An evaluation of the online universal programme COPING parent: A feasibility study.

<em>Background</em>: COPING parent (Confident Parent Internet Guide) is an online universal parenting programme designed for parents of children aged 3-8 who are interested in learning positive parenting strategies to address everyday parenting challenges. Most people now have access to the internet and many parents seek online parenting advice, so it is important to ensure that advice is both evidence-based and freely available. The 10-week online COPING parent programme presents information and activities based on core social learning theory principles. The programme provides information and video examples of parenting skills, uses quizzes to test knowledge and suggests home practice activities. This study was undertaken to obtain feedback on the usefulness and acceptability of the programme to inform its further development. <br /><em>Design and Methods:</em> The programme was created using the LifeGuide software and participants (n=20) were asked to complete one chapter of the programme each week and provide feedback. This feasibility study was undertaken to highlight any technical issues and suggest modifications prior to a more rigorous evaluation. <br /><em>Results:</em> Both participant feedback and programme usage data are reported. Thirteen feedback forms were returned and programme usage data was downloaded for all participants. Feedback suggested modifications that included adaptations to enable the programme to be accessed by tablet users, an option to look back over previously completed chapters, the inclusion of more video examples of positive parenting and text message prompting to address attrition challenges

Evaluation of the COPING parent online universal programme

Parents can face many new challenges in bringing up children with many now accessing the internet for general parenting support and advice. Much is known about patterns of parenting that support children’s positive development and a lot of research has demonstrated the effectiveness of parenting programmes to support parents of high challenge children. These interventions teach positive parenting skills, including relationship building, play, positive reinforcement and emotional regulation generally taught through discussion, training in observation skills and positive role modelling. The growing evidence for the effectiveness of teaching parents positive parenting strategies has demonstrated the potential of such programmes to improve the mental health and well-being of both parents and children. However, there is relatively little evidence-based information on parenting available in general. Many of the available programmes target children at-risk of developing conduct problems or families living in high-risk areas (e.g. Flying Start areas), meaning that the majority of parents do not have access to evidence-based information. Universal parenting programmes have the potential to promote positive child well-being and prevent future mental health problems. Advantages of a universal provision include (1) providing support for parents whose children do not have problems but who are concerned to parent their children in ways that provide them with the best outcomes, (2) facilitating access to evidence-based information for parents who are facing common everyday parenting challenges, but not currently in receipt of services, (3) impacting on societal norms by promoting positive parenting more widely, and (4) encouraging positive child development. The COPING parent (COnfident Parent INternet Guide) programme is a web-based universal programme that presents evidence informed parenting principles to support all parents in establishing positive relationships with children and promoting their children’s Evaluation of the COPING parent programme well being and development. This thesis reports on the development and evaluation of the programme in a randomised controlled trial with intervention and wait-list control conditions. Chapter 2 is a review of universally available parenting programmes, based on social learning theory principles, that were either offered to a universal population or included universal goals i.e. development of parenting skills and promotion of child developmental outcomes. This review highlighted the need for more research to establish the effectiveness of universal programmes on promoting positive parenting skills and child development. This leads to chapter 3, which is a review of web-based interventions for behaviour change, both behaviour in general (such as weight-loss and smoking) and parenting behaviour are included. This review highlighted the need for further evaluations of web-based parenting interventions and associated attrition challenges. Chapter 3 discusses the many challenges, which parents can face, and how these challenges can compromise parenting, child behaviour and parent-child interactions. Chapter 4 contains a brief review of interventions created using the LifeGuide software and a detailed description of the development of the COPING parent programme. Chapter 5 is a published paper (Owen & Hutchings, 2017) reporting our feasibility study that was conducted to gain user feedback from an early version of the programme. Feedback suggested modifications that included adaptations to enable the programme to be accessed by tablet users; an option to look back over previously completed chapters, the inclusion of more video examples of positive parenting and text message reminders to address engagement. Chapter 6 is the published protocol paper (Owen, Griffith & Hutchings, 2017) providing details of the methodology of the main trial. Chapter 7 is the main outcomes paper, and reports the findings from the evaluation of the programme, limitations and suggested improvements. The COPING parent web-based universal programme was effective in increasing observed praise and reducing observed indirect commands for parents who completed at least one chapter of the programme, however trial Evaluation of the COPING parent programme challenges included low engagement, high attrition at follow-up and softare challenges. The final chapter of this thesis provides a summary of the research findings and discusses implications, strengths and limitations and future directions. This was the first evaluation of the COPING parent online universal programme, an intervention for all parents of children aged 3-8 years who have an interest in learning more about positive parenting strategies. Findings from the main trial were promising and suggest that an online universal programme can significantly increase the positive parenting skills that are associated with good child outcomes for some parents. This thesis has highlighted the importance of providing all parents with the opportunity to access evicence-based support and further develop their parenting competencies in order to promote children’s development

Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial

Background Previous evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear. Methods RADICALS-HD was an international randomised controlled trial to test the efficacy of ADT used in combination with postoperative radiotherapy for prostate cancer. Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to radiotherapy alone (no ADT) or radiotherapy with 6 months of ADT (short-course ADT), using monthly subcutaneous gonadotropin-releasing hormone analogue injections, daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as distant metastasis arising from prostate cancer or death from any cause. Standard survival analysis methods were used, accounting for randomisation stratification factors. The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67). Analyses followed the intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047. Findings Between Nov 22, 2007, and June 29, 2015, 1480 patients (median age 66 years [IQR 61–69]) were randomly assigned to receive no ADT (n=737) or short-course ADT (n=743) in addition to postoperative radiotherapy at 121 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 9·0 years (IQR 7·1–10·1), metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688–1·140], p=0·35). 10-year metastasis-free survival was 79·2% (95% CI 75·4–82·5) in the no ADT group and 80·4% (76·6–83·6) in the short-course ADT group. Toxicity of grade 3 or higher was reported for 121 (17%) of 737 participants in the no ADT group and 100 (14%) of 743 in the short-course ADT group (p=0·15), with no treatment-related deaths. Interpretation Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial

Background Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain. Methods RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov , NCT00541047 . Findings Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60–69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0–10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 [95% CI 0·612–0·975]; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6–75·7) in the short-course ADT group and 78·1% (74·2–81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths. Interpretation Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy. Funding Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society

SARS-CoV-2 Omicron is an immune escape variant with an altered cell entry pathway

Vaccines based on the spike protein of SARS-CoV-2 are a cornerstone of the public health response to COVID-19. The emergence of hypermutated, increasingly transmissible variants of concern (VOCs) threaten this strategy. Omicron (B.1.1.529), the fifth VOC to be described, harbours multiple amino acid mutations in spike, half of which lie within the receptor-binding domain. Here we demonstrate substantial evasion of neutralization by Omicron BA.1 and BA.2 variants in vitro using sera from individuals vaccinated with ChAdOx1, BNT162b2 and mRNA-1273. These data were mirrored by a substantial reduction in real-world vaccine effectiveness that was partially restored by booster vaccination. The Omicron variants BA.1 and BA.2 did not induce cell syncytia in vitro and favoured a TMPRSS2-independent endosomal entry pathway, these phenotypes mapping to distinct regions of the spike protein. Impaired cell fusion was determined by the receptor-binding domain, while endosomal entry mapped to the S2 domain. Such marked changes in antigenicity and replicative biology may underlie the rapid global spread and altered pathogenicity of the Omicron variant

