CRIMSON [CRisis plan IMpact: Subjective and Objective coercion and eNgagement] Protocol: A randomised controlled trial of joint crisis plans to reduce compulsory treatment of people with psychosis

Background: The use of compulsory treatment under the Mental Health Act (MHA) has continued to rise in the UK and in other countries. The Joint Crisis Plan (JCP) is a statement of service users' wishes for treatment in the event of a future mental health crisis. It is developed with the clinical team and an independent facilitator. A recent pilot RCT showed a reduction in the use of the MHA amongst service users with a JCP. The JCP is the only intervention that has been shown to reduce compulsory treatment in this way. The CRIMSON trial aims to determine if JCPs, compared with treatment as usual, are effective in reducing the use of the MHA in a range of treatment settings across the UK. Methods/Design: This is a 3 centre, individual-level, single-blind, randomised controlled trial of the JCP compared with treatment as usual for people with a history of relapsing psychotic illness in Birmingham, London and Lancashire/Manchester. 540 service users will be recruited across the three sites. Eligible service users will be adults with a diagnosis of a psychotic disorder (including bipolar disorder), treated in the community under the Care Programme Approach with at least one admission to a psychiatric inpatient ward in the previous two years. Current inpatients and those subject to a community treatment order will be excluded to avoid any potential perceived pressure to participate. Research assessments will be conducted at baseline and 18 months. Following the baseline assessment, eligible service users will be randomly allocated to either develop a Joint Crisis Plan or continue with treatment as usual. Outcome will be assessed at 18 months with assessors blind to treatment allocation. The primary outcome is the proportion of service users treated or otherwise detained under an order of the Mental Health Act (MHA) during the follow-up period, compared across randomisation groups. Secondary outcomes include overall costs, service user engagement, perceived coercion and therapeutic relationships. Sub-analyses will explore the effectiveness of the JCP in reducing use of the MHA specifically for Black Caribbean and Black African service users (combined). Qualitative investigations with staff and service users will explore the acceptability of the JCPs. Discussion: JCPs offer a potential solution to the rise of compulsory treatment for individuals with psychotic disorders and, if shown to be effective in this trial, they are likely to be of interest to mental health service providers worldwide

Randomized controlled trial and economic evaluation of nurse-led group support for young mothers during pregnancy and the first year postpartum versus usual care

Background Child maltreatment is a significant public health problem. Group Family Nurse Partnership (gFNP) is a new intervention for young, expectant mothers implemented successfully in pilot studies. This study was designed to determine the effectiveness and cost effectiveness of gFNP in reducing risk factors for maltreatment with a potentially vulnerable population. Methods A multi-site randomized controlled parallel-arm trial and prospective economic evaluation was conducted, with allocation via remote randomization (minimization by site, maternal age group) to gFNP or usual care. Participants were expectant mothers aged <20 with at least one live birth, or 20–24 with no live births and with low educational qualifications. Data from maternal interviews at baseline and when infants were two, six and 12 months, and video recording at 12 months, were collected by researchers blind to allocation. Cost information came from weekly logs completed by gFNP family nurses and other service delivery data reported by participants. Primary outcomes measured at 12 months were parenting attitudes (Adult- Adolescent Parenting Index, AAPI-2) and maternal sensitivity (CARE index). The economic evaluation was conducted from a UK NHS and personal social services perspective with cost-effectiveness expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. Main analyses were intention to treat with additional complier average causal effects (CACE) analyses. Results Between August 2013 and September 2014, 492 names of potential participants were received of whom 319 were eligible and 166 agreed to take part, 99 randomly assigned to receive gFNP and 67 to usual care. There were no between-arms differences in AAPI-2 total (7·5/10 in both, SE 0.1), difference adjusted for baseline, site and maternal age-group 0·06 (95% CI -0·15 to 0·28, p=0·59) or CARE Index (intervention 4·0 (SE 0·3); control 4·7(SE 0·4); difference adjusted for site and maternal age-group -0·68; 95% CI -1·62 to 0·16, p=0·25) scores. The probability that gFNP is cost-effective based on the QALY measure did not exceed 3%. Conclusions The trial did not support gFNP as a means of reducing the risk of child maltreatment in this population but slow recruitment adversely affected group size and consequently delivery of the intervention