Randomised pilot and feasibility trial of a group intervention for men who perpetrate intimate partner violence against women.

BACKGROUND: There is a need for robust evidence on the effectiveness and cost-effectiveness of domestic abuse perpetrator programmes in reducing abusive behaviour and improving wellbeing for victim/survivors. While any randomised controlled trial can present difficulties in terms of recruitment and retention, conducting such a trial with domestic abuse perpetrators is particularly challenging. This paper reports the pilot and feasibility trial of a voluntary domestic abuse perpetrator group programme in the United Kingdom. METHODS: This was a pragmatic individually randomised pilot and feasibility trial with an integrated qualitative study in one site (covering three local-authority areas) in England. Male perpetrators were randomised to either the intervention or usual care. The intervention was a 23-week group programme for male perpetrators in heterosexual relationships, with an average of three one-to-one sessions, and one-to-one support for female current- or ex-partners delivered by third sector organisations. There was no active control treatment for men, and partners of control men were signposted towards domestic abuse support services. Data were collected at three-monthly intervals for nine months from male and female participants. The main objectives assessed were recruitment, randomisation, retention, data completeness, fidelity to the intervention model, and acceptability of the trial design. RESULTS: This study recruited 36 men (22 randomly allocated to attend the intervention group programme, 14 to usual care), and 15 current- or ex-partners (39% of eligible partners). Retention and completeness of data were high: 67% of male (24/36), and 80% (12/15) of female participants completed the self-reported questionnaire at nine months. A framework for assessing fidelity to the intervention was developed. In interviews, men who completed all or most of the intervention gave positive feedback and reported changes in their own behaviour. Partners were also largely supportive of the trial and were positive about the intervention. Participants who were not allocated to the intervention group reported feeling disappointed but understood the rationale for the trial. CONCLUSIONS: It was feasible to recruit, randomise and retain male perpetrators and female victim/survivors of abuse and collect self-reported outcome data. Participants were engaged in the intervention and reported positive benefits. The trial design was seen as acceptable. TRIAL REGISTRATION: ISRCTN71797549, submitted 03/08/2017, retrospectively registered 27/05/2022.

The effectiveness of sexual assault referral centres with regard to mental health and substance use: a national mixed-methods study - the MiMoS Study.

Background: Sexual assault referral centres have been established to provide an integrated service that includes forensic examination, health interventions and emotional support. However, it is unclear how the mental health and substance use needs are being addressed. Aim: To identify what works for whom under what circumstances for people with mental health or substance use issues who attend sexual assault referral centres. Setting and sample: Staff and adult survivors in English sexual assault referral centres and partner agency staff. Design: A mixed-method multistage study using realist methodology comprising five work packages. This consisted of a systematic review and realist synthesis (work package 1); a national audit of sexual assault referral centres (work package 2); a cross-sectional prevalence study of mental health and drug and alcohol needs (work package 3); case studies in six sexual assault referral centre settings (work package 4), partner agencies and survivors; and secondary data analysis of outcomes of therapy for sexual assault survivors (work package 5). Findings: There is a paucity of evidence identified in the review to support specific ways of addressing mental health and substance use. There is limited mental health expertise in sexual assault referral centres and limited use of screening tools based on the audit. In the prevalence study, participants (n = 78) reported high levels of psychological distress one to six weeks after sexual assault referral centre attendance (94% of people had symptoms of post-traumatic stress disorder). From work package 4 qualitative analysis, survivors identified how trauma-informed care potentially reduced risk of re-traumatisation. Sexual assault referral centre staff found having someone with mental health expertise in the team helpful not only in helping plan onward referrals but also in supporting staff. Both sexual assault referral centre staff and survivors highlighted challenges in onward referral, particularly to NHS mental health care, including gaps in provision and long waiting times. Work package 5 analysis demonstrated that people with recorded sexual assault had higher levels of baseline psychological distress and received more therapy but their average change scores at end point were similar to those without sexual trauma. Limitations: The study was adversely affected by the pandemic. The data were collected during successive lockdowns when services were not operating as usual, as well as the overlay of anxiety and isolation due to the pandemic. Conclusions: People who attend sexual assault centres have significant mental health and substance use needs. However, sexual assault referral centres vary in how they address these issues. Access to follow-up support from mental health services needs to be improved (especially for those deemed to have 'complex' needs) and there is some indication that co-located psychological therapies provision improves the survivor experience. Routine data analysis demonstrated that those with sexual assault can benefit from therapy but require more intensity than those without sexual assault. Future work: Further research is needed to evaluate the effectiveness and cost-effectiveness of providing co-located psychological therapy in the sexual assault referral centres, as well as evaluating the long-term needs and outcomes of people who attend these centres. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (16/117/03) and is published in full in Health and Social Care Delivery Research; Vol. 11, No. 21. Trial registration: This trial is registered as PROSPERO 2018 CRD42018119706 and ISRCTN 18208347.