Evaluation of the COPING parent online universal programme

Parents can face many new challenges in bringing up children with many now accessing the internet for general parenting support and advice. Much is known about patterns of parenting that support children’s positive development and a lot of research has demonstrated the effectiveness of parenting programmes to support parents of high challenge children. These interventions teach positive parenting skills, including relationship building, play, positive reinforcement and emotional regulation generally taught through discussion, training in observation skills and positive role modelling. The growing evidence for the effectiveness of teaching parents positive parenting strategies has demonstrated the potential of such programmes to improve the mental health and well-being of both parents and children. However, there is relatively little evidence-based information on parenting available in general. Many of the available programmes target children at-risk of developing conduct problems or families living in high-risk areas (e.g. Flying Start areas), meaning that the majority of parents do not have access to evidence-based information. Universal parenting programmes have the potential to promote positive child well-being and prevent future mental health problems. Advantages of a universal provision include (1) providing support for parents whose children do not have problems but who are concerned to parent their children in ways that provide them with the best outcomes, (2) facilitating access to evidence-based information for parents who are facing common everyday parenting challenges, but not currently in receipt of services, (3) impacting on societal norms by promoting positive parenting more widely, and (4) encouraging positive child development. The COPING parent (COnfident Parent INternet Guide) programme is a web-based universal programme that presents evidence informed parenting principles to support all parents in establishing positive relationships with children and promoting their children’s Evaluation of the COPING parent programme well being and development. This thesis reports on the development and evaluation of the programme in a randomised controlled trial with intervention and wait-list control conditions. Chapter 2 is a review of universally available parenting programmes, based on social learning theory principles, that were either offered to a universal population or included universal goals i.e. development of parenting skills and promotion of child developmental outcomes. This review highlighted the need for more research to establish the effectiveness of universal programmes on promoting positive parenting skills and child development. This leads to chapter 3, which is a review of web-based interventions for behaviour change, both behaviour in general (such as weight-loss and smoking) and parenting behaviour are included. This review highlighted the need for further evaluations of web-based parenting interventions and associated attrition challenges. Chapter 3 discusses the many challenges, which parents can face, and how these challenges can compromise parenting, child behaviour and parent-child interactions. Chapter 4 contains a brief review of interventions created using the LifeGuide software and a detailed description of the development of the COPING parent programme. Chapter 5 is a published paper (Owen & Hutchings, 2017) reporting our feasibility study that was conducted to gain user feedback from an early version of the programme. Feedback suggested modifications that included adaptations to enable the programme to be accessed by tablet users; an option to look back over previously completed chapters, the inclusion of more video examples of positive parenting and text message reminders to address engagement. Chapter 6 is the published protocol paper (Owen, Griffith & Hutchings, 2017) providing details of the methodology of the main trial. Chapter 7 is the main outcomes paper, and reports the findings from the evaluation of the programme, limitations and suggested improvements. The COPING parent web-based universal programme was effective in increasing observed praise and reducing observed indirect commands for parents who completed at least one chapter of the programme, however trial Evaluation of the COPING parent programme challenges included low engagement, high attrition at follow-up and softare challenges. The final chapter of this thesis provides a summary of the research findings and discusses implications, strengths and limitations and future directions. This was the first evaluation of the COPING parent online universal programme, an intervention for all parents of children aged 3-8 years who have an interest in learning more about positive parenting strategies. Findings from the main trial were promising and suggest that an online universal programme can significantly increase the positive parenting skills that are associated with good child outcomes for some parents. This thesis has highlighted the importance of providing all parents with the opportunity to access evicence-based support and further develop their parenting competencies in order to promote children’s development

An evaluation of the online universal programme COPING Parent: a feasibility study

<em>Background</em>: COPING parent (Confident Parent Internet Guide) is an online universal parenting programme designed for parents of children aged 3-8 who are interested in learning positive parenting strategies to address everyday parenting challenges. Most people now have access to the internet and many parents seek online parenting advice, so it is important to ensure that advice is both evidence-based and freely available. The 10-week online COPING parent programme presents information and activities based on core social learning theory principles. The programme provides information and video examples of parenting skills, uses quizzes to test knowledge and suggests home practice activities. This study was undertaken to obtain feedback on the usefulness and acceptability of the programme to inform its further development. <br /><em>Design and Methods:</em> The programme was created using the LifeGuide software and participants (n=20) were asked to complete one chapter of the programme each week and provide feedback. This feasibility study was undertaken to highlight any technical issues and suggest modifications prior to a more rigorous evaluation. <br /><em>Results:</em> Both participant feedback and programme usage data are reported. Thirteen feedback forms were returned and programme usage data was downloaded for all participants. Feedback suggested modifications that included adaptations to enable the programme to be accessed by tablet users, an option to look back over previously completed chapters, the inclusion of more video examples of positive parenting and text message prompting to address attrition challenges