Condition category
Mental and Behavioural Disorders
Date applied
17/02/2019
Date assigned
04/04/2019
Last edited
03/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Autism spectrum disorder (ASD) is a complex neuro-developmental disorder that begins in early childhood and persists throughout adulthood. ASD affects three crucial areas of development: social communication, social interaction and creative or imaginative play. Early intensive intervention is recommended for young children who are affected by it. Previous studies indicated intact musical responsiveness in children with ASD and the interactive potential of music that can be used to improve skills in social-affective interaction in children with ASD. Up until now, most of previous early intervention studies in music therapy focused on examining behavioral changes. This study employs one of the most pragmatic trial design investigating effects of improvisational music therapy for a year exploring the children’s behavioral and neurological, developmental changes, and the relationship of those changes with the mother’s maternal behavior and that of the mental health state.

Who can participate?
Children with autism spectrum disorder aged between 24 – 72 months old without complication of other serious disorders such as visual and hearing impairments, attention deficit & hyper activity, schizophrenia, etc.

What does the study involve?
Improvisational music therapy plus standard care will be compared with standard care without improvisational music therapy condition. Standard care condition may involve a wide range of other treatments such as speech language therapy, early special education, behavioral cognitive therapy, kindergarten, special physical education, sensory integration therapy, etc. Some discrepancies of each child regarding standard care condition such as types of intervention, frequency and duration are expected, as we do not determine what interventions each child should receive, as this is a real world trial (pragmatic trial).

What are the possible benefits and risks of participating?
As we are recruiting children only for experimental group (improvisational music therapy) and using already existing data for control group. Research funding covers for almost all costs of tests and once a week music therapy for a year. Majority of tests are non-invasive and improvisational music therapy employs child-centered approach. In order to conduct the child neuroimaging, sedative will be administered, and the child might experience drowsiness after the MRI procedure due to the sedative medication (pocral). During the MRI, the child might experience some anxiety and fear. In such case, the MRI procedure will be stopped. There has been no reported case of side effect in improvisational music therapy for children with ASD.

Where is the study run from?
There are six centres: Jeonju University and Seoul National University Hospital are two leading centres in this trial, and four music therapy centres (Hanvit Music Therapy Center; SookMyung Child Development Center; Susaek Child Development Center; Jiuem child development center).

When is the study starting and how long is it expected to run for?
01/08/2018 to 31/08/2020

Who is funding the study?
National Research Foundation of Korea (Korean government)

Who is the main contact?
Prof. Jinah Kim, jinahkim@jj.ac.kr

Trial website

Contact information

Type

Scientific

Primary contact

Prof JINAH KIM

ORCID ID

Contact details

Jeonju University
Dept. of Creative Arts Therapy
Cheonjamro 303
Wansan-gu
Jeonju
55069
Korea
South
82-63-2203021
kim_jinah@hotmail.com

Type

Scientific

Additional contact

Prof Byung-Nyun Kim

ORCID ID

Contact details

Seoul National University Hospital
Jongro-gu
Yengun-dong 128
Seoul
03080
Korea
South
82-10-3637-1558
kbn1@snu.ac.kr

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NRF- 2017S1A5A2A03068100

Study information

Scientific title

Music therapy outcome study for children with Autism Spectrum Disorder through integration of child neuroimaging and neuropsychology: An exploratory study

Acronym

MANE

Study hypothesis

Finely tuned, sensitive, responsive and attentive use of music towards the developmental needs and state of the child with ASD will open and maintain the communicative channel with the child. The child's ability for social communication will increase positively over time and restricted and repetitive behaviours will decrease over time. Skills in social communication and self-regulation may be better in improvisational music therapy than in the standard care condtion, and these behavioural changes may be reflected in overall neurological changes examined through child neuroimaging and neuropsychology.

Ethics approval

Approved 26/07/2018, Seoul National University College of Medicine Institutional review board (Seoul National University Hospital, Jongro-gu, Yengun-dong 128, Seoul, 03080; 82-2-2072-0694; snuhirb@gmail.com), ref: 1805-045-945

Study design

Interventional design using propensity score matching method (non-randomized), single-blinded (assessor blinded) multicenter study.

