Condition category
Mental and Behavioural Disorders
Date applied
13/01/2020
Date assigned
31/01/2020
Last edited
31/01/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Schizophrenia is a severe long-term mental health condition. It causes a range of different psychological symptoms. Doctors often describe schizophrenia as a type of psychosis. This means the person may not always be able to distinguish their own thoughts and ideas from reality. Around 15 people per 100,000 are diagnosed with schizophrenia in England every year. Black people are much more likely to receive this diagnosis than other ethnic groups. They have longer periods without receiving treatment. This can increase stress and family conflict. Family Intervention (FI) is a ‘talking treatment’ that helps reduce conflict. Service users receiving FI stay well longer. NICE recommends FI for families affected by schizophrenia. However, Black families are less likely than others to be offered talking treatments.

Previously, the researchers worked with Caribbean families, community members, and healthcare professionals to develop a culturally-appropriate FI. It was called ‘Culturally-adapted FI’ - ‘CaFI’ for short. We changed an existing FI to make it ‘less White’, including how things like racism and spiritual beliefs affect people’s experiences of schizophrenia. People liked CaFI. Of 26 family units that started CaFI, 24 completed all 10 sessions. CaFI therapists also liked it. Service users, therapists and families all said that CaFI should become available to everyone, especially African people.

This study will test CaFI compared to usual care with people from Sub-Saharan African/Caribbean/Mixed backgrounds.

Who can participate?
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’, diagnosed with schizophrenia or related diagnoses.

What does the study involve?
Each service user and their family will have a 50% chance of receiving CaFI. The other 50% will continue with their usual care. All participants will complete questionnaire assessments and interviews at four time-points in the study.

What are the possible benefits and risks of participating?
Benefits:
The feasibility pilot study of CaFI showed that service users, relatives/carers, and (service user-nominated) FSMs reported positive service user benefits, including improved symptoms (better mood, less paranoia), improved social functioning, and active planning to return to work and fulltime education. Therapeutic alliance was positively rated by all groups. Improved communication between service users, families, and health professionals was also reported. We expect participants to experience similar benefits as part of this multi-site trial, including a reduced risk of relapse.
Risk:
There is a risk that some participants may become distressed when reflecting on personal experiences of living with mental illness and its impact on family relationships.

Where is the study run from?
7 NHS Trusts in Northwest, Midlands, London, and South West England

When is the study starting and how long is it expected to run for?
April 2020 to February 2023

Who is funding the study?
National Institute for Health Research (NIHR), UK

Who is the main contact?
Helen Wilson (scientific)
Helen.Wilson@gmmh.nhs.uk
Prof. Dawn Edge (scientific)
dawn.edge@manchester.ac.uk
Jamal Alston (public)
jamal.alston@gmmh.nhs.uk

Trial website

https://sites.manchester.ac.uk/cafi/

Contact information

Type

Scientific

Primary contact

Mrs Helen Wilson

ORCID ID

Contact details

CaFI Office
3rd Floor Rawnsley Building
Hathersage Road
Manchester
M13 9WL
United Kingdom
+44 (0)161 276 5272
Helen.Wilson@gmmh.nhs.uk

Type

Scientific

Additional contact

Prof Dawn Edge

ORCID ID

Contact details

Coupland I
University of Manchester
Oxford Road
Manchester
M13 9WL
United Kingdom
+44 (0)161 275 2570
dawn.edge@manchester.ac.uk

Type

Public

Additional contact

Mr Jamal Alston

ORCID ID

Contact details

CaFI Office
3rd Floor Rawnsley Building
Hathersage Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 276 5272
jamal.alston@gmmh.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 44117, IRAS 266123

Study information

Scientific title

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

Acronym

Study hypothesis

The Culturally-adapted Family Intervention (CaFI) therapy is more effective than usual care (e.g. other psychological therapies) and better value for money for African and Caribbean people diagnosed with schizophrenia in the United Kingdom.

Ethics approval

Approval pending, South Central – Hampshire B REC (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; 0207 104 8057; nrescommittee.southcentral-hampshireb@nhs.net), ref 19/SC/0607

Study design

Interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Schizophrenia, schizotypal and delusional disorders

Intervention

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 with them. Where this is not possible and participants cannot suggest alternatives, the researchers shall provide details of Family Support Members (FSMs) from whom they can choose someone to support them during therapy. Participants will attend 10 x 1h sessions within a 20-week window. Control participants will continue with usual care, and they will not have access to CaFI.

