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JAN

JOURNAL OF ADVANCED NURSING

RESEARCH PROTOCOL

Music in mind, a randomized controlled trial of music therapy for


young people with behavioural and emotional problems: study protocol
Sam Porter, Valerie Holmes, Katrina McLaughlin, Fiona Lynn, Chris Cardwell, Hannah-Jane Braiden,
Jackie Doran & Sheelagh Rogan
Accepted for publication 17 December 2011

Correspondence to S. Porter:
e-mail: s.porter@qub.ac.uk
Sam Porter PhD RN
Professor
School of Nursing and Midwifery,
Queens University Belfast, UK
Valerie Holmes BSc PhD RN
Lecturer in Health Sciences
School of Nursing and Midwifery,
Queens University Belfast, UK
Katrina McLaughlin BSc PhD
Research Fellow
Institute of Childcare Research,
Queens University Belfast, UK
Fiona Lynn BSc PhD
Research Fellow
School of Nursing and Midwifery,
Queens University Belfast, UK
Chris Cardwell BSc PhD
Lecturer in Statistics
School of Medicine, Dentistry and
Biomedical Science,
Queens University Belfast, UK
Hannah-Jane Braiden BSc PhD
Educational Psychologist
Western Education and Library Board,
Omagh, UK
Jackie Doran BSc PhD
Research Fellow
School of Nursing and Midwifery,
Queens University Belfast, UK

PORTER S., HOLMES V., MCLAUGHLIN K., LYNN F., CARDWELL C., BRAIDEN
H . - J . , D O R A N J . & R O G A N S . ( 2 0 1 2 ) Music in mind, a randomized controlled
trial of music therapy for young people with behavioural and emotional problems:
study protocol. Journal of Advanced Nursing 68(10), 23492358. doi: 10.1111/
j.1365-2648.2011.05936.x

Abstract
Aims. This article is a report of a trial protocol to determine if improvizational music
therapy leads to clinically significant improvement in communication and interaction
skills for young people experiencing social, emotional or behavioural problems.
Background. Music therapy is often considered an effective intervention for young
people experiencing social, emotional or behavioural difficulties. However, this
assumption lacks empirical evidence.
Study design. Music in mind is a multi-centred single-blind randomized controlled trial
involving 200 young people (aged 816 years) and their parents. Eligible participants
will have a working diagnosis within the ambit of International Classification of Disease
10 Mental and Behavioural Disorders and will be recruited over 15 months from six
centres within the Child and Adolescent Mental Health Services of a large health and
social care trust in Northern Ireland. Participants will be randomly allocated in a 1:1
ratio to receive standard care alone or standard care plus 12 weekly music therapy
sessions delivered by the Northern Ireland Music Therapy Trust. Baseline data will be
collected from young people and their parents using standardized outcome measures for
communicative and interaction skills (primary endpoint), self-esteem, social functioning, depression and family functioning. Follow-up data will be collected 1 and 13 weeks
afterthefinalmusictherapysession.Acost-effectivenessanalysiswillalsobecarriedout.
Discussion. This study will be the largest trial to date examining the effect of music
therapy on young people experiencing social, emotional or behavioural difficulties and
will provide empirical evidence for the use of music therapy among this population.
Trial registration. This study is registered in the ISRCTN Register, ISRCTN96352204.
Ethical approval was gained in October 2010.
Keywords: child and adolescent mental health nursing, communication skills, music
therapy, randomized controlled trial

continued on page 2

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S. Porter et al.