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet (available only in Korean)

Condition

Autism Spectrum Disorder

Intervention

Music Therapy

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Severity of autism measured using the Autism Diagnostic Observation Schedule (ADOS) and Childhood Autism Rating Scale-2 (CARS 2) at baseline, 6 months, post-intervention (12months).

Secondary outcome measures

Collected at baseline, in-between (6 month later/ approx. 24th session), and post (12 month later, 48th session):
Child questionnaires:
1. Social Responsiveness Scale (SRS)
2. Aberrant Behavior Checklist (ABC)
3. The Social Communication Questionnaire (SCQ)
4. Social Maturity Scale (SMS)
5. Child Behavior Checklist 1.5-5 (CBCL 1.5-5)
Parent’s questionnaires:
6. Beck Depression Inventory (BDI)
7. State-Trait Anxiety Inventory (STAI-T/S)
8. Maternal Behavior Research Instrument (MBRI)
9. Korean Parenting Stress Index (PSI)
10. Mental Health Continuum-Short Form (MHC-SF)
11. Carer-QoL-7D / Child QoL (VAS)
12. Concomitant Treatment form

Pre and Post tests (baseline and 12 months later):
13. Neuroimaging: aMRI/DTI/rsfMRI
14. Psychoeducational Profile-Revised (PEP-R)
15. Baseline test only: Blood and Urine for detecting DNA and harmful environmental exposure
16. Post-trial in-depth interview with the mothers and the therapist (thematic analysis; qualitative study)
17. Behavioral analysis through video recording of music therapy session for establishing treatment fidelity
18. Parents/ therapists interviews after the completion of the trial

Overall trial start date

01/11/2017

Overall trial end date

31/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged between 24 - 72 months
2. Autism Spectrum Disorder confirmed by DSM-V and ADOS

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

50, with N=25 in each arm.

Participant exclusion criteria

1. Hearing/visual impairement, congenital genetic disease (cerebral palsy)
2. Seizure and other neurological condition
3. Other psychiatric disorder such as ADHD, schizophrenia, depression, bi-polar
4. Previous and on-going experiences of music therapy
5. Medication such as risperidone, aripirazole, SSRI, etc.

Recruitment start date

15/09/2018

Recruitment end date

31/07/2019

Locations

Countries of recruitment

Korea, South

Trial participating centre

Seoul National University Hospital
Jongro-gu Yengun-dong 128
Seoul
03080
Korea, South

Trial participating centre

Sukmyung child development center
Kyungi-do Jeonjeonyup Hamilyedang 1 ro 30-9
Namyangju-si
12066
Korea, South

Trial participating centre

Hanvit Music Therapy Center
Kwangjin-g Kwangjang-dong 114 Kresco 610
Seoul
04969
Korea, South

Trial participating centre

Jiuem psycho-education center
Kawngjin-gu Jayangro 130
Seoul
05343
Korea, South

Trial participating centre

Susaek Child-Adolescent Counseling Center
Eunpyung-gu Susaek-dong 366-1
Seoul
03489
Korea, South

Trial participating centre

Creative Arts Therapy Department, Jeonju University
Jeonju Wansan-gu Hyojadong Cheonjam-ro 303
Jeonju
55069
Korea, South

Sponsor information

Organisation

Seoul National University Hospital, IRB

Sponsor details

Seoul National University Hospital
Jongro-gu
Yengun-dong 28
Seoul
03080
Korea
South
82-2-2072-4056
yaelim.snuh@gmail.com

Sponsor type

Research council

Website

http://www.snuh.org

Funders

Funder type

Research organisation

Funder name

National Research Foundation of Korea

Alternative name(s)

NRF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Korea, South

Results and Publications

Publication and dissemination plan

1. Publication of research findings in peer-reviewed journals
2. Presentation on research at conferences (international/domestic)
3. Local autism communities, parent workshops and educations, and possible media exposure

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

30/10/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/04/2019: Trial’s existence confirmed by IRB