• Assessing the medium-term impact of a home-visiting programme on child maltreatment in England: protocol for a routine data linkage study.

      Ludd-Widger, Fiona V.; Cannings-John, Rebecca; Channon, Sue; Fitzsimmons, Deborah; Hood, Kerenza; Jones, Kerina H.; Kemp, Alison; Kenkre, Joyce; Longo, Mirella; McEwan, Kirsten; et al. (BMJ Publishing Group Ltd., 2017-05-03)
      ABSTRACT Introduction Child maltreatment involves acts of omission (neglect) or commission (abuse) often by caregivers that results in potential or actual harm to a child. The Building Blocks trial (ISRCTN23019866) assessed the short-term impact of an intensive programme of antenatal and postnatal visiting by specially trained nurses to support young pregnant women in England. The Building Blocks: 2–6 Study will assess the medium-term impacts of the programme for mothers and children (n=1562), through the linkage of routinely collected data to the trial data, with a particular emphasis on the programme’s impact on preventing child maltreatment. Methods and analysis We have developed a bespoke model of data linkage whereby outcome data for the trial cohort will be retrieved by linked anonymous data abstraction from NHS Digital, Office for National Statistics and the Department for Education’s National Pupil Database. Participants will be given reasonable opportunity to opt out of this study prior to data transfer. The information centres will match participants to the information held in their databases using standard identifiers and send extracts to a third-party safe haven. The study will have 80% power to detect a 4% difference (4%vs8%) for the binary primary outcome of child in need status (from birth to key stage 1) at a two-sided 5% alpha level by following up 602 children in each trial arm. Analysis will be by intention to treat using logistic multilevel modelling. A cost-and-consequences analysis will extend the time frame of the economic analysis from the original trial. Ethics and dissemination The study protocol has been approved by the National Health Service Wales Research Ethics Committee and the Health Research Authority’s Confidentiality Advisory Group. Methods of innovative study design and findings will be disseminated through peer-reviewed journals and conferences; results will be of interest to clinical and policy stakeholders in the UK.
    • Availability of breastfeeding peer-support in the UK: a cross-sectional survey.

      Grant, Aimee; McEwan, Kirsten; Tedstone, Sally; Greene, Giles; Copeland, Lauren; Hunter, Billie; Sanders, Julia; Phillips, Rhiannon; Brown, Amy; Robling, Mike; et al. (Wiley, 2017-07-07)
      Peer support is recommended by the World Health Organization for the initiation and continuation of breastfeeding, and this recommendation is included in United Kingdom (U.K.) guidance. There is a lack of information about how, when, and where breastfeeding peer support was provided in the U.K. We aimed to generate an overview of how peer support is delivered in the U.K. and to gain an understanding of challenges for implementation. We surveyed all U.K. infant feeding coordinators (n = 696) who were part of U.K.‐based National Infant Feeding Networks, covering 177 National Health Service (NHS) organisations. We received 136 responses (individual response rate 19.5%), covering 102 U.K. NHS organisations (organisational response rate 58%). We also searched NHS organisation websites to obtain data on the presence of breastfeeding peer support. Breastfeeding peer support was available in 56% of areas. However, coverage within areas was variable. The provision of training and ongoing supervision, and peer‐supporter roles, varied significantly between services. Around one third of respondents felt that breastfeeding peer‐support services were not well integrated with NHS health services. Financial issues were commonly reported to have a negative impact on service provision. One quarter of respondents stated that breastfeeding peer support was not accessed by mothers from poorer social backgrounds. Overall, there was marked variation in the provision of peer‐support services for breastfeeding in the U.K. A more robust evidence base is urgently needed to inform guidance on the structure and provision of breastfeeding peer‐support services.
    • Controlled antenatal thyroid screening II: Effect of treating maternal suboptimal thyroid function on child cognition.