We undertook several studies including: Searching and examining published research (review). A survey that asked sexual assault referral centres how mental health and substance use are addressed. Questionnaires: survivors who had recently attended a sexual assault referral centre completed questionnaires on mental health, alcohol and drugs, and quality of life. Interviews with staff at sexual assault referral centres and survivors of assualts. Routine data: we analysed anonymous data from mental health services to compare how those with sexual assault benefit from psychological therapy. We combined the findings from all the aspects of the study to conclude that most people who attend sexual assault referral centres have significant mental health needs; however, the response to these needs is variable within sexual assault referral centres. Survivors report that the sexual assault referral centres offer a caring and supportive service, but many also reported difficulties in accessing the right support afterwards. Where there was co-located psychological therapy, there were benefits for both survivors and the wider team. We also showed that, despite high needs, people surviving sexual assault can benefit from therapies but may need more therapy than those who have not experienced sexual assault.

Effectiveness and cost-effectiveness of psychiatric mother and baby units: quasi-experimental study.

BACKGROUND: Psychiatric mother and baby units (MBUs) are recommended for severe perinatal mental illness, but effectiveness compared with other forms of acute care remains unknown. AIMS: We hypothesised that women admitted to MBUs would be less likely to be readmitted to acute care in the 12 months following discharge, compared with women admitted to non-MBU acute care (generic psychiatric wards or crisis resolution teams (CRTs)). METHOD: Quasi-experimental cohort study of women accessing acute psychiatric care up to 1 year postpartum in 42 healthcare organisations across England and Wales. Primary outcome was readmission within 12 months post-discharge. Propensity scores were used to account for systematic differences between MBU and non-MBU participants. Secondary outcomes included assessment of cost-effectiveness, experience of services, unmet needs, perceived bonding, observed mother-infant interaction quality and safeguarding outcome. RESULTS: Of 279 women, 108 (39%) received MBU care, 62 (22%) generic ward care and 109 (39%) CRT care only. The MBU group (n = 105) had similar readmission rates to the non-MBU group (n = 158) (aOR = 0.95, 95% CI 0.86-1.04, P = 0.29; an absolute difference of -5%, 95% CI -14 to 4%). Service satisfaction was significantly higher among women accessing MBUs compared with non-MBUs; no significant differences were observed for any other secondary outcomes. CONCLUSIONS: We found no significant differences in rates of readmission, but MBU advantage might have been masked by residual confounders; readmission will also depend on quality of care after discharge and type of illness. Future studies should attempt to identify the effective ingredients of specialist perinatal in-patient and community care to improve outcomes.

The identification and treatment of mental health and substance misuse problems in sexual assault services: A systematic review.

BACKGROUND: Specialist sexual assault services, which collect forensic evidence and offer holistic healthcare to people following sexual assault, have been established internationally. In England, these services are called sexual assault referral centres (SARCs). Mental health and substance misuse problems are common among SARC attendees, but little is known about how SARCs should address these needs. This review aims to seek and synthesise evidence regarding approaches to identification and support for mental health and substance misuse problems in SARCs and corresponding services internationally; empirical evidence regarding effective service models; and stakeholders' views and policy recommendations about optimal SARC practice. METHODS: A systematic review was undertaken. PsycINFO, MEDLINE, IBSS and CINAHL were searched from 1975 to August 2018. A web-based search up to December 2018 was also conducted to identify government and expert guidelines on SARCs. Quality assessment and narrative synthesis were conducted. RESULTS: We included 107 papers. We found that identification based on clinical judgement, supportive counselling and referral to other services without active follow-up were the most common approaches. Evaluations of interventions for post-rape psychopathology in attendees of sexual assault services provided mixed evidence of moderate quality. Very little evidence was found regarding interventions or support for substance misuse. Stakeholders emphasised the importance of accessibility, flexibility, continuity of care, in-house psychological support, staff trained in mental health as well as specialist support for LGBT groups and people with learning difficulties. Guidelines suggested that SARCs should assess for mental health and substance misuse and provide in-house emotional support, but the extent and nature of support were not clarified. Both stakeholders and guidelines recommended close partnership between sexual assault services and local counselling services. CONCLUSIONS: This review suggests that there is big variation in the mental health and substance misuse provision both across and within different sexual assault service models. We found no robust evidence about how sexual assault services can achieve good mental health and substance misuse outcomes for service users. Clearer guidance for service planners and commissioners, informed by robust evidence about optimal service organisations and pathways, is required. PROSPERO registration number: CRD42018119706.

Intelligence in offspring born to women exposed to intimate partner violence: a population-based cohort study.

Background: Intimate partner violence (IPV) is a risk factor for developmental problems in offspring. Despite a high prevalence of IPV in the UK and elsewhere, the longer-term outcomes of offspring born to exposed mothers remain under-researched. Methods: Population-based cohort study. We assessed IPV prevalence by type and timing for 3,153 mother-child pairs with complete data within our study population and examined associations between IPV and offspring IQ. We used multiple-imputation to evaluate bias due to our exclusion of observations with missing covariate data. Results: Nearly one in five mothers reported IPV during the study period, with 17.6% reporting emotional violence and 6.8% reporting physical violence. Taking into account potential confounders, the IQ scores of children born to mothers exposed to physical violence remained lower than those of maternally unexposed children (full-scale IQ = -2.8 points [95%CI -4.9 to -0.7], verbal IQ = -2.2 [95%CI -4.4 to -0.1], performance IQ = -2.7 [95%CI  -5.0 to -0.5]) and odds of below-average intelligence (IQ<90) remained increased for full-scale (OR 1.48 [95%CI 1.03 to 2.14] and performance IQ (OR 1.48 [95%CI 1.08 to 2.04]) but not verbal IQ (OR 1.06 [95%CI 0.69 to 1.64]). Most physical violence occurred postnatally, and relative odds were most substantial when mothers were exposed to violence across pre-/perinatal and postnatal study periods (OR performance IQ<90 = 2.97 [95%CI 1.30 to 6.82]). Conclusions: Maternal exposure to physical IPV is associated with lower offspring IQ at age 8. Associations persisted after adjusting for potential confounders and were driven by violence occurring postnatally.

Protocol for a quasi-experimental study of the effectiveness and cost-effectiveness of mother and baby units compared with general psychiatric inpatient wards and crisis resolution team services (The ESMI study) in the provision of care for women in the postpartum period.

INTRODUCTION: Research into what constitutes the best and most effective care for women with an acute severe postpartum mental disorder is lacking. The effectiveness and cost-effectiveness of psychiatric mother and baby units (MBUs) has not been investigated systematically and there has been no direct comparison of the outcomes of mothers and infants admitted to these units, compared with those accessing generic acute psychiatric wards or crisis resolution teams (CRTs). Our primary hypothesis is that women with an acute psychiatric disorder, in the first year after giving birth, admitted to MBUs are significantly less likely to be readmitted to acute care (an MBU, CRTs or generic acute ward) in the year following discharge than women admitted to generic acute wards or cared for by CRTs. METHODS AND ANALYSIS: Quasi-experimental study of women accessing different types of acute psychiatric services in the first year after childbirth. Analysis of the primary outcome will be compared across the three service types, at 1-year postdischarge. Cost-effectiveness will be compared across the three service types, at 1-month and 1-year postdischarge; explored in terms of quality-adjusted life years. Secondary outcomes include unmet needs, service satisfaction, maternal adjustment, quality of mother-infant interaction. Outcomes will be analysed using propensity scoring to account for systematic differences between MBU and non-MBU participants. Analyses will take place separately within strata, defined by the propensity score, and estimates pooled to produce an average treatment effect with weights to account for cohort attrition. ETHICS AND DISSEMINATION: The study has National Health Service (NHS) Ethics Approval and NHS Trust Research and Development approvals. The study has produced protocols on safeguarding maternal/child welfare. With input from our lived experience group, we have developed a dissemination strategy for academics/policy-makers/public.

