Mindful With Your Baby in a Non-clinical Setting

NCT05210075 | Completed

• 1 other identifier: 2015-CDE-4632
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stress Reduction

Outcome Measures

Primary Outcomes (12)

• Parental stress change from waitlist to start of intervention

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

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

• Parental stress change from start of intervention until end of intervention

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Mindfulness change from waitlist to start of intervention

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

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

• Mindfulness change from start of intervention until end of intervention

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

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

• Mindfulness change from start of intervention until follow-up session

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

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

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

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

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

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

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

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

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

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

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

Study Arms (1)

A wait list controlled

EXPERIMENTAL

A wait list controlled

Behavioral: Mindful with your Baby program

Interventions

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.

A wait list controlled

Eligibility Criteria

• Age: Up to 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Amsterdam: lead

Related Publications (5)

• Potharst ES, Aktar E, Rexwinkel M, Rigterink M, Bogels SM. Mindful with Your Baby: Feasibility, Acceptability, and Effects of a Mindful Parenting Group Training for Mothers and Their Babies in a Mental Health Context. Mindfulness (N Y). 2017;8(5):1236-1250. doi: 10.1007/s12671-017-0699-9. Epub 2017 Apr 13.

  PMID: 28989548 BACKGROUND

• Loyd BH, Abidin RR. Revision of the Parenting Stress Index. J Pediatr Psychol. 1985 Jun;10(2):169-77. doi: 10.1093/jpepsy/10.2.169. No abstract available.

  PMID: 4020601 BACKGROUND

• Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

  PMID: 7726811 BACKGROUND

• de Bruin EI, Topper M, Muskens JG, Bogels SM, Kamphuis JH. Psychometric properties of the Five Facets Mindfulness Questionnaire (FFMQ) in a meditating and a non-meditating sample. Assessment. 2012 Jun;19(2):187-97. doi: 10.1177/1073191112446654.

  PMID: 22589426 BACKGROUND

• Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.

  PMID: 16443717 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc.

Model Details: A wait-list controlled pilot trial

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 27, 2022
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share