Predictors of Study Attrition in a Randomized Controlled Trial Evaluating a Perinatal Home-Visiting Program with Mothers with Psychosocial Vulnerabilities.
Predictors of Study Attrition in a Randomized Controlled Trial Evaluating a Perinatal Home-Visiting Program with Mothers with Psychosocial Vulnerabilities.
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DOI：
10.1371/journal.pone.0142495
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发表时间：
2015
期刊：
影响因子：
3.7
通讯作者：
CAPEDP Study Group
中科院分区：
文献类型：
--
作者：
Foulon S;Greacen T;Pasquet B;Dugravier R;Saïas T;Guedeney N;Guedeney A;Tubach F;CAPEDP Study Group
评估围产期家访计划的随机对照试验经常面临高流失率的问题。本研究的目的是在一项评估法国围产期家访计划的试验中确定研究磨损的预测因素。CAPEDP是一项法国随机试验，比较了使用心理学家的围产期家访计划和常规护理(N=440)。第一次评估是在怀孕27周时纳入试验，最后一次评估是在孩子两岁时。计算产后3个月和24个月的流失率。用逐步Logistic回归分析社会、心理和父母养育因素对早期(产后3个月至产后3个月)和晚期(产后3至24个月)磨耗的预测作用。术后3个月和24个月的流失率分别为17%和63%。在24个月时，控制组(70.6%)比干预组(55.2%)有更多的磨损。确定了五个早期磨耗的独立预测因素：已经堕胎；有更大的依恋不安全感，用脆弱依恋风格问卷(VASQ)衡量；在纳入时用症状自评量表(SCL-90)评估的精神症状总体严重程度较低，目前既没有工作也没有学习；以及宣布怀孕期间不吸烟。被随机分配到对照组，在11岁之前经历过早期父母死亡，以及产后3个月的精神症状(SCL-90)总体严重程度较低是与后来的自然减退相关的唯一变量。这项研究为确定在评估家访计划的试验中可能需要特定支持以避免学习磨损的母亲提供了关键信息。
Randomised controlled trials evaluating perinatal home-visiting programs are frequently confronted with the problem of high attrition rates. The aim of the present study is to identify predictors of study attrition in a trial evaluating a perinatal home-visiting program in France. CAPEDP is a French randomized trial comparing a perinatal home-visiting program using psychologists versus usual care (N = 440). The first assessment was at inclusion into the trial at the 27th week of pregnancy and the final assessment when the child reached the age of two. Attrition rates were calculated at 3 and 24 months postpartum. Stepwise logistic regression was used to identify predictors of early (between inclusion and 3 months postpartum) and later (between 3 and 24 months postpartum) attrition among social, psychological and parenting factors. Attrition rates were 17% and 63% at 3 and 24 months respectively. At 24 months, there was significantly more attrition in the control arm (70.6%) compared to the intervention arm (55.2%). Five independent predictors of early attrition were identified: having already had an abortion; having greater attachment insecurity as measured with the Vulnerable Attachment Style Questionnaire (VASQ); having lower global severity of psychiatric symptoms as assessed with the Symptom Check-List (SCL-90) at inclusion, being neither currently employed nor studying; and declaring no tobacco consumption during pregnancy. Being randomized into the control arm, having undergone early parental loss before age 11 and having lower global severity of psychiatric symptoms (SCL-90) at 3 months postpartum were the only variables associated with later attrition. This study provides key information for identifying mothers who may require specific support to avoid study attrition in trials evaluating a home-visiting program.