Condition category
Mental and Behavioural Disorders
Date applied
19/07/2010
Date assigned
01/11/2010
Last edited
01/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jinah Kim

ORCID ID

Contact details

Department of Arts Therapy
College of Alternative Medicine
Jeonju University
Hyojadong 3 ga
1200 Wansangu
Jeonju
560-759
Korea
South
+82 (0)63 220 3021
jinahkim@jj.ac.kr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KRF-2009-32A-B00203

Study information

Scientific title

Music therapy for abused children in poverty: A 2 stage, single centre, randomised controlled trial

Acronym

MTFACP

Study hypothesis

Music therapy will have positive effects on behavioural problems such as internalizing problems (depressed/axious, withdrawn), externalizing problems (delinquent/aggressive behaviours), attention problems of abused children in poverty. As results of music therapy interventions, such behaviours of these children will improve comapred to pre-test period with post-test period.

Ethics approval

The Human Research Ethics Board at Jeonju University approved on the 4th of February 2010 (ref: JJIRBAPR-2010-001)

Study design

Single centre randomised waitlist controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet [in Korean]

Condition

Child abuse/ neglect: physical, verbal, emotional, sexual abuse and neglect.
Absolute poverty: Below minimum wage threshold for family in Korea.

Intervention

1. Preliminary survey on 300 children from local child centres in Jeonlabukdo area, Korea to identify children at risk.
2. Pilot study: Individual music therapy for 4 children who are exposed to child abuse/neglect and poverty. Pre/Post test using standardized self-reporting scale (Child Behavior Checklist [CBCL], Youth Self Report [YSR], Self Esteem Scale [SES], etc) and behavioural observation through session DVD recordings.
3. Main intervention:
3.1. First part: Random assignment to Group music therapy (treatment) vs. waiting group (no treatment). Pre/post measurements (CBCL, YSR, SES, etc) and behavioural observation through DVD recordings. Random assignment of 20 % of music therapy group children to individual music therapy. This is to compare treatment, no treatment and treatment intensity.
3.2. Second part: Group music therapy for both experimental and waiting group. This is to compare effects of longer and shorter intervention. Social intervention (family therapy, parents and teacher education) is offered. This is to compare child intervention only with child intervention plus social intervention.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Subscales CBCL and YSR - depressed/anxious, withdrawn, delinquent, aggressive sub-scales.
2. Children's Depression Inventory (CDI)
3. Revised Children’s Manifest Anxiety Scale (RCMAS)
4. Self Esteem Scale (SES)
Outcomes measured pre- and post-intervention

Secondary outcome measures

1. DVD recordings of the session: both musical and non-musical target behaviours will be measured (in-between selected sessions)
2. In-depth post intervention interview with few participants

Overall trial start date

02/04/2010

Overall trial end date

30/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between seven to tweleve years old (primary school children's age in Korea)
2. The subject has experienced both childhood abuse/neglect (physical, emotional, verbal, sexual abuse and neglect) and absolute poverty (below minimum wage threshold for family)
3. The subject should be able to visit and attend once a week music therapy session for the trial period
4. The subject has no prior experience of music therapy
5. If the subject is on psychiatric medication, the medication should be stabilised prior to the trial and there should not be any change of medication

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Total 344 (survey - 300; pilot study - 4; main study - 40)

Participant exclusion criteria

1. If the subject has severe mental illnesses such as diagnostic co-morbidity
2. If the subject changes the medication during the trial
3. If the subject does not come to music therapy session without prior notice more than 4 times
4. If the subject has any psychological intervention (art, play, music therapy, or counselling) during the trial
5. If the subject has previous experience of music therapy, or has been in music therapy, art therapy, play therapy recently

Recruitment start date

02/04/2010

Recruitment end date

30/03/2012

Locations

Countries of recruitment

Korea, South

Trial participating centre

Department of Arts Therapy
Jeonju
560-759
Korea, South

Sponsor information

Organisation

National Research Foundation of Korea (NRF) (South Korea)

Sponsor details

Gajeongro 165
Yuseong-gu
Daejeon Metropolital City
Daejeon
305-350
Korea
South

Sponsor type

Research council

Website

http://www.nrf.go.kr

Funders

Funder type

Research council

Funder name

National Research Foundation of Korea (NRF) (South Korea) - Formerly Korean Research Foundation (ref: KRF-2009-32A-B00203)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes