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

Stress Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04454736
• Other study ID #: Grebosz-Haring SingingStudy
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 2023

Study information

• Verified date: May 2022
• Source: University of Salzburg
• Contact: Katarzyna Grebosz-Haring, Dr.
• Phone: +43 - 662 - 8044 - 2370
• Email: katarzyna.grebosz-haring[@]sbg.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: July 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• "Amateur" Group Singing
45-minute singing session led by a professional choirmaster without a therapeutic background once a week
• "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.

Locations

Country	Name	City	State
Austria	Salzburger Landeskliniken, Universitätsklinik für Kinder- und Jugendpsychiatrie	Salzburg
Austria	University Mozarteum Salzburg/University of Salzburg	Salzburg
Austria	University of Vienna	Vienna

Sponsors (5)

Lead Sponsor	Collaborator
University of Salzburg	Paracelsus Medical University, Salzburger Landeskliniken, Universität Mozartuem Salzburg, University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (4)

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. — View 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. — View 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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Mood	Multidimensional Mood State Questionnaire (MDBF, short version; Steyer, Notz, Schwenkmezger, & Eid, 1997)	every week pre- and post singing sessions for six months
Secondary	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
Secondary	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
Secondary	Life Quality	Pediatric Quality of Life Inventory (PEDsQL; Varni, 2001)	once a month for six months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Stress Perception	Visual Analogue Scale (VAS; 0-100; higher score means a worse outcome)	every week pre- and post singing sessions for six months
Secondary	Prosocial Behavior	Social Network Map (Tracey & Whittaker, 1990)	every two weeks post singing sessions for six months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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