Sheelagh Rogan MB ChB


Consultant Psychiatrist
Child and Adolescent Mental Health Team,
Belfast Health and Social Care Trust, UK

Introduction
Evidence about the efficacy of music therapy for children
and adolescents with social, emotional and behavioural
difficulties is not clear cut. First, the conclusions of reviews
of the evidence base are contradictory. Second, the
evidence base is weak, consisting mainly of small, methodologically problematic studies. These factors are related,
in that important evidence of efficacy only emerges from
meta-analytical aggregations of studies. A descriptive
review treating studies individually found them each too
small and methodologically weak to provide adequate
evidence. Although meta-analysis has identified statistically
significant evidence of the efficacy of music therapy, thus
far, there is no evidence for its effectiveness in clinical
settings. Only one study of clinical effectiveness has been
carried out to date.

mental and control group, there was no information concerning how many, if any, studies randomized allocation or
blinded assessors.
Ball (2004) adopted the Succinct and Timely Evaluated
Evidence Review (STEER) methodology, which involved a
pragmatic and descriptive (i.e. non-meta-analytic) review of
major sources of published literature. The review included all
randomized controlled trials and case series with at least 10
participants. Two randomized crossover trials (Buday 1995,
Brownell 2002) and one case series (Edgerton 1994) met the
inclusion criteria. Buday (1995) found that children (n = 10)
receiving music therapy spoke significantly more words and
imitated significantly more actions. Brownell (2002) found
that half the children (n = 2) had significantly fewer repetitions in their monitored behaviour over the course of music
therapy, whereas half did not. Edgerton (1994) found
statistically significant improvements in all children (n = 11)
as measured by the un-validated Communicative Responses/
Acts Score Sheet (CRASS).
Although all cited studies reported important improvements in children receiving music therapy, Ball concluded
that, because of methodological weaknesses in the studies,
they could not support a recommendation about the clinical
effectiveness of music therapy. He pointed to:
the poor quality of the evidence, in particular the biased selection of

Background
There have been several reviews investigating the evidence of
the efficacy of music therapy for young people who are
experiencing social, emotional or behavioural difficulties
relating to pervasive developmental disorders such as autistic
spectrum disorder. We are aware of one meta-analysis
(Whipple 2004), one evaluated evidence review (Ball
2004) and one Cochrane Collaboration Review (Gold et al.
2006). In relation to young people with diagnosed mental
health difficulties and psychopathology, we are aware of one
meta-analysis (Gold et al. 2004) and one subsequent quasiexperimental study (Gold et al. 2007).
Whipple (2004), in a meta-analysis of 12 dependent
variables from nine studies concluded that the use of music
in treatment of young people with autism has a relatively
high effect (99). However, despite claims that a nonsignificant homogeneity Q value indicated that the results
should be considered as homogenous, there was considerable
heterogeneity in the interventions and study designs included,
which compromised the capacity of the review to come to
strong methodological or clinical conclusions (Gold et al.
2006). A lack of information about the degree of rigour used
in inclusion criteria exacerbated this problem. For example,
although studies were required to include both an experi2350

the children, the small numbers involved, the contamination effect


of the crossover design of many of the studies, the uncertain relevance
of many of the outcome measures, and the short follow-up. (2004,
p. 9)

Gold et al.s (2006) Cochrane systematic review of the


literature on music therapy for autism spectrum disorder
selected all randomized controlled trials and controlled
clinical trials comparing music therapy or music therapy
plus standard care to placebo therapy, no therapy or standard
care. Their review differed from that of Balls (2004) in that it
included non-published material, excluded case series and
involved a meta-analysis of included studies. Following
assessment for relevance and quality, three small studies
(total n = 24) were included in the review. Two were the
randomized crossover trials included in Balls review (Buday
1995, Brownell 2002). In addition, Gold et al. (2006)
included an unpublished Masters thesis reporting on a
randomized parallel group trial (Farmer 2003). All three
trials compared music therapy to a placebo activity to
control for the non-specific effects of music therapy. The
duration of the trials was extremely short, varying between 1
and 4 weeks, with all being limited to five music therapy
sessions delivered over the period of a week. None included
follow-up assessments. The results of meta-analysis showed a
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medium, clinically significant, effect size (Cohen 1988) for


