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RESEARCH PROTOCOL
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.
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
Music in mind
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
2351
S. Porter et al.
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
Exclusion criteria
2352
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.
Associated outcome
measure
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S. Porter et al.
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
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
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.
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
2012 Blackwell Publishing Ltd
Music in mind
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.
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.
References
Achenbach T.M. & Rescorla L.A. (2001) Manual for the ASEBA
School-Age Forms & Profiles. University of Vermont, Research
Center for Children, Youth, & Families, Burlington, VT.
Ball C.M. (2004) Music therapy for children with autistic spectrum
disorder. STEER 4(1), 111. Retrieved from http://scholar.
googleusercontent.com/scholar?q=cache:z1r6at_7cDYJ:scholar.google.
com/ on 5 January 2012.
Brownell M.D. (2002) Musically adapted social stories to modify
behaviors in students with autism: four case studies. Journal of
Music Therapy 34, 117144.
Bruscia K.E. (1987) Improvisational Models of Music Therapy.
Charles C Thomas Publications, Springfield.
Music in mind
Buday E.M. (1995) The effects of signed and spoken words taught
with music on sign and speech imitation by children with autism.
Journal of Music Therapy 32, 189202.
Cohen J. (1988) Statistical Power Analysis for the Behavioral Sciences, 2nd edn. Lawrence Erlbaum, Hillsdale, NJ.
Edgerton C.L. (1994) The effect of improvisational music therapy on
the communicative behaviors of autistic children. Journal of Music
Therapy 31, 3162.
Epstein N.B., Baldwin L.M. & Bishop D.S. (1983) The McMaster
Family Assessment Device. Journal of Marital and Family Therapy
9, 171180.
EuroQol Group (1990) EuroQol: a facility for the measurement of
health-related quality of life. Health Policy 16, 199208.
Farmer K.J. (2003) The Effect of Music vs. Nonmusic Paired with
Gestures on Spontaneous Verbal and Nonverbal Communication
Skills of Children With Autism Between the Ages 1-5 (Masters
Thesis). Florida State University (School of Music), Tallahassee, FL.
Gagner-Tjellesen D., Yurkovich E.E. & Gragert M. (2001) Use of
music therapy and other ITNIs in acute care. Journal of Psychosocial Nursing and Mental Health Services 39(10), 2637.
Gold C., Voracek M. & Wigram T. (2004) Effects of music therapy
for children and adolescents with psychopathology: a meta-analysis. Journal of Child Psychology and Psychiatry 45(6), 1054
1063.
Gold C., Wigram T. & Elefant C. (2006) Music therapy for autistic
spectrum disorder. Cochrane Database of Systematic Reviews.
Issue 2, Art. No.: CD004381, doi: 10.1002/14651858.CD004381.
pub2.
Gold C., Wigram T. & Voracek M. (2007) Effectiveness of music
therapy for children and adolescents with psychopathology: a quasiexperimental study. Psychotherapy Research 17(3), 289296.
Gresham F.M. & Elliott S.N. (2008) Social Skills Improvement
System. NCS Pearson Inc, Minneapolis, MN.
Higgins J.P.T. & Green S. (2008) Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [Updated September
2008]. The Cochrane Collaboration. Retrieved from http://
www.cochrane-handbook.org.
Lee Y.Y., Chan M.F. & Mok E. (2010) Effectiveness of music
intervention on the quality of life of older people. Journal of
Advanced Nursing 66(12), 26772687.
Rosenberg M. (1965) Society and the Adolescent Self-Image.
Princeton University Press, Princeton, NJ.
Silverman M.J. (2007) Evaluating current trends in psychiatric music
therapy: a descriptive analysis. Journal of Music Therapy 44(4),
388414.
Vickers A.J. & Altman D.G. (2001) Analysing controlled trials with
baseline and follow up measurements. British Medical Journal 323,
11231124.
Weissman M.M., Orvaschel H. & Padian N. (1980) Childrens
symptom and social functioning self report scales: comparison of
mothers and childrens reports. Journal of Nervous Mental
Disorders 168(12), 736740.
Whipple J. (2004) Music in intervention for children and adolescents
with autism: a meta-analysis. Journal of Music Therapy 41(2),
90106.
2357
S. Porter et al.
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