      Hales, Charlotte; Taylor, Peter N.; Channon, Sue; Paradice, Ruth; McEwan, Kirsten; Zhang, Lei; Gyedu, Michael; Bakhsh, Ameen; Okosieme, Onyebuchi; Muller, Ilaria; et al. (Oxford Academic, 2018-01-15)
      Context and Objective The Controlled Antenatal Thyroid Screening (CATS) study investigated treatment of suboptimal gestational thyroid function (SGTF) on childhood cognition and found no difference in intelligence quotient (IQ) at 3 years between children of treated and untreated SGTF mothers. We have measured IQ in the same children at age 9.5 years and included children from normal gestational thyroid function (normal-GTF) mothers. Design, Setting, and Participants One examiner, blinded to participant group, assessed children’s IQ (Wechsler Intelligence Scale for Children, Fourth Edition UK), long-term memory, and motor function (Developmental Neuropsychological Assessment II) from children of 119 treated and 98 untreated SGTF mothers plus children of 232 mothers with normal-GTF. Logistic regression explored the odds and percentages of an IQ < 85 in the groups. Results There was no difference in IQ < 85 between children of mothers with normal-GTF and combined SGTF, i.e., treated and untreated (fully adjusted odds ratio [OR] = 1.15 [95% confidence interval (CI) 0.52, 2.51]; P = 0.731). Furthermore, there was no significant effect of treatment [untreated OR = 1.33 (95% CI 0.53, 3.34); treated OR = 0.75 (95% CI 0.27, 2.06) P = 0.576]. IQ < 85 was 6.03% in normal-GTF, 7.56% in treated, and 11.22% in untreated groups. Analyses accounting for treated-SGTF women with free thyroxine > 97.5th percentile of the entire CATS-I cohort revealed no significant effect on a child’s IQ < 85 in CATS-II. IQ at age 3 predicted IQ at age 9.5 (P < 0.0001) and accounted for 45% of the variation. Conclusions Maternal thyroxine during pregnancy did not improve child cognition at age 9.5 years. Our findings confirmed CATS-I and suggest that the lack of treatment effect may be a result of the similar proportion of IQ < 85 in children of women with normal-GTF and SGTF.
    • A descriptive study of feelings of arrested escape (entrapment) and arrested anger in people presenting to an emergency department following an episode of self-harm.

      Clarke, Martin; McEwan, Kirsten; Ness, Jennifer; Waters, Keith; Basran, Jaskaran; Gilbert, Paul; Derbyshire Healthcare NHS Foundation Trust; Nottinghamshire Healthcare NHS Foundation Trust; Cardiff University; University of Derby (Frontiers, 2016-09-14)
      To explore the role of elevated feelings of anger and desires to escape (fight/flight), which are experienced as inhibited, blocked, and arrested (i.e., arrested anger and arrested flight/escape leading to feelings of entrapment). This descriptive study developed measures of arrested anger and arrested flight and explored these in the context of a recent self-harm event in people presenting to a Hospital’s Emergency Department (ED).
    • Do therapeutic imagery practices affect physiological and emotional indicators of threat in high self-critics?

      Duarte, Joana; McEwan, Kirsten; Barnes, Christopher; Gilbert, Paul; Maratos, Frances A.; University of Coimbra; University of Derby; Cardiff University; Cognitive and Behavioural Centre for Research and Intervention; University of Coimbra; Portugal; Institute of Primary Care and Population Health; School of Medicine; Cardiff University; Wales UK; et al. (Wiley, 2015-09)
      Objectives: Imagery is known to be a powerful means of stimulating various physiological processes and is increasingly used within standard psychological therapies. Compassion-focused imagery (CFI) has been used to stimulate affiliative emotion in people with mental health problems. However, evidence suggests that self-critical individuals may have particular difficulties in this domain with single trials. The aim of the present study was to further investigate the role of self-criticism in responsiveness to CFI by specifically pre-selecting participants based on trait self-criticism. Design: Using the Forms of Self-Criticism/Self-Reassuring Scale, 29 individuals from a total sample of 139 were pre-selected to determine how self-criticism impacts upon an initial instance of imagery. Methods: All participants took part in three activities: a control imagery intervention (useable data N = 25), a standard CFI intervention (useable data N = 25), and a non-intervention control (useable data N = 24). Physiological measurements (alpha amylase) as well as questionnaire measures of emotional responding (i.e., the Positive and Negative Affect Schedule, the Types of Positive Affect Scale, and the State Adult Attachment Scale) were taken before and after the different interventions. Results: Following both imagery interventions, repeated measures analyses revealed that alpha amylase increased significantly for high self-critics compared with low self-critics. High self-critics (HSC) also reported greater insecurity on entering the imagery session and more negative CFI experiences compared with low self-critics. Practitioner Points: Data demonstrate that HSC respond negatively to imagery interventions in a single trial. This highlights that imagery focused therapies (e.g., CFI) need interventions that manage fears, blocks, and resistances to the techniques, particularly in HSC. An initial instance of imagery (e.g., CFI) can be frightening for people who have a tendency to be self-critical. This research provides examples of physiological and emotional responses to imagery type therapies in high and low self-critics, and associated clinical implications. Therapists may find it helpful to be mindful that when introducing imagery based therapies, highly self-critical patients need interventions that manage fears, blocks, and resistances to the techniques.
    • An exploration into depression-focused and anger-focused rumination in relation to depression in a student population.