music therapy compared with placebo therapy on non-verbal
communication skills, and a small to medium effect size on
verbal communication. Previous measures of communication
in the evaluation of music therapy demonstrate low interrater
reliability and remain unpublished (Gold et al. 2006) or have
not been validated nor checked for reliability (Ball 2003).
Gold et al. (2006) identified several characteristics of the
reviewed studies that demonstrated strength of evidence
there was no performance bias or attrition bias and interrater
reliability was high. Moreover, because the placebo control
conditions contained potentially efficacious techniques, Gold
et al. (2006) observed that the results of the included studies
were likely to underestimate the effects of music therapy.
However, Gold et al. (2006) identified the same sort of
weaknesses as Ball (2004) limited information on randomization and allocation concealment, limited use of assessor
blindness, lack of standardized scales and small sample sizes
were all identified as factors limiting the strength of evidence.
The reviewers were able to state that music therapy may
have positive effects on communicative skills of children with
autistic spectrum disorder (2006, p. 9). However, they
observed that only short-term effects had been examined,
leaving the degree to which music therapy has enduring
effects unknown. Indeed, a basic assumption of crossover
studies is that effects of treatment will rapidly wash out.
Gold et al. (2004) conducted a meta-analysis on the effects
of music therapy on children and adolescents with psychopathology. Their analysis showed a highly statistically
significant, medium to large effect on clinically relevant
outcomes. These results allowed Gold et al. (2004) to state
that music therapy produces a clinically relevant effect of a
considerable size and is therefore recommended for clinical
use (1060). However, the inclusion criteria used for the
meta-analysis were not as rigorous as those recommended by
the Cochrane Collaboration (Higgins & Green 2008). Of the
11 studies included, one was randomized, one was quasirandomized and one had an unclear allocation procedure.
The rest had no control, were non-randomly allocated, or
involved both groups receiving music therapy. Moreover, the
studies were all small scale (largest n = 26) and solely
measured the efficacy of music therapy. Among Gold et al.s
(2004) recommendations were the need for larger-scale
studies to examine the effectiveness of music therapy in
clinical settings.
In response to their suggestion, the same authors (Gold
et al. 2007) have subsequently conducted a large prospective
quasi-experimental study of the effectiveness of music
therapy for young people with psychopathology in clinical
settings. Clients in the intervention group were offered one
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Music in mind

45-minute session per week for 25 weeks, after which


followed post-test assessment. Overall, the primary outcome
variables did not reveal an important interaction. Effectiveness was only confirmed for a minority of clients without
co-morbid conditions. In comparing this lack of significance
with the highly important effects identified in their previous
meta-analysis, Gold et al. (2007) suggest that there may be
a discrepancy between good efficacy, suggesting music
therapy is a powerful treatment option, and poor effectiveness, suggesting that in routine work it does not work as
well as it could (p. 293). They go on to suggest that this
may be due to the complex problems inherent in clinical
practice as compared to experimental studies. They identify
the need for large-scale pragmatic RCTs to measure effectiveness under routine clinical conditions. They also recommend, on the basis of anecdotal reports, clinically based
studies of a longer time period of music therapy than that of
their study. However, the rationale for this recommendation
is not clear, in that efficacy has been demonstrated to result
from much smaller dosages of music therapy that the 25
weekly sessions offered here. Given evidence of rapid
efficacy, it is difficult to understand how effectiveness would
be improved by extending the duration of treatment beyond
6 months.
The fundamental rationale for this study lies in the fact
that there is no unequivocal evidence about whether music
therapy can help young people with a range of social,
emotional or behavioural problems. From the literature we
can extrapolate a number of requirements for future
research: there is a need for large scale randomized
controlled trials; those trials should involve parallel groups,
should be methodologically rigorous and robust; should
use standardized and psychometrically sound outcome
measures; should focus on effectiveness in clinical settings
and should include longer term follow-up assessments. This
trial has been designed to meet all of the above requirements. It will be the largest randomized controlled trial to
date examining the effect of music therapy upon this
population.

