Strengthened parental support for expectant parents – a pilot to assess trial feasibility and preliminary outcomes
| ISRCTN | ISRCTN11445342 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11445342 |
| Secondary identifying numbers | 20223263 |
- Submission date
- 05/12/2024
- Registration date
- 06/12/2024
- Last edited
- 16/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The support expectant parents receive is an important protective factor for their children. It is extra important to offer support that reduces the risk of stress, depression and anxiety already during pregnancy. These conditions not only cause suffering for the pregnant woman but also pose risks for the foetus and the future mental health of the child. For expectant parents there is both an increased risk for mental ill-health and a unique opportunity to promote mental wellbeing for the whole family. The overarching goal for this project is therefore to strengthen parental support during pregnancy. The specific aim is to do a pilot study to see if it can be scaled up to a larger study. Doing a pilot means that we want to test things like recruiting and keeping participants in the study, collecting the data and also looking at preliminary results about how the support works. If running the study is smooth, the researchers can continue with a larger study to test how well the support works.
Who can participate?
Expectant parents who speak Swedish and are at least 18 years old
What does the study involve?
We have adapted mindfulness-based parental support to Swedish maternal health services. This new parental support is called ‘Parenting with Awareness and Compassion’. It includes four group meetings and material on a homepage. During the group meetings mindfulness and yoga practises are mixed with information about childbirth, breastfeeding, the needs of a newborn and new parents, as well as couple communication. Half of the participants will receive this new support and the other half (the control group) will receive the standard support given in maternal healthcare. The participants will fill out questionnaires about their quality of life, mental health and how it feels to be a parent. They will fill out the questionnaires three times: Around the middle of the pregnancy (gestational weeks 20-25), toward the end of the pregnancy (gestational weeks 32-34) and 3 months after their baby is born.
What are the possible benefits and risks of participating?
The participants who will receive the new support may feel more prepared and strengthened for childbirth and parenting. The risk of side effects, like anxiety or emotional sensitivity, from such support is low. All participants will receive gifts for the baby, a blanket and a baby book as thanks for their time filling out questionnaires.
Where is the study run from?
Uppsala University (Sweden)
When is the study starting and how long is it expected to run for?
April 2022 to October 2026
Who is funding the study?
The Kamprad Family Foundation (Sweden)
Who is the main contact?
Dr Gunilla Lönnberg, gunilla.lonnberg@uu.se
Contact information
Public, Scientific, Principal Investigator
Husargatan 3, Box 564
Uppsala
752 37
Sweden
 ORCID ID |
0000-0002-4835-9325 |
|---|---|
| Phone | +46 (0)72 999 96 22 |
| gunilla.lonnberg@uu.se |
Study information
| Study design | Multicenter interventional single-blinded pilot randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Pilot randomized controlled trial |
| Study setting(s) | Other |
| Study type | Other, Prevention, Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A pilot to assess the feasibility of a randomized controlled trial evaluating a strengthened parental support program vs standard support for expectant parents |
| Study acronym | PACT |
| Study objectives | The rationale is to address uncertainties regarding the feasibility of conducting a full scale randomized controlled trial and if appropriate modify the study design. |
| Ethics approval(s) |
Approved 27/09/2023, The Swedish Ethical Review Authority (Box 2110, Uppsala, 750 02, Sweden; +46 (0)10 475 08 00; registrator@etikprovning.se), ref: 2023-05031-01