      Gilbert, Paul; Cheung, Mimi; Irons, Christopher Paul; McEwan, Kirsten; Cardiff University; Kingsway Hospital; University of Derby (British Association for Behavioural and Cognitive Psychotherapies, 2005-07-01)
      Research has shown an important link between depression and rumination. This study set out to explore depression-focused rumination and anger-focused rumination in relation to shame and entrapment, and depression. 166 undergraduate students completed a battery of self-report questionnaires measuring current depression, rumination on depressive symptoms, rumination on anger, and the frequency of shame-focused and entrapment-focused thoughts. Both depression-focused and anger-focused rumination were related to depression, and to the frequency of shame and entrapment thoughts. In a mediational model, the link between depression-focused rumination and depression was partially mediated by feeling trapped by, and wanting to escape from, one's thoughts and feelings. Thus the link between rumination and depression is complex. Although rumination may contribute to depression by generating a spiral of negative thinking and negative feeling, feeling trapped and unable to control one's rumination, and being flight motivated, may add a further dimension to the depressogenic qualities of rumination.
    • M11 A randomised controlled feasibility trial of a physical activity behaviour change intervention compared to social interaction in huntington’s disease.

      Busse, Monica; Quinn, Lori; Drew, Cheney; Kelson, Mark; Trubey, Rob; McEwan, Kirsten; Jones, Carys; Townson, Julia; Dawes, Helen; Tudor-Edwards, Rhiannon; et al. (BMJ Publishing Group Ltd., 2016-09-13)
      Background Regular physical activity has health benefits for people with Huntington’s disease (HD), however consistent engagement is challenging. We report the results of a single blind, multi-site, randomised controlled feasibility trial of a physical activity intervention in HD. Methods Participants were randomly assigned to physical activity or social contact control interventions. The primary outcome was feasibility. Short-term benefit was assessed with the Physical Performance Test (PPT), a measure of functional ability. A range of exploratory outcomes including home and community mobility (Life Space), self-efficacy (Lorig), physical activity (International Physical Activity Questionnaire (IPAQ)), as well as disease-specific measures of motor and cognitive function were evaluated. Intervention fidelity and delivery costs were established. The trial was registered (ISRCTN 65378754 (13/03/2014)). Results We recruited 46 people with HD; 22 were randomised to the physical intervention (n = 16 analysed); 24 to social contact (n = 22 analysed). Retention, fidelity and adherence met pre-determined criteria. IPAQ scores in the physical intervention group were 142% higher (1.42; 95% CI: [−22%%, 653%]); and self-efficacy for exercise (1.6; 95% CI: [0.6, 2.7]) was also higher. Life Space scores were 12 points different between groups; 95% CI: [−2, 27]. Cognitive function was better in the physical intervention group with 2·9 more correct responses (95% CI: [0.01, 5.9]) on the Symbol Digit Modality test. There were no differences in other exploratory outcome measures and in particular no between-group differences in the PPT (treatment effect: 0.3, 95% CI: [−2.1, 2.7]). Mean (SD) physical intervention per session cost was £56.97 (£34.72). Conclusion A physical activity coaching intervention is feasible, can improve self-efficacy, physical activity behaviours and cognitive function in people with HD and represents excellent value for money in a devastating disease.
    • Optimising mobility outcome measures in Huntington's disease.

      Busse, Monica; Quinn, Lori; Khalil, Hanan; McEwan, Kirsten; Cardiff University; Jordan University of Science and Technology (IOS Press, 2014)
      Abstract. Background: Many of the performance-based mobility measures that are currently used in Huntington’s disease (HD) were developed for assessment in other neurological conditions such as stroke. Objective: We aimed to assess the individual item-response of commonly used performance-based mobility measures, with a view to optimizing the scales for specific application in Huntington’s Disease (HD). Method: Data from a larger multicentre, observational study were used. Seventy-five people with HD (11 pre-manifest & 64 manifest) were assessed on the Six-Minute Walk Test, 10-Meter Walk Test, Timed “Up & Go” Test (TUG), Berg Balance Scale (BBS), Physical Performance Test (PPT), Four Square Step Test, and Tinetti Mobility Test (TMT). The Unified Huntington’s Disease Rating Scale (UHDRS) Total Motor Score, Functional Assessment Scale and Total Functional Capacity scores were recorded, alongside cognitive measures. Standard regression analysis was used to assess predictive validity. Individual item responses were investigated using a sequence of approaches to allow for gradual removal of items and the subsequent creation of shortened versions. Psychometric properties (reliability and discriminant ability) of the shortened scales were assessed. Results: TUG ( 0.46, CI 0.20-3.47), BBS ( −0.35, CI−2.10-0.14), and TMT ( −0.45, CI−3.14-0.64) were good disease specific mobility measures. PPT was the best measure of functional performance ( 0.42, CI 0.00-0.43 for TFC & 0.57 CI 0.15-0.81 for FAS). Shortened versions of BBS and TMT were developed based on item analysis. The resultant BBS and TMT shortened scales were reliable for use in manifest HD. ROC analysis showed that shortened scales were able to discriminate between manifest and pre-manifest disease states. Discussion:OurdatasuggeststhatthePPTisappropriateasageneralmeasureoffunctioninindividualswithHD,andwehave identified shortened versions of the BBS and TMT that measure the unique gait and balance impairments in HD. These scales, alongside the TUG, may therefore be important measures to consider in future clinical trials.
    • Physical activity self-management and coaching compared to social interaction in huntington disease: results from the ENGAGE-HD randomized, controlled, pilot feasibility trial.

