Child Development Disorders, SpecificNCT03188016
Improvised Music to Enhance Intensive Interaction Version 1
A study testing Intensive Interaction with Music and Standard Intensive Interaction in people with Child Development Disorders, Specific and Developmental Communication Disorders, run by Beacon Hill Academy at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Child Development Disorders, Specific, Developmental Communication Disorders
- What is being tested?
- Intensive Interaction with Music and Standard Intensive Interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2017to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- the criteria the school normally applies, namely severely restricted capacity, and/or absent or limited motivation, for interpersonal interaction
Who cannot join
- any child who already receives Intensive Interaction or individual or small group music therapy or has done so in the previous school year.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Beacon Hill Academy
South Ockendon, Essex, RM15 5AY
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- Intensive Interaction with Music, Standard Intensive Interaction
- Keywords
- "music therapy", "Intensive Interaction", "non-verbal communication", "musical improvisation", "feasibility study", "randomised controlled trial"
- Medical subject headings
- Developmental Disabilities, Communication Disorders, Nonverbal Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Interaction with MusicBehavioural
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.
Standard Intensive InteractionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Interaction with music | Experimental | 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 Receives: Behavioral: Intensive Interaction with Music |
| Standard Intensive Interaction | Active comparator | Weekly Intensive Interaction (Nind \& Hewett) from a trained support worker Receives: Behavioral: Standard Intensive Interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks between baseline measurement and outcome measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start23 Oct 2017 (estimated)
- Primary completion2 Mar 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Why it stopped: Unfavourable ethical opinion, principally on grounds of inadequate sample size
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child Development Disorders, SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Homogenous group randomly split into experimental and control groups to receive same number and duration of treatments
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beacon Hill Academy
- Sponsor type
- University, hospital or other
- Collaborators
- The Music Therapy Charity Ltd, Anglia Ruskin University
- Responsible party
- Principal investigator, Dr John B A Strange, Beacon Hill Academy
- Investigators
- John BA Strange, PhD, Principal investigator, Voluntary research contract to Beacon Hill Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188016
- Sponsor's protocol ID
- JBASMT2
- Other IDs
- BHR/MT/SLT-1
- Status last verified
- May 2018
- First submitted
- 10 Jun 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
http://davehewett.com/about-intensive-interaction
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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03188016
- Acronym / sponsor ID
- JBASMT2
- Keywords
- "music therapy", "Intensive Interaction", "non-verbal communication", "musical improvisation", "feasibility study", "randomised controlled trial"
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unfavourable ethical opinion, principally on grounds of inadequate sample size
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beacon Hill AcademyUniversity, hospital or other
- Collaborators
- The Music Therapy Charity Ltd, Anglia Ruskin University
- Study start
- 23 Oct 2017 (estimated)
- Primary completion
- 2 Mar 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Homogenous group randomly split into experimental and control groups to receive same number and duration of treatments
| Arm | Type | Receives |
|---|---|---|
| Intensive Interaction with music | Experimental | Behavioral: Intensive Interaction with MusicWeekly 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 |
| Standard Intensive Interaction | Active comparator | Behavioral: Standard Intensive InteractionWeekly Intensive Interaction (Nind \& Hewett) from a trained support worker |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- the criteria the school normally applies, namely severely restricted capacity, and/or absent or limited motivation, for interpersonal interaction
Key exclusion criteria (1 listed)
- any child who already receives Intensive Interaction or individual or small group music therapy or has done so in the previous school year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Interaction with MusicIntensive 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. | Behavioural | Intensive Interaction with music |
| Standard Intensive InteractionIntensive 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. | Behavioural | Standard Intensive Interaction |
Primary outcome
Pre-Verbal Communication Schedule
Time frame: 16 weeks between baseline measurement and outcome measurement
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Backgroundhttp://davehewett.com/about-intensive-interaction
- BackgroundStrange, 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.
- BackgroundStrange, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John BA Strange, PhD principal investigator
Voluntary research contract to Beacon Hill Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Interaction with Music and Standard Intensive Interaction in people with Child Development Disorders, Specific and Developmental Communication Disorders, run by Beacon Hill Academy at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-Verbal Communication Schedule (time frame: 16 weeks between baseline measurement and outcome measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188016, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.