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The Good Behaviour Game intervention to improve behavioural and other outcomes for children aged 7–8 years: a cluster RCT 良好行为游戏干预改善7-8岁儿童的行为和其他结果:聚类随机对照试验
Pub Date : 2022-05-01 DOI: 10.3310/vkof7695
N. Humphrey, Alexandra Hennessey, Patricio Troncoso, Margarita Panayiotou, Louise Black, Kimberly J. Petersen, L. Wo, Carla Mason, Emma Ashworth, Kirsty Frearson, J. Boehnke, R. Pockett, Julia Lowin, D. Foxcroft, M. Wigelsworth, Ann Lendrum
Universal, school-based behaviour management interventions can produce meaningful improvements in children’s behaviour and other outcomes. However, the UK evidence base for these remains limited. The objective of this trial was to investigate the impact, value for money and longer-term outcomes of the Good Behaviour Game. Study hypotheses centred on immediate impact (hypothesis 1); subgroup effects (at-risk boys, hypothesis 2); implementation effects (dosage, hypothesis 3); maintenance/sleeper effects (12- and 24-month post-intervention follow-ups, hypothesis 4); the temporal association between mental health and academic attainment (hypothesis 5); and the health economic impact of the Good Behaviour Game (hypothesis 6). This was a two-group, parallel, cluster-randomised controlled trial. Primary schools (n = 77) were randomly assigned to implement the Good Behaviour Game for 2 years or continue their usual practice, after which there was a 2-year follow-up period. The trial was set in primary schools across 23 local authorities in England. Participants were children (n = 3084) aged 7–8 years attending participating schools. The Good Behaviour Game is a universal behaviour management intervention. Its core components are classroom rules, team membership, monitoring behaviour and positive reinforcement. It is played alongside a normal classroom activity for a set time, during which children work in teams to win the game to access the agreed rewards. The Good Behaviour Game is a manualised intervention delivered by teachers who receive initial training and ongoing coaching. The measures were conduct problems (primary outcome; teacher-rated Strengths and Difficulties Questionnaire scores); emotional symptoms (teacher-rated Strengths and Difficulties Questionnaire scores); psychological well-being, peer and social support, bullying (i.e. social acceptance) and school environment (self-report Kidscreen survey results); and school absence and exclusion from school (measured using National Pupil Database records). Measures of academic attainment (reading, standardised tests), disruptive behaviour, concentration problems and prosocial behaviour (Teacher Observation of Child Adaptation Checklist scores) were also collected during the 2-year follow-up period. There was no evidence that the Good Behaviour Game improved any outcomes (hypothesis 1). The only significant subgroup moderator effect identified was contrary to expectations: at-risk boys in Good Behaviour Game schools reported higher rates of bullying (hypothesis 2). The moderating effect of the amount of time spent playing the Good Behaviour Game was unclear; in the context of both moderate (≥ 1030 minutes over 2 years) and high (≥ 1348 minutes over 2 years) intervention compliance, there were significant reductions in children’s psychological well-being, but also significant reductions in their school absence (hypothesis 3). The only medium-ter
普遍的、以学校为基础的行为管理干预措施可以对儿童的行为和其他结果产生有意义的改善。然而,英国的证据基础仍然有限。本试验的目的是调查良好行为游戏的影响、性价比和长期结果。以直接影响为中心的研究假设(假设1);亚组效应(高危男孩,假设2);实施效果(剂量,假设3);维持/睡眠影响(干预后12个月和24个月的随访,假设4);心理健康与学业成绩之间的时间关联(假设5);以及良好行为游戏对健康经济的影响(假设6)。这是一项两组、平行、整群随机对照试验。小学(n = 77)被随机分配实施2年的良好行为游戏或继续他们的常规练习,之后有2年的随访期。该试验在英格兰23个地方当局的小学进行。参与者为儿童(n = 3084名),年龄7-8岁,就读于参与学校。良好行为游戏是一种普遍的行为管理干预措施。它的核心组成部分是课堂规则、团队成员、监督行为和积极强化。在规定的时间内,它与正常的课堂活动一起进行,在此期间,孩子们组队工作,赢得游戏,以获得商定的奖励。良好行为游戏是由接受初步培训和持续指导的教师进行的手工干预。测量指标是行为问题(主要结果;教师评定的优势和困难问卷得分);情绪症状(教师评定的优势和困难问卷得分);心理健康、同伴和社会支持、欺凌(即社会接受度)和学校环境(自我报告的Kidscreen调查结果);以及缺课和失学(使用国家学生数据库记录衡量)。在2年的随访期间,还收集了学业成绩(阅读、标准化测试)、破坏行为、注意力问题和亲社会行为(教师对儿童适应情况的观察检查表分数)的测量。没有证据表明良好行为游戏改善了任何结果(假设1)。发现的唯一显著的亚组调节效应与预期相反:良好行为游戏学校的高危男孩报告了更高的欺凌率(假设2)。玩“良好行为游戏”所花时间的调节作用尚不清楚;在中度(≥ 1030分钟超过2年)和高(≥ 2年内1348分钟)干预依从性,儿童的心理健康显著降低,但他们的缺课率也显著降低(假设3)。唯一的中期干预效果是在24个月时获得同伴和社会支持,但这是负面的(假设4)。在对个体内部和个体之间的影响进行分解后,我们发现儿童的心理健康与其学业成绩之间没有时间上的个体内部关联(假设5)。最后,我们的成本-后果分析表明,良好行为游戏不能提供物有所值的结果(假设6)。局限性包括仅对几个次要结果进行测试后设计;次优实施剂量(通过符合者平均因果效应估计减轻);以及中度儿童级流失(主要结果分析为18.5%),特别是在试验后随访期(通过使用全信息最大似然程序减轻)。关于计划差异化仍然存在问题(例如,良好行为游戏与现有行为管理实践的区别有多大,这在其影响方面有什么不同吗?),以及良好行为游戏在与补充预防干预相结合时是否有影响力(如前几次试验中的情况)。根据此处报告的调查结果,不能推荐“良好行为游戏”。本试验注册号为ISRCTN64152096。该项目由国家卫生与保健研究所公共卫生研究计划资助,并将在《公共卫生研究》上全文发表;第10卷第7期。有关更多项目信息,请访问NIHR期刊图书馆网站。
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引用次数: 3
Examining the Effects of COVID-19 Pandemic on Africa’s Natural Resources Sector 审查COVID-19大流行对非洲自然资源部门的影响
Pub Date : 2022-04-29 DOI: 10.5923/j.phr.20221202.02
E. Merem, Y. Twumasi, J. Wesley, D. Olagbegi, M. Crisler, C. Romorno, M. Alsarari, P. Isokpehi, A. Hines, G. Hirse, G. S. Ochai, E. Nwagboso, S. Fageir, S. Leggett, J. Offiah, S. Emeakpor
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引用次数: 0
A psychological intervention by community pharmacies to prevent depression in adults with subthreshold depression and long-term conditions: the CHEMIST pilot RCT 社区药房的心理干预预防阈下抑郁症成人和长期条件:化学家试点RCT