The study
Aims
Music in mind has two key aims:
To examine if improvizational music therapy in addition to
standard care leads to a clinically significant improvement
in communicative and interactional skills (primary endpoint), social functioning, self-esteem, depression and
family functioning in young people with social, emotional
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or behavioural difficulties, compared to standard care


alone.
To assess the financial costs and benefits of music therapy.

Design/methodology
Trial design
Music in mind is a multi-centre (n = 6) single-blind randomized controlled trial with two parallel arms. The experimental arm will involve the administration of
improvizational music therapy in addition to standard care.
The control arm will involve the administration of standard
or usual care alone. To ensure a focus on practical effectiveness, the trial will be conducted under normal clinical
conditions, and will include a follow-up assessment 1 and
13 weeks after the completion of the music therapy intervention.
Participants
Participants will be 200 young people aged between
8-16 years old, with a working diagnosis of social, emotional
or behavioural difficulties and their parents. This is operationally defined as a working diagnosis within the ambit of
the International Classification of Disease 10 (ICD-10)
Mental and Behavioural Disorders (F00F99) as assessed by
the professional in charge of their care. Eligibility criteria are
outlined in Table 1.
Participants will be recruited from the Child and
Adolescent Mental Health Service (CAMHS) of a large
Health and Social Care Trust in Northern Ireland. Recruitment will take place from six community care (Tier 3)
facilities.

Intervention
Participants will be randomly assigned to one of two groups.
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. Standard care will
be recorded in the case report form as reported by the
participant and from the medical notes.
Experimental group. In addition to the standard care
described above, clients assigned to the experimental group
will receive psychodynamic improvizational music therapy in
an individual setting, delivered by the Northern Ireland
Music Therapy Trust. Music therapy will be conducted for
30 minutes once a week and will take place in a CAMHS
outpatient setting. 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 therapists involved in delivering the intervention have
been professionally trained in its use.
The Alvin model of music therapy is one of free improvization, whereby the therapist does not impose any structure
or rules upon the client. Rather, the client is encouraged to
explore music and sounds in their own way. The client can
create music and sound through their voice, an instrument or

Table 1 Music in mind eligibility criteria.


Inclusion criteria

Exclusion criteria

Aged between 8 and 16 years old


Must have a working diagnosis within the ambit of ICD-10 of
Mental and Behavioural Disorders (F00F99). This includes disorders
falling within the following classifications:
(a) Mood (affective) disorders (F30F39), for example, depression
(b) Neurotic, stress related and somatoform disorders (F4048), for
example, anxiety disorders, obsessive compulsive disorder and posttraumatic stress disorder
(c) Disorders of psychological development (F80F89), for example,
pervasive developmental disorder
(d) Behavioural and emotional disorders with onset usually occurring
in childhood and adolescence (F9098), for example, hyperkinetic
disorders and conduct disorders
The young person and their parent/guardian must freely consent to
participation following receipt of information about the trial

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Chronic and severe substance abuse


A diagnosis of psychosis
Repeated suicidal behaviour
Incapacity to complete self-administered questionnaires with
assistance from researcher
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
Inability to attend music therapy sessions at a Tier 3 facility
Previously involved in music in mind
Non-consent

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Music in mind

Outcomes
Primary outcome. Music in mind has two primary endpoints:
The effect of music therapy upon communicative and
interactional skills 1 week after completion of the music
therapy course (parental report).
The effect of music therapy upon communicative and
interactional skills 1 week after completion of the music
therapy course (self report).
Communicative and interactional skills will be measured
using the Social Skills Improvement System Rating Scales
(SSIS Rating scales; Gresham & Elliott 2008). This scale
provides a standardized, multi-rater and age sensitive assessment across two domains; communication/social interaction
with others and problem behaviours.

