Improvisational music therapy for children with autism spectrum disorder assessed using brain imaging
| ISRCTN | ISRCTN18340173 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18340173 |
| Secondary identifying numbers | NRF- 2017S1A5A2A03068100 |
- Submission date
- 17/02/2019
- Registration date
- 04/04/2019
- Last edited
- 21/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Jeonju University
Dept. of Creative Arts Therapy
Cheonjamro 303
Wansan-gu
Jeonju
55069
Korea, South
| Phone | 82-63-2203021 |
|---|---|
| kim_jinah@hotmail.com |
Scientific
Seoul National University Hospital
Jongro-gu
Yengun-dong 128
Seoul
03080
Korea, South
| Phone | 82-10-3637-1558 |
|---|---|
| kbn1@snu.ac.kr |
Study information
| 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 |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet (available only in Korean) |
| Scientific title | Music therapy outcome study for children with Autism Spectrum Disorder through integration of child neuroimaging and neuropsychology: An exploratory study |
| Study acronym | MANE |
| Study objectives | 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 condition, and these behavioural changes may be reflected in overall neurological changes examined through child neuroimaging and neuropsychology. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | Autism Spectrum Disorder |
| Intervention | Music Therapy |
| Intervention type | Behavioural |
| 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 (12 months) |
| 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 study start date | 01/11/2017 |
| Completion date | 31/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 24 Months |
| Upper age limit | 72 Months |
| Sex | Both |
| Target number of participants | 50, with N=25 in each arm. |
| Key inclusion criteria | 1. Aged between 24 - 72 months 2. Autism Spectrum Disorder confirmed by DSM-V and ADOS |
| Key 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. |
| Date of first enrolment | 15/09/2018 |
| Date of final enrolment | 30/08/2019 |
Locations
Countries of recruitment
- Korea, South
Study participating centres
Yengun-dong 128
Seoul
03080
Korea, South
Jeonjeonyup
Hamilyedang 1 ro 30-9
Namyangju-si
12066
Korea, South
Kwangjang-dong 114
Kresco 610
Seoul
04969
Korea, South
Jayangro 130
Seoul
05343
Korea, South
Susaek-dong 366-1
Seoul
03489
Korea, South
Wansan-gu
Hyojadong
Cheonjam-ro 303
Jeonju
55069
Korea, South
Sponsor information
Research council
Seoul National University Hospital
Jongro-gu
Yengun-dong 28
Seoul
03080
Korea, South
| Phone | 82-2-2072-4056 |
|---|---|
| yaelim.snuh@gmail.com | |
| Website | http://www.snuh.org |
"ROR" |
https://ror.org/01z4nnt86 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- 한국연구재단이 창의적 연구와, National Research Foundation (South Korea), NRF
- Location
- Korea, South
Results and Publications
| Intention to publish date | 30/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
21/08/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/07/2019 to 30/08/2019.
2. The intention to publish date was changed from 30/10/2020 to 30/10/2021.
03/04/2019: Trial’s existence confirmed by IRB
