背景:已经研究并实施了针对无家可归风险青年的各种服务提供模式,包括获得住房和身心健康资源。然而,即使有了这些干预措施,我们仍然不知道如何最好地管理这些人群的抑郁和焦虑症状以及药物使用率,这主要是因为缺乏可行性数据.
方法:本文介绍了伦敦一项混合方法研究的结果,加拿大,研究了实施生物心理社会干预的可行性,天空学校,年龄在16至25岁之间的高危青年(n=49)。该研究还从服务用户的角度记录了有关程序有用性的定性响应。天空学校的干预包括社会情感学习与SudarshanKriya瑜伽相结合,一个标准化的基于瑜伽的呼吸锻炼程序。干预计划分为两个阶段:主动学习阶段和强化阶段。收集了以下可行性结果度量:(1)每月接触的潜在参与者数量,(2)筛选成功的人数(比例),(3)参与筛选的参与者比例,(4)研究中的保留率,(5)对研究方案的坚持率,(6)已完成的计划评级比例,(7)每个案例的干预成本,(8)分析最终数据的完整性,(9)收集所有数据的时间长度,(10)所有收集数据的质量,(11)确定合作的社区组织是否愿意按照研究方案进行研究,(12)确定是否有任何能力问题,合作伙伴提供干预和调查人员能够执行他们承诺要做的任务,(13)确定将数据输入计算机是否有任何问题,(14)有关干预措施安全性的初步数据,(15)治疗效果的初步估计。
结果:所有可行性结果措施都是可收集的。在伦敦,加拿大在这一面临无家可归风险的青年群体中进行试点研究是可行的。研究结果中最重要的是高保留率(61.2%)和总体积极的定性反馈,并提出了许多潜在的建议,以改善干预措施的交付和质量。然而,我们的招募率显著较低(每周0.27名参与者),这表明需要多个研究点才能获得足够的样本量以进行后续的确定性试验.
结论:未来的研究人员在设计随机对照试验以进一步评估SKY学校的疗效和耐受性时,可能会考虑这项可行性研究的结果。
背景:试验注册:Clinicaltrials.gov,标识符NCT02749240。2016年4月22日注册,https://clinicaltrials.gov/ct2/show/NCT02749240。
BACKGROUND: Various service provision models for youth at risk of homelessness have been researched and implemented, including access to housing and physical and mental health resources. However, even with these interventions, we remain unaware of how best to manage symptoms of depression and anxiety and the rate of drug use in these populations primarily because of a lack of feasibility data.
METHODS: This paper presents the results of a mixed-methods
study in London, Canada, that examined the feasibility of implementing a biopsychosocial intervention, SKY Schools, in at-risk youth aged between 16 and 25 (n = 49). The
study also recorded qualitative responses about the program\'s usefulness from the perspective of the service users. The SKY Schools intervention consisted of social-emotional learning combined with Sudarshan Kriya Yoga, a standardized yoga-based breathing exercise routine. The intervention program was divided into two phases: an active learning phase and a reinforcement phase. The following feasibility outcome measures were collected: (1) the number of potential participants approached per month, (2) number (proportion) who were successfully screened, (3) the proportion of screened participants who enrolled, (4) the rate of retention in the study, (5) rate of adherence to study protocol, (6) proportion of planned ratings that were completed, (7) intervention cost per case, (8) completeness of final data for analysis, (9) length of time to collect all data, (10) quality of all collected data, (11) determining if partnering community organizations were willing to conduct the study as per study protocol, (12) determining if there were any capacity issues with partners providing intervention and investigators being able to perform the tasks that they were committed to doing, (13) determining if there were any problems of entering the data into a computer, (14) preliminary data about the safety of the intervention, and (15) preliminary estimate of treatment effects.
RESULTS: All feasibility outcome measures were collectible. In the city of London, Canada it was feasible to conduct a pilot study in this population of youth at risk of homelessness. Foremost among the findings was a high retention rate (61.2%) and overall positive qualitative feedback with a number of potential suggestions to improve the delivery and quality of the intervention. However, we had a significantly low recruitment rate (0.27 participants per week) suggesting that multiple sites will be needed to achieve an adequate sample size for a subsequent definitive
trial.
CONCLUSIONS: Future researchers may consider the findings of this feasibility study when designing a randomized control
trial to further assess the efficacy and tolerability of SKY Schools.
BACKGROUND: Trial registration: Clinicaltrials.gov, identifier NCT02749240. Registered April 22, 2016, https://clinicaltrials.gov/ct2/show/NCT02749240 .