Mindful Moment: Feasibility and Preliminary Efficacy of a Web-based Mindful and Compassionate Parenting Training

NCT04892082 | Completed

• 2 other identifiers: MindfulMoment/132588/2017SFRH/BD/132588/2017
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Parenting Stress

Keywords

Parenting stress; Mindful Parenting; Compassion; Postpartum period; Mother-infant relationship; eHealth

Outcome Measures

Primary Outcomes (1)

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

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

  8 weeks

Secondary Outcomes (13)

• Feasibility of the program for postpartum mothers as measured by the pattern of program usage

  8 weeks

• 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

Study Arms (2)

Mindful Moment

EXPERIMENTAL

Mothers who present parenting stress equal or above 41 score on PSS will receive a web-based intervention to reduce parenting stress (the Mindful Moment program).

Behavioral: Mindful Moment

Control

ACTIVE COMPARATOR

All mothers who present parenting stress will have access to Mindful Moment intervention. The control group only receive the intervention at the end of the intervention group.

Other: Waiting-List Control (WLC)

Interventions

Mindful Moment BEHAVIORAL

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.

Mindful Moment

Waiting-List Control (WLC) OTHER

The control group only receive the intervention at the end of the intervention group.

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Coimbra: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

Faculty of Psychology and Education Sciences, University of Coimbra

Coimbra, 3000-115, Portugal

Location

Related Publications (1)

• Fernandes DV, Monteiro F, Canavarro MC, Moreira H. A Web-Based, Mindful, and Compassionate Parenting Training for Mothers Experiencing Parenting Stress: Results from a Pilot Randomized Controlled Trial of the Mindful Moment Program. Mindfulness (N Y). 2022;13(12):3091-3108. doi: 10.1007/s12671-022-02016-0. Epub 2022 Nov 10.

  PMID: 36408119 DERIVED

Study Officials

• Daniela V. Fernandes, MsC

  Faculty of Psychology and Education Sciences, University of Coimbra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single-blind - the investigator is unaware of the intervention assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment - Participants are being randomized to intervention or control groups at a 1:1 ratio

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 19, 2021
• Study Start: April 15, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)