Condition category
Mental and Behavioural Disorders
Date applied
18/10/2010
Date assigned
25/10/2010
Last edited
31/10/2016
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 Sam Porter

ORCID ID

Contact details

School of Nursing and Midwifery
Queen's University Belfast
10 Malone Road
Belfast
BT9 5BN
United Kingdom
+44 (0)2890 976 550
s.porter@qub.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 4, 6th October 2010

Study information

Scientific title

A randomised controlled trial measuring the effects of music therapy on the communicative skills of children and adolescents with behavioural and emotional problems and/or pervasive developmental disorders

Acronym

MiM

Study hypothesis

The null hypothesis for this research is that music therapy in addition to standard care will not lead to an improvement in communicative and interactional skills compared to standard care alone, as measured one week after completion of the music therapy course.

Ethics approval

The Office for Research Ethics Committees Northern Ireland (ORECNI) HSC REC1, 14/10/2010, ref: 10/NIR01/52

Study design

Multicentre single-blind randomised 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 the contact details to request a patient information sheet

Condition

Social, emotional or behavioural difficulties in paediatrics

Intervention

Participants will be randomly assigned to two groups. The interventions will be provided and monitored for 12 weeks.

1. Control group:
Clients assigned to the control group will receive standard care only, which will consist of psychiatric counselling and/or medication. The dose and frequency of standard care will be as deemed appropriate by the CAMHS professional in charge of their treatment.

2. Experimental group:
In addition to the standard care described above, clients assigned to the experimental group will receive psychodynamic improvisational music therapy in an individual setting. Music therapy will be conducted for 30 minutes once a week. A total of 12 sessions will be offered, with the aim of completing at least 10 sessions. In line with the intention-to-treat principle, clients who attend fewer sessions will not be excluded from data analysis.

The model of music therapy delivered will be the Alvin model of 'Free Improvisation' (Bruscia 1987). This is the model that is currently adopted by the Northern Ireland Music Therapy Trust in its work with young people with mental health difficulties. The music therapist(s) involved have been professionally trained in its use.

As with the control group, the dose and frequency of standard care will be as deemed appropriate by the CAMHS professional in charge of their treatment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The effect of music therapy upon communicative and interactional skills one week after completion of the music therapy course (parental and self report)

Secondary outcome measures

1. The effect of music therapy upon communicative and interactional skills 13 weeks after completion of the music therapy course (parental and self report)
2. The effect of music therapy upon self esteem one week and 13 weeks after completion of the music therapy course (self report)
3. The effect of music therapy upon social functioning one week and 13 weeks after completion of the music therapy course (parental report)
4. The effect of music therapy upon depression one week and 13 weeks after completion of the music therapy course (self report)
5. The effect of music therapy upon family functioning one week and 13 weeks after completion of the music therapy course (parental report)
6. The cost-effectiveness of music therapy

Overall trial start date

01/08/2010

Overall trial end date

28/02/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Young people aged between 8 and 16 years old, either sex
2. Working diagnosis within the ambit of the International Classification of Diseases, version 10 (ICD-10) of Mental and Behavioural Disorders (F00 - F99) as assessed within the Trust and/or by the Child and Adolescent Mental Health Services (CAMHS) professional in charge of their care. This includes disorders falling within the following classifications:
2.1. Mood (affective) disorders (F30 - F39), e.g., depression
2.2. Neurotic, stress related and somatoform disorders (F40 - 48), e.g., anxiety disorders, obsessive compulsive disorder and posttraumatic stress disorder
2.3. Disorders of psychological development (F80 - F89), e.g., pervasive developmental disorder (autism spectrum disorders)
2.4. Behavioural and emotional disorders with onset usually occurring in childhood and adolescence (F90 - 98), e.g., hyperkinetic disorders and conduct disorders
3. Recruited from the CAMH Service of the Belfast Health and Social Care Trust, Northern Ireland
4. Musical skills are not required. Prior musical skills will not lead to exclusion from the study.
5. The young person and their parent/guardian (who will also be asked to participate in the research) must freely consent to participation following receipt of information about the trial

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Chronic and severe substance abuse: problems related to addiction lie outside the aims of this study. Moreover, substance abuse is likely to compromise concentration during sessions, and commitment to completing the therapeutic regime.
2. Psychosis: a secondary diagnosis of psychosis would presume a requirement for care additional to standard care
3. Repeated suicidal behaviour: a history of suicidal behaviour would presume a requirement for care additional to standard care
4. Incapacity to complete self-administered questionnaires with assistance from researcher: patients who, due to a learning disability as identified in a statement of educational needs, or who are unable to adequately understand written or verbal English, are deemed incapable of completing the self-reporting tests will not be included in the study
5. Receiving any other treatments or therapies outside of standard care which may interfere with Music in Mind. Patients who are in receipt of another creative therapy.
6. Inability to attend music therapy sessions at a Tier 3 facility: if circumstances of the client or parent/guardian are such that they will be unable to attend for trial visits or music therapy sessions (if randomised to treatment group) they will be excluded from the trial
7. Previously involved in Music in Mind. Young people who have previously been randomised for participation in Music in Mind are not eligible to be recruited at a later stage.
8. Non-consent: participants who decide not to consent, or whose parents/guardians decide not to consent will be excluded from the trial. These will be assured that this decision will have no implications for the care that they receive. The provision of music therapy in addition to standard care will be available to them if a clinical decision is made that this is appropriate.

Recruitment start date

01/08/2010

Recruitment end date

28/02/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen's University Belfast
Belfast
BT9 5BN
United Kingdom

Sponsor information

Organisation

Queen's University Belfast (UK)

Sponsor details

Research Office
Room 01.085 (103N) Lanyon Building
Block 1 Main Site
Belfast
BT7 1NN
United Kingdom
+44 (0)2890 972 594
m.lunny@qub.ac.uk

Sponsor type

University/education

Website

http://www.qub.ac.uk/

Funders

Funder type

Charity

Funder name

Big Lottery Fund (ref: C984A1530)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22235808
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27786359

Publication citations

  1. Results

    Porter S, Holmes V, McLaughlin K, Lynn F, Cardwell C, Braiden HJ, Doran J, Rogan S, Music in mind, a randomized controlled trial of music therapy for young people with behavioural and emotional problems: study protocol., J Adv Nurs, 2012, 68, 10, 2349-2358, doi: 10.1111/j.1365-2648.2011.05936.x.

Additional files

Editorial Notes

RP 31/10/2016: Publication reference added.