Economic evaluation. An economic evaluation will be conducted to determine which one of the two treatment options
(i.e. standard care alone or music therapy in addition to
standard care) will achieve desired outcomes of improvements in communicative skills, self-esteem and social functioning at the lowest costs. A societal perspective will be
adopted, with plans for a full economic evaluation in the
form of a cost-effectiveness analysis.
The primary and secondary outcome measures will be used
alongside a quality of life measure, EQ-5D, to determine the
effectiveness of music therapy. Information on resource use
(direct costs) and costs to research participants (indirect
costs) for the two treatment options will be gathered. A
retrospective method will be used to collect data on health
services resource use. Data on indirect costs will be collected
prospectively through the completion of cost diaries by the
parent/guardian of participants. For the cost-effectiveness
analysis two measures of cost effectiveness will be used.
Firstly, unit costs of improvement (if any) as measured by the
primary outcome measures will be determined for participants in each treatment option. Unit costs of improvement
for the primary outcome measure will be defined as the
difference between baseline and follow-up scores divided by
treatment costs, yielding an estimate of how many units of
improvement on the primary outcome measure will be
obtained per 100 of treatment costs. Secondly, to determine
the cost for each of the two treatment options to produce a
desirable outcome, the total costs of providing the specific
treatment option will be divided by the number of participants in that treatment condition who achieved a clinically
significant improvement in the primary outcome.

Secondary outcomes. Table 2 lists the secondary endpoints


and associated measurement tools. Secondary endpoints are
ranked according to priority.

Sample size justification


A sample size of 99 patients completing the trial in each
group will have an 80% power to detect a mean difference of

through movement. They may choose to do this individually


or alongside the therapist. In addition, the client may
spontaneously create music or may prefer to respond to the
direction of the therapist. This model of therapy can be
active, where the client makes music, and/or receptive where
the client is encouraged to listen to music. The therapist
scaffolds the session through providing appropriately timed
support and encouragement tailored to suit the assessed needs
of the client and to meet the overall therapeutic objectives.
The dose and frequency of standard care, for the
experimental group will be as deemed appropriate by the
CAMHS professional in charge of the young persons
treatment. Standard care will be recorded in the case report
form as reported by the participant and from the medical
notes.

Table 2 Secondary endpoints and associated measurement tools.


Secondary
endpoints

Associated outcome
measure

The effect of music therapy upon communicative and interactional


skills 13 weeks after completion of the music therapy course (parental
and self report)
The effect of music therapy upon self-esteem 1 and 13 weeks after
completion of the music therapy course (self report)
The effect of music therapy upon social functioning 1 and 13 weeks
after completion of the music therapy course (parental report)
The effect of music therapy upon depression 1 and 13 weeks after
completion of the music therapy course (self report)
The effect of music therapy upon family functioning 1 and 13 weeks
after completion of the music therapy course (parental report)
The cost effectiveness of music therapy

The SSIS will be used

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Rosenberg Self-Esteem Scale (Rosenberg 1965). Completed by young


person
Child Behaviour Checklist (Achenbach & Rescorla 2001). Completed
by parent
Centre for Epidemiological Studies Depression Scale for Children
(CES-DC; Weissman et al. 1980). Completed by young person
Family Assessment Device (Epstein et al. 1983). Completed by parent
EQ-5D (EuroQol Group, 1990). Cost diaries. Completed by parent

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S. Porter et al.

04 SD s in the two groups at the 5% significance level for the


primary outcome. The effect size used is Cohens d (Cohen
1988). Correspondence from the Assessment & Information
Pearson Support Centre (Krause, personal communication),
stated that using Cohens d the effect size needs to be at least
035 to show the treatment effect. Cohens d has been used
widely in this area and is recommended for use when no
better basis for estimating the ES index is available (Cohen
1988, p. 25). To allow for a dropout rate of 20%, 250
children and young people will be recruited to the study.

random variable block lengths of 2, 4, 6 and 8. Randomization will be carried out independently by the Northern
Ireland Clinical Research Support Centre (CRSC). The randomization list will be stored in a locked cabinet and access
will be restricted to the administering staff in CRSC. Due to
the nature of the trial the young people will know which
group (experimental/control) they have been allocated to.
This information will be provided directly (by the CRSC)
to the music therapist delivering the intervention. The
researcher will remain blind to the allocation and the young
people and their parents will be asked not to reveal their
group allocation to the researcher during follow-up data
collection study visits.

