Title: Culturally-adapted Family Intervention (CaFI) for African Caribbeans with schizophrenia and their families: A feasibility study of implementation and acceptability
Funder: Department of Health (England)

Abstract: African Caribbeans have the highest prevalence of schizophrenia most difficult relationships with mental health services and greatest persistent inequalities in care of all ethnic groups in the UK[1-3]. Responding to NICE schizophrenia guidelines[4] highlighting lack of evidence-based psychological interventions for this ethnic group we aim to: i) create a culturally-adapted family intervention (CaFI)[5] ii) test the feasibility of its implementation iii) evaluate its accessibility and acceptability to African Caribbean patients and their families in hospital and community settings. We will deliver CaFI via ‘proxy families’ (trusted individual nominated by patients where there is little or no contact with biological families e.g. youth/community workers) to address an important access barrier for African Caribbeans who experience high levels of family disruption[6]. Our rationale is that: i) Successful implementation of CaFI will facilitate and improve engagement in services for African Caribbean patients with schizophrenia (ICD F20-29)[7] ii) Better and earlier engagement will improve access to evidence-based interventions improving outcomes iii) Successfully implementing FI in this group will pave the way to improving access for other socially-excluded groups. RESEARCH QUESTIONS1. How can existing evidence-based FI be culturally-adapted for African Caribbeans with schizophrenia? 2. Is it feasible for CaFI to be delivered in hospital and community settings?3. Can proxy families serve as acceptable alternatives where biological families are unavailable?4. Will CaFI be acceptable to patients families and health professionals?SUMMARY PLAN OF INVESTIGATION PHASE 1: CULTURALLY-ADAPTING THE INTERVENTION (Months 0 – 9)PHASE 1A) LITERATURE REVIEW: NICE acknowledge lack of evidence for culturally-adapted psychosocial interventions in schizophrenia and ethnic minorities. Our systematic search for evidence will widen to ‘mental health disorders’ and ‘psychosocial interventions’ before focusing on ‘cultural adaptation’ ‘FI’ and ‘ethnic minorities’. PHASE 1B) FOCUS GROUP: We shall collect qualitative data in 3 focus groups to provide a range of views on how best to culturally-adapt FI[5] training needs of family therapists and ‘proxy families’. Participants will be i) current or former patients ii) families/ carers/advocates and iii) health professionals (n=24-30 in total). Patients will be of African Caribbean descent. Other participants can be of any ethnic background. PHASE 1C) CONSENSUS STUDY: In a Consensus Development Conference[8] key stakeholders (n=24) will culturally-adapt FI by synthesising data from Phases 1A & 1B with information on an existing evidence-based FI[5] develop a manual to support delivery and identify suitable outcome measures. Stakeholders will include patients professionals and user/carer groups such as Diverse Minds Rethink Manchester and the Carers Trust.PHASE 2: TRAINING (Months 10 – 14)We shall provide cultural competency training for the therapists to deliver CaFI and 3 ‘clinical competency’ seminars (one per year) for staff in participating units. We will also train individuals identified by patients volunteers and service-user peers to become ‘proxy families’.PHASE 3: FEASIBILITY STUDY (Months 15 – 32)PHASE 3A: DELIVERING AND EVALUATING THE INTERVENTIONWe shall test CaFI in acute rehabilitation and community settings in Manchester Mental Health & Social Care NHS Trust (MHSCT). Key objectives are a) testing feasibility of delivering CaFI to African Caribbean patients and families b) estimating important parameters for design of future randomised controlled trial (RCTs). Over 12 months 30 consenting patients and/or their families will receive CaFI. ‘Proxy families’ will substitute for absent biological families. The intervention: A manual of CaFI will be produced during Phase 1 including session content number of sessions and time between sessions. Based on the exising model of FI [5] and NICE guidance[4] we anticipate the intervention will comprise 10 1-2 hour sessions delivered over 16-20 weeks. Core components are likely to include patient and family assessment psycho-education stress management and problem-solving. Data collection and analysis Quantitative: A key measure of the success of CaFI will be engagement by patients their families and ‘proxy families’. Our primary outcome measure is rates of recruitment uptake and attrition. We will also assess reasons for refusal and non-completers as well as collecting demographic and outcome data identified in Phase 1. Secondary outcome measures may include: Family Questionnaire (FQ)[9]; Knowledge About Schizophrenia Interview (KASI [10]); Short Form Survey (SF-12 version 2[11]) and its preference-based utility index (SF-6D) to facilitate economic evaluation and estimate quality adjusted life years (QALYs). Baseline measures will be taken pre- and post-intervention and at 3 months’ follow-up by the research assistant (RA). Data analysis is primarily descriptive as our feasibility study is not powered for hypothesis testing [12]. STATA[13] will be used for analysis.Qualitative: Qualitative data on the acceptability and accessibility of CaFI (e.g. ease of understanding ‘user-friendliness’ of the manual) will be collected throughout using feedback forms and interviews with ‘key informants’ and at 3-months’ follow-up using semi-structured questionnaires. Focusing particularly on perceptions of usefulness cultural-appropriateness accessibility and facilitators/barriers to implementation will help us design future pilot studies and a multi-site RCT to test CaFI against standard FI and usual care. Qualitative data will be digitally recorded transcribed checked for accuracy and analysed using thematic content analysis[14]. NVivo[15] will support data management and analysis. PHASE 3B: FIDELITY STUDY (Months 30 – 32)Adherence to the manual and delivery of the intervention will be tested by independent review of a 25% sample of recorded FI sessions using a 60-item assessment checklist. Additional data on uptake attrition and engagement (e.g. number of completed sessions and reasons for non-completion) will also enable assessment of fidelity. Additionally we will conduct in-depth qualitative interviews with family therapists and support workers about their experience of delivering the intervention and using the manual.


Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES;7.3 MANAGEMENT AND DECISION MAKING
Health categories: MENTAL HEALTH