Pub Date : 2022-03-01 DOI: 10.3310/ekze0617
E. Littlewood, C. Chew‐Graham, Elizabeth Coleman, S. Gascoyne, C. Sloan, Shehzad Ali, J. Badenhorst, D. Bailey, S. Crosland, C. E. Kitchen, D. McMillan, C. Pearson, A. Todd, C. Whittlesea, C. Bambra, C. Hewitt, Claire Jones, A. Keding, E. Newbronner, Alastair Paterson, Shelley Rhodes, E. Ryde, Paul Toner, Michelle Watson, S. Gilbody, D. Ekers
Depression is common in people with long-term health conditions, and this combination can lead to worsened health outcomes and increased health-care costs. Subthreshold depression, a risk factor for major depression, is prevalent in this population, but many people remain untreated due to the demand on services. The community pharmacy may be an alternative setting to offer mental health support; however, insufficient evidence exists to support implementation. To conduct a feasibility study and pilot randomised controlled trial of a community pharmacy-delivered psychological intervention aimed at preventing depression in adults with long-term health conditions. A feasibility study with nested qualitative evaluation and an external pilot, two-arm, 1 : 1 individually randomised controlled trial with nested process and economic evaluations. Community pharmacies in the north of England. Adults aged ≥ 18 years with subthreshold depression and at least one long-term health condition. A bespoke enhanced support intervention (behavioural activation within a collaborative care framework) involving up to six sessions delivered by trained community pharmacy staff (intervention facilitators) compared with usual care. Recruitment and retention rates, completeness of outcome measures and intervention engagement. The intended primary outcome was depression severity at 4 months, assessed by the Patient Health Questionnaire-9. In the feasibility study, 24 participants were recruited. Outcome measure completeness was 95–100%. Retention at 4 months was 83%. Seventeen participants (71%) commenced intervention sessions and all completed two or more sessions. Depression symptoms reduced slightly at 4 months. The process evaluation suggested that the intervention was acceptable to participants and intervention facilitators. In the pilot randomised controlled trial, 44 participants (target of 100 participants) were randomised (intervention, n = 24; usual care, n = 20). Outcome measure completeness was 100%. Retention at 4 months was 93%. Eighteen participants (75%) commenced intervention sessions and 16 completed two or more sessions. Depression symptoms reduced slightly at 4 months, with a slightly larger reduction in the usual-care arm, although the small sample size limits any conclusions. The process evaluation reported good acceptability of the intervention and identified barriers associated with study implementation and its impact on core pharmacy functions. The economic analysis revealed some indication of reduced resource use/costs associated with the intervention, but this is limited by the small sample size. Intervention costs were low. The main limitation is the small sample size due to difficulties with recruitment and barriers to implementing the study within existing pharmacy practices. The community pharmacy represents a new setting to deliver a depression prevention intervention. Recruitme
抑郁症在有长期健康状况的人中很常见,这种组合可能导致健康状况恶化和医疗费用增加。阈下抑郁症是严重抑郁症的一个风险因素,在这一人群中很普遍,但由于对服务的需求,许多人仍然没有得到治疗。社区药房可能是提供心理健康支持的替代场所;然而,没有足够的证据支持执行。对社区药房提供的心理干预进行可行性研究和试点随机对照试验,旨在预防患有长期健康状况的成年人患抑郁症。具有嵌套定性评估和外部试点的可行性研究,双臂,1 : 1项具有嵌套过程和经济评估的单独随机对照试验。英格兰北部的社区药房。年龄≥ 患有阈下抑郁症18年,至少有一种长期健康状况。与常规护理相比,定制的强化支持干预(在协作护理框架内的行为激活)包括由受过培训的社区药房工作人员(干预促进者)提供的多达六次会议。征聘率和留用率、成果衡量标准的完整性和干预参与度。预期的主要结果是通过患者健康问卷-9评估4个月时的抑郁严重程度。在可行性研究中,招募了24名参与者。结果测量的完整性为95–100%。4个月时的保留率为83%。17名参与者(71%)开始了干预课程,所有参与者都完成了两次或两次以上的课程。抑郁症状在4个月时略有减轻。过程评估表明,参与者和干预促进者可以接受干预措施。在试点随机对照试验中,44名参与者(目标为100名参与者)被随机分配(干预 = 24;常规护理,n = 20) 。结果测量的完整性为100%。4个月时的保留率为93%。18名参与者(75%)开始了干预课程,16名参与者完成了两次或两次以上的课程。抑郁症症状在4个月时略有减轻,常规护理组的症状减轻幅度略大,尽管样本量小限制了任何结论。过程评估报告了干预措施的良好可接受性,并确定了与研究实施相关的障碍及其对核心药学功能的影响。经济分析显示,与干预相关的资源使用/成本有所减少,但这受到样本量小的限制。干预成本很低。主要限制是由于招募困难和在现有药学实践中实施研究的障碍,样本量较小。社区药房代表了一个提供抑郁症预防干预的新环境。招聘是一项挑战,药房工作人员在繁忙的药房工作中遇到了有效实施该研究的障碍。尽管存在这些挑战,但仍证明了良好的保留率和干预参与度,过程评估表明,在这种情况下,干预是可以接受的。据我们所知,这是第一项证明社区药房工作人员可以接受抑郁症预防干预培训的研究。需要进一步的工作来解决在社区药房环境中招募、提供干预和实施心理干预的障碍。本试验注册号为ISRCTN11290592。该项目由国家卫生研究所公共卫生研究计划资助,并将在《公共卫生研究》上全文发表;第10卷第5期。有关更多项目信息,请访问NIHR期刊图书馆网站。
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引用次数: 3
Peer-led physical activity intervention for girls aged 13 to 14 years: PLAN-A cluster RCT 13至14岁女孩同伴主导的体育活动干预:PLAN-A分组随机对照试验
Pub Date : 2022-03-01 DOI: 10.3310/zjqw2587
R. Jago, Byron Tibbitts, K. Willis, E. Sanderson, R. Kandiyali, Thomas Reid, S. MacNeill, R. Kipping, R. Campbell, S. Sebire, W. Hollingworth