      Busse, Monica; Quinn, Lori; Drew, Cheney; Kelson, Mark; Trubey, Rob; McEwan, Kirsten; Jones, Carys; Townson, Julia; Dawes, Helen; Tudor-Edwards, Rhiannon; et al. (Oxford Academic, 2017-03-24)
      Abstract Background: Self-management and self-efficacy for physical activity is not routinely considered in neurologic rehabilitation. Objective: We assessed feasibility and outcomes of a 14 week physical activity self-management and coaching intervention compared with social contact in Huntington's disease (HD) to inform the design of a future full-scale trial. Design: Assessor blind, multi-site, randomized pilot feasibility trial. Setting: Participants were recruited and assessed at baseline, 16 weeks following randomisation, and then again at 26 weeks in HD specialist clinics with intervention delivery by trained coaches in the participants’ homes. Patients and Intervention: People with HD were allocated to the ENGAGE-HD physical activity coaching intervention or a social interaction intervention. Measurements: Eligibility, recruitment, retention and intervention adherence were determined at 16 weeks. Other outcomes of interest included measures of functional, home and community mobility, self-efficacy, physical activity and disease-specific measures of motor and cognition. Fidelity and costs for both the physical activity and social comparator interventions were established. Results: Forty % (n=46) of eligible patients were enrolled and 22 randomised to the physical intervention and 24 to social intervention. Retention rates in the physical intervention and social intervention were 77% and 92% respectively. Minimum adherence criteria were achieved by 82% of participants in the physical intervention and 100% in the social intervention. There was no indication of between group treatment effects on function, however increases in self-efficacy for exercise and self-reported levels of physical activity in the physical intervention lends support to our pre-defined intervention logic model. Limitations: The use of self-report measures may have introduced bias. Conclusions: An HD physical activity self-management and coaching intervention is feasible and worthy of further investigation.
    • Pragmatic Randomised controlled trial of a trauma-focused guided self-help Programme versus InDividual trauma-focused cognitive behavioural therapy for post-traumatic stress disorder (RAPID): trial protocol.

      Nollett, Claire; Lewis, Catrin; Kitchiner, Neil; Roberts, Neil; Addison, Katy; Brookes-Howell, Lucy; Cosgrove, Sarah; Cullen, Katherine; Ehlers, Anke; Heke, Sarah; et al. (Springer Nature, 2018-03-27)
      Abstract Background: There is good evidence that trauma-focused therapies for Post-Traumatic Stress Disorder are effective. However, they are not always feasible to deliver due a shortage of trained therapists and demands on the patient. An online trauma-focused Guided Self-Help (GSH) programme which could overcome these barriers has shown promise in a pilot study. This study will be the first to evaluate GSH against standard face-to-face therapy to assess its suitability for use in the NHS. Methods: The study is a large-scale multi-centre pragmatic randomised controlled non-inferiority trial, with assessors masked to treatment allocation. One hundred and ninety-two participants will be randomly allocated to receive either face-to-face trauma-focused cognitive behaviour therapy (TFCBT) or trauma-focused online guided self-help (GSH). The primary outcome will be the severity of symptoms of PTSD over the previous week as measured by the Clinician Administered PTSD Scale for DSM5 (CAPS-5) at 16 weeks post-randomisation. Secondary outcome measures include PTSD symptoms over the previous month as measured by the CAPS-5 at 52 weeks plus the Impact of Event Scale – revised (IES-R), Work and Social Adjustment Scale (WSAS), Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder-7 (GAD-7), Alcohol Use Disorders Test (AUDIT-O), Multidimensional Scale for Perceived Social Support (MSPSS), short Post-Traumatic Cognitions Inventory (PTCI), Insomnia Severity Index (ISI) and General Self Efficacy Scale (GSES) measured at 16 and 52 weeks post-randomisation. Changes in health-related quality of life will be measured by the EQ-5D and the level of healthcare resource utilisation for health economic analysis will be determined by an amended version of the Client Socio-Demographic and Service Receipt Inventory European Version. The Client Satisfaction Questionnaire (CSQ) will be collected at 16 weeks post-randomisation to evaluate treatment satisfaction. Discussion: This study will be the first to compare online GSH with usual face-to-face therapy for PTSD. The strengths are that it will test a rigorously developed intervention in a real world setting to inform NHS commissioning. The potential challenges of delivering such a pragmatic study may include participant recruitment, retention and adherence, therapist retention, and fidelity of intervention delivery.