Recruitment of participants
Screening for eligibility will take place during routine outpatient appointments. In addition, CAMHS professionals will
periodically review their caseloads for eligible patients. The
professional in charge of their care refers the young person to
the project after consideration of the exclusion and inclusion
criteria as outlined in Table 1. This professional also provides a
detailed description of the study to the potential participants.
Participants and their parent/guardian will be provided
with age appropriate information sheets (aged 811, 1216
or adult), access to an information website and the opportunity to ask questions. Full written informed consent will be
obtained from the young person and from the parent/
guardian at the first study visit.

Treatment period
As shown in Figure 1, questionnaire data will be collected at
randomization (baseline), 1 and 13 weeks after the final
music therapy session, or an equivalent timeframe for those
assigned to the control group. Measurement instruments are
standardized with demonstrated validity, reliability and sensitivity to change. Questionnaires will be prioritized, that is,
the questionnaire relating to the primary endpoint will be
completed first, followed by those relating to secondary
outcomes. This will ensure that if a participant does not finish
the questionnaires, we have obtained priority data.

Randomization
The randomization list will be computer-generated, using
nQuery Advisor version 16.01 (Statistical Solutions, Cork,
Ireland), stratified by centre with a 1:1 allocation using with

Trial monitoring
An independently chaired Trial Steering Committee (TSC)
will be responsible for overall supervision of the trial including ratification of the protocol prior to the commencement of the

Young people aged 8 to 16 screened for eligibility by practitioner at routine out-patient appointment

Eligible young people and their parents provided with information leaflets

No consentrecorded but not

Once notification of interest slip is received researcher contacts family

followed up.

At study visit 1: written consent obtained. Demographic data and baseline questionnaires completed.
Cost diary explained.

Case report form faxed to northern ireland clinical research support centre. Randomisation occurs
and participants allocated anonymous ID. Researcher remains blind.
Treatment group receive standard care and 12
weeks of music therapy

Control group receive standard care alone

Study visit 2: Data collected and cost diary reviewed. Case report form completed.
Study visit 3: Data collected and cost diary reviewed. Case report and end of trial form completed.

Figure 1 Overview of music in Mind Study Procedure.


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trial. The TSC will meet at least six monthly to monitor


recruitment, study progress and any serious adverse events. In
addition to the authors, the TSC will be made up of a subcommittee consisting of the independent members including;
a patient representative (the parent of an eligible young person), an independent expert in music therapy, an independent
biostatistician and an independent expert on clinical trials. A
representative from the Northern Ireland Music Therapy
Trust and the trial statistician are also members of the TSC.
The independent members of the sub-committee will also
convene separately, and report any recommendations to the
full TSC, which will be implemented by the trial team as
necessary and appropriate.
Statistical analysis plan
Final analysis of the primary and secondary outcome measures will be carried out at study closure defined as the date of
database lock. The principle of intention to treat analysis will
be performed blind to treatment allocation. Data will be
analysed using SPSS (IBM Corporation, Armonk, NY, USA).
The change in the outcome variable from baseline to 1 week
(and 13 weeks) after delivery of the final music therapy session will be compared between the experimental and control
group using analysis of covariance (Vickers & Altman 2001).
To detect differences within groups repeated measures ANOVA s will be used.

