Prime Heather, Muise Amy, Benyamin Veronica, Thabane Lehana, Wade Mark
Department of Psychology, York University, 4700 Keele St, Toronto, ON, M3J 1P3, Canada.
Health Research Methods, Evidence & Impact, McMaster University, 1280 Main St. W, Hamilton, ON, L8S 4L8, Canada.
Pilot Feasibility Stud. 2022 Aug 6;8(1):170. doi: 10.1186/s40814-022-01115-y.
The COVID-19 pandemic has introduced or amplified stress and challenge within couples' relationships. Among those who are particularly vulnerable to heightened conflict and lower relationship satisfaction during this time are interparental couples with young children, whose relationships may have already been tenuous prior to the pandemic. Stress within the interparental relationship may have ripple effects on all family subsystems and child adjustment. The Love Together Parent Together (L2P2) program is a brief, low-intensity writing intervention adapted for parents of young children that was designed to reduce conflict-related distress and prevent declines in relationship satisfaction. Based on an original writing intervention by Finkel and colleagues, L2P2 has adapted the intervention duration and study population to be appropriate to the current global context. This study will examine the key feasibility metrics related to this adapted program with the goal of identifying problems and informing parameters of future pilot and/or main RCTs.
The current study is a non-randomized feasibility study, using a single-arm, pre-test/post-test design to primarily assess the feasibility of an evaluative RCT, and to secondarily assess the potential effects on outcomes to be used in a future RCT. Couples will be recruited through three community-based agencies with the goal of obtaining a socio-demographically diverse sample. The first 20 couples to enroll will be included. Baseline and post-intervention surveys will be conducted, and a writing intervention will take place (three 7-min sessions over the course of 5 weeks). The primary outcomes will be feasibility metrics of recruitment rates, appropriateness of eligibility criteria, sample diversity, retention, uptake, adherence, and acceptability. In addition, we will develop an objective measure of couple "we-ness" based on an analysis of writing samples. The secondary outcomes will include couples' measures (i.e., relationship quality, perceived partner responsiveness, self-reported responsiveness, conflict-related distress), and additional family outcomes (i.e., parent-child relations, parental/child mental health). Criteria for success are outlined, and failure to meet the criteria will result in adaptations to the measurement schedule, intervention design, recruitment approach, and/or other elements of the program.
This feasibility study will inform several components of the procedures used for a subsequent pilot RCT, in which we will examine the feasibility of the methodology used to evaluate the program (e.g., randomization, attrition to follow-up assessment/across groups, and sample size estimation, preliminary effectiveness), as well as the main RCT, which will investigate the effectiveness of the intervention on primary outcome measures and mediating pathways.
ClinicalTrials.gov , NCT05143437.
新冠疫情在夫妻关系中带来或加剧了压力与挑战。在此期间，特别容易出现冲突加剧和关系满意度降低的人群包括有幼儿的父母，他们的关系在疫情之前可能就已脆弱。父母间关系中的压力可能会对所有家庭子系统和孩子的适应产生连锁反应。“携手相爱，共同育儿”（L2P2）项目是一项针对幼儿父母的简短、低强度写作干预措施，旨在减少与冲突相关的困扰并防止关系满意度下降。基于芬克尔及其同事的原创写作干预措施，L2P2对干预时长和研究人群进行了调整，以适应当前的全球背景。本研究将考察与这一调整后的项目相关的关键可行性指标，目的是识别问题并为未来的试点研究和/或主要随机对照试验提供参数信息。
本研究是一项非随机可行性研究，采用单组前测/后测设计，主要评估评估性随机对照试验的可行性，其次评估对未来随机对照试验中使用的结果的潜在影响。将通过三个社区机构招募夫妻，目标是获得一个社会人口统计学特征多样的样本。前20对报名的夫妻将被纳入。将进行基线调查和干预后调查，并实施写作干预（在5周内进行三次每次7分钟的课程）。主要结果将是招募率、资格标准的适宜性、样本多样性、留存率、参与度、依从性和可接受性等可行性指标。此外，我们将基于对写作样本的分析开发一种衡量夫妻“我们感”的客观方法。次要结果将包括夫妻的各项指标（即关系质量感知伴侣响应性、自我报告的响应性、与冲突相关的困扰），以及其他家庭结果（即亲子关系、父母/孩子心理健康）。概述了成功标准，未达到标准将导致对测量时间表、干预设计、招募方法和/或项目的其他要素进行调整。
这项可行性研究将为后续试点随机对照试验所使用程序的几个组成部分提供信息，在该试验中，我们将考察用于评估该项目的方法的可行性（例如随机化、随访评估/跨组失访以及样本量估计、初步有效性），以及主要随机对照试验，该试验将研究干预对主要结果指标和中介途径的有效性。
ClinicalTrials.gov，NCT05143437。
