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Improvised Music to Enhance Intensive Interaction Version 1

Primary Purpose

Child Development Disorders, Specific, Developmental Communication Disorders

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intensive Interaction with Music
Standard Intensive Interaction
Sponsored by
Beacon Hill Academy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Development Disorders, Specific focused on measuring "music therapy", "Intensive Interaction", "non-verbal communication", "musical improvisation", "feasibility study", "randomised controlled trial"

Eligibility Criteria

3 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beacon Hill Academy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive Interaction with music

Standard Intensive Interaction

Arm Description

Weekly Intensive Interaction (Nind & Hewett) from a trained support worker plus music improvised by a music therapist with the aim of enhancing child - support worker interaction

Weekly Intensive Interaction (Nind & Hewett) from a trained support worker

Outcomes

Primary Outcome Measures

Pre-Verbal Communication Schedule
A multi-element questionnaire administered face to face by a trained administrator to those most familiar with the subject (normally the parents/carers) to obtain a profile of communicative capacity and its application in all domains and an overall score. In this study those completing the questionnaire will be those staff most familiar with each participant (excluding those administering the experimental or control intervention.

Secondary Outcome Measures

Full Information

First Posted
June 10, 2017
Last Updated
May 1, 2018
Sponsor
Beacon Hill Academy
Collaborators
The Music Therapy Charity Ltd, Anglia Ruskin University
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1. Study Identification

Unique Protocol Identification Number
NCT03188016
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Unfavourable ethical opinion, principally on grounds of inadequate sample size
Study Start Date
October 23, 2017 (Anticipated)
Primary Completion Date
March 2, 2018 (Anticipated)
Study Completion Date
June 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beacon Hill Academy
Collaborators
The Music Therapy Charity Ltd, Anglia Ruskin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Development Disorders, Specific, Developmental Communication Disorders
Keywords
"music therapy", "Intensive Interaction", "non-verbal communication", "musical improvisation", "feasibility study", "randomised controlled trial"

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Homogenous group randomly split into experimental and control groups to receive same number and duration of treatments
Masking
ParticipantOutcomes Assessor
Masking Description
Participants are effectively masked since their parents/carers giving consent on their behalf will be masked regarding which arm their children are assigned to. (Participants themselves lack intellectual capacity to understand or consent to study participation)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive Interaction with music
Arm Type
Experimental
Arm Description
Weekly Intensive Interaction (Nind & Hewett) from a trained support worker plus music improvised by a music therapist with the aim of enhancing child - support worker interaction
Arm Title
Standard Intensive Interaction
Arm Type
Active Comparator
Arm Description
Weekly Intensive Interaction (Nind & Hewett) from a trained support worker
Intervention Type
Behavioral
Intervention Name(s)
Intensive Interaction with Music
Intervention Description
Intensive Interaction is a form of non-verbal communicative behaviour performed by a support worker to encourage and develop spontaneous communicative behaviour by the treatment subject, for which support workers are prepared by a speech and language therapist. The music in the intervention is live music improvised by a (UK) registered music therapist present in the room with treatment subject and support worker, who watches but does not participate socially in their interactions, and who develops musical input to encourage and enhance those interactions.
Intervention Type
Behavioral
Intervention Name(s)
Standard Intensive Interaction
Intervention Description
Intensive Interaction is a form of non-verbal communicative behaviour performed by a support worker to encourage and develop spontaneous communicative behaviour by the treatment subject, for which support workers are prepared by a speech and language therapist.
Primary Outcome Measure Information:
Title
Pre-Verbal Communication Schedule
Description
A multi-element questionnaire administered face to face by a trained administrator to those most familiar with the subject (normally the parents/carers) to obtain a profile of communicative capacity and its application in all domains and an overall score. In this study those completing the questionnaire will be those staff most familiar with each participant (excluding those administering the experimental or control intervention.
Time Frame
16 weeks between baseline measurement and outcome measurement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John BA Strange, PhD
Organizational Affiliation
Voluntary research contract to Beacon Hill Academy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beacon Hill Academy
City
South Ockendon
State/Province
Essex
ZIP/Postal Code
RM15 5AY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
http://davehewett.com/about-intensive-interaction
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background

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Improvised Music to Enhance Intensive Interaction Version 1

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