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Protocol for the RELATE trial : a feasibility and pilot randomised controlled trial of a low-intensity group intervention for young people in care with elevated posttraumatic stress symptoms
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Hiller, Rachel M., Davis, Rebecca S., Devaney, John, Halligan, Sarah L., Meiser-Stedman, Richard, Smith, Patrick J., Stallard, Paul, Kandiyali, Rebecca and MacNeill, Stephanie J. (2021) Protocol for the RELATE trial : a feasibility and pilot randomised controlled trial of a low-intensity group intervention for young people in care with elevated posttraumatic stress symptoms. Pilot and Feasibility Studies, 7 (1). 204. doi:10.1186/s40814-021-00936-7
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Official URL: https://doi.org/10.1186/s40814-021-00936-7
Abstract
Introduction: Young people in out-of-home care have often experienced trauma, such as direct maltreatment or witnessing violence. There is good evidence that rates of mental health difficulties are high in this group, including posttraumatic stress disorder (PTSD), a trauma-specific mental health outcome. There remains less evidence to guide how to effectively address elevated PTSD symptoms (PTSS) in these young people, particularly in ways that are feasible and scalable for stretched social-care and mental health services. Methods and analysis: This protocol describes a feasibility study comprising a pilot two-arm randomised controlled trial (RCT). Participants (N = 50) will be randomised to either (a) a group-based trauma-focused programme (Teaching Recovery Techniques), delivered by mental health practitioners both online and in-person, or (b) care-as-usual. Primarily, the trial aims to explore the key feasibility and protocol acceptability questions, including rates of recruitment and retention, as well as the acceptability of the intervention (particularly the online delivery format) to participants and services. In addition, outcomes including PTSS (primary clinical outcome), depression and functioning will be assessed at baseline (pre-randomisation), post-intervention and at a 3-month follow-up. Ethics and dissemination: Ethical approval has been received from the Health Research Authority (Wales REC1 Ref 20/WA/0100) and University, with further approval from the host trust and social care site. The results will inform the design of a definitive RCT. Dissemination will include peer-reviewed journal articles reporting the qualitative and quantitative results, as well as presentations at conferences and lay summaries. Trial registration: ClinicalTrials.gov, NCT04467320. Registered on 13 July 2020.
| Item Type: | Journal Article | ||||||
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| Subjects: | H Social Sciences > HV Social pathology. Social and public welfare R Medicine > RA Public aspects of medicine R Medicine > RC Internal medicine R Medicine > RJ Pediatrics |
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| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
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| SWORD Depositor: | Library Publications Router | ||||||
| Library of Congress Subject Headings (LCSH): | Post-traumatic stress disorder , Post-traumatic stress disorder -- Prevention, Post-traumatic stress disorder -- Treatment, Post-traumatic stress disorder in adolescence, Foster home care , Youth -- Institutional care, Youth -- Mental health services | ||||||
| Journal or Publication Title: | Pilot and Feasibility Studies | ||||||
| Publisher: | BioMed Central Ltd. | ||||||
| ISSN: | 2055-5784 | ||||||
| Official Date: | 13 November 2021 | ||||||
| Dates: |
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| Volume: | 7 | ||||||
| Number: | 1 | ||||||
| Article Number: | 204 | ||||||
| DOI: | 10.1186/s40814-021-00936-7 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access | ||||||
| RIOXX Funder/Project Grant: |
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