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

May 12, 2022 updated by: Katarzyna Grebosz-Haring, University of Salzburg

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Salzburg, Austria, 5020
        • Recruiting
        • Salzburger Landeskliniken, Universitätsklinik für Kinder- und Jugendpsychiatrie
        • Contact:
        • Principal Investigator:
          • Leonhard Thun-Hohenstein, Prof. Dr.
      • Salzburg, Austria, 5020
        • Recruiting
        • University Mozarteum Salzburg/University of Salzburg
        • Contact:
        • Principal Investigator:
          • Katarzyna A Grebosz-Haring, Dr.
      • Vienna, Austria, 1010
        • Recruiting
        • University of Vienna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBGmentdis
Children and adolescents with mental disorders at the Department of Child and Adolescents Psychiatry in Salzburg, Austria
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
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
120-minute singing session led by a professional choirmaster without a therapeutic background three times a week. Assessments take place twice a week.

What is the study measuring?

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
Time Frame: every two weeks pre- and post singing sessions for 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
Time Frame: every two weeks pre- and post singing sessions for 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
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
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
Time Frame: every two weeks pre- and post singing sessions for 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
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)
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
Time Frame: every week pre- and post singing sessions for six months
Multidimensional Mood State Questionnaire (MDBF, short version; Steyer, Notz, Schwenkmezger, & Eid, 1997)
every week pre- and post singing sessions for six months
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)
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
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)
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
Time Frame: once a month for six months
Pediatric Quality of Life Inventory (PEDsQL; Varni, 2001)
once a month for six months
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)
once at the beginning of the study, once after 6 months
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)
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
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)
every week post singing sessions for six months
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)
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
Time Frame: every week pre- and post singing sessions for six months
Visual Analogue Scale (VAS; 0-100; higher score means a worse outcome)
every week pre- and post singing sessions for six months
Prosocial Behavior
Time Frame: every two weeks post singing sessions for six months
Social Network Map (Tracey & Whittaker, 1990)
every two weeks post singing sessions for six months
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)
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)
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)
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
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)
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
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
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
Time Frame: Pre and post every creative workshop in the group of children and adolescents with psychiatric disorders
Positive and negative affect schedule (PANAS)
Pre and post every creative workshop in the group of children and adolescents with psychiatric disorders

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

June 27, 2020

First Posted (Actual)

July 1, 2020

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Grebosz-Haring SingingStudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

July 2020-until the end of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress

Clinical Trials on "Amateur" Group Singing

3
Subscribe