Increasing physical activity among girls is a public health priority. Peers play a central role in influencing adolescent behaviour. Peer-led interventions may increase physical activity in adolescent girls, and a feasibility trial had shown that PLAN-A (Peer-led physical Activity iNtervention for Adolescent girls) had evidence of promise to increase physical activity in adolescent girls. The objective was to test whether or not PLAN-A can increase adolescent girls’ physical activity, relative to usual practice, and be cost-effective. This was a two-arm, cluster-randomised controlled trial, including an economic evaluation and a process evaluation. State-funded secondary schools in the UK with girls in Year 9 (aged 13–14 years) participated in the trial. All Year 9 girls in participating schools were eligible. Schools were the unit of allocation. They were randomised by an independent statistician, who was blinded to school identities, to the control or intervention arm, stratified by region and the England Index of Multiple Deprivation score. The intervention comprised peer nomination (i.e. identification of influential girls), train the trainers (i.e. training the instructors who delivered the intervention), peer supporter training (i.e. training the peer-nominated girls in techniques and strategies underpinned by motivational theory to support peer physical activity increases) and a 10-week diffusion period. The primary outcome was accelerometer-assessed mean weekday minutes of moderate to vigorous physical activity among Year 9 girls. The follow-up measures were conducted 5–6 months after the 10-week intervention, when the girls were in Year 10 (which was also 12 months after the baseline measures). Analysis used a multivariable, mixed-effects, linear regression model on an intention-to-treat basis. Secondary outcomes included weekend moderate to vigorous physical activity, and weekday and weekend sedentary time. Intervention delivery costs were calculated for the economic evaluation. A total of 33 schools were approached; 20 schools and 1558 pupils consented. Pupils in the intervention arm had higher Index of Multiple Deprivation scores than pupils in the control arm. The numbers randomised were as follows: 10 schools (n = 758 pupils) were randomised to the intervention arm and 10 schools (n = 800 pupils) were randomised to the control arm. For analysis, a total of 1219 pupils provided valid weekday accelerometer data at both time points (intervention, n = 602; control, n = 617). The mean weekday moderate to vigorous physical activity was similar between groups at follow-up. The central estimate of time spent engaging in moderate to vigorous physical activity was 2.84 minutes lower in the intervention arm than in the control arm, after adjustment for baseline mean weekday moderate to vigorous physical activity, the number of valid days of data and the stratification variables; however, thi
增加女孩的体育活动是公共卫生的优先事项。同龄人在影响青少年行为方面发挥着核心作用。同伴主导的干预措施可能会增加青春期女孩的体育活动,一项可行性试验表明,PLAN-a(针对青春期女孩的同伴主导的体育活动干预措施)有证据表明有可能增加少女的体育活动。其目的是测试PLAN-A相对于常规做法是否可以增加少女的体育活动,并且是否具有成本效益。这是一项双臂、集群随机对照试验,包括经济评估和过程评估。英国国家资助的中学有9年级(13-14岁)的女孩参加了试验。参与学校的所有九年级女生都符合资格。学校是分配的单位。他们由一位不了解学校身份的独立统计学家随机分配到对照组或干预组,按地区和英格兰多重剥夺指数评分进行分层。干预措施包括同伴提名(即确定有影响力的女孩)、培训培训师(即培训实施干预的教师)、同伴支持者培训(即培训同伴提名的女孩掌握以动机理论为基础的技术和策略,以支持同伴体育活动的增加)和10周的扩散期。主要结果是加速度计评估的9年级女孩中中等至剧烈体育活动的平均工作日分钟数。随访措施在10周干预后5-6个月进行,当时女孩在10年级(也是基线措施后12个月)。分析采用多变量、混合效应、基于意向治疗的线性回归模型。次要结果包括周末适度到剧烈的体育活动,以及工作日和周末的久坐时间。为经济评估计算了干预措施的实施成本。共接触了33所学校;20所学校和1558名学生表示同意。干预组学生的多重剥夺指数得分高于对照组学生。随机抽取的数字如下:10所学校(n = 758名学生)被随机分配到干预组和10所学校(n = 800名学生)被随机分配到对照组。为了进行分析,共有1219名学生在两个时间点提供了有效的工作日加速度计数据(干预,n = 602;控制,n = 617)。在随访中,两组的平均工作日中等至剧烈的体育活动相似。在对基线平均工作日中等至剧烈体力活动、数据有效天数和分层变量进行调整后,干预组进行中等至剧烈体育活动的时间的中心估计值比对照组低2.84分钟;然而,这种差异在统计学上并不显著(95%置信区间为5.94至0.25;p = 0.071)。次要结果在臂间没有差异。干预费用从每位学生20.85英镑到48.86英镑不等,平均费用为31.16英镑。没有一个审判仅限于英格兰西南部。没有证据表明,与通常的做法相比,PLAN-A增加了9年级女孩的体育活动,因此,它不具有成本效益。未来的工作应该评估整个学校方法在促进学校体育活动方面的效用。本试验注册号为ISRCTN14539759。该项目由国家卫生研究所公共卫生研究计划资助,并将在《公共卫生研究》上全文发表;第10卷第6期。有关更多项目信息,请访问NIHR期刊图书馆网站。该试验是与布里斯托尔随机试验合作组织(BRTC)合作设计和交付的,该组织是英国临床研究委员会(UKCRC)注册的临床试验单位,作为布里斯托尔试验中心的一部分,正在接受NIHR临床试验单位的支持资金。该试验的赞助商是布里斯托尔大学研究与企业发展部www.Bristol.ac.uk/red/。提供干预的费用由英格兰体育资助。
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引用次数: 2
E-health interventions targeting STIs, sexual risk, substance use and mental health among men who have sex with men: four systematic reviews 针对男男性行为者的性传播感染、性风险、药物使用和精神健康的电子保健干预措施:四项系统审查
Pub Date : 2022-03-01 DOI: 10.3310/brwr6308
R. Meiksin, G. Melendez‐Torres, A. Miners, J. Falconer, T. Witzel, P. Weatherburn, C. Bonell
Human immunodeficiency virus/sexually transmitted infections, sexual risk, substance (alcohol and other legal and illegal drugs) use and mental ill health constitute a ‘syndemic’ of mutually reinforcing epidemics among men who have sex with men. Electronic health (e-health) interventions addressing these epidemics among men who have sex with men might have multiplicative effects. To our knowledge, no systematic review has examined the effectiveness of such interventions on these epidemics among men who have sex with men. The objective was to synthesise evidence addressing the following: (1) What approaches and theories of change do existing e-health interventions employ to prevent human immunodeficiency virus/sexually transmitted infections, sexual risk, alcohol/drug use or mental ill health among men who have sex with men? (2) What factors influence implementation? (3) What are the effects of such interventions on the aforementioned epidemics? (4) Are such interventions cost-effective? A total of 24 information sources were searched initially (October–November 2018) [the following sources were searched: ProQuest Applied Social Sciences Index and