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临床试验/NCT05210075
NCT05210075已完成不适用

Mindful With Your Baby for Mothers of Infants With (Parental) Stress in a Non-clinical Setting: A Wait-list Controlled Pilot Trial

University of Amsterdam0 个研究点目标入组 17 人开始时间: 2016年1月1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
17
主要终点
Parental stress change from waitlist to start of intervention

研究概览

简要总结

In this pilot waitlist-controlled trial, 17 mothers with infants (2-15 months) admitted themselves for a Mindful with your Baby (MwyB) training in a non-clinical setting because of (parental) stress. MwyB was offered in groups of three to six dyads and consisted of eight 2-hour sessions. Participants completed questionnaires on symptoms of parental stress, stress, depression, anxiety, mindfulness and self-compassion at 8-week waitlist, pretest, posttest and 8-week follow-up.

详细描述

This study used a quasi-experimental design. Participants were recruited in various ways. After admitting themselves to the study, participants were called by the trainer, to check inclusion criteria: a subjective experience of (parental) stress, and the ability to speak and read Dutch. Exclusion criteria were: a current unsafe situation for the baby, and maternal psychosis or suicidality. None of the mothers that admitted themselves were excluded. Participants gave informed consent online, before completing the first set of online questionnaires using forced responses via Qualtrics software. A waitlist assessment was administered 8 weeks prior to the start of the training, to control for the effects of time, assessment and other intervention. The pretest assessment took place in the week before the start of the training, posttest the week after the end of the training and follow-up eight weeks after the end of the training, respectively.

Intervention The MwyB training consists of 8 weekly 2-hour sessions, and a follow-up session 8 weeks after the last session. It is adapted to the presence of the babies (in 7 of the 9 sessions), and the themes that play a role for most mothers with a baby. The MwyB training was given and studied before from May 20213 until september 2016 in a clinical setting, given by a mental health psychologist/mindfulness/mindful parenting trainer plus an infant mental health specialist (study published in 2017, see citations). In this study the training was given in a non-clinical setting by a licensed midwife/mindfulness/mindful parenting/mindfulness based childbirth and parenting trainer plus an assistant (a master student Psychology or Pedagogics). The main role of the assistant was to ensure both physical and emotional safety of the babies during the meditation in which mothers closed their eyes. Four groups of 3 to 6 dyads were given between March 2016 and December 2017.

Measures

  • Parental stress. Parental stress was assessed with the short form of the Dutch Parenting Stress Index, based on the American Parenting Stress Index.
  • Symptoms of stress, depression, and anxiety. Maternal symptoms of stress, depression, and anxiety were assessed by a short form of the Depression Anxiety Stress Scales (DASS-21).
  • Mindfulness. Mindfulness was assessed using the short form of the Dutch version of the five-facet mindfulness questionnaire. See citation.
  • Self-compassion. To measure self-compassion the 3-item Self-Compassion Scale (SCS-3) was used.
  • Acceptability. Acceptability was assessed by an evaluation questionnaire at posttest. An adapted version of the stress reduction program evaluation, developed at the Center for Mindfulness of the University of Massachusetts Medical School, was used. Session attendance rate, reported in the evaluation questionnaire, was calculated by dividing the number of attended sessions by the total number of sessions.

Data analyses

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • a subjective experience of (parental) stress, and the ability to speak and read Dutch.

排除标准

  • a current unsafe situation for the baby, and maternal psychosis or suicidality.

结局指标

主要结局

Parental stress change from waitlist to start of intervention

时间窗: The change between waitlist assessment at 8 weeks pre-intervention and 1 week pre-intervention assessment

Short form of the Dutch Parenting Stress Index, minimum 1 (better), maximum 6 (worse)

Parental stress change from start of intervention until end of intervention

时间窗: The change between 1 week pre-intervention assessment and 1 week post-intervention assessment.

Short form of the Dutch Parenting Stress Index, minimum 1 (better), maximum 6 (worse)

Parental stress change from start of intervention until follow-up session

时间窗: The change between 1 week pre-intervention assessment and 8 weeks post-intervention assessment.

Short form of the Dutch Parenting Stress Index minimum 1 (better), maximum 6 (worse)

Change in symptoms of stress, depression, and anxiety from waitlist to start of intervention

时间窗: The change between waitlist assessment at 8 weeks pre-intervention and 1 week pre-intervention assessment

The Depression Anxiety Stress Scales, short form, minimum 0 (better), maximum 3 (worse)

Change in symptoms of stress, depression, and anxiety from start of intervention until end of intervention

时间窗: The change between 1 week pre-intervention assessment and 1 week post-intervention assessment.

The Depression Anxiety Stress Scales, short form, minimum 0 (better), maximum 3 (worse)

Change in symptoms of stress, depression, and anxiety from start of intervention until follow-up session

时间窗: The change between 1 week pre-intervention assessment and 8 weeks post-intervention assessment.

The Depression Anxiety Stress Scales, short form, minimum 0 (better), maximum 3 (worse)

Mindfulness change from waitlist to start of intervention

时间窗: The change between waitlist assessment at 8 weeks pre-intervention and 1 week pre-intervention assessment

The Dutch version of the five-facet mindfulness questionnaire, short form, minimum 1 (worse), maximum 5 (better) .

Mindfulness change from start of intervention until end of intervention

时间窗: The change between 1 week pre-intervention assessment and 1 week post-intervention assessment.

The Dutch version of the five-facet mindfulness questionnaire, short form, minimum 1 (worse), maximum 5 (better) .

Mindfulness change from start of intervention until follow-up session

时间窗: The change between 1 week pre-intervention assessment and 8 weeks post-intervention assessment.

The Dutch version of the five-facet mindfulness questionnaire, short form, minimum 1 (worse), maximum 5 (better) .

Self-compassion change from waitlist to start of intervention.

时间窗: The change between waitlist assessment at 8 weeks pre-intervention and 1 week pre-intervention assessment

3-item Self-Compassion Scale, minimum 1 (worse), maximum 7 (better)

Self-compassion change from start of intervention until end of intervention

时间窗: The change between 1 week pre-intervention assessment and 1 week post-intervention assessment.

3-item Self-Compassion Scale, minimum 1 (worse), maximum 7 (better)

Self-compassion change from start of intervention until follow-up session

时间窗: The change between 1 week pre-intervention assessment and 8 weeks post-intervention assessment.

3-item Self-Compassion Scale, minimum 1 (worse), maximum 7 (better)

次要结局

未报告次要终点

研究者

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

Irena Veringa-Skiba MSc

MSc.

University of Amsterdam

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