Condition category
Mental and Behavioural Disorders
Date applied
06/12/2012
Date assigned
06/12/2012
Last edited
11/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

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
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.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13536

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 below 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 measures

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

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
Keith.brennan@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

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

Results - basic reporting

Publication summary

2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23622123

Publication citations

  1. 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.

Additional files

Editorial Notes