Ethical considerations
Ethics and governance approvals
Ethical approval has been granted by the Office of Research
Ethics in Northern Ireland (ORECNI, Reference: 10/NIR01/
52). The study is sponsored and indemnified by the University
(Reference: B10/49) and co-sponsored by the Health and
Social Care Trust in which the research will take place
(10115SR-FC).
Ethical approval was gained in October 2010.
Obtaining informed consent
Full written informed consent will be obtained from the
young person and from the parent/guardian at the first study
visit before they can be registered on the study. As noted in
the eligibility criteria (Table 1), a dual method of consent is
required for participation, that is, both parent/carer and the
young person must give consent to participate following
receipt of age appropriate information about the trial.
Inherent in this is the idea that young people must have a
level of competency to consent. Referring practitioners will
be asked to assess this prior to referral. Special consideration
will be given to young people who may have difficulty with
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Music in mind

written information in that visual/pictorial information sheets


will be provided. All families will also be provided with a
detailed verbal explanation of the study.

Discussion
Mental illness and its associated social, emotional or
behavioural difficulties is one of the largest health problems
facing modern society. The costs of mental ill health,
economically, socially and in human costs are immense.
With this in mind there is an understanding of the need to
employ population based approaches to promote wellbeing
from a young age for all children. Simultaneously providing
timely, beneficial and cost effective interventions targeted at
young people who are already experiencing difficulties must
also be a priority.
Currently young people with mental health difficulties are
supported and treated by a range of services across both the
statutory and voluntary sectors, including the CAMHS. Such
services offer multi-disciplinary support and a variety of
interventions including psycho-pharmaceutical approaches
and a wide range of therapeutical and systemic approaches.
Each of these approaches has varying degrees of efficacy,
as evidenced by empirical literature. However, several
approaches lack this evidence and instead rely heavily on
professional judgement, experiential and anecdotal reports.
To give an effective and efficient service for children and
young people it is necessary to determine the benefits, both in
terms of human outcomes and economics, of these interventions. Music in mind is an opportunity to ascertain if music
therapy is beneficial in terms of the aforementioned outcomes. Providing high quality empirical evidence of its
effectiveness will help guide policy makers in determining
the appropriateness of investment in music therapy.
It is well known that young people are both challenging to
recruit and retain in trials. To encourage young people to
engage with the research, a number of incentives will be
offered. Firstly, a certificate to mark participation in the study
will be presented to all young people taking part on
completion of their questionnaires at each study visit. In
addition, they will be presented with a 15 multi-store gift
voucher on completion of the trial to maximize study
retention, particularly for those young people randomized
to the control group. Furthermore, monthly newsletters to the
healthcare professionals caring directly for the young people
eligible for this study will be circulated with the aim of
maximizing recruitment by keeping staff informed of recruitment targets, answering frequently asked questions and by
raising awareness of both music therapy and the rationale for
the continuing research.
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S. Porter et al.

What is already known about this topic


Given that mental illness and its associated social,
emotional or behavioural difficulties is one of the largest
health problems facing modern society, providing
timely, beneficial and cost effective interventions is a
key priority.
Evidence about the efficacy of music therapy for
children and adolescents with social, emotional and
behavioural difficulties is not clear-cut.
Although a meta-analysis of music therapy research
identified statistically significant evidence of the efficacy
of music therapy, thus far, there is no evidence for its
effectiveness in clinical settings. Only one study of
clinical effectiveness has been carried out to date.

What this paper adds


Although the existing research studies report important
benefits of music therapy, the evidence base is weak and
consists mainly of small methodologically problematic
studies, rendering accurate recommendations about
clinical efficacy impossible.
This randomized controlled trial, addresses
methodological weakness in previous research, through
providing a rigorous, large scale investigation into the
effects of music therapy for children and adolescents
who are experiencing mental health difficulties.

