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

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 h...

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Autores principales:	Rachel M. Hiller, Rebecca S. Davis, John Devaney, Sarah L. Halligan, Richard Meiser-Stedman, Patrick Smith, Paul Stallard, Rebecca Kandiyali, Stephanie MacNeill
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Posttraumatic stress disorder PTSD Intervention Foster care Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/cd6e4aa9c7f6456485f04d3dab8cf2d4
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spelling	oai:doaj.org-article:cd6e4aa9c7f6456485f04d3dab8cf2d42021-11-14T12:12:42ZProtocol 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 symptoms10.1186/s40814-021-00936-72055-5784https://doaj.org/article/cd6e4aa9c7f6456485f04d3dab8cf2d42021-11-01T00:00:00Zhttps://doi.org/10.1186/s40814-021-00936-7https://doaj.org/toc/2055-5784Abstract 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.Rachel M. HillerRebecca S. DavisJohn DevaneySarah L. HalliganRichard Meiser-StedmanPatrick SmithPaul StallardRebecca KandiyaliStephanie MacNeillBMCarticlePosttraumatic stress disorderPTSDInterventionFoster careMedicine (General)R5-920ENPilot and Feasibility Studies, Vol 7, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Posttraumatic stress disorder PTSD Intervention Foster care Medicine (General) R5-920
spellingShingle	Posttraumatic stress disorder PTSD Intervention Foster care Medicine (General) R5-920 Rachel M. Hiller Rebecca S. Davis John Devaney Sarah L. Halligan Richard Meiser-Stedman Patrick Smith Paul Stallard Rebecca Kandiyali Stephanie MacNeill 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
description	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.
format	article
author	Rachel M. Hiller Rebecca S. Davis John Devaney Sarah L. Halligan Richard Meiser-Stedman Patrick Smith Paul Stallard Rebecca Kandiyali Stephanie MacNeill
author_facet	Rachel M. Hiller Rebecca S. Davis John Devaney Sarah L. Halligan Richard Meiser-Stedman Patrick Smith Paul Stallard Rebecca Kandiyali Stephanie MacNeill
author_sort	Rachel M. Hiller
title	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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	BMC
publishDate	2021
url	https://doaj.org/article/cd6e4aa9c7f6456485f04d3dab8cf2d4
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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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