Clinical trial NCT03188016: Improvised Music to Enhance Intensive Interaction Version 1
Official title: Feasibility Study: Improvised Music to Enhance the Effectiveness of Intensive Interaction in Developing Interpersonal Communication of Profoundly Intellectually Disabled Children and Young People
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Child Development Disorders, Specific
Developmental Communication Disorders
Keywords: "music therapy"
"Intensive Interaction"
"non-verbal communication"
"musical improvisation"
"feasibility study"
"randomised controlled trial"
Lead sponsor: Beacon Hill Academy
Sponsor class: OTHER
Collaborators: name: The Music Therapy Charity Ltd
name: Anglia Ruskin University
First posted: 2017-06-15
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Homogenous group randomly split into experimental and control groups to receive same number and duration of treatments
Primary purpose: TREATMENT

Brief summary: The project will investigate the effectiveness of a specialised musical-clinical approach used as an adjunct to an established non-musical intervention in the enhancement of interpersonal interaction.

6 school pupils with profound disability will be randomly allocated to experimental and control groups. The control group will receive only Intensive Interaction for 16 sessions. The experimental group will receive four sessions of Intensive Interaction, followed by twelve sessions of Intensive Interaction plus improvised music. Music therapists will follow a flexible manual written to ensure that their music supports the interaction between pupil and learning support assistant (LSA) without direct social interaction with either.

Changes in capacity for interpersonal interaction will be assessed by a standardised assessment instrument, the Pre-Verbal Communication Schedule (PVCS), administered to both experimental and control groups before the 1st session and after the 16th session.

There will also be a qualitative process study of the experimental group conducted by video observation by the researchers involved.

The project is funded in equal shares by the Music Therapy Charity and Beacon Hill Academy.

Detailed description: This is a small feasibility study to be conducted at a single research site, a special school for sensory and physical needs. The study is intended both to trial the research methodology and to estimate the effect size likely to be found if a larger study were carried out.

Intensive Interaction is a form of behavioural intervention developed by Nind and Hewett and extensively practised in schools and other institutions caring for people with profound intellectual disability who require special support in order to develop (non-verbal) interpersonal communication. Whilst the term Intensive Interaction can describe the attitude and behavioural style of staff throughout their contact with subjects, it can also, as in this study, refer to specific scheduled times in which the approach is adopted by staff with individual pupils or service users.

The subjects of this study are among those for whom Intensive Interaction is most beneficial, as assessed by the speech and language therapist at the research site. As these pupils would normally receive this intervention on account of their assessed needs, Intensive Interaction is designated the 'active comparator' (otherwise known as 'treatment as usual').

Since in the experimental condition two staff support each subject simultaneously, there is a need to distinguish effects attributable to the additional music from those attributable to the behaviour of the primary interactors. By treating Intensive Interaction as the active comparator it is hoped any effects of added music may be isolated.

Improvised music is in this study being trialed as an adjunctive therapy to Intensive Interaction. Previous research suggests that music improvised music therapist can under certain conditions facilitate the development of interpersonal interaction between subject and support worker. To replicate the conditions under which the previous study found this to be the case, the musical intervention has been manualised to guide the 2 music therapists who will provide the improvised supportive music. They will add music from session 5 of a total of 16, having observed the progress of Intensive Interaction without music during the first 4 sessions in order to make a detailed assessment of needs and how music might meet them.

A standardised assessment instrument, the Pre-Verbal Communication Schedule (PVCS), will be administered before each subject's first session of Intensive Interaction, and again after her/his 16th session to obtain a global view of non-verbal communicative behaviour. Pre- and post-test scores will be compared. The theoretical basis of both Intensive Interaction and the specific use of adjunctive improvised music is primarily affective, but it is important that any benefits should also be detectable in functional terms, hence the choice of PVCS rather than a more affectively orientated measure.

Additionally, qualitative data on the therapeutic process will be extracted from post-session notes and observations of video recordings of the sessions by those involved in the work with each participant.

Should the effectiveness of the specialised musical-clinical approach be supported by the results, a larger study could then establish the approach as an additional psycho-social resource for developing the interpersonal interaction skills of those with profound intellectual disability. The approach requires a modest level of additional training for a registered music therapist, but no additional qualification.

Eligibility criteria: Inclusion Criteria:

* the criteria the school normally applies, namely severely restricted capacity, and/or absent or limited motivation, for interpersonal interaction

Exclusion Criteria:

* any child who already receives Intensive Interaction or individual or small group music therapy or has done so in the previous school year.

Primary outcomes:
measure: Pre-Verbal Communication Schedule
timeFrame: 16 weeks between baseline measurement and outcome measurement
Secondary outcomes:
Other outcomes:
Locations:
city: South Ockendon
country: United Kingdom
facility: Beacon Hill Academy
state: Essex
Study officials:
affiliation: Voluntary research contract to Beacon Hill Academy
name: John BA Strange, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: http://davehewett.com/about-intensive-interaction
citation: Strange, J. (2017a) 'Assistants as Interaction Partners: The Experience of Learning Support Assistants in Group Music Therapy.' ' In J. Strange, H. Odell-Miller and E. Richards (eds) Collaboration and Assistance in Music Therapy Practice: Roles, Relationships, Challenges (pp. 22-35). London: Jessica Kingsley Publishers.
citation: Strange, J. (2017b) 'Improvised music to support client-assistant interaction: The perceptions of music therapists.' In J. Strange, H. Odell-Miller and E. Richards (eds) Collaboration and Assistance in Music Therapy Practice: Roles, Relationships, Challenges (pp. 235-252). London:Jessica Kingsley Publishers.