Abstracts; Campbell Library; EBSCO Cumulative Index to Nursing and Allied Health Literature Plus, Wiley Online Library The Cochrane Library; Centre for Reviews and Dissemination databases (the Database of Abstracts of Reviews of Effects and the NHS Economic Evaluation Database); the Health Technology Assessment database; Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-Centre) database of health promotion research (Bibliomap); ProQuest Dissertations & Theses Global; OvidSP EconLit; OvidSP EMBASE; OvidSP Global Health; OvidSP Health Management Information Consortium; ProQuest International Bibliography of the Social Sciences; Ovid MEDLINE ALL; OvidSP PsycINFO; Web of Science Science Citation Index Expanded; Elsevier Scopus; OvidSP Social Policy & Practice; Web of Science Social Sciences Citation Index Expanded; ProQuest Sociological Abstracts; ClinicalTrials.gov; World Health Organization International Clinical Trials Registry Platform; EPPI-Centre Trials Register of Promoting Health Interventions; and the OpenGrey database], and an updated search of 19 of these was conducted in April 2020. Reference lists of included reports were searched and experts were contacted. Eligible reports presented theories of change and/or process, outcome and/or economic evaluations of e-health interventions offering ongoing support to men who have sex with men to prevent human immunodeficiency virus/sexually transmitted infections, sexual risk behaviour, alcohol/drug use and/or common mental illnesses. References were screened by title/abstract, then by full text. Data extraction and quality assessments used existing tools. Theory and process reports were synthesised using qualitative methods. Outcome and economic data were synthesised narratively; outcome data were meta-a
人体免疫机能丧失病毒/性传播感染、性风险、物质(酒精和其他合法和非法药物)使用以及精神健康不良构成男男性行为者之间相互加强的流行病的"综合症"。针对男男性行为者中这些流行病的电子保健(电子保健)干预措施可能会产生倍增效应。据我们所知,还没有系统的审查审查这些干预措施对男男性行为者中这些流行病的有效性。目标是综合针对以下问题的证据:(1)现有电子保健干预措施采用了哪些方法和变革理论来预防男男性行为者中的人类免疫缺陷病毒/性传播感染、性风险、酒精/药物使用或精神疾病?(2)影响实施的因素是什么?(3)这些干预措施对上述流行病的影响是什么?(4)这些干预措施是否具有成本效益?初步检索了24个信息源(2018年10 - 11月)[检索了以下来源:ProQuest应用社会科学索引和摘要;坎贝尔库;护理与相关健康文献累加索引、Wiley在线图书馆、Cochrane图书馆;评价和传播数据库中心(效果评价摘要数据库和国民保健制度经济评价数据库);卫生技术评估数据库;政策和实践证据信息和协调中心(EPPI-Centre)健康促进研究数据库(Bibliomap);ProQuest全球学位论文;OvidSP EconLit;OvidSP EMBASE;OvidSP全球健康;健康管理信息联盟;ProQuest国际社会科学书目;奥维德MEDLINE;OvidSP PsycINFO;Web of Science科学引文索引扩展爱思唯尔斯高帕斯;社会政策与实践;Web of Science社会科学引文索引扩展社会学文摘;ClinicalTrials.gov;世界卫生组织国际临床试验注册平台;促进健康干预措施中心试验登记册;和OpenGrey数据库],并于2020年4月对其中19个进行了更新搜索。检索了纳入报告的参考文献列表,并联系了专家。合格的报告介绍了为男男性行为者提供持续支持以预防人体免疫缺陷病毒/性传播感染、性风险行为、酒精/药物使用和/或常见精神疾病的电子保健干预措施的变革理论和/或过程、结果和/或经济评价。参考文献按标题/摘要筛选,然后按全文筛选。数据提取和质量评估使用现有工具。采用定性方法综合理论和工艺报告。结果和经济数据以叙述的方式综合;结果数据进行meta分析。原始搜索检索到27个符合条件的报告。更新的搜索检索到10个符合条件的报告。其中包括关于23项干预措施的28项研究的37份报告:33份关于变革理论,12份关于过程评估,16份关于结果评估,1份关于经济评估。研究问题1:确定了五种干预类型-“在线模块化”,“电脑游戏”和“非交互式”限时/模块化干预,以及“由评估组织的内容”和“一般内容”的开放式干预。三种类型的改变干预理论被确定,重点是“认知/技能”,“自我监控”和“认知治疗”。研究问题2:基于参与者特征的个性化定制特别可接受,参与者重视反映其经验的干预内容。研究问题3:几乎没有证据表明对人体免疫缺陷病毒或性传播感染有影响。该分析并未表明干预措施在减少人类免疫缺陷病毒或性传播感染方面是有效的。性传播感染的整体荟萃分析报告,与对照组相比,干预组的性传播感染略有不显著增加。荟萃分析发现,这对性风险行为有显著影响。由于研究的异质性,不能对药物使用的结果进行meta分析。针对这一结果的研究没有提供一致的有效性证据。试验没有报告对酒精使用或心理健康的影响。研究问题4:关于成本效益的证据有限。合格报告的质量是可变的,经济综合仅限于一项合格的研究。在改变干预理论和影响接受电子卫生干预的因素方面存在共性。有效性的证据有限。 未来的试验应评估干预措施对多种综合征因素的影响,其中包括性风险、药物使用和精神健康;纳入充分的后续行动和样本量,以查明对人体免疫机能丧失病毒/性传播感染的影响;并结合严格的流程和经济评估。本研究注册号为PROSPERO CRD42018110317。该项目由国家卫生研究所(NIHR)公共卫生研究方案资助,将全文发表在《公共卫生研究》上;第10卷第4期请参阅NIHR期刊图书馆网站了解更多项目信息。
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引用次数: 1
The Parents under Pressure parenting programme for families with fathers receiving treatment for opioid dependence: the PuP4Dads feasibility study 父亲接受阿片类药物依赖治疗的家庭的“压力下的父母养育计划”:PuP4Dads可行性研究
Pub Date : 2022-01-01 DOI: 10.3310/yowk7214
A. Whittaker, L. Elliott, Julie Taylor, S. Dawe, P. Harnett, A. Stoddart, P. Littlewood, R. Robertson, B. Farquharson, H. Strachan
The impact of parental drug use on children is a major public health problem. However, opioid-dependent fathers have been largely ignored in parenting research. To implement and test the feasibility and acceptability of the Parents under Pressure programme (PuP4Dads) for opioid-dependent fathers and their families, and to determine whether or not a full-scale evaluation could be conducted. A mixed-methods feasibility study. Two non-NHS family support services for parents who use drugs in Scotland. Fathers prescribed opioid substitution therapy (n = 25), their partners (n = 17) and children, as well as practitioners, supervisors, service managers and referrers. A home-visiting programme, including an integrated theoretical framework, case formulation, collaborative goal-setting and modules designed to improve parenting, the caregiving environment and child welfare. The programme was delivered flexibly over 6 months by accredited practitioners. Feasibility progression criteria included the recruitment target (n = 24 fathers), acceptability of PuP4Dads, father engagement in the study (including a minimum of 66% of fathers completing PuP and a minimum of 10 fathers completing baseline and post-treatment research interviews), engagement in qualitative interviews (including a minimum of 10 fathers and 90% practitioner uptake and 80% manager uptake), focus groups (with a minimum of 80% referrer uptake), adequate