Post-intervention data will be collected within a month after each intervention participant has completed their 10th session. Control participants will be invited to complete data collection at the 20-week time-point from enrolling in the study (the therapy window). Follow-up data will be collected at 6 months and 12 months for both intervention and control participants. Thus, data will be collected at four time-points per participant.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Relapse (as defined by a worsening of symptoms lasting over two weeks, a Cochrane recommended measure) assessed using case-notes/medical records (service users only) throughout the study

Secondary outcome measures

At baseline, after 10th session (intervention) or 20-weeks (control), 6 months, and 12 months:
1. Number of psychiatric and compulsory admissions (service users) measured using patient records
2. Length of inpatient stays (service users) measured using patient records
3. Perceived coercion (service users) measured using
4. Positive, negative, and general symptoms measured using the Positive and Negative Syndrome Scale (PANSS) (service users)
5. Social functioning measured using the Personal and Social Performance Scale (PSP) (service users)
6. Illness perceptions measured using the Brief Illness Perception Questionnaire (Brief-IPQ) (service users and family members/FSMs)
7. Knowledge about psychosis measured using the Knowledge about Psychosis Interview (KAPI) (family members/FSMs)
8. Knowledge about psychosis measured using the Culturally-adapted Knowledge about Psychosis Questionnaire
9. Emotional distress measured using the General Health Questionnaire (GHQ-12) (family members/FSMs)
10. Health status and quality of life measured using the EQ5D-5L (service users and family members/FSMs)
11. Quality of staff-service user relationships measured using the Working Alliance Inventory (WAI) (service users and therapists/key workers)
12. Service engagement of service users measured using the Service Engagement Scale (SES)

Overall trial start date

01/09/2017

Overall trial end date

30/09/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Ethnicity: 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. Diagnosis: Schizophrenia or related diagnoses (ICD F20-29/ DSM-IV). We shall exclude to those with non-psychotic or organic brain disorder or cognitive impairment
3. Capacity: Assessed by Care Coordinators/key workers as having the capacity to provide informed consent and to participate in therapy.
4. Assessed by Care Coordinators/key workers as not presenting a high, short-term risk to self or others

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 404; UK Sample Size: 404

Participant 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

Recruitment start date

01/04/2020

Recruitment end date

01/01/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Prestwich Hospital
Greater Manchester Mental Health NHS Foundation Trust Harrop House Bury New Road Prestwich
Manchester
M25 3BL
United Kingdom

Trial participating centre

University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

Trial participating centre

Healthy Minds Bury
Pennine Care NHS Foundation Trust 225 Old Street
Ashton-under-Lyne
OL6 7SR
United Kingdom

Trial participating centre

Mersey Care NHS Foundation Trust
V7 Building Kings Business Park Prescot
Liverpool
L34 1PJ
United Kingdom

Trial participating centre

Queen Elizabeth Hospital Birmingham
University Hospitals Birmingham NHS Foundation Trust Mindelsohn Way
Birmingham
B15 2TH
United Kingdom

Trial participating centre

Coventry And Warwickshire Partnership NHS Trust
Wayside House
Coventry
CV6 6NY
United Kingdom

Trial participating centre

University of Warwick
Kirby Corner Rd
Coventry
CV4 7AL
United Kingdom

Trial participating centre

Tatchbury Mount Hospital
Calmore
Southampton
SO40 2RZ
United Kingdom

Trial participating centre

King's College London
Health Service & Population Research De Crespigny Park
London
SE5 8AF
United Kingdom

Trial participating centre

Maudsley Hospital
South London and Maudsley NHS Foundation Trust Denmark Hill
London
SE5 8AZ
United Kingdom

Sponsor information

Organisation

Greater Manchester West Mental Health NHS Foundation Trust

Sponsor details

Prestwich Hospital
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
+44 (0)161 2710076
sarah.leo@gmmh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

https://www.gmw.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: HTA 16/167/76

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.
Repository: UK Data Archive/University of Manchester
When data will be made available: Six to twelve months after study conclusion.
What criteria for data to be shared, with whom: Future researchers.
Whether consent from participants is needed: Participants will have consented to the participant information sheet, which specifies that data will be freely available to the public on the UK Data Archive for ten years. It is stated that future researchers will be able to use their data.
Comments on data anonymisation: Participants will be allocated a study number. Personal identifiable data and participant study numbers will not be stored in the same location.
Ethical or legal restrictions: No patient identifiable data will be available.

Intention to publish date

01/02/2024

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/01/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR)