Evaluating the effectiveness and cost effectiveness of the 'strengthening families, strengthening communities' group-based parenting programme: study protocol and initial insights.

BACKGROUND: Up to 20% of UK children experience socio-emotional difficulties which can have serious implications for themselves, their families and society. Stark socioeconomic and ethnic inequalities in children's well-being exist. Supporting parents to develop effective parenting skills is an important preventive strategy in reducing inequalities. Parenting interventions have been developed, which aim to reduce the severity and impact of these difficulties. However, most parenting interventions in the UK focus on early childhood (0-10 years) and often fail to engage families from ethnic minority groups and those living in poverty. Strengthening Families, Strengthening Communities (SFSC) is a parenting programme designed by the Race Equality Foundation, which aims to address this gap. Evidence from preliminary studies is encouraging, but no randomised controlled trials have been undertaken so far. METHODS/DESIGN: The TOGETHER study is a multi-centre, waiting list controlled, randomised trial, which aims to test the effectiveness of SFSC in families with children aged 3-18 across seven urban areas in England with ethnically and socially diverse populations. The primary outcome is parental mental well-being (assessed by the Warwick-Edinburgh Mental Well-Being Scale). Secondary outcomes include child socio-emotional well-being, parenting practices, family relationships, self-efficacy, quality of life, and community engagement. Outcomes are assessed at baseline, post intervention, three- and six-months post intervention. Cost effectiveness will be estimated using a cost-utility analysis and cost-consequences analysis. The study is conducted in two stages. Stage 1 comprised a 6-month internal pilot to determine the feasibility of the trial. A set of progression criteria were developed to determine whether the stage 2 main trial should proceed. An embedded process evaluation will assess the fidelity and acceptability of the intervention. DISCUSSION: In this paper we provide details of the study protocol for this trial. We also describe challenges to implementing the protocol and how these were addressed. Once completed, if beneficial effects on both parental and child outcomes are found, the impact, both immediate and longer term, are potentially significant. As the intervention focuses on supporting families living in poverty and those from minority ethnic communities, the intervention should also ultimately have a beneficial impact on reducing health inequalities. TRIAL REGISTRATION: Prospectively registered Randomised Controlled Trial ISRCTN15194500 .

Patient and companion shared decision making and satisfaction with decisions about starting cholinesterase medication at dementia diagnosis.

BACKGROUND: there is little research on how people with dementia are involved in treatment decisions at diagnosis. OBJECTIVE: to measure shared decision making when starting cholinesterase inhibitors, investigate associations with contextual factors and explore satisfaction and experience of the diagnostic meeting. SETTING: nine UK memory clinics in two geographical locations. SUBJECTS: 74 people receiving dementia diagnoses (with 69 companions) and 21 doctors. METHODS: we video-recorded 74 memory clinic consultations and rated doctor-shared decision making behaviours using the Observing Patient Involvement in Decision Making scale (OPTION-5 scale). Patients and companions rated their satisfaction and experience. Mixed-effects regressions investigated involvement and (i) number people present, meeting length, capacity, cognitive functioning, diagnosis; and (ii) patient/companion satisfaction and consultation experience. RESULTS: mean consultation time was 26.7 min. Mean OPTION-5 score was 22.5/100 (Standard Deviation = 17.3). Doctors involved patients in decisions more often when patients had mixed dementia (ß = 10.13, 95% confidence interval 1.25-19.0, P = 0.025) and in shorter meetings (ß = -0.51, 95% CI -0.87 to -0.15, P = 0.006). Patient and companion satisfaction were high and not associated with whether doctors invited patient involvement. Half of patients and one-third companions were uncertain about the meeting outcome, experienced communication barriers and negative emotions. CONCLUSIONS: consultations scored low on shared decision making, but were comparable to other settings and were not lower with more cognitively impaired patients. Negative patient and companion experiences reflect the importance of supporting healthcare providers to address patient and companion emotions and need for information.

Cognitive vulnerability to bipolar disorder in offspring of parents with bipolar disorder.

BACKGROUND: Bipolar disorder is a highly heritable illness, with a positive family history robustly predictive of its onset. It follows that studying biological children of parents with bipolar disorder may provide information about developmental pathways to the disorder. Moreover, such studies may serve as a useful test of theories that attribute a causal role in the development of mood disorders to psychological processes. METHOD: Psychological style (including self-esteem, coping style with depression, domain-specific risk-taking, sensation-seeking, sensitivity to reward and punishment, and hypomanic personality and cognition) was assessed in 30 offspring of bipolar parents and 30 children of well parents. Parents of both child groups completed identical assessments. RESULTS: Although expected differences between parents with bipolar disorder and well parents were detected (such as low self-esteem, increased rumination, high sensitivity to reward and punishment), offspring of bipolar parents were, as a group, not significantly different from well offspring, apart from a modest trend towards lower adaptive coping. When divided into affected and non-affected subgroups, both groups of index children showed lower novelty-seeking. Only affected index children showed lower self-esteem, increased rumination, sensitivity to punishment, and hypomanic cognitions. Notably, these processes were associated with symptoms of depression. CONCLUSION: Psychological abnormalities in index offspring were associated with having met diagnostic criteria for psychiatric illnesses and the presence of mood symptoms, rather than preceding them. Implications of the present findings for our understanding of the development of bipolar disorder, as well as for informing early interventions, are discussed.

