NCT04892082

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

Completed NA Last updated 2 November 2022

What this trial tests

NA trial testing Mindful Moment in Parenting Stress in 292 participants. Completed in 31 October 2021.

Timeline

15 April 2021

Primary endpoint
31 October 2021

31 October 2021

Quick facts

Lead sponsor	University of Coimbra
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	292
Start date	15 April 2021
Primary completion	31 October 2021
Estimated completion	31 October 2021
Sites	1 location across Portugal

Drugs / interventions tested

• Mindful Moment
• Waiting-List Control (WLC)

Conditions studied

• Parenting Stress — all drugs for Parenting Stress →

Sponsor

University of Coimbra

Who can join

Adults 18 to 50, female only, with Parenting Stress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Fernandes DV, Monteiro F, Canavarro MC, Moreira H. · · 2022 · cited 12× · PMID 36408119 · DOI 10.1007/s12671-022-02016-0