fidelity and no adverse events. The following researcher-administered validated questionnaires were used: the Brief Child Abuse Potential Inventory, the Parenting Sense of Competence Scale, the Difficulties in Emotion Regulation Scale, the Paternal Antenatal Attachment Scale, the Maternal Antenatal Attachment Scale, the Emotional Availability Scale, the Brief Infant Toddler Social and Emotional Assessment, the Strengths and Difficulties Questionnaire, the Conflict Tactics Scale, Treatment Outcome Profile and the EuroQol-5 Dimensions, five-level version. Other sources included parent-completed service use (an economic measure), social work child protection data, NHS opioid substitution therapy prescription data and practitioner-reported attendance data. We also conducted interviews with fathers (n = 23), mothers (n = 14), practitioners (n = 8), supervisors (n = 2) and service managers (n = 7); conducted focus groups with referrers (n = 28); and held an ‘expert event’ with stakeholders (n = 39). The PuP4Dads was successfully delivered within non-NHS settings and was considered acceptable and suitable for the study population. Referrals (n = 44) resulted in 38 (86%) eligible fathers, of whom 25 (66%) fathers and 17 partners/mothers consented to participate. Most fathers reported no previous parenting support. A total of 248 sessions was delivered to the 20 fathers and 14 mothers who started the intervention. Fourteen fathers (and 10 mothers) completed ≥ 6 sessions and six fathers (and fo
父母吸毒对儿童的影响是一个重大的公共卫生问题。然而,依赖阿片类药物的父亲在育儿研究中基本上被忽视了。为阿片类药物依赖的父亲及其家庭实施和测试压力下的父母计划(PuP4Dads)的可行性和可接受性,并确定是否可以进行全面评估。混合方法可行性研究。为苏格兰吸毒父母提供的两项非nhs家庭支持服务。父亲开了阿片类药物替代疗法(n = 25),他们的伴侣(n = 17)和孩子,以及从业人员、主管、服务经理和转诊者。一项家访计划,包括综合的理论框架、个案编制、合作设定目标和旨在改善养育、照顾环境和儿童福利的单元。该课程由认可的执业医师在6个月内灵活授课。可行性进展标准包括招募目标(n = 24名父亲)、PuP4Dads的可接受性、父亲参与研究(包括至少66%的父亲完成PuP,至少10名父亲完成基线和治疗后研究访谈)、参与定性访谈(包括至少10名父亲,90%的从业者接受,80%的管理者接受)、焦点小组(至少80%的转诊者接受)、足够的保真度和无不良事件。使用了以下研究者管理的有效问卷:《儿童虐待潜力简易量表》、《父母能力感量表》、《情绪调节困难量表》、《父亲产前依恋量表》、《母亲产前依恋量表》、《情绪可得性量表》、《婴幼儿社交与情绪简易评估》、《优势与困难问卷》、《冲突策略量表》、《治疗结果简介》和《EuroQol-5量表》五层次版本。其他来源包括父母完成的服务使用(一项经济措施)、社会工作儿童保护数据、NHS阿片类药物替代治疗处方数据和医生报告的出勤数据。我们还对父亲(n = 23)、母亲(n = 14)、从业人员(n = 8)、主管(n = 2)和服务经理(n = 7)进行了访谈;与推荐人进行焦点小组(n = 28);并与利益相关者举行了一次“专家活动”(n = 39)。PuP4Dads在非nhs环境下成功交付,被认为是可接受的,适合研究人群。经推荐(n = 44),有38位(86%)符合条件的父亲,其中25位(66%)父亲和17位伴侣/母亲同意参与。大多数父亲报告说,他们以前没有接受过育儿方面的支持。开始干预的20位父亲和14位母亲共接受了248次治疗。14位父亲(10位母亲)完成≥6次治疗,6位父亲(4位母亲)完成≤5次治疗。父亲和母亲的出勤率相等(平均71%)。父亲的平均订婚时间为26周,母亲为30周。23名父亲在基线时完成访谈,16名父亲在随访1时完成访谈13名父亲在随访2时完成访谈。结果测量耐受性良好;但是,有些措施是否适当取决于家庭情况。研究人员管理的问卷几乎没有丢失数据。家长、从业人员和管理人员报告说,PuP4Dads的好处包括以下几点:对父亲的治疗重点改善了父母的情绪调节,提高了对孩子需求的理解和反应,有更好的多机构工作,该计划与实践的“精神”和政策议程非常契合。学习强调了在整个服务范围内采用和实施支持、改善招募和留住父亲的战略、同时管理父母双方的复杂需求、了解影响方案实施的背景因素以及影响干预参与和结果的变量的重要性。缺乏情感可用性和经济(服务使用)数据。对PuP4Dads进行更大的评估是可行的。需要进一步的工作来证明PuP4Dads的有效性和成本影响。我们需要更好地了解干预是如何起作用的,对谁起作用,在什么情况下以及为什么起作用。当前对照试验ISRCTN43209618。该项目由国家卫生研究所(NIHR)公共卫生研究方案资助,将全文发表在《公共卫生研究》上;第10卷第3期请参阅NIHR期刊图书馆网站了解更多项目信息。
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引用次数: 1
Process and impact of implementing a smoke-free policy in prisons in Scotland: TIPs mixed-methods study 在苏格兰监狱实施无烟政策的过程和影响:TIPs混合方法研究
Pub Date : 2022-01-01 DOI: 10.3310/wglf1204
K. Hunt, A. Brown, D. Eadie, N. McMeekin, K. Boyd, L. Bauld, P. Conaglen, P. Craig, E. Demou, A. Leyland, J. Pell, R. Purves, E. Tweed, Tom Byrne, R. Dobson, L. Graham, Danielle Mitchell, R. O’Donnell, H. Sweeting, S. Semple
Prisons had partial exemption from the UK’s 2006/7 smoking bans in enclosed public spaces. They became one of the few workplaces with continuing exposure to second-hand smoke, given the high levels of smoking among people in custody. Despite the introduction of smoke-free prisons elsewhere, evaluations of such ‘bans’ have been very limited to date. The objective was to provide evidence on the process and impact of implementing a smoke-free policy across a national prison service. The Tobacco in Prisons study was a three-phase, multimethod study exploring the periods before policy formulation (phase 1: pre announcement), during preparation for implementation (phase 2: preparatory) and after implementation (phase 3: post implementation). The study was set in Scotland’s prisons. Participants were people in custody, prison staff and providers/users of prison smoking cessation services. Comprehensive smoke-free prison rules were implemented across all of Scotland’s prisons in November 2018. The main outcome measures were second-hand smoke levels, health outcomes and perspectives/experiences, including facilitators of successful transitions to smoke-free prisons. The study utilised cross-sectional surveys of staff (total, n = 3522) and people in custody (total, n = 5956) in each phase; focus groups and/or one-to-one interviews with staff (n = 237 across 34 focus groups; n = 38 interviews), people in custody (n = 62 interviews), providers (n = 103 interviews) and users (n = 45 interviews) of prison smoking cessation services and stakeholders elsewhere (n = 19); measurements of second-hand smoke exposure (e.g. 369,208 minutes of static measures in residential areas at three time points); and routinely collected data (e.g. medications dispensed, inpatient/outpatient visits). Measures of second-hand smoke were substantially (≈ 90%) reduced post implementation, compared