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.

Hiller, Rachel M., Davis, Rebecca S., Devaney, John, Halligan, Sarah L., Meiser-Stedman, Richard, Smith, Patrick, Stallard, Paul, Kandiyali, Rebecca and MacNeill, Stephanie (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. ISSN 2055-5784

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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: Article
Additional Information: Funding Information: This trial is funded by the National Institute for Health Research (NIHR) through a Research for Patient Benefit Programme grant awarded to RH (NIHR200586). The funding body have not been involved in producing this manuscript or the design or running of the study.
Uncontrolled Keywords: foster care,intervention,ptsd,posttraumatic stress disorder,medicine (miscellaneous) ,/dk/atira/pure/subjectarea/asjc/2700/2701
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
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Depositing User: LivePure Connector
Date Deposited: 27 Oct 2021 02:24
Last Modified: 24 Nov 2021 03:12
URI: https://ueaeprints.uea.ac.uk/id/eprint/81896
DOI: 10.1186/s40814-021-00936-7

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