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21/532 Intensive Interaction for children and young people with profound and multiple learning disabilities

Contents

Introduction

The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.

Research question

What is the clinical and cost-effectiveness of Intensive Interaction for improving communication in children and young people with profound and multiple learning disabilities?

  1.  Intervention: Intensive Interaction plus standard educational and speech and language practice in educational settings and at home. The intervention and its possible components including the role of primary caregivers and families, should be clearly described.
  2. Patient group: Children and young people with profound and multiple learning disabilities (PMLD). Exact inclusion criteria to be defined and justified by applicants. Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field
  3. Setting: Community
  4. Control: Standard educational and speech and language practice in educational settings and at home to be clearly described and defined by applicants.
  5. Study design: A randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment and adherence. Clear stop/go criteria should be provided to inform progression from pilot to full trial.     
  6. Important outcomes: Communication skills. Quality of life. Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise.
  7. Other outcomes: Social and emotional engagement; education outcomes; carer outcomes; service user/carer acceptability; challenging behaviour; self-harm; treatment fidelity; adverse effects; social care outcomes; cost-effectiveness.
  8. Minimum duration of follow-up: One year. Longer-term follow up: If appropriate, researchers should consider obtaining consent to allow potential future follow-up through efficient means (such as routine data) as part of a separately funded study.

Rationale

Children and young people with profound and multiple learning disabilities (PMLD) are also likely to have other complex health conditions, a need for high levels of support with most aspects of their everyday lives and great difficulty communicating. Though facing daily challenges, it is without doubt that children and young people with PMLD can lead meaningful and happy lives. Their ability to communicate their feelings, likes, dislikes, wishes and needs to caregivers is an essential part of achieving a good quality of life for them and their families.

Children and young people with PMLD communicate in ways such as facial expressions, vocal sounds and body language. To facilitate their communication, they must be supported by a well-trained communication partner who understands their means of communication and can identify and use effective ways to communicate with them. The inability to communicate successfully can result in children and young people with PMLD exhibiting behaviours such as stereotypy, screaming to express frustration or discomfort, self-injuring or withdrawing from interaction.

Core and Essential Service Standards for Supporting People with PMLD published in 2017, states that staff should be trained in appropriate total communication approaches to maximise expressive and receptive communication for children and young people with PMLD. Although there is a range of communication interventions in use, the evidence base for them is inadequate and there are uncertainties about their clinical and cost-effectiveness.

In 2014 the James Lind Alliance Childhood Disability Research Priority Setting Partnership identified uncertainties about the timing and intensity of speech and language therapy as one of its top priorities. Further work including an NIHR funded scoping study of current practice and perceived research needs, identified the need for speech and language therapies to be evaluated: Intensive Interaction was identified as the priority intervention for evaluation.

Intensive Interaction uses pre-verbal communication techniques to build a relationship between the person with PMLD and their communication partner. There are measures which are specifically designed for use with people with limited communication such as the Communication Complexity Scale.

Therefore, the HTA programme is now interested in commissioning research into the clinical and cost-effectiveness of Intensive Interaction in order to ensure that children and young people with PMLD receive a communication intervention that is based on a robust evidence base. Applicants should consider how to engage caregivers and families in the study and take into account throughout how the intervention will be rolled out.

Co-production, which ensures that the research demonstrates an equal partnership with service commissioners, providers and service users (or their advocates), should be embedded throughout the life cycle of the project from application to completion. Applicants may wish to consult the NIHR INVOLVE guidance on co-producing research.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page.  To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 1 December 2021. Applications will be considered by the HTA Funding Committee at its meeting in January 2022.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

Important: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2022.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition. For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared. 

Should you have any queries please contact us by email: htacommissioning@nihr.ac.uk