scholarly journals Evaluating the effectiveness and cost effectiveness of the ‘strengthening families, strengthening communities’ group-based parenting programme: study protocol and initial insights

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Annemarie Lodder ◽  
Anita Mehay ◽  
Hana Pavlickova ◽  
Zoe Hoare ◽  
Leandra Box ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Study Protocol ◽  
Well Being ◽  
Preventive Strategy ◽  
Parenting Interventions ◽  
Post Intervention ◽  
Parenting Programme ◽  
Randomised Controlled ◽  
Strengthening Families ◽  
Mental Well Being

Abstract 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.

Brief digital interventions to support the psychological well-being of NHS staff during the COVID-19 pandemic: a three-arm pilot randomised controlled trial (Preprint)

2021 ◽  
Author(s):  
Johannes De Kock ◽  
Helen Ann Latham ◽  
Richard G. Cowden ◽  
Breda Cullen ◽  
Katia Narzisi ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Well Being ◽  
Rate Of Change ◽  
Mental Toughness ◽  
Psychological Interventions ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Health And Social Care ◽  
Randomised Controlled ◽  
Mental Well Being

BACKGROUND Health and social care staff are at high risk of experiencing adverse mental health outcomes during the COVID-19 pandemic. Hence, there is a need to prioritize and identify ways to effectively support their psychological wellbeing. Compared to traditional psychological interventions, digital psychological interventions are cost effective treatment options that allow for large-scale dissemination and transcend social distancing, overcome rurality, and minimize clinician time. OBJECTIVE This study reports outcomes of a CONSORT-compliant parallel-arm pilot randomised controlled trial (RCT) examining the potential usefulness of an existing and a novel digital psychological intervention aimed at supporting psychological health among NHS staff working through the COVID-19 pandemic. METHODS NHS Highland (NHSH) frontline staff volunteers (N = 169) were randomly assigned to the newly developed NHSH Staff Wellbeing Project (NHSWBP), an established digital intervention (My Possible Self; MPS), or to a waitlist (WL) condition for four weeks. Attempts were made to blind participants to which digital intervention they were allocated. The interventions were fully automated, without any human input or guidance. We measured five self-reported psychological outcomes over three time points: before (baseline), middle (after 2 weeks) and after treatment (4 weeks). The primary outcomes were anxiety (GAD-7), depression (PHQ-9) and mental well-being (Warwick-Edinburgh Mental Well-being Scale). The secondary outcomes included mental toughness (Mental Toughness Index) and gratitude (the Gratitude Questionnaire). RESULTS Retention rates at middle and post-intervention were 77% (n = 130) and 63.3% (n = 107), respectively. At post-intervention, small differences were noted between the WL condition and the two treatment conditions on anxiety (vs. MPS: d = .07, 95% CI: -.20, .33; vs. NHSWBP: d = .06, 95% CI: -.19, .31), depression (vs. MPS: d = .37, 95% CI: .07, .66; vs. NHSWBP: d = .18, 95% CI: -.11, .46), and mental well-being (vs. MPS: d = -.04, 95% CI: -.62, -.08; vs. NHSWBP: d = -.15, 95% CI: -.41, .10). A similar pattern of between-group differences was found for the secondary outcomes. The NHSWBP group generally had larger within group effects than the other groups and displayed a greater rate of change compared to the other conditions on all outcomes, except for gratitude, where the rate of change was greatest for the MPS group. CONCLUSIONS Conclusions: Our analyses provided encouraging results for the use of brief digital psychological interventions in improving psychological well-being among health and social care workers. Future multi-site RCTs, with power to reliably detect differences, are needed to determine the efficacy of contextualised interventions relative to existing digital treatments. CLINICALTRIAL Trial registration: ISRCTN18107122

Improvement in Cognitive Abilities, Mental and Emotional Well-being of Teenagers following a Meditation Retreat: An Open-Trial pilot study