with baseline, largely confirming the views of staff and people in custody that illicit smoking is not a major issue post ban. Several factors that contributed to the successful implementation of the smoke-free policy, now accepted as the ‘new normal’, were identified. E-cigarette use has become common, was recognised (by both staff and people in custody) to have facilitated the transition and raises new issues in prisons. The health economic analysis (lifetime model) demonstrated that costs were lower and the number of quality-adjusted life-years was larger for people in custody and staff in the ‘with smoke-free’ policy period than in the ‘without’ policy period, confirming cost-effectiveness against a £20,000 willingness-to-pay threshold. The ability to triangulate between different data sources mitigated limitations with constituent data sets. To our knowledge, this is the first study internationally to analyse the views of prison staff and people in custody; objective measurements of second-hand smoke exposure and
英国2006/7年度颁布的封闭公共场所禁烟令部分豁免了监狱。鉴于在押人员的高吸烟率,他们成为少数几个持续接触二手烟的工作场所之一。尽管其他地方也引进了无烟监狱,但迄今为止对这种“禁令”的评价非常有限。目的是就在全国监狱系统中实施无烟政策的过程和影响提供证据。监狱中的烟草研究是一项分三个阶段的多方法研究,探索政策制定前(第一阶段:公告前)、准备实施期间(第二阶段:准备)和实施后(第三阶段:实施后)的时期。这项研究以苏格兰的监狱为背景。参与者是在押人员、监狱工作人员和监狱戒烟服务的提供者/使用者。2018年11月,苏格兰所有监狱实施了全面的监狱无烟规定。主要的结果衡量指标是二手烟水平、健康结果和观点/经验,包括成功过渡到无烟监狱的促进者。该研究在每个阶段对工作人员(总数,n = 3522)和在押人员(总数,n = 5956)进行了横断面调查;焦点小组和/或与工作人员进行一对一访谈(34个焦点小组中n = 237人;N = 38次访谈)、在羁押者(N = 62次访谈)、监狱戒烟服务提供者(N = 103次访谈)和使用者(N = 45次访谈)以及其他地方的利益相关者(N = 19);二手烟暴露的测量(例如,在三个时间点对居民区进行369,208分钟的静态测量);并定期收集数据(例如,药物分配,住院/门诊就诊)。与基线相比,实施后的二手烟测量量大幅(≈90%)减少,这在很大程度上证实了工作人员和在押人员的观点,即禁止后非法吸烟不是一个主要问题。报告确定了几个促成无烟政策成功实施的因素,这一政策现已被视为“新常态”。电子烟的使用已经变得很普遍,(工作人员和在押人员都承认)电子烟促进了过渡,并在监狱中引发了新的问题。健康经济分析(终身模型)表明,在“无烟”政策期间,被拘留者和工作人员的成本较低,质量调整生命年数也大于“不吸烟”政策期间,这证实了相对于2万英镑的支付意愿门槛的成本效益。在不同数据源之间进行三角测量的能力减轻了成分数据集的限制。据我们所知,这是国际上首次分析监狱工作人员和在押人员观点的研究;在执行无烟监狱政策之前、期间和之后,对二手烟暴露和日常健康及其他结果进行客观测量;并评估成本效益。研究结果与考虑类似立法的司法管辖区有关,无论电子烟是否被允许。该研究为合作伙伴提供了一个模式,并且作为对国家监狱系统的多维研究,增加了以前缺乏的国际证据基础。优先事项是了解如何支持在押人员在出狱后保持无烟状态,以及干预措施是否可以使其家人受益;评估支持希望减少或戒烟的人们的新指南;并了解监狱吸电子烟的做法/文化如何加强或削弱长期吸烟的减少。本研究注册号为研究注册表4802。该项目由国家卫生研究所(NIHR)公共卫生研究方案资助,将全文发表在《公共卫生研究》上;第10卷第1期请参阅NIHR期刊图书馆网站了解更多项目信息。
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引用次数: 2
Early positive approaches to support for families of young children with intellectual disability: the E-PAtS feasibility RCT 早期支持智力残疾幼儿家庭的积极方法:E-PAtS可行性随机对照试验
Pub Date : 2022-01-01 DOI: 10.3310/heyy3556
Elinor Coulman, N. Gore, Gwenllian Moody, Melissa Wright, J. Segrott, D. Gillespie, S. Petrou, F. Lugg-Widger, Sungwook Kim, J. Bradshaw, R. McNamara, A. Jahoda, G. Lindsay, Jacqui Shurlock, V. Totsika, C. Stanford, S. Flynn, A. Carter, Christian Barlow, R. Hastings
Parents of children with intellectual disability are 1.5–2 times more likely than other parents to report mental health difficulties. There is a lack of clinically effective and cost-effective group well-being interventions designed for family carers of young children with intellectual disability. To examine the feasibility of a randomised controlled trial of the clinical effectiveness and cost-effectiveness of the Early Positive Approaches to Support (E-PAtS) intervention. A feasibility study (including randomisation of families into a two-arm trial), questionnaires to assess the feasibility of proposed outcome measures (including resource use and health-related quality of life) and practitioner/family carer interviews. An additional question was included in an online UK survey of families, conducted by the research team to assess usual practice, and a survey of provider organisations. Families recruited from community contexts (i.e. third sector, local authority services, special schools) and self-referral. The E-PAtS intervention was delivered by trained community-based providers. Families with at least one child aged 1.5–5 years with an intellectual disability. At least one parent had to have English-language ability (spoken) for E-PAtS programme participation and participants had to provide informed consent. E-PAtS intervention – two caregivers from each family invited to eight 2.5-hour group sessions with usual practice. Usual practice – other support provided to the family, including other parenting support. To assess randomisation willingness/feasibility, recruitment of providers/parents, retention, usual practice, adherence, fidelity and feasibility of proposed outcome measures (including the Warwick–Edinburgh Mental Well-Being Scale as the proposed primary outcome measure, and parent anxiety/depression, parenting, family functioning/relationships, child behavioural/emotional problems and adaptive skills, child and parent quality of life, and family services receipt as the proposed secondary outcome measures). Seventy-four families (95 carers) were recruited from three sites (with 37 families allocated to the intervention). From referrals, the recruitment rate was 65% (95% confidence interval 56% to 74%). Seventy-two per cent of families were retained at the 12-month follow-up (95% confidence interval 60% to 81%). Exploratory regression analysis showed that the mean Warwick–Edinburgh Mental Well-Being Scale well-being score was 3.96 points higher in the intervention group (95% confidence interval –1.39 to 9.32 points) at 12 months post randomisation. High levels of data completeness were achieved on returned questionnaires. Interviews (n = 25) confirmed that (1) recruitment, randomisation processes and the intervention were acceptable to family carers, E-PAtS facilitators and community staff; (2) E-PAtS delivery were consistent with the logic model; and (3) researchers requesting conse