Women's Experiences of Vulvodynia: An Interpretative Phenomenological Analysis of the Journey Toward Diagnosis.

Vulvodynia is the experience of idiopathic pain characterized by burning, soreness, or throbbing in the external female genitalia or vulva and is estimated to be experienced by 4-16% of the female population, yet only half of women seek help regarding their symptoms. Of the women who do seek help, only around 2% obtain a diagnosis. Therefore, the aim of the current study was to explore the experiences of women with vulvodynia on their journey toward diagnosis, by using semi-structured interviews and an interpretative phenomenological analysis (IPA) methodology. Eight women were interviewed, and their experiences were analyzed and interpreted into three master themes, each with constituent sub-themes: (1) The Journey Is a Battle, (2) "What Is Vulvodynia?": Ambivalence Toward Diagnosis, and (3) Patriarchy, Women, and Sex. Overall, women perceived a healthcare system which was dismissive and shaming, with an inadequate knowledge of vulvodynia. This in turn impacted on women's psychological well-being. Psychological understanding, one-to-one therapy, and consultation and training for healthcare professionals may help to improve the psychological well-being of women with vulvodynia.

Women's Subjective Experiences of Living with Vulvodynia: A Systematic Review and Meta-Ethnography.

Vulvodynia, the experience of an idiopathic pain in the form of burning, soreness, or throbbing in the vulval area, affects around 4-16% of the population. The current review used systematic search strategies and meta-ethnography as a means of identifying, analyzing, and synthesizing the existing literature pertaining to women's subjective experiences of living with vulvodynia. Four key concepts were identified: (1) Social Constructions: Sex, Women, and Femininity: Women experienced negative consequences of social narratives around womanhood, sexuality, and femininity, including the prioritization of penetrative sex, the belief that it is the role of women to provide sex for men, and media portrayals of sex as easy and natural. (2) Seeking Help: Women experienced the healthcare system as dismissive, sometimes being prescribed treatments that exacerbated the experience of pain. (3) Psychological and Relational Impact of Vulvodynia: Women experienced feeling shame and guilt, which in turn led to the experience of psychological distress, low mood, anxiety, and low self-esteem. Moreover, women reported feeling silenced which in turn affected their heterosexual relationships and their peer relationships by feeling social isolated. (4) A Way Forward: Women found changing narratives, as well as group and individual multidisciplinary approaches, helpful in managing vulvodynia. The findings of the review conclude that interventions at the individual level, as well as interventions aimed at equipping women to challenge social narratives, may be helpful for the psychological well-being of women with vulvodynia.

Cognition in school-age children exposed to levetiracetam, topiramate, or sodium valproate.

OBJECTIVE: To investigate the effects of prenatal exposure to monotherapy levetiracetam, topiramate, and valproate on child cognitive functioning. METHODS: This was a cross-sectional observational study. Children exposed to monotherapy levetiracetam (n = 42), topiramate (n = 27), or valproate (n = 47) and a group of children born to women who had untreated epilepsy (n = 55) were enrolled retrospectively from the UK Epilepsy and Pregnancy Register. Assessor-blinded neuropsychological assessments were conducted between 5 and 9 years of age. Information was collected on demographic and health variables and adjusted for in multiple regression analyses. RESULTS: In the adjusted analyses, prenatal exposure to levetiracetam and topiramate were not found to be associated with reductions in child cognitive abilities, and adverse outcomes were not associated with increasing dose. Increasing dose of valproate, however, was associated with poorer full-scale IQ (-10.6, 95% confidence interval [CI] -16.3 to -5.0, p < 0.001), verbal abilities (-11.2, 95% CI -16.8 to -5.5, p < 0.001), nonverbal abilities (-11.1, 95% CI -17.3 to -4.9, p < 0.001), and expressive language ability (-2.3, 95% CI -3.4 to -1.6, p < 0.001). Comparisons across medications revealed poorer performance for children exposed to higher doses of valproate in comparison to children exposed to higher doses of levetiracetam or topiramate. CONCLUSIONS: Preconception counseling should include discussion of neurodevelopmental outcomes for specific treatments and their doses and women should be made aware of the limited nature of the evidence base for newer antiepileptic drugs.

