title: The E Sibling Project - exploratory randomised controlled trial of an online multi-component psychoeducational intervention for siblings of individuals with first episode psychosis.
abstract: BACKGROUND
  Siblings of individuals with first episode psychosis are natural partners to promote service users' recovery and are themselves vulnerable to mental ill health due to the negative impact of psychosis within the family. This study aims to develop and undertake a preliminary evaluation of the efficacy of an online multi-component psychoeducational intervention for siblings of individuals with first episode psychosis. The impetus for the intervention arose from siblings' expressed needs for peer support and information on psychosis, coping and management strategies for common symptoms and ways to promote recovery.
  
  
  METHODS
  The project design draws on the Medical Research Council framework for the design and evaluation of complex interventions. Mixed methods comprising collection of qualitative focus group data, systematic review and expert advisory group consultation are used to develop the theoretical basis for and design of the intervention. This protocol focuses on the modelling and piloting phase which uses a randomised controlled trial with factorial design to test the efficacy of the intervention. Outcome data on participants' mental wellbeing, knowledge, perceived self-efficacy and experiences of caregiving will be assessed at baseline, at end of the intervention (10 weeks later) and at 10 week follow-up. In addition, a post-intervention semi-structured interview with 20% of the participants will explore their experiences and acceptability of the intervention.
  
  
  CONCLUSIONS
  This multi-component online psychoeducational intervention aims to enhance siblings' knowledge about psychosis and their coping capacity, thus potentially improving their own mental wellbeing and promoting their contribution to service users' recovery. The factorial design randomised controlled trial with a supplementary process evaluation using semi-structured interviews and usage-monitoring will collect preliminary evidence of efficacy, feasibility and acceptability, as well as feedback about the barriers and strategies to using such an innovative resource. The RCT will provide data for estimating the likely effect size of the intervention on outcomes for siblings and inform the development of a definitive future trial.
  
  
  BACKGROUND
  Trial registration: ISRCTN01416694.
authors.affiliation: Florence Nightingale School of Nursing & Midwifery, King's College London, 57 Waterloo Road, London, SE1 8WA, England. jacqueline.sin@kcl.ac.uk
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Sin
authors.forename: Claire
authors.initials: C
authors.lastname: Henderson
authors.forename: Vanessa
authors.initials: V
authors.lastname: Pinfold
authors.forename: Ian
authors.initials: I
authors.lastname: Norman
mesh_terms: D000223:Adaptation, Psychological; D002985:Clinical Protocols; D006266:Health Education; D006801:Humans; D008603:Mental Health; D011618:Psychotic Disorders / Q000175:diagnosis / Q000523:psychology*; D012107:Research Design; D012801:Sibling Relations; D035781:Siblings / Q000523:psychology*