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ISRCTN
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ISRCTN01416694
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DOI
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10.1186/ISRCTN01416694
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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The E Sibling Project - an online information and peer support resource
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Scientific title
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Exploratory randomised controlled trial of an online multi-component psychoeducational intervention for siblings of individuals with first-episode psychosis
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Acronym
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N/A
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Serial number at source
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13536
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Study hypothesis
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Siblings of individuals with first episode psychosis (FEP) are both a vulnerable group to develop mental ill health due to the negative impact caused by the psychosis within the family, as well as being the most effective and natural agents to promote service users’ recovery. This study aims to develop and evaluate an online multi-component psychoeducational intervention for this commonly overlooked group of resources and family members. The intervention aims to enhance siblings’ knowledge about psychosis and their coping capacity, thus reducing their vulnerability to mental ill health as well as improving their contribution to the service users’ recovery. The intervention content and delivery formats will be designed as informed by evidence in the literature as well as the siblings’ inputs through consultations and an expert advisory group. Mixed methods incorporated within the MRC phased research design for complex interventions will be used to develop and undertake a preliminary evaluation of the intervention. Qualitative data collection methods such as focus groups and semi-structured individual interviews with siblings will be employed in conjunction with a factorial design randomised trial with several outcome measures to test the effectiveness, feasibility and acceptability of the newly developed intervention with the target population.
More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13536
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Lay summary
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Lay summary under review 3
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Ethics approval
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First MREC, 22 November 2012 ref: 12/LO/1537
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Study design
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Randomised interventional study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Mental Health; Psychosis
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Participants - inclusion criteria
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1. Aged 16 years or above
2. Has a brother or sister receiving or has received service from a local EIPS over the last three years
3. Is based within Greater London or Berkshire areas themselves
4. Has at least weekly contact with their ill brother or sister on average over the last 3 months
5. Understands English in usual online communications
6. Has daily access to internet use
7. Male or female participants
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Participants - exclusion criteria
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1. Siblings of individuals whose primary diagnosis is not first-episode psychosis or who is not/ has not been under the care of Early Intervention in Psychosis Service within the last three years at the time of joining the trial
2. Siblings themselves who have a diagnosed major mental illness that require secondary /specialised mental health care treatment, either as medication or talking/ psychological therapy
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Anticipated start date
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01/05/2013
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Anticipated end date
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31/12/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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UK Sample Size: 144;
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Interventions
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E Sibling Project, It is anticipated that the final intervention will comprise multiple components and the following characteristics: psychoeducation focusing on information-giving on psychosis, common treatment and management strategies for symptoms with a feature called "Ask the Expert" and a peer support element that uses a virtual discussion network with secured and moderated discussion boards on commonly encountered issues and experiences to facilitate mutual sharing and discussion between siblings.
Follow Up Length: 3 months
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Primary outcome measure(s)
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Siblings' mental wellbeing using Warwich-Edinburgh Mental Wellbeing Scale measured at baseline, 10 weeks, at end of using intervention and after 20 weeks.
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Secondary outcome measure(s)
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1. Knowledge of mental health using Mental Health Knowledge Schedule (MAKS) measured at baseline, 10 weeks, at end of using intervention and after 20 weeks
2. Positive and negative experience of caring using Experience of Caregiving Index (ECI) measured at baseline, 10 weeks, at end of using intervention and after 20 weeks
3. Self efficacy using the Assessment of Perceived General Self-Efficacy (APGSE) measured at baseline, 10 weeks, at end of using intervention and after 20 weeks
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Sources of funding
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NIHR Doctoral Research Fellowship (UK) ref: DRF-2011-04-129
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Trial website
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Publications
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Contact name
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Ms
Jacqueline
Sin
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Address
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King's College London
Florence Nightingale School of Nursing and Midwifery
James Clerk Maxwell Building
57 Waterloo Road
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City/town
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London
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Zip/Postcode
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SE1 8WA
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Country
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United Kingdom
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Email
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jacqueline.sin@kcl.ac.uk
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Sponsor
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King's College London (UK)
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Address
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Division of applied biomedical research
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City/town
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London
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Zip/Postcode
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WC2R 2LS
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Country
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United Kingdom
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Email
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Keith.brennan@kcl.ac.uk
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Sponsor website:
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http://www.kcl.ac.uk/
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Date applied
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06/12/2012
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Last edited
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06/12/2012
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Date ISRCTN assigned
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06/12/2012
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