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Various communication interventions are routinely used but their clinical and cost-effectiveness are unclear. Intensive Interaction (II) is one intervention that focuses on early interaction abilities. II can be delivered by staff in educational settings and\/or at home. Despite many settings already implementing II, staff are sometimes untrained or have not received up to date training, potentially leading to inconsistencies in how the technique is applied and the quality of the interactions. We will provide structured training in II to educational setting staff and parents\/carers with coordinated activities developed jointly for each child\/young person to be delivered within the educational setting and at home. This study aims to establish whether Intensive Interaction delivered within educational settings improves communication skills of children and young people with PMLD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A multi-site pragmatic cluster randomised controlled trial comparing usual care with Intensive Interaction and usual care. Clusters will be educational settings. This study will recruit 330 participants (aged 3\u201325\u00a0years) with PMLD from 66 educational settings within Great Britain. Each participant will have a corresponding teacher, parent\/carer, and interventionist. Potential participants will be screened by their educational setting for eligibility prior to giving informed consent. Data will be collected at baseline, 32\u00a0weeks, and 52\u00a0weeks post-randomisation and will assess health and educational outcomes including participants\u2019 communication skills, behaviour, wellbeing, and quality of life. The primary outcome is communication skills, measured by the Communication Complexity Scale (CCS) at 32\u00a0weeks post-randomisation. Setting staff will video record an interaction with each participating child\/young person. Communication will be coded by members of the research team blinded to allocation using the CCS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This study addresses a much used but currently under-researched intervention and results will inform the support provided to children and young people with PMLD in their educational settings and at home.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      The trial was prospectively registered on the ISRCTN registry on 3rd May 2023 (registration number: ISRCTN81099965,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/www.isrctn.com\/ISRCTN81099965\" ext-link-type=\"uri\">https:\/\/www.isrctn.com\/ISRCTN81099965<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-026-09669-5","type":"journal-article","created":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T23:14:50Z","timestamp":1775776490000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Intensive Interaction for children and young people with profound and multiple learning disabilities (INTERACT): study protocol for a cluster randomised controlled trial, economic evaluation and process evaluation"],"prefix":"10.1186","volume":"27","author":[{"given":"Kerry J.","family":"Bell","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jill","family":"Bradshaw","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Judy","family":"Clegg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katie","family":"Whiteside","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kalpita","family":"Baird","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charlie","family":"Peck","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arabella","family":"Scantlebury","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Han-I.","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joy","family":"Adamson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amanda","family":"Allard","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane E.","family":"Blackwell","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katie","family":"Carlisle","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Imogen","family":"Fountain","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nick","family":"Gore","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fliss","family":"Kyffin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer","family":"Miller","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adenike","family":"Okanlawon","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lindsay","family":"Pennington","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lyn","family":"Robinson-Smith","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Ronaldson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emma","family":"Standley","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joanne","family":"Sweeney","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lucy","family":"Ziegler","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine","family":"Hewitt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2026,4,10]]},"reference":[{"key":"9669_CR1","unstructured":"Public Health England. 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This covered the recruitment of educational settings providing settings to children and young people under the age of 16. The full ethical approval submission was sent to the Health Sciences Research Governance Committee, University of York, and the submission was acknowledged and logged by the committee Chair on 23rd May 2023, as per committee procedures for externally reviewed research. NHS REC approval was awarded by London - Camden & Kings Cross Research Ethics Committee (Ref: 24\/LO\/0415, date: 24th June 2024) and Scotland A REC (Ref: 24\/SS\/0059, date: 30th July 2024) to enable us to recruit participants aged 16\u201325\u00a0years who lack capacity to consent for themselves in England, Wales and Scotland. REC approval superseded university-level ethical approval and became the primary research governance for the trial for its duration. Written, informed consent to participate will be obtained on behalf of all participating children and young people from a parent or carer; for children aged 16\u00a0years or over, this will be in the capacity of a consultee. For looked-after children, additional consent from the local authority will be obtained where a care order is in place.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {30}"}},{"value":"Not applicable; we have not included any details, images or videos relating to an individual person.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"CH is Chair of the NIHR HTA General Committee (2023\u2013). All other authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {7b}"}}],"article-number":"371"}}