Funding for this research was provided by:
National Institute for Health Research (PDF-2014-07-045)
Text and Data Mining valid from 2018-06-09
Received: 18 January 2018
Accepted: 25 May 2018
First Online: 9 June 2018
: RM is a qualified and registered social worker and Senior Research Associate. She was awarded a NIHR post-doctoral fellowship; the study described within this protocol is part of the programme of work funded within her fellowship.
: Ethical approval was granted by Health Research Authority Social Care REC (reference: 16/IEC08/0037). Any future minor and substantial amendments will be submitted to HRA social care REC for ethical consideration and future changes to protocol will be included in publications. Newcastle University will act as sponsor for the research and will undertake regular audit. The Programme Management Group will be responsible for ensuring the appropriate and timely implementation of the trial. An external, independent steering committee will provide overall supervision for a trial on behalf of the trial sponsor and trial funder and will ensure that the trial is conducted to rigorous standards, including adequate data monitoring. Adverse events identified by intervening practitioners are considered unlikely. Should the participant become distressed, the intervening practitioner will debrief the participant and sign post him or her to appropriate support services. Any adverse events that are observed will be reported to the steering committee, who will consider the criteria for discontinuing or modifying the allocated intervention. Serious breaches of protocol will be reported to the trial sponsor. The independent steering committee will also make the final decision to terminate the trial prematurely, should this appear to be the appropriate course of action.
: The authors declare that they have no competing interests.
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