- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04454736
Psychobiological Responses to Choral Singing in Mentally Ill and Healthy Children and Adolescents
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Katarzyna Grebosz-Haring, Dr.
- Phone Number: +43 - 662 - 8044 - 2370
- Email: katarzyna.grebosz-haring@sbg.ac.at
Study Locations
-
-
-
Salzburg, Austria, 5020
- Recruiting
- Salzburger Landeskliniken, Universitätsklinik für Kinder- und Jugendpsychiatrie
-
Contact:
- Leonhard Thun-Hohenstein, Prof.Dr.
- Phone Number: 34201 +43 (0) 57255
- Email: l.thun-hohenstein@salk.at
-
Principal Investigator:
- Leonhard Thun-Hohenstein, Prof. Dr.
-
Salzburg, Austria, 5020
- Recruiting
- University Mozarteum Salzburg/University of Salzburg
-
Contact:
- Katarzyna A Grebosz-Haring, Dr.
- Phone Number: +43 - 662 - 8044 - 2370
- Email: katarzyna.grebosz-haring@sbg.ac.at
-
Principal Investigator:
- Katarzyna A Grebosz-Haring, Dr.
-
Vienna, Austria, 1010
- Recruiting
- University of Vienna
-
Contact:
- Urs M Nater, Prof. Dr.
- Phone Number: 47220 +43 1 4277
- Email: urs.nater@univie.ac.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
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
General 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...Enrolling by invitationStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
University of PadovaRecruitingStress | Stress Disorder | Work Related StressItaly
-
Dana-Farber Cancer InstituteEnrolling by invitationStress | Post Traumatic Stress Disorder | Work Related StressUnited States
-
Syracuse VA Medical CenterUS Department of Veterans AffairsCompletedEmotional Stress | Psychological Stress | Life StressUnited States
-
Duquesne UniversityUniversity of California, San Diego; West Penn Allegheny Health System; El Centro... and other collaboratorsTerminated
-
University of Sao PauloCompleted
-
Royal Cornwall Hospitals TrustEnrolling by invitationStress | Stress, Psychological | Stress, JobUnited Kingdom
-
Taichung Veterans General HospitalUnknown
-
Northumbria UniversityVolac International LtdRecruitingStress | Mood | Physiological StressUnited Kingdom
Clinical Trials on "Amateur" Group Singing
-
University of NottinghamRecruiting
-
Johns Hopkins UniversityCompleted
-
Royal College of MusicImperial College London; Chelsea and Westminster NHS Foundation TrustCompletedDepression, PostpartumUnited Kingdom
-
NYU Langone HealthCompletedHigh-intensity Group Vocal Exercise to Improve Laryngeal Function in Patients With Parkinson DiseaseParkinson DiseaseUnited States
-
University of Southern CaliforniaNot yet recruitingAnxiety | Social Behavior | Speech Perception
-
Imperial College LondonCompleted
-
University of SalzburgUniversity of Vienna; Confraternität Private HospitalNot yet recruiting
-
NORCE Norwegian Research Centre ASUniversity of Nottingham; University Medical Center Groningen; University of... and other collaboratorsActive, not recruitingDepression | DementiaUnited Kingdom, Australia, Germany, Netherlands, Norway, Turkey
-
Stockholm UniversityThe Swedish Research Council; Region StockholmCompletedIrritable Bowel SyndromeSweden