Implications for practice and/or policy


Currently young people with mental health difficulties
are supported and treated by a range of services across
both the statutory and voluntary sectors, including the
Child and Adolescent Mental Health Services.
To provide an effective and efficient service to children
and young people interventions used to treat mental
health difficulties in this population need to be
supported by empirical evidence.
It is necessary to determine the benefits, both in terms of
human outcomes and economics, of music therapy
before recommending it as a suitable intervention to be
used in the health service.

Music in mind is a pragmatic trial with a focus on


effectiveness within the clinical setting. The trial is designed
to compare music therapy in addition to standard or usual
care with standard or usual care alone in young people with
social, emotional or behavioural difficulties. Given the wide
2356

variations in the conditions of the young people eligible to


take part and the multiplicity of participating care centres,
standard care is likely to vary according to individual need
and professional practice. However, given the pragmatic
nature of the trial, designed to assess effectiveness in everyday
clinical conditions, these variations can be tolerated as they
are characteristic of the normal delivery of care. Variation in
individual standard care packages will be confined to the
parameters of clinicians definitions of standard care.
Potential participants that clinicians deem are receiving
treatments or therapies outside of standard care will be
excluded from the study. The possible effects of variation will
be compensated for by the randomization of a large number
of participants. In addition, the randomization process will
be stratified according to locus of care to take into account
variations between centres. Furthermore, we will record the
details of the care given to all participants to enable subgroup
analysis to explore the impact of music therapy in respect of
variations in standard care.
The intervention delivered in this trial is the Alvin model of
music therapy (Bruscia 1987), one of free improvization
owing to the idea that the therapist does not impose any
structure or rules upon the client. This model of music
therapy is that currently used by the Northern Ireland Music
Therapy Trust, delivered by music therapists to young people
in CAMHS. Music therapy is increasingly used as a therapeutic option in the mental health field with a recent report
by Silverman (2007) reporting that 21% of American music
therapists surveyed worked in mental health. Indeed, music
therapy is also used clinically as an independent therapeutic
nursing intervention, particularly in acute care settings
(Gagner-Tjellesen et al. 2001) and in care of the older people
(Lee et al. 2010). While the Alvin model of music therapy
requires a professionally trained music therapist for delivery,
it is important that all members of the multi-professional
team, including mental health nurses, are aware of all the
available therapeutic options, the rationale for their use and
the potential benefits for their patients. Thus, to enable
informed, evidence-based practice it is now paramount that
the use of music therapy, as a treatment option for young
people experiencing social, emotional or behavioural problems, is rigorously evaluated in this randomized clinical
control trial. The results of this trial will add to the limited
evidence base to inform practice internationally. Use of ICD10 definitions to define eligibility criteria will maximize the
generalizability of the findings to similar populations internationally.
Recruitment to Music in Mind commenced in January
2011 and will continue for a period of 15 months, with a
further 6 months for completion of follow-up. A further
 2012 Blackwell Publishing Ltd

JAN: RESEARCH PROTOCOL

6 months will be required to collate, clean and enter the data


and to carry out statistical analysis and economic modelling
and for preparation of reports for presentation and publication.

Acknowledgements
We acknowledge our grant co-applicants, the Northern
Ireland Music Therapy Trust, for provision of the music
therapy intervention, the administration of grant monies, and
the co-ordination of recruitment to ensure the blinding of the
research team. We also acknowledge the contribution of
members of the Independent Trial Steering Committee:
C. McDowell (Chair), A. Oldfield, R. Boyd, F. Davidson,
K. Diamond, J. Allen.

Funding
Music in Mind is funded by a grant from The Big Lottery
Fund (C984A1530).

Conflict of interest
No conflicts of interest have been declared by the authors.

Author contributions
SP, VH, FL, KMcL, CC, H-JB, JD and SR were responsible
for the study conception and design. They also approved the
final manuscript. SP, VH, FL, KMcL, CC and H-JB were
responsible for the drafting of the manuscript. JD and SR
made critical revisions to the article for important intellectual
content. CC provided statistical expertise. SP, VH, FL,
KMcL, CC and SR obtained funding.

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