Clinical trial NCT04454736: Psychobiological Responses to Choral Singing in Mentally Ill and Healthy Children and Adolescents
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Keywords: Mental health
Youth
Singing
Music
Stress
Cortisol
Alpha Amylase
Immunoglobulin A
Lead sponsor: University of Salzburg
Sponsor class: OTHER
Collaborators: name: Universität Mozartuem Salzburg
name: Salzburger Landeskliniken
name: Paracelsus Medical University
name: University of Vienna
First posted: 2020-07-01
Enrollment: 135
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change Short-Term Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) from pre- to post singing session over six months
timeFrame: every two weeks pre- and post singing sessions for six months
measure: Change Short-Term Immune Function from pre- to post singing session over six months
timeFrame: every two weeks pre- and post singing sessions for six months
measure: Change from Baseline Chronic Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) at three and six months
timeFrame: 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
measure: Change Short-Term Neuroendocrine Stress (Autonomic Nervous System) from pre- to post singing session over six months
timeFrame: every two weeks pre- and post singing sessions for six months
Secondary outcomes:
measure: Psychological Stress
timeFrame: 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
measure: Mood
timeFrame: every week pre- and post singing sessions for six months
measure: Emotional Skills
timeFrame: 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
measure: Self-Esteem
timeFrame: 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
measure: Life Quality
timeFrame: once a month for six months
measure: Performance Anxiety
timeFrame: once at the beginning of the study, once after 6 months
measure: Social Skills
timeFrame: 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
measure: Evaluation of the choir session
timeFrame: every week post singing sessions for six months
measure: Chronical Stress
timeFrame: 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
measure: Stress Perception
timeFrame: every week pre- and post singing sessions for six months
measure: Prosocial Behavior
timeFrame: every two weeks post singing sessions for six months
measure: Psychological Stability (parents view)
timeFrame: 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
measure: Psychological Stability (children view)
timeFrame: 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
measure: Emotional Control
timeFrame: 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
measure: Specific personality and character traits such as curiosity, reward dependency, cooperativity, and self-steering ability
timeFrame: At the beginning of creative workshops, and at a follow-up after three months in the group of children and adolescents with psychiatric disorders
measure: Current emotional state
timeFrame: Pre and post every creative workshop in the group of children and adolescents with psychiatric disorders
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken, Universitätsklinik für Kinder- und Jugendpsychiatrie
city: Salzburg
country: Austria
facility: University Mozarteum Salzburg/University of Salzburg
city: Vienna
country: Austria
facility: University of Vienna
Study officials:
affiliation: University Mozarteum Salzburg, University of Salzburg
name: Katarzyna Grebosz-Haring, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Salzburger Landeskliniken Betriebsges.m.b.H.
name: Leonhard Thun-Hohenstein, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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: 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.