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Completed

NCT Number: NCT05210075

Mindful With Your Baby in a Non-clinical Setting

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.

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Key information

Conditions

Stress Reduction

Age range

Up to 50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

All outcomes were tested with multilevel regression models that are known to accommodate missing data and dependence between observations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Mindful with your Baby program

Behavioral

The training Mindful with your baby consists of eight weekly 2-h sessions, plus a follow-up session 8 weeks later. The first and the fifth sessions are with the mothers only. The rest of the sessions are with both mothers and babies present. The sessions are finished by explaining the new home practices. Home practice consists of reading handouts about mindfulness and mindful parenting for mothers with a baby, formal and informal meditation practice.

Primary outcomes

  1. Parental stress change from waitlist to start of intervention

    Time frame: 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)

  2. Parental stress change from start of intervention until end of intervention

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

  7. Mindfulness change from waitlist to start of intervention

    Time frame: 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) .

  8. Mindfulness change from start of intervention until end of intervention

    Time frame: 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) .

  9. Mindfulness change from start of intervention until follow-up session

    Time frame: 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) .

  10. Self-compassion change from waitlist to start of intervention.

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Amsterdam

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 27, 2022
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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