Discontinuing financial incentives for adherence to antipsychotic depot medication: long-term outcomes of a cluster randomised controlled trial.

OBJECTIVES: In a cluster randomised controlled trial, offering financial incentives improved adherence to antipsychotic depot medication over a 1-year period. Yet, it is unknown whether this positive effect is sustained once the incentives stop. METHODS AND ANALYSES: Patients in the intervention and control group were followed up for 2 years after the intervention. Primary and secondary outcomes were assessed at 6 months and 24 months post intervention. Assessments were conducted between September 2011 and November 2014. RESULTS: After the intervention period, intervention and control groups did not show any statistically significant differences in adherence, neither in the first 6 months (71% and 77%, respectively) nor in the following 18 months (68%, 74%). There were no statistically significant differences in secondary outcomes, that is, adherence ≥95% and untoward incidents either. CONCLUSIONS: It may be concluded that incentives to improve adherence to antipsychotic maintenance medication are effective only for as long as they are provided. Once they are stopped, adherence returns to approximately baseline level with no sustained benefit. TRIAL REGISTRATION NUMBER: ISRCTN77769281; Results.

Effectiveness of one-to-one volunteer support for patients with psychosis: protocol of a randomised controlled trial.

INTRODUCTION: Social isolation is common in patients with psychosis and associated with a number of negative outcomes. Programmes in which volunteers provide one-to-one support-often referred to as befriending-have been reputed to achieve favourable outcomes. However, trial-based evidence for their effectiveness is limited. METHODS AND ANALYSIS: This is a randomised controlled trial comparing the effects of one-to-one volunteer support with an active control condition for patients with psychosis over a 1-year period. Patients in the intervention group will receive the support of a volunteer for 1 year, who will meet them weekly and engage them in social and recreational activities. Patients in the control group will not receive support from a volunteer. In both groups, patients will be given a booklet detailing locally available social activities and otherwise receive treatment as usual. Patients, volunteers, clinicians and researchers involved in the delivery of the intervention will not be blinded to group assignment, while researchers carrying out data collection will be blinded. Data collection will be conducted at baseline, at 6 and 12 months. The primary outcome is the amount of time spent engaging in social activities per day. Secondary outcomes include symptoms, quality of life, self-esteem and costs of care. Attitudes of volunteers towards mentally ill people will be assessed. Finally, in-depth interviews will be conducted with patients and volunteers. ETHICS AND DISSEMINATION: The study has been approved by the National Research Ethics Service (NRES) Committee London-Camden & Kings Cross (reference 15/LO/0674). The findings of the trial will be published in open access peer-reviewed journals and in the National Institute for Health Research (NIHR) journals library, and presented at scientific conferences. In addition, findings will be summarised for a lay audience and circulated to all relevant National Health Service (NHS) and voluntary organisations. TRIAL REGISTRATION NUMBER: ISRCTN14021839; Pre-results.

The effect of financial incentives on adherence to antipsychotic depot medication: does it change over time?

OBJECTIVE: A recent cluster-randomized controlled trial found that offering financial incentives improves adherence to long-acting injectable antipsychotics (LAIs). The present study investigates whether the impact of incentives diminishes over time and whether the improvement in adherence is linked to the amount of incentives offered. METHOD: Seventy-three teams with 141 patients with psychotic disorders (using ICD-10) were randomized to the intervention or control group. Over 1 year, patients in the intervention group received £15 (US $23) for each LAI, while control patients received treatment as usual. Adherence levels, ie, the percentage of prescribed LAIs that were received, were calculated for quarterly intervals. The amount of incentives offered was calculated from the treatment cycle at baseline. Multilevel models were used to examine the time course of the effect of incentives and the effect of the amount of incentives offered on adherence. RESULTS: Adherence increased in both the intervention and the control group over time by an average of 4.2% per quarterly interval (95% CI, 2.8%-5.6%; P < .001). Despite this general increase, adherence in the intervention group remained improved compared to the control group by between 11% and 14% per quarterly interval. There was no interaction effect between time and treatment group. Further, a higher total amount of incentives was associated with poorer adherence (ßbootstrapped = -0.11; 95% CIbootstrapped, -0.20 to -0.01; P = .023). CONCLUSIONS: A substantial effect of financial incentives on adherence to LAIs occurs within the first 3 months of the intervention and is sustained over 1 year. A higher total amount of incentives does not increase the effect. TRIAL REGISTRATION: ISRCTN.com identifier: ISRCTN77769281 and UKCRN.org identifier: 7033.