2021 ◽  
Vol 11 ◽  
Author(s):  
Divya Kanchibhotla ◽  
Saumya Subramanian ◽  
Shashank Kulkarni
Keyword(s):  
Cognitive Abilities ◽  
Well Being ◽  
Poor Mental Health ◽  
Cognitive Capacity ◽  
World Health ◽  
Repeated Measure ◽  
Post Intervention ◽  
Meditation Retreat ◽  
Mental Well Being

Background: Background: Today’s teenagers face several challenges that result in poor mental health, depression and anxiety. Several studies in the past decade have explored meditation as an adjunctive therapy for mental illness however the long term residual benefits of meditation have rarely been studied. Objective: The aim of the study was to investigate the benefits of a four day meditation retreat on cognitive abilities, mental and emotional well-being of teenagers. Methods: 303 teenagers participated in this study. Cognitive abilities of the students were measured using theSix letter cancellation test (SLCT). Mental and emotional well-being was measured using World Health Organization Well-being index (WHO-5) and Strength and Difficulties questionnaire (SDQ) respectively. Data analysis was performed using paired sample t-test and repeated measure ANOVA. Results: Teenagers demonstrated a 33% increase in average accuracy for SLCT post intervention. WHO-5 mental well-being index scores also increased significantly (p <1). The participants experienced significant reduction in emotional problems and hyperactivity as measured by SDQ. The benefits of the retreat continued to persist, when measured after 40 days of the intervention. Conclusion: A well-structured meditation retreat has significant and long term benefits on teenagers’ mental well-being, emotional stability and cognitive capacity.

scholarly journals Individual health trainers to support health and well-being for people under community supervision in the criminal justice system: the STRENGTHEN pilot RCT

2019 ◽  
Vol 7 (20) ◽  
pp. 1-136
Author(s):  
Lynne Callaghan ◽  
Tom P Thompson ◽  
Siobhan Creanor ◽  
Cath Quinn ◽  
Jane Senior ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Health Research ◽  
Pilot Trial ◽  
Well Being ◽  
Public Health Research ◽  
Scale Scores ◽  
Mental Well Being ◽  
Health And Well Being ◽  
Full Trial

Background Little is known about the effectiveness or cost-effectiveness of interventions, such as health trainer support, to improve the health and well-being of people recently released from prison or serving a community sentence, because of the challenges in recruiting participants and following them up. Objectives This pilot trial aimed to assess the acceptability and feasibility of the trial methods and intervention (and associated costs) for a randomised trial to assess the effectiveness and cost-effectiveness of health trainer support versus usual care. Design This trial involved a pilot multicentre, parallel, two-group randomised controlled trial recruiting 120 participants with 1 : 1 individual allocation to receive support from a health trainer and usual care or usual care alone, with a mixed-methods process evaluation, in 2017–18. Setting Participants were identified, screened and recruited in Community Rehabilitation Companies in Plymouth and Manchester or the National Probation Service in Plymouth. The intervention was delivered in the community. Participants Those who had been out of prison for at least 2 months (to allow community stabilisation), with at least 7 months of a community sentence remaining, were invited to participate; those who may have posed an unacceptable risk to the researchers and health trainers and those who were not interested in the trial or intervention support were excluded. Interventions The intervention group received, in addition to usual care, our person-centred health trainer support in one-to-one sessions for up to 14 weeks, either in person or via telephone. Health trainers aimed to empower participants to make healthy lifestyle changes (particularly in alcohol use, smoking, diet and physical activity) and take on the Five Ways to Well-being [Foresight Projects. Mental Capital and Wellbeing: Final Project Report. 2008. URL: www.gov.uk/government/publications/mental-capital-and-wellbeing-making-the-most-of-ourselves-in-the-21st-century (accessed 24 January 2019).], and also signposted to other options for support. The control group received treatment as usual, defined by available community and public service options for improving health and well-being. Main outcome measures The main outcomes included the Warwick–Edinburgh Mental Well-being Scale scores, alcohol use, smoking behaviour, dietary behaviour, physical activity, substance use, resource use, quality of life, intervention costs, intervention engagement and feasibility and acceptability of trial methods and the intervention. Results A great deal about recruitment was learned and the target of 120 participants was achieved. The minimum trial retention target at 6 months (60%) was met. Among those offered health trainer support, 62% had at least two sessions. The mixed-methods process evaluation generally supported the trial methods and intervention acceptability and feasibility. The proposed primary outcome, the Warwick–Edinburgh Mental Well-being Scale scores, provided us with valuable data to estimate the sample size for a full trial in which to test the effectiveness and cost-effectiveness of the intervention. Conclusions Based on the findings from this pilot trial, a full trial (with some modifications) seems justified, with a sample size of around 900 participants to detect between-group differences in the Warwick-Edinburgh Mental Well-being Scale scores at a 6-month follow-up. Future work A number of recruitment, trial retention, intervention engagement and blinding issues were identified in this pilot and recommendations are made in preparation of and within a full trial. Trial registration Current Controlled Trials ISRCTN80475744. Funding This project was funded by the National Institute for Health Research Public Health Research programme and will be published in full in Public Health Research; Vol. 7, No. 20. See the National Institute for Health Research Journals Library website for further project information.

