The effect on relapse of Culturally-adapted Family Intervention (CaFI) compared to usual care among African and Caribbean people diagnosed with psychosis in the UK: a randomised controlled trial
Schizophrenia, schizotypal and delusional disorders
Current intervention as of 04/10/2021: Design: A randomised controlled trial (RCT) with two participant groups will be used. The trial will include an internal pilot to test CaFI’s feasibility with African participants. The researchers will also implement a process evaluation to find out what will make it easier/harder for CaFI to be taken up by services. The trial will be ‘blind’, which means that RAs collecting the data will not know which group each participant has been allocated to. This is done to avoid bias in data collection. Methodology & procedure: In the implementation phase, process evaluation data will be collected through the trial. The researchers will conduct semi-structured interviews at two different time points (3 and 9 months) with 30 members of staff (therapists, care coordinators, NHS senior leaders and service managers, commissioners) purposively sampled wing people over time will enable us to tap into their perceptions and experiences of the intervention, and what factors affect CaFI’s implementation in services. Interviews will be audio-recorded, transcribed verbatim, anonymised and analysed using Normalisation Process Theory (May & Finch, 2009). Trained Clinical Study Officers (CSOs) and RAs will take informed consent and complete baseline assessments from participants in an initial meeting. An additional meeting will be arranged if this is not feasible. Parents/guardians of participants under the age of 16 will be present at consent taking. However, the assessments will be conducted confidentially 1-to-1 with all service users to eliminate the possibility of bias caused by parental/guardian presence during data collection. Following baseline data collection, participants will be randomised into one of the two conditions: the intervention group (who will receive CaFI) or the control group (usual care). Intervention group participants will be asked to nominate relatives, carers, or Key Workers (or equivalent) to attend the CaFI sessions w
Current inclusion criteria as of 04/10/2021: Service users: 1. People of Sub-Saharan African and Caribbean descent, including those who self-identify as ‘Black British’, ‘Black Caribbean’, ‘Black African’, ‘African-Caribbean’ or ‘Mixed’ African/Caribbean 2. At least one parent/grandparent born in a sub-Saharan African/Caribbean country 3. Diagnosis of schizophrenia or related psychoses (ICD F20-29/ DSM-V) (American Psychiatric Association, 2013; World Health Organization, 1992) 4. Receiving treatment via psychiatric inpatient services (acute or rehabilitation), forensic or within community services within a participating NHS Trust 5. 14 years or older in keeping with the age groups served by Early Intervention Services and adult services 6. Assessed by researchers as having the capacity to provide informed consent 7. Assessed by care teams as being well enough to participate in therapy 8. Sufficient understanding of the English language to complete measures 9. No significant cognitive impairment implicated in aetiology (e.g. organic disorder) 10. Does not present a high short-term risk to themselves or others as assessed by care teams Family members and nominated Family Support Members (FSMs): Family members and nominated family support members do not have to be of African or Caribbean origin. All participants: 1. Assessed by researchers as having the capacity to provide informed consent 2. Family members and nominated FSMs must be aged 14 years or older 3. Sufficient proficiency in English to enable completion of measures _____ Previous inclusion criteria as of 05/02/2021: 1. People of Sub-Saharan African and Caribbean descent, including those who self-identify as ‘Black British’, ‘Black Caribbean’, ‘Black African’, ‘African-Caribbean’ or ‘Mixed’ African/Caribbean 2. At least one parent/grandparent born in a Sub Saharan Africa/Caribbean country 3. Diagnosis of schizophrenia or related psychoses (ICD F20-29/ DSM-V) (American Psychiatric Association, 2013; World
Current exclusion criteria as of 04/10/2021: Service users: 1. Organic brain disorder 2. Cognitive impairment sufficient to impact completion of assessment measures 3. Substance use as primary diagnosis 4. Currently receiving any form of family intervention Family members and nominated Family Support Members (FSMs): 1. Service user does not meet ethnicity or diagnostic criteria 2. Cognitive impairment sufficient to impact completion of assessment measures 3. Inability to understand study information or to give informed consent and complete measures _____ Previous exclusion criteria as of 05/02/2021: 1. Organic brain disorder 2. Cognitive impairment sufficient to impact completion of assessment measures 3. Substance use as primary diagnosis. 4. Currently receiving any form of family intervention _____ Previous exclusion criteria: 1. As substance use often co-occurs with psychoses, this will not be an exclusion criterion unless it is the primary diagnosis 2. Under the age of 14. However, family members under 14 (e.g. siblings) can participate if they are able to give assent, depending on parental/guardian consent 3. Family members, and FSMs do not have to be of Caribbean or Sub-Saharan background