The E Sibling Project - an online information and peer support resource

ISRCTN	ISRCTN01416694
DOI	https://doi.org/10.1186/ISRCTN01416694
Secondary identifying numbers	13536

Submission date: 06/12/2012
Registration date: 06/12/2012
Last edited: 03/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration and not expected to be available in the future

Contact information

Ms Jacqueline Sin
Scientific

King's College London
Florence Nightingale School of Nursing and Midwifery
James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom

Email	jacqueline.sin@kcl.ac.uk

Study information

Study design	Randomised interventional study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Exploratory randomised controlled trial of an online multi-component psychoeducational intervention for siblings of individuals with first-episode psychosis
Study objectives	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(s)	First MREC, 22/11/2012 ref: 12/LO/1537
Health condition(s) or problem(s) studied	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
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 study start date	01/05/2013
Completion date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	UK Sample Size: 144;
Key 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
Key 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
Date of first enrolment	01/05/2013
Date of final enrolment	31/12/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

King's College London

London
SE1 8WA
United Kingdom

Sponsor information

King's College London (UK)
University/education

Division of applied biomedical research
London
WC2R 2LS
England
United Kingdom

Email	Keith.brennan@kcl.ac.uk
Website	http://www.kcl.ac.uk/
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Government

NIHR Doctoral Research Fellowship (UK) ref: DRF-2011-04-129

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	26/04/2013	Yes	No
Results article	results	01/10/2014	Yes	No
Results article	results	01/09/2016	Yes	No

Editorial Notes

03/10/2018: Publication references added.