智障儿童的父母报告心理健康问题的可能性是其他父母的1.5-2倍。目前缺乏针对智力残疾幼儿的家庭照顾者设计的临床有效且具有成本效益的群体福祉干预措施。研究早期积极支持方法(E-PAtS)干预的临床有效性和成本效益的随机对照试验的可行性。可行性研究(包括将家庭随机纳入两组试验),评估拟议结果测量(包括资源利用和与健康相关的生活质量)可行性的问卷调查,以及从业者/家庭护理人员访谈。研究小组对英国家庭进行了一项在线调查,以评估通常的做法,并对提供服务的组织进行了一项调查,其中包括一个额外的问题。从社区(即第三部门、地方当局服务、特殊学校)招募的家庭和自我转介。E-PAtS干预由训练有素的社区提供者提供。至少有一名年龄在1.5至5岁的智障儿童的家庭。参加e - pat计划的家长中至少有一位必须具备英语能力(口语),并且参与者必须提供知情同意。E-PAtS干预-每个家庭邀请两名护理员参加8次2.5小时的小组会议。通常做法-为家庭提供其他支持,包括其他养育子女的支持。评估随机化意愿/可行性、提供者/父母的招募、保留、惯例、依从性、保真度和拟议结果测量的可行性(包括作为拟议主要结果测量的沃里克-爱丁堡心理健康量表,以及父母焦虑/抑郁、养育、家庭功能/关系、儿童行为/情感问题和适应技能、儿童和父母的生活质量),和家庭服务收据作为建议的次要结果指标)。从三个地点招募了74个家庭(95名护理人员)(其中37个家庭被分配到干预中)。从推荐来看,招聘率为65%(95%置信区间为56%至74%)。在12个月的随访中保留了72%的家庭(95%置信区间为60%至81%)。探索性回归分析显示,干预组在随机分组后12个月的沃里克-爱丁堡心理健康量表幸福感得分平均高出3.96分(95%置信区间为-1.39至9.32分)。在返回的问卷中获得了高水平的数据完整性。访谈(n = 25)证实:(1)家庭照顾者、e - pat辅助人员和社区工作人员可以接受招募、随机化过程和干预措施;(2) E-PAtS交付符合逻辑模型;(3)未来研究人员要求获得常规数据的同意是可以接受的。记录的e - pat会话显示出良好的保真度(96%的组件存在)。依从性(即至少有一名家庭护理人员参加了8次E-PAtS中的5次)为76%。成功收集了与健康有关的生活质量和服务收据数据。英国一项评估常规做法的在线调查(n = 673)显示,10%的智障儿童家庭在12个月内接受了任何干预。一项提供者调查(n = 15)表明愿意参与未来的研究。获得会话录音的保真度是困难的。需要审查征聘程序以改善多样性,需要制定战略以改善主要成果的完成情况。研究过程是可行的。E-PAtS的干预措施很受欢迎,对家庭的影响也很积极。未来组织参与的一个障碍是为干预成本提供资金。一项明确的试验来测试E-PAtS的临床效果和成本效益是可行的。当前对照试验ISRCTN70419473。该项目由国家卫生研究所(NIHR)公共卫生研究方案资助,将全文发表在《公共卫生研究》上;第10卷第2期请参阅NIHR期刊图书馆网站了解更多项目信息。
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引用次数: 1
Mental health support and training to improve secondary school teachers’ well-being: the WISE cluster RCT 心理健康支持和培训以提高中学教师的幸福感:WISE集群随机对照试验
Pub Date : 2021-11-01 DOI: 10.3310/phr09120
J. Kidger, Rhiannon Evans, S. Bell, H. Fisher, Nicholas Turner, W. Hollingworth, S. Harding, Jillian Powell, R. Brockman, L. Copeland, R. Araya, R. Campbell, T. Ford, D. Gunnell, Richard Morris, S. Murphy
Health and Safety Executive data show that teachers are at heightened risk of mental health difficulties, yet few studies have attempted to address this. Poor teacher mental health may impact on the quality of support provided to young people, who also report increased mental health difficulties themselves. To test the effectiveness of an intervention aiming to improve secondary school teachers’ well-being through mental health support and training. A cluster randomised controlled trial with embedded process and economic evaluations. Twenty-five mainstream, non-fee-paying secondary schools in the south-west of England and South Wales, stratified by geographical area and free school meal entitlement, randomly allocated to intervention or control groups following collection of baseline measures (n = 12, intervention; n = 13, control) between May and July 2016. All teachers in the study schools at any data collection. All students in year 8 (baseline) and year 10 (final follow-up). Each intervention school received three elements: (1) a 1-day mental health first aid for schools and colleges training session delivered to 8% of all teachers; (2) a 1-hour mental health session delivered to all teachers; and (3) 8% of staff trained in the 2-day standard mental health first aid training course set up a confidential peer support service for colleagues. Control schools continued with usual practice. The primary outcome was teacher well-being (using the Warwick–Edinburgh Mental Wellbeing Scale). Secondary outcomes were teacher depression, absence and presenteeism, and student well-being, mental health difficulties, attendance and attainment. Follow-up was at 12 and 24 months. Data were analysed using intention-to-treat mixed-effects repeated-measures models. A cost–consequence analysis to compare the incremental cost of the intervention against the outcomes measured in the main analysis. A mixed-methods study (i.e. qualitative focus groups and interviews, quantitative surveys, checklists and logs) to examine intervention implementation, activation of the mechanisms of change outlined in the logic model, intervention acceptability and the wider context. All 25 schools remained in the study. A total of 1722 teachers were included in the primary analysis. We found no difference in mean teacher well-being between study arms over the course of follow-up (adjusted mean difference –0.90, 95% confidence interval –2.07 to 0.27). There was also no difference in any of the secondary outcomes (p-values 0.203–0.964 in the fully adjusted models). The average cost of the intervention was £9103 (range £5378.97–12,026.73) per intervention school, with the average cost to Welsh schools being higher because of a different delivery model. The training components were delivered with high fidelity, although target dosage was sometimes missed. The peer support service was delivered with variable fidelity, and repo