scholarly journals SUGAR-DIP trial: oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029808 ◽  
Author(s):  
Leon de Wit ◽  
Doortje Rademaker ◽  
Daphne N Voormolen ◽  
Bettina M C Akerboom ◽  
Rosalie M Kiewiet-Kemper ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Glycaemic Control ◽  
Study Protocol ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Large For Gestational Age ◽  
Secondary Outcome ◽  
Oral Glucose ◽  
Open Label ◽  
Randomised Controlled

IntroductionIn women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM.MethodsThe SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle.Ethics and disseminationThe study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals.Trial registration numberNTR6134; Pre-results.

scholarly journals School-based intervention study examining approaches for well-being and mental health literacy of pupils in Year 9 in England: study protocol for a multischool, parallel group cluster randomised controlled trial (AWARE)

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029044 ◽  
Author(s):  
Daniel Hayes ◽  
Anna Moore ◽  
Emily Stapley ◽  
Neil Humphrey ◽  
Rosie Mansfield ◽  
...  
Keyword(s):  
Mental Health ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Implementation Evaluation ◽  
Cluster Randomised ◽  
Parallel Group ◽  
Randomised Controlled

IntroductionThe prevalence of emotional difficulties in young people is increasing. This upward trend is largely accounted for by escalating symptoms of anxiety and depression. As part of a public health response, there is increasing emphasis on universal prevention programmes delivered in school settings. This protocol describes a three-arm, parallel group cluster randomised controlled trial, investigating the effectiveness and cost-effectiveness of two interventions, alongside a process and implementation evaluation, to improve mental health and well-being of Year 9 pupils in English secondary schools.MethodA three-arm, parallel group cluster randomised controlled trial comparing two different interventions, the Youth Aware of Mental Health (YAM) or the Mental Health and High School Curriculum Guide (The Guide), to Usual Provision. Overall, 144 secondary schools in England will be recruited, involving 8600 Year 9 pupils. The primary outcome for YAM is depressive symptoms, and for The Guide it is intended help-seeking. These will be measured at baseline, 3–6 months and 9–12 months after the intervention commenced. Secondary outcomes measured concurrently include changes to: positive well-being, behavioural difficulties, support from school staff, stigma-related knowledge, attitudes and behaviours, and mental health first aid. An economic evaluation will assess the cost-effectiveness of the interventions, and a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, feasibility, utility), and their moderating effects on the outcomes of interest, and perceived impact.Ethics and disseminationThis trial has been approved by the University College London Research Ethics Committee. Findings will be published in a report to the Department for Education, in peer-reviewed journals and at conferences.Trial registration numberISRCTN17631228.ProtocolV1 3 January 2019. Substantial changes to the protocol will be communicated to the trials manager to relevant parties (eg, ISRCTN).

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