Mindful Moment: Feasibility and Preliminary Efficacy of a Web-based Mindful and Compassionate Parenting Training
Condition: Parenting Stress
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.

      The main goal of this research is to evaluate Mindful Moment by considering several
      indicators: 1) Mindful Moment's feasibility in terms of adherence, dropout and the pattern of
      program usage (e.g., number of completed modules, number of pages accessed in each module);
      2) Mindful Moment's acceptability in terms of users' global perceptions of the program; and
      3) preliminary evidence of Mindful Moment's efficacy in terms of primary (parenting stress)
      and secondary outcomes (e.g., mindful parenting; self-compassion; depressive and anxiety
      symptoms).

      The research design of the trial followed the methodological recommendations for the
      development and evaluation of web-based interventions. A usability test was already conducted
      through phone-call with 4 mothers who explored the website while verbalizing their experience
      and opinions (think-aloud sessions). At the end, a brief questionnaire was completed by each
      participant. The results allowed to identify and implement modifications and the final
      version of Mindful Moment was achieved, allowing for a pilot RCT efficacy study.

      The pilot RCT will be a two-arm trial, conducted with mothers who presented parenting stress
      (PSS ≥ 41 score). The intervention condition (the Mindful Moment program) will be compared
      with a control condition (Waiting-List control group). The sample will include mothers who
      delivered a baby in the postpartum period (up to 18 months postpartum). Mothers are being
      already recruited online through social media and websites and forums focused on motherhood.
      The dissemination of the study will also be made in HealthCare Centers, after the approval
      already obtained from Regional Administration of Health Center (ARS-Center). A minimum number
      of 30 mothers per condition will be required (N = 60). Accounting for the proportion of
      mothers who presented moderate or high parenting stress (a total score on PSS of 41 or more)
      and the 50% of attrition rate over time, an anticipated sample of 600 mothers will be
      enrolled in the study.

      Mothers who demonstrate interest in the study were informed of the study goals, the structure
      and arms of the research and the researchers' and participants' roles. Mothers who agree to
      participate in the study gave their informed consent. All ethical requirements for research
      with humans were guaranteed. Mothers were screened for the presence of parenting stress. In
      case of lower levels of parenting stress, mothers' participation in the study ended. In case
      of presenting moderate or high levels of parenting stress (PSS ≥ 41), mothers were randomly
      assigned (blocked randomization, with allocation concealment) to one of the conditions: the
      intervention (Mindful Moment program) or the control condition (WLC group).

      A researcher (clinical psychologist) will contact mothers in the intervention condition,
      aiming to explain the program's structure and provide assistance during the course of the
      study.

      Participation in the 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 (8-weeks after post-intervention) assessments. 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).
    

Intervention name(s): Mindful Moment; Waiting-List Control (WLC)
Intervention type(s): Behavioral; Other
Intervention description(s): The Mindful Moment program is a web-based self-guided cognitive-behavioral intervention to reduce parenting stress, targeting postpartum mothers. It consists of 6 weekly modules, each module targeting a specific thematic content, and providing mothers with both information and specific therapeutic strategies (with a strong focus on the third wave of cognitive-behavioral techniques) to address each thematic content. Modules are sequential.; The control group only receive the intervention at the end of the intervention group.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment - Participants are being randomized to intervention or control groups at a 1:1 ratio
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Parenting stress; Mindful Parenting; Compassion; Postpartum period; Mother-infant relationship; eHealth