健康与安全执行局的数据显示,教师面临心理健康问题的风险更高,但很少有研究试图解决这一问题。教师心理健康状况不佳可能会影响向年轻人提供支持的质量,他们自己也报告心理健康问题增加。测试旨在通过心理健康支持和培训改善中学教师幸福感的干预措施的有效性。一项具有嵌入过程和经济评估的集群随机对照试验。英格兰西南部和南威尔士的25所主流非付费中学,按地理区域和免费学校餐权利进行分层,在收集基线测量后随机分配给干预组或对照组(n = 12、干预;n = 13,对照)。研究学校的所有教师都在收集任何数据。8年级(基线)和10年级(最终随访)的所有学生。每个干预学校都得到了三个要素:(1)为8%的教师提供为期一天的中小学心理健康急救培训;(2) 向所有教师提供1小时的心理健康课程;以及(3)8%接受过为期两天的标准心理健康急救培训的员工为同事设立了保密的同伴支持服务。控制学校继续照常上课。主要结果是教师的幸福感(使用沃里克-爱丁堡心理健康量表)。次要结果是教师抑郁、缺勤和出勤、学生幸福感、心理健康困难、出勤率和成绩。随访时间分别为12个月和24个月。使用意向治疗混合效应重复测量模型对数据进行分析。成本-后果分析,将干预的增量成本与主要分析中测量的结果进行比较。混合方法研究(即定性焦点小组和访谈、定量调查、检查表和日志),以检查干预措施的实施、逻辑模型中概述的变化机制的激活、干预措施的可接受性和更广泛的背景。所有25所学校都留在了研究中。共有1722名教师参与了初步分析。我们发现,在随访过程中,研究组之间的平均教师幸福感没有差异(调整后的平均差异为0.90,95%置信区间为2.07至0.27)。任何次要结果也没有差异(完全调整模型中的p值为0.203至0.964)。每个干预学校的平均干预成本为9103英镑(范围为5378.97至12026.73英镑),由于不同的交付模式,威尔士学校的平均成本更高。尽管有时会错过目标剂量,但训练成分的传递具有高保真度。同伴支持服务的忠诚度各不相同,据报道教师的使用率较低(5.9-6.1%)。干预措施的可接受性较高,但参与者报告高级领导的支持率较低,对学校文化的影响最小。参与者和研究团队被揭盲,自我报告主要结果指标和对同伴支持服务使用的不准确测量。中等教育中的幸福感(WISE)干预措施在改善教师或学生的幸福感或减少心理健康困难方面并不有效,可能是因为背景障碍阻碍了它融入学校生活。确定实现系统级变革的方法和高级领导的持续支持对未来基于学校的心理健康干预措施很重要。当前对照试验ISRCTN95909211。该项目由国家卫生研究所公共卫生研究方案资助,并将在《公共卫生研究》上全文发表;第9卷第12期。有关更多项目信息,请访问NIHR期刊图书馆网站。干预费用由威尔士公共卫生部、英格兰公共卫生部和布里斯托尔市议会承担。
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引用次数: 3
One-to-one volunteer befriending to reduce symptoms of depression in people with intellectual disability: a feasibility RCT 一对一志愿者交友减轻智障患者抑郁症状:可行性随机对照试验
Pub Date : 2021-10-01 DOI: 10.3310/phr09100
Afia Ali, E. Mckenzie, Zara Rasoul, A. Hassiotis, S. Priebe, B. Lloyd-Evans, Rebecca Jones, M. Panca, R. Omar, S. Finning, S. Moore, Christine Roe, M. King
Little is known about the effectiveness of befriending for people with intellectual disability and whether or not befriending improves depressive symptoms and social outcomes. This pilot trial aimed to assess the feasibility and acceptability of conducting a future full-scale randomised controlled trial of one-to-one befriending for people with intellectual disability who had depressive symptoms. This was a parallel-group, two-armed randomised controlled trial incorporating an exploratory economic analysis and a mixed-methods process evaluation. Outcome assessments were conducted at baseline and at 6 months post randomisation by a research assistant who was blind to allocation. We aimed to approach 50 participants, with a view to recruiting 40. Participants with intellectual disability were recruited from one NHS trust and from referrals to two community befriending services. The intervention was delivered by community befriending services. Adults with mild or moderate intellectual disability with a score on the Glasgow Depression Scale for people with a Learning Disability of ≥ 5 were included. Those attending a day service/college for ≥ 3 days a week were excluded. Volunteers were aged ≥ 18 years and had no history of prior convictions. Participants in the intervention group were matched with a volunteer befriender and were expected to meet once per week for 1 hour, over 6 months. Volunteers recorded activities in a logbook. Volunteers received training and regular supervision. Both groups received usual care and a resource booklet of local activities. The feasibility outcomes and progression criteria were recruitment of at least 70% of participants approached; matching of at least 70% of participants in the intervention group to a volunteer; a dropout rate of < 30% of participants and volunteers; adherence to the intervention (10 meetings between pairs); acceptability of the intervention; and feasibility of collecting data on costs and resource use for an economic evaluation. Changes in depressive symptoms (primary clinical outcome: Glasgow Depression Scale) and self-esteem, quality of life, social participation, social support, health-related quality of life and service use were recorded at 6 months. Outcomes in volunteers were also assessed. We recruited only 16 participants with intellectual disability (40% of target) and 10 volunteers. Six of the eight (75%) participants in the intervention group were matched with a befriender and there was good adherence (mean number of meetings attended 11.8; range 1–21 meetings). Going to a cafe/restaurant and having a conversation were the most frequent activities. All participants were retained at follow-up, but two volunteers dropped out. Trial procedures and the intervention might be acceptable, but modifications were suggested. Data on costs and resource use were obtained, but there were discrepancies in the health-related quality-of-life data.
对智障人士交朋友的有效性知之甚少,也不知道交朋友是否能改善抑郁症状和社会结果。本试点试验旨在评估对有抑郁症状的智障人士进行一对一交友的未来全面随机对照试验的可行性和可接受性。这是一项平行组、双臂随机对照试验,包括探索性经济分析和混合方法过程评估。结果评估在基线和随机化后6个月由一名对分配不知情的研究助理进行。我们的目标是接近50名参与者,以期招募40名。智力残疾的参与者是从一个NHS信托机构和转介到两个社区友好服务机构招募的。干预是由社区友好服务提供的。研究对象为轻度或中度智力障碍的成人,其格拉斯哥抑郁量表(Glasgow Depression Scale)的学习障碍评分≥5分。每周参加日班或学院≥3天者排除在外。志愿者年龄≥18岁,无犯罪前科。干预组的参与者与一名志愿者朋友配对,并期望每周见一次面,持续1小时,持续6个月。志愿者在日志上记录活动。志愿者接受培训和定期监督。两组都得到了常规护理和当地活动的资料小册子。可行性结果和进展标准是招募至少70%的参与者;干预组中至少70%的参与者与志愿者匹配;参与者和志愿者的退学率< 30%;坚持干预措施(两组间10次会议);干预的可接受性;收集成本和资源利用数据进行经济评价的可行性。在6个月时记录抑郁症状(主要临床结果:格拉斯哥抑郁量表)和自尊、生活质量、社会参与、社会支持、与健康相关的生活质量和服务使用的变化。对志愿者的结果也进行了评估。我们只招募了16名智力残疾的参与者(目标的40%)和10名志愿者。干预组8名参与者中有6名(75%)与朋友配对,并且有良好的依从性(平均参加会议次数11.8;范围1-21次会议)。去咖啡馆/餐馆和聊天是最常见的活动。所有参与者都在随访中被保留,但有两名志愿者退出。试验程序和干预可能是可以接受的,但建议进行修改。获得了成本和资源使用的数据,但与健康有关的生活质量数据存在差异。这项研究的延误妨碍了其他征聘战略的使用,计划的12个月后续行动也无法完成。招聘不可行,但其他可行性结果较为积极。可以通过其他研究设计,如观察性研究,来评估对智障人士的友好程度。当前对照试验ISRCTN63779614。该项目由国家卫生研究所(NIHR)公共卫生研究方案资助,将全文发表在《公共卫生研究》上;第九卷,第10期请参阅NIHR期刊图书馆网站了解更多项目信息。
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