Stress ReductionNCT05210075
Mindful With Your Baby in a Non-clinical Setting
A study testing Mindful with your Baby program in people with Stress Reduction, run by University of Amsterdam.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 50 years, women only
- Conditions the study is for
- Stress Reduction
- What is being tested?
- Mindful with your Baby program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- a subjective experience of (parental) stress, and the ability to speak and read Dutch.
Who cannot join
- a current unsafe situation for the baby, and maternal psychosis or suicidality.
About this study
Official title: Mindful With Your Baby for Mothers of Infants With (Parental) Stress in a Non-clinical Setting: A Wait-list Controlled Pilot Trial
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.
Read the detailed description
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.
- Conditions
- Stress Reduction
- Being tested
- Mindful with your Baby program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful with your Baby programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| A wait list controlled | Experimental | A wait list controlled Receives: Behavioral: Mindful with your Baby program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental stress change from waitlist to start of intervention
Short form of the Dutch Parenting Stress Index, minimum 1 (better), maximum 6 (worse)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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) .
Measured: 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) .
Measured: 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) .
Measured: 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)
Measured: 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)
Measured: 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)
Measured: The change between 1 week pre-intervention assessment and 8 weeks post-intervention assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Jan 2016
- Primary completion1 Dec 2017
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stress ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A wait-list controlled pilot trial
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irena Veringa-Skiba MSc, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210075
- Sponsor's protocol ID
- 2015-CDE-4632
- Status last verified
- Nov 2023
- First submitted
- 16 Dec 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared if a reasonable scientific request will be provided.
Publications
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.
PubMed 28989548Loyd 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.
PubMed 4020601Lovibond 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.
PubMed 7726811de 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.
PubMed 22589426Baer 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.
PubMed 16443717
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful With Your Baby for Mothers of Infants With (Parental) Stress in a Non-clinical Setting: A Wait-list Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT05210075
- Acronym / sponsor ID
- 2015-CDE-4632
- Conditions
- Stress Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of AmsterdamUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A wait-list controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| A wait list controlled | Experimental | Behavioral: Mindful with your Baby programA wait list controlled |
Who may qualify
- Ages
- Up to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- a subjective experience of (parental) stress, and the ability to speak and read Dutch.
Key exclusion criteria (1 listed)
- a current unsafe situation for the baby, and maternal psychosis or suicidality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful with your Baby programThe 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. | Behavioural | A wait list controlled |
Primary outcome
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)
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)
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)
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)
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)
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)
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) .
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) .
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) .
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Background: PubMed 28989548Potharst 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.
- Background: PubMed 4020601Loyd 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.
- Background: PubMed 7726811Lovibond 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.
- Background: PubMed 22589426de 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.
- Background: PubMed 16443717Baer 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.
- Individual participant dataSharing planned: No. Data can be shared if a reasonable scientific request will be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful with your Baby program in people with Stress Reduction, run by University of Amsterdam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05210075, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.