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)
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 r...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2019-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/8/e029349.full |
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| author | Patricia Jane Vickery Tamsin Ford Fiona C Warren Jenny Limond Shari L. Wade A Jeffery Annie Hawton Janet Smithson Sarah Haworth Anna-Lynne Ruth Adlam |
| author_facet | Patricia Jane Vickery Tamsin Ford Fiona C Warren Jenny Limond Shari L. Wade A Jeffery Annie Hawton Janet Smithson Sarah Haworth Anna-Lynne Ruth Adlam |
| author_sort | Patricia Jane Vickery |
| collection | DOAJ |
| description | 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 |
| format | Article |
| id | doaj-art-c13d66beff26464295ee73ddb5e1e0e7 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-c13d66beff26464295ee73ddb5e1e0e72025-08-20T02:27:50ZengBMJ Publishing GroupBMJ Open2044-60552019-08-019810.1136/bmjopen-2019-029349Clinical 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)Patricia Jane Vickery0Tamsin Ford1Fiona C Warren2Jenny Limond3Shari L. Wade4A Jeffery5Annie Hawton6Janet Smithson7Sarah Haworth8Anna-Lynne Ruth Adlam93 Peninsula Clinical Trials Unit, Plymouth University, Plymouth, UKprofessorPrimary Care Research Group, University of Exeter, Exeter, UKCollege of Life and Environmental Sciences, University of Exeter, Exeter, UK2 Cincinnati Children’s Hospital Medical Center, Cincinnati, UK4 Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, Devon, UKUniversity of Exeter, Exeter, UK1 University of Exeter, Exeter, UK6 Patient Representative, Exeter, UK7 Psychology, University of Exeter, Exeter, UKIntroduction 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 ISRCTN10906069https://bmjopen.bmj.com/content/9/8/e029349.full |
| spellingShingle | Patricia Jane Vickery Tamsin Ford Fiona C Warren Jenny Limond Shari L. Wade A Jeffery Annie Hawton Janet Smithson Sarah Haworth Anna-Lynne Ruth Adlam 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) BMJ Open |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/9/8/e029349.full |
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