IQ at 6 years after in utero exposure to antiepileptic drugs: a controlled cohort study.

OBJECTIVE: To delineate the risk to child IQ associated with frequently prescribed antiepileptic drugs. METHODS: Children born to women with epilepsy (n = 243) and women without epilepsy (n = 287) were recruited during pregnancy and followed prospectively. Of these, 408 were blindly assessed at 6 years of age. Maternal and child demographics were collected and entered into statistical models. RESULTS: The adjusted mean IQ was 9.7 points lower (95% confidence interval [CI] -4.9 to -14.6; p < 0.001) for children exposed to high-dose (>800 mg daily) valproate, with a similar significant effect observed for the verbal, nonverbal, and spatial subscales. Children exposed to high-dose valproate had an 8-fold increased need of educational intervention relative to control children (adjusted relative risk, 95% CI 8.0, 2.5-19.7; p < 0.001). Valproate at doses <800 mg daily was not associated with reduced IQ, but was associated with impaired verbal abilities (-5.6, 95% CI -11.1 to -0.1; p = 0.04) and a 6-fold increase in educational intervention (95% CI 1.4-18.0; p = 0.01). In utero exposure to carbamazepine or lamotrigine did not have a significant effect on IQ, but carbamazepine was associated with reduced verbal abilities (-4.2, 95% CI -0.6 to -7.8; p = 0.02) and increased frequency of IQ <85. CONCLUSIONS: Consistent with data from younger cohorts, school-aged children exposed to valproate at maternal doses more than 800 mg daily continue to experience significantly poorer cognitive development than control children or children exposed to lamotrigine and carbamazepine.

The prevalence of neurodevelopmental disorders in children prenatally exposed to antiepileptic drugs.

The aim of this study was to compare the prevalence of diagnosed neurodevelopmental disorders in children exposed, in utero, to different antiepileptic drug treatments. A prospective cohort of women with epilepsy and a control group of women without epilepsy were recruited from antenatal clinics. The children of this cohort were followed longitudinally until 6 years of age (n=415). Diagnosis of a neurodevelopmental disorder was made independently of the research team. Multiple logistic regression analysis revealed an increase in risk of neurodevelopmental disorders in children exposed to monotherapy sodium valproate (VPA) (6/50, 12.0%; aOR 6.05, 95%CI 1.65 to 24.53, p=0.007) and in those exposed to polytherapy with sodium VPA (3/20, 15.0%; aOR 9.97, 95% CI 1.82 to 49.40, p=0.005) compared with control children (4/214; 1.87%). Autistic spectrum disorder was the most frequent diagnosis. No significant increase was found among children exposed to carbamazepine (1/50) or lamotrigine (2/30). An accumulation of evidence demonstrates that the risks associated with prenatal sodium VPA exposure include an increased prevalence of neurodevelopmental disorders. Whether such disorders are discrete or represent the severe end of a continuum of altered neurodevelopmental functioning requires further investigation. Replication and extension of this research is required to investigate the mechanism(s) underpinning the relationship. Finally, the increased likelihood of neurodevelopmental disorders should be communicated to women for whom sodium VPA is a treatment option.

Prenatal exposure to anti-epileptic drugs: the need for preconception counselling.

There is accumulating evidence that prenatal exposure to antiepileptic drugs (AEDs) poses an increased risk to the fetus. There is robust evidence surrounding the incidence of major congenital malformations following exposure to some commonly prescribed AEDs, and growing evidence that prenatal exposure to certain AEDs is also associated with a reduction in cognitive functioning and an increase in neurodevelopmental disorders in childhood. This article discusses some of the findings in regards to pregnancy outcome after exposure to AEDs, the possible implications for the child and, given recent findings, the need for preconception counselling for women with epilepsy of childbearing potential.