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The feasibility and acceptability of a preventive intervention programme for children with depressed parents: study protocol for a randomised controlled trial

机译:父母抑郁儿童预防干预计划的可行性和可接受性:一项随机对照试验的研究方案

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Background One of the most important risk factors for childhood depression is being the child of a depressed parent. These at-risk children have two to four times the probability of having an affective episode compared with their peers. Preventive interventions such as Beardslee’s Preventive Intervention Program (PIP) that are targeted at children of depressed parents have proven effective in many countries. The PIP is a family-based approach that works by promoting resilience in children and increasing positive interactions within the family. In this pilot randomised controlled trial (RCT), we will determine the acceptability and feasibility of an adapted version of this intervention in Chile. Methods/design We are conducting a pilot RCT with a manualized intervention. The intervention will be delivered in seven weekly sessions at the family home. It is targeted mostly at parents but will also measure outcomes among the children. Control subjects will follow their treatment as usual. Feasibility and acceptability will be assessed by recruitment, adherence, dropout and level of missing data, as well as the burden of scales and measurement tools. Families will be followed for 11?months. Discussion Given the negative lifelong consequences of depression and the burden they represent, preventive programmes are not only feasible but necessary. Despite the successful implementation of this intervention in different countries, an adaptation to the Chilean reality will be prerequisite. The results of this pilot study will inform a definitive trial that will make the case for its national implementation. Trial registration Clinicaltrials.gov trial identifier: NCT02593266 . Registration date: 30 Octo 2015.
机译:背景技术儿童期抑郁症最重要的危险因素之一是父母沮丧的孩子。与同龄人相比,这些处于危险中的孩子发生情感发作的可能性是其同龄人的2-4倍。在许多国家/地区,针对熊父母的孩子的预防干预措施,例如Beardslee的预防干预计划(PIP),已被证明是有效的。 PIP是一种基于家庭的方法,可通过提高儿童的适应能力并增加家庭内部的积极互动来发挥作用。在该试验性随机对照试验(RCT)中,我们将确定此干预措施的改编版本在智利的可接受性和可行性。方法/设计我们正在通过人工干预进行试点RCT。干预将在家庭住所中每周进行七次。它主要针对父母,但也将衡量孩子的结局。对照对象将照常进行治疗。可行性和可接受性将通过招募,遵守,遗漏和丢失数据的水平以及量表和度量工具的负担进行评估。家庭将被追踪11个月。讨论鉴于抑郁症的终身负面后果及其所带来的负担,预防方案不仅是可行的,而且是必要的。尽管在不同国家成功实施了这种干预措施,但必须适应智利的现实。这项初步研究的结果将为确定性试验提供依据,这将为其在全国范围内的实施提供依据。试用注册Clinicaltrials.gov试用标识符:NCT02593266。注册日期:2015年10月30日。

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