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Clinical and cost-effectiveness of teen online problem-solving for adolescents who have survived an acquired brain injury in the UK: protocol for a randomised, controlled feasibility study (TOPS-UK)
  1. Jenny Limond1,
  2. Shari L. Wade2,
  3. Patricia Jane Vickery3,
  4. A Jeffery4,
  5. Fiona C Warren5,
  6. Annie Hawton1,
  7. Janet Smithson1,
  8. Tamsin Ford1,
  9. Sarah Haworth6,
  10. Anna-Lynne Ruth Adlam7
  1. 1 University of Exeter, Exeter, UK
  2. 2 Cincinnati Children’s Hospital Medical Center, Cincinnati, UK
  3. 3 Peninsula Clinical Trials Unit, Plymouth University, Plymouth, UK
  4. 4 Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, Devon, UK
  5. 5 University of Exeter Medical School, Institute of Health Research, Exeter, UK
  6. 6 Patient Representative, Exeter, UK
  7. 7 Psychology, University of Exeter, Exeter, UK
  1. Correspondence to Dr Jenny Limond; j.limond{at}exeter.ac.uk

Abstract

Introduction Paediatric acquired brain injury is a leading cause of mortality in children in the UK. Improved treatment during the acute phase has led to increased survival rates, although with life-long morbidity in terms of social and emotional functioning. This is the protocol for a feasibility randomised controlled trial with an embedded qualitative study and feasibility economic evaluation. If feasible, a later definitive trial will test the effectiveness and cost-effectiveness of an online intervention to enhance problem solving ability versus treatment as usual.

Methods and analysis Twenty-five adolescents and their families identified by primary or secondary care clinicians at participating UK National Health Service Trusts will be recruited and individually randomised in a 1:1 ratio to receive the online intervention or treatment as usual. Participants will be followed up by online questionnaires 17 weeks after randomisation to capture acceptability of the study and intervention and resource use data. Qualitative interviews will capture participants’ and clinicians’ experiences of the study.

Ethics and dissemination This study has been granted ethical approval by the South West-Exeter Research Ethics Committee (ref 17/SW/0083). Results will be disseminated via peer-reviewed publications and will inform the design of a larger trial.

Trial registration number ISRCTN10906069

  • Childand adolescent psychology
  • executive function
  • problem-solving
  • online
  • randomised controlled trialmalrotation
  • volvulus
  • asymptomatic
  • bilious
  • ladd’s

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Contributors All authors except AJ and SH were co-applicants on the NIHR RfPB grant application and as such were involved in the design of this feasibility study. All authors contributed to successive drafts of this paper. JL was the CI for the first year of the study and led on developing the intervention, finalising the protocol and drafting this manuscript. SW designed the study intervention and contributed to study design. JV contributed to the study design and oversaw trial management. AJ is the trial manager, responsible for the day-to-day running of the trial and contributed to drafts of this manuscript. FW is the trial statistician and provided expertise in the overall design of the trial. AH was responsible for the design and analysis of the economic evaluation component. JS was responsible for the design and analysis of the qualitative component. TF contributed to study design and provided advice and guidance on study delivery. SH contributed to trial management from a PPI perspective. AA was the lead grant applicant and took over as CI from JL for the second year of the study, providing clinical expertise and drafting and revising this manuscript.

  • Funding This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0614-34081). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. The funder has no role in study design or the collection, management, analysis or interpretation of data.

  • Competing interests None declared.

  • Ethics approval This study has been granted ethical approval by the South West-Exeter Research Ethics Committee (ref 17/SW/0083).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement After the end of the study, information collected may be made available as an anonymised participant level data set to other researchers under an appropriate data sharing agreement.

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