跳至主要内容
临床试验/NCT04892082
NCT04892082已完成不适用

Mindful Moment, a Web-based Mindful and Compassionate Parenting Training for Mothers During the Postpartum Period: A Pilot Randomized Controlled Trial

University of Coimbra2 个研究点 分布在 1 个国家目标入组 292 人开始时间: 2021年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
292
试验地点
2
主要终点
Feasibility of the program for postpartum mothers as measured by adherence and dropout rate

研究概览

简要总结

Mindful Moment (a web-based mindful and compassionate parenting training) is a self-guided program for postpartum mothers, based on the Mindful Parenting Training developed by Bögels and Restifo (2014) and the Mindful with Your Baby Training (Potharst et al., 2017, 2019). The main goal of this research is to assess the feasibility (e.g., user's adherence, dropout) and acceptability of Mindful Moment and to gather preliminary evidence of its efficacy.

This pilot RCT (Randomized Controlled Trial) will be a two-arm trial. Mothers with a child aged up to 18 months old will be enrolled in the study. A minimum number of 60 mothers will be enrolled in the study. After agreeing to participate in the study, the mothers will be screened for the presence of parenting stress (PSS [Parenting Stress Scale] ≥ 41, Mixão et al., 2007). In case of 41 points score or more, mothers will be asked to complete baseline assessment. Then, mothers who completed baseline assessment will be randomly assigned to one of two conditions: the intervention (Mindful Moment program) or the control condition (Waiting-List control [WLC]). The sample will be recruited online.

The feasibility of Mindful Moment will be evaluated in terms of user's adherence and dropout. Participation in this study will last 16 weeks. The Mindful Moment program will last 8 weeks. Participants in both conditions will be invited via email to complete baseline, post-intervention, and follow-up assessment (8-weeks after post-intervention). Assessments will include self-report questionnaires to assess user's acceptability and satisfaction, several indicators (e.g., parenting stress, depressive and anxiety symptoms, infant's temperament), and mechanisms that may be involved in the treatment response (e.g., mindful parenting, self-compassion).

详细描述

In the present study, the feasibility (e.g., user's adherence, dropout), acceptability and preliminary efficacy of a web-based intervention to decrease mothers' parenting stress in the postpartum period (the Mindful Moment program) will be tested. The design and content development of the Mindful Moment program was conducted through a formative evaluation process.

Although the birth of a child is a time of great happiness, it is also a period of major adjustment for parents. This period encompasses several demands and reorganizations (e.g., changes in routines, new relationships with partner and family) and psychological and emotional challenges (e.g., ability to regulate the baby's emotional states and one's own internal states). These demands often increase stress levels. It is well-stablished in literature that parenting stress may interfere with sensitive parenting and the ability to form a secure attachment with the child. It is also well-established that the quality of parental care is a major determinant of the child's cognitive, social, and emotional development. Therefore, psychological interventions aimed at helping mothers adjust better to the postpartum period and develop adaptive parenting skills are much needed.

Mindfulness (the capacity to pay nonjudgmental attention to the present moment) and self-compassion (attitude of kindness toward one's suffering and desire to relieve it) skills can be highly beneficial for parents since they are well-known psychological resources that help individuals adaptively cope with stress. Mindful applied to the parenting context can be defined as a more accepting, emotionally attuned, and compassionate way of parenting and it is characterized by parenting practices that promote responsive and sensitive care to the child's needs. Although the scarcity of research during the postpartum period, a few studies have shown that mindful parenting training may reduce mothers' psychopathological symptoms and may promote a more positive mother-infant relationship through the promotion of mindful parenting skills. Likewise, online mindful parenting training seems to be an easily accessible and valuable intervention for mothers with elevated levels of parenting stress including in the postpartum period.

Mindful Moment is a self-guided web-based intervention grounded on CBT (Cognitive-Behavioral Therapy) principles that also includes recent developments in mindfulness and compassion based-therapies, specifically for the postpartum context. This program focuses on the decreasing of parenting stress and the development and enhancement of psychological resources such as mindful parenting and self-compassion.

Mindful Moment is constituted by 6 modules, each module addressing one or two specific thematic contents (1. Mindful parenting and parenting stress; 2. Beginner's mind; 3. Self-compassion and self-care; 4. Reactive vs. responsive parenting; 5. Relationship with others [social support and communication]; 6. Mindful parenting for life). In each module, participants will be provided with both psychoeducational content and therapeutic strategies. Informational material will be given in text format, combined with audio and video.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Single-blind - the investigator is unaware of the intervention assignment

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Having 18 years or more.
  • Having a child aged up to 18 months old.
  • Being female.
  • Being Portuguese.
  • Being a resident of Portugal.
  • Internet access at home.
  • Presence of parenting stress (PSS ≥ 41).

排除标准

  • Current diagnosis of serious mental health condition (e.g., schizophrenia, substance abuse, bipolar disorder, and personality disorder).
  • Language difficulties that impede comprehension/reading-writing.
  • All participants will be informed that they will be randomized to one of the study groups and that will only be included if they give informed consent to participate in the study.

结局指标

主要结局

Feasibility of the program for postpartum mothers as measured by adherence and dropout rate

时间窗: 8 weeks

Measured through the number of completers and users that dropped out from the web-based intervention before completing it.

次要结局

  • Acceptability of the program for postpartum mothers(8 weeks)
  • Number of mothers with parenting stress using Parenting Stress Scale (PSS) (score ≥ 41)(Baseline)
  • Changes from baseline in the severity of parenting stress(Baseline, 8 weeks, 16 weeks)
  • Changes from baseline in mindful parenting skills(Baseline, 8 weeks, 16 weeks)
  • Changes from baseline in mother-infant bonding(Baseline, 8 weeks, 16 weeks)
  • Changes from baseline in anxiety symptoms(Baseline, 8 weeks, 16 weeks)
  • Feasibility of the program for postpartum mothers as measured by the pattern of program usage(8 weeks)
  • Changes from baseline in dispositional mindfulness(Baseline, 8 weeks, 16 weeks)
  • Changes from baseline in parenting styles(Baseline, 8 weeks, 16 weeks)
  • Changes from baseline in mother's perception of infant temperament(Baseline, 8 weeks, 16 weeks)
  • Changes from baseline in self-criticism and self-compassion(Baseline, 8 weeks, 16 weeks)
  • Changes from baseline in depressive symptoms(Baseline, 8 weeks, 16 weeks)
  • Changes from baseline in mindful self-care(Baseline, 8 weeks, 16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniela Filipa Ventura Fernandes

Principal Investigator

University of Coimbra

研究点 (2)

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