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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Psychological and Biological Responses to Choral Singing in Mentally Ill, Socially Underprivileged and Privileged Healthy Children and Adolescents: An Open, Single-Arm, Controlled Study

Conditions
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Stress

Intervention / Treatment
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* Behavioral: Amateur Group Singing
* Behavioral: Professional Group Singing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Short-Term Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) from pre- to post singing session over six months | Biological Stress Marker: Salivary Cortisol | every two weeks pre- and post singing sessions for six months | 
| Change Short-Term Immune Function from pre- to post singing session over six months | Biological Marker: Salivary Immunoglobulin A | every two weeks pre- and post singing sessions for six months | 
| Change from Baseline Chronic Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) at three and six months | Biological Stress Marker: Hair Cortisol | 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 | 
| Change Short-Term Neuroendocrine Stress (Autonomic Nervous System) from pre- to post singing session over six months | Salivary Alpha-Amylase | every two weeks pre- and post singing sessions for six months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental health, Youth, Singing, Music, Stress, Cortisol, Alpha Amylase, Immunoglobulin A