investigator: Anja C Feneberg, MSc

Sponsors and Collaborators

University of Salzburg

Universität Mozartuem Salzburg

Salzburger Landeskliniken

Paracelsus Medical University

University of Vienna

Investigators

• Principal Investigator: Katarzyna Grebosz-Haring, Dr.; University Mozarteum Salzburg, University of Salzburg
• Principal Investigator: Leonhard Thun-Hohenstein, Prof. Dr.; Salzburger Landeskliniken Betriebsges.m.b.H.

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: Katarzyna Grebosz-Haring, Senior Scientist, Principal Investigator, University of Salzburg
• ClinicalTrials.gov Identifier: NCT04454736
• Other Study ID Numbers: Grebosz-Haring SingingStudy
• First Posted: July 1, 2020
• Last Update Posted: May 19, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: July 2020-until the end of the study

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Katarzyna Grebosz-Haring, University of Salzburg:

Mental health; Youth; Singing; Music; Stress; Cortisol; Alpha Amylase; Immunoglobulin A