Contact information
Type
Scientific
Primary contact
Ms Jacqueline Sin
ORCID ID
Contact details
King's College London
Florence Nightingale School of Nursing and Midwifery
James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom
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jacqueline.sin@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13536
Study information
Scientific title
Exploratory randomised controlled trial of an online multi-component psychoeducational intervention for siblings of individuals with first-episode psychosis
Acronym
Study hypothesis
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.
Ethics approval
First MREC, 22/11/2012 ref: 12/LO/1537
Study design
Randomised interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Mental Health; Psychosis
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Siblings' mental wellbeing using Warwich-Edinburgh Mental Wellbeing Scale measured at baseline, 10 weeks, at end of using intervention and after 20 weeks.
Secondary outcome measures
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
Overall trial start date
01/05/2013
Overall trial end date
31/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 144;
Participant exclusion criteria
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
Recruitment start date
01/05/2013
Recruitment end date
31/12/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
London
SE1 8WA
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Division of applied biomedical research
London
WC2R 2LS
United Kingdom
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Keith.brennan@kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR Doctoral Research Fellowship (UK) ref: DRF-2011-04-129
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/23622123
2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/25394550
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27121259
Publication citations
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Protocol
Sin J, Henderson C, Pinfold V, Norman I, The E Sibling Project - exploratory randomised controlled trial of an online multi-component psychoeducational intervention for siblings of individuals with first episode psychosis., BMC Psychiatry, 2013, 13, 123, doi: 10.1186/1471-244X-13-123.