The inter-relationship between mood, self-esteem and response styles in adolescent offspring of bipolar parents: an experience sampling study.

The response styles theory of depression (Nolen-Hoeksema, 1991) proposes three main strategies individuals employ in response to low mood: rumination, active coping (distraction and problem-solving) and risk taking. Although recent research has suggested this theory has utility in understanding the symptoms of bipolar disorder (BD), the role of these processes in conferring vulnerability to the condition is poorly understood. Twenty-three adolescent children of patients with BD and 25 offspring of well parents completed the Experience Sampling Method (ESM; Csikszentmihalyi and Larson, 1987) diary for six days. Longitudinal analyses were carried out to examine inter-relationships between mood, self-esteem and response styles. Increased negative as well as positive mood resulted in greater rumination in both groups. Low self-esteem triggered greater risk-taking at the subsequent time point in the at-risk group, while negative affect instigated increased active coping in the control group. In both groups, engagement in risk-taking improved mood at the subsequent time point, whilst rumination dampened self-esteem. Differential longitudinal associations between mood, self-esteem and response styles between at-risk and control children suggest early psychological vulnerability in the offspring of BD parents, with important indications for early intervention.

Discrepancies between explicit and implicit self-esteem and their relationship to symptoms of depression and mania.

OBJECTIVES: Self-esteem is a key feature of bipolar symptomatology. However, so far no study has examined the interaction between explicit and implicit self-esteem in individuals vulnerable to bipolar disorder. DESIGN: Cross-sectional design was employed. METHODS: Thirty children of parents with bipolar disorder and 30 offspring of control parents completed Hamilton Rating Scale for Depression, the Bech-Rafaelson Mania Scale, the Self-esteem Rating Scale and the Implicit Association Test. RESULTS: No differences between groups were revealed in levels of explicit or implicit self-esteem. However, bipolar offspring showed increased levels of symptoms of depression and mania. Furthermore, depressive symptoms were associated with low explicit self-esteem, whilst symptoms of mania were associated with low implicit self-esteem. When self-esteem discrepancies were examined, damaged self-esteem (i.e., low explicit but high implicit self-esteem) was associated with depression, whilst no associations between mania and self-esteem discrepancies were found. CONCLUSIONS: Not only explicit, but also implicit self-esteem, and the interactions between the two are of relevance in bipolar symptoms. Clinical implications and future research directions are discussed. PRACTITIONER POINTS: Explicit as well as implicit SE, and particularly their relationship, are relevant for mental health. Fluctuations in implicit SE may serve as an early indicator for risk of bipolarity. Psychotherapeutic approaches may be more suitable for one kind of SE challenge than the other.

The dynamics of mood and coping in bipolar disorder: longitudinal investigations of the inter-relationship between affect, self-esteem and response styles.

BACKGROUND: Previous research has suggested that the way bipolar patients respond to depressive mood impacts on the future course of the illness, with rumination prolonging depression and risk-taking possibly triggering hypomania. However, the relationship over time between variables such as mood, self-esteem, and response style to negative affect is complex and has not been directly examined in any previous study--an important limitation, which the present study seeks to address. METHODS: In order to maximize ecological validity, individuals diagnosed with bipolar disorder (N = 48) reported mood, self-esteem and response styles to depression, together with contextual information, up to 60 times over a period of six days, using experience sampling diaries. Entries were cued by quasi-random bleeps from digital watches. Longitudinal multilevel models were estimated, with mood and self-esteem as predictors of subsequent response styles. Similar models were then estimated with response styles as predictors of subsequent mood and self-esteem. Cross-sectional associations of daily-life correlates with symptoms were also examined. RESULTS: Cross-sectionally, symptoms of depression as well as mania were significantly related to low mood and self-esteem, and their increased fluctuations. Longitudinally, low mood significantly predicted rumination, and engaging in rumination dampened mood at the subsequent time point. Furthermore, high positive mood (marginally) instigated high risk-taking, and in turn engaging in risk-taking resulted in increased positive mood. Adaptive coping (i.e. problem-solving and distraction) was found to be an effective coping style in improving mood and self-esteem. CONCLUSIONS: This study is the first to directly test the relevance of response style theory, originally developed to explain unipolar depression, to understand symptom changes in bipolar disorder patients. The findings show that response styles significantly impact on subsequent mood but some of these effects are modulated by current mood state. Theoretical and clinical implications are discussed.