Title: The effect on relapse of Culturally-adapted Family Intervention (CaFI) compared to usual care among African & Caribbean people diagnosed with psychosis in the UK: a Randomised Controlled Trial
Funder: Department of Health and Social Care

Abstract: BACKGROUND: Schizophrenia and other psychoses cost the UK around 12 billion pounds every year(18). Many people with these illnesses cannot work. Families and friends often give ‘informal care’ so the actual cost is probably much higher than we think. Supporting people with schizophrenia is stressful. Families are often in conflict. Black people in the UK are diagnosed with schizophrenia more than other ethnic groups(19,20). They get into services later than others and have longer periods at home without any treatment(21). This can increase conflict, with families calling the police to help sort things out. Police involvement and being ‘sectioned’ under the Mental Health Act is part of a ‘negative care pathway’ that Black people experience more than others(22). They have higher doses of medication and more seclusion as inpatients and stay longer in hospital, making their treatment more expensive and less satisfactory(23). Helping families understand service users’ experiences and service users understand how their behaviour affects their families reduces family conflict. Family Intervention (FI) is a ‘talking treatment’ that helps with this. Service users who receive FI are more likely to take their medication and generally look after themselves better. This stops them becoming unwell again and get treatment sooner if they do, so they go into hospital less often(24). NICE recommends FI for families affected by schizophrenia. Some people, especially Black service users, do not have regular contact with their families. For them to receive FI, we need to do things differently. _x000D_ NEW THERAPY: In previous research, we worked with Caribbean service users, carers and health professionals to develop Culturally-adapted FI (CaFI). We changed the FI content to make it ‘less White’. For example, looking at how things like racism and spirituality affect people’s experiences of mental illness. So that people without families could get CaFI, service users could choose people they trust to work with them. If they could not suggest anyone, we recruited and trained community members, called Family Support Members (FSMs) to help. Half the people who received CaFI did so with FSMs so they are clearly needed. People who tried CaFI really liked it. Out of 26 families that started CaFI, 24 completed all 10 sessions. CaFI therapists and other health workers also liked it. Everyone thought it should be available to other ethnic groups. _x000D_ STUDY DESIGN: We will test CaFI compared to usual care with 386 Africans, Caribbeans and people of ‘Mixed’ African/Caribbean heritage. Each service user and their family will have a 50/50 chance of getting CaFI. Although there are differences between African and Caribbeans, they tell us that being Black means their experiences are so similar that this makes good sense. The study will run for 54 months across 6 NHS Trusts in Northwest, Midlands, London, and South West England. Testing CaFI in different parts of the country will help us understand how to make it become part of everyday care. _x000D_ STUDY AIMS: _x000D_ 1) See if CaFI works better and costs less than usual care. _x000D_ 2) Find out what will make it easier/harder for CaFI to be taken up by services. _x000D_ 3) Understand what needs to be done to deliver CaFI in different parts of the country.

Lay abstract: AIMS: i) Evaluate CaFI’s clinical and cost-effectiveness in Sub Saharan African and Caribbean populations. ii) Determine how to maximise facilitators/overcome barriers to successful implementation. _x000D_ DESIGN: Blind-rated RCT with internal Stop/Go pilot and process evaluation._x000D_ SETTING: 6 NHS Mental Health Trusts: 3 Northwest, 2 Midlands, 1 London, 1 South West. _x000D_ POPULATION: African and Caribbean origin service users (including ‘Black British’ and ‘Mixed’) in inpatient, rehabilitation, community, and forensic settings. _x000D_ HEALTH TECHNOLOGY: 10 x 1 hour sessions of Culturally-adapted Family Intervention (CaFI) delivered within a 20 week ‘therapy window’. _x000D_ PRIMARY OUTCOME: Reduction in relapse (as defined by an exacerbation of symptoms lasting over two weeks(7))._x000D_ SECONDARY OUTCOMES: Number of psychiatric and compulsory admissions, length of inpatient stays, service use, Perceived Coercion(8), Positive and Negative Syndrome Scale (PANSS)(9), Personal and Social Performance Scale (PSP)(10), Brief Illness Perception Questionnaire (Brief-IPQ)(11), Knowledge about Psychosis Interview (KAPI)(12), General Health Questionnaire (GHQ-12)(13), EQ-5D-5L(14), Working Alliance Inventory (WAI)(15), Service Engagement Scale (SES)(16). _x000D_ SAMPLE SIZE: Meta-analyses show a 0.55 - relative risk of relapse after family intervention without cultural adaptation(17); 40% of controls per year relapsed in the comparison arm. Reducing relapse risk from 40% during follow-up to 24% equates to a clinically-significant difference. Recruiting 386 participants across 6 NHS Trusts (193 in each arm) gives 90% power. Randomisation will be stratified by location and ethnicity. Within each stratum, participants will be randomly allocated (1:1) to the intervention or control arms in blocks of size 4, 6 or 8 with size randomly chosen. _x000D_ STATISTICAL ANALYSES: Will use an intention-to-treat approach. Log-rank tests will compare survival distributions of the two arms. If assumptions are met, Cox’s proportional hazards model will be fitted to adjust for covariates. _x000D_ ECONOMIC EVALUATION: Cost effectiveness acceptability analysis of bootstrapped net costs and QALYs to estimate the probability that CaFI is cost effective at 12 months. Service use data, collected from all participants, will be used to estimate costs from an NHS & Social Care perspective. Regression analysis will estimate net costs and QALYs, accounting for missing data and covariates. Sensitivity analyses will assess broader perspectives for cost, choice of outcome measure and impact of missing data._x000D_ PROCESS EVALUATION: Semi-structured interviews with 30 staff (e.g. therapists, care coordinators, NHS senior leaders and service managers, commissioners) will explore potential implementation barriers and facilitators. We will purposively sample participants across all sites. Interviews will be analysed using Framework Analysis. We will assess fidelity to the therapy manual (= 10% of sessions), therapists’ ability to deal with culturally-specific issues and number of sessions completed. _x000D_ TIMETABLE: 54 months: 12m study set-up (including acceptability testing with Africans); 22m total recruitment period; 12m Stop/Go pilot; 12m follow-up per participant; 3m closedown, analysis and write-up (See Gantt chart).

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH