Specialty: Mental Health, Primary sub-specialty: Psychosis
Conditions
Interventions
Participants are randomised via a clinical trials unit telephone service using an allocation ratio of 1:1 and permuted blocks of size 4 and 6 to one of two groups.
Intervention group:
Sponsors
University of Manchester
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patient participants: 1. Aged 18 years or more 2. Have at least one infant aged birth to 12 months who they care for or are going to care for 3. Are in the third trimester of pregnancy and are expected to reside on the MBU following delivery 4. Are able to comprehend and understand English to provide consent to the study 5. Are able to provide written informed consent. Note: MBU staff routinely assesses their capacity Staff participants: 1. Permanent full-time or part-time members of the Mother and Baby Unit (MBU) staff team 2. Have worked on the MBU for at least six months 3. Proficient in English to understand the study, provide written, informed consent and can take part in interviews
Exclusion criteria
Exclusion criteria: Patient participants: 1. Participants who do not have a sufficiently good working knowledge of English to provide written informed consent and understand and complete questionnaires. Use of interpreters is beyond the scope of this feasibility study, but could be built into a definitive trial. Note: If interpreters are involved in the routine care of a participant, then their inclusion can be considered. 2. Participants whose current symptoms seriously compromise their ability to concentrate on the assessments or intervention sessions. Examples include participants who experience persistent and loud auditory hallucinations that they clearly react to. Eligibility can be reassessed once a participant’s acute symptoms subside. 3. Participants who show severe personality disorder traits including significant current self-harming behaviours (such as attempting suicide). Note: MBU staff assess these behaviours as part of routine practice alongside risk issues. 4. Participants whose infant will be removed from their care on a non-temporary basis 5. Participants whose discharge has been scheduled within 7 days from date of recruitment Staff participants: 1. Nursing students or bank staff who work on the MBU on a temporary basis only. 2. Have less than six months experience of working on the MBU.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal confidence and competence is measured using the Maternal Efficacy Questionnaire at baseline and 8-10 weeks and 6 months post-baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-Report Outcomes (completed by participants): 1. Maternal mood is measured using the Brief Depression Anxiety and Stress Scale at baseline and 8-10 weeks and 6 months 2. Mother-infant relationship is measured using the Postpartum Bonding Questionnaire at baseline and 8-10 weeks and 6 months 3. Quality of life is measured using the EQ-5D-5L at baseline and 8-10 weeks and 6 months 4. Mental illness symptom severity and distress is measured using the Brief Symptom Scale at baseline and 8-10 weeks and 6 months Observer-Rated Outcomes (completed by MBU staff): 1. Mental illness symptoms are measured using the Brief Psychiatric Rating Scale at baseline and 8-10 weeks and 6 months 2. Mental illness symptom improvement from admission (to the MBU) to discharge is measured using the Clinical Global Impression Scales at baseline and 8-10 weeks and 6 months 4. Infant wellbeing is measured using the Louis Mother and Child Risk Observation (Louis MACRO) at baseline and 8-10 weeks and 6 months 5. Health outcomes are measured using Health of the Nation Outcome Scales (HoNOs) at baseline and 8-10 weeks and 6 months Feasibility and Acceptability Outcomes: 1. Feasibility of recruitment will be measured through recording how participants found out about the study, recruitment rates, number of potential participants found eligible, initially approached by Mother and Baby Unit (MBU) staff, consented to be approached by the research team, and approached about the study by the research team, reasons for declining to be approached or take take part in the study if known and percentage of eligible participants consented and their characteristics 2. Feasibility of randomisation will be assessed by recording number of refusals to be randomised 3. Engagement/retention in the study an | — |
Countries
England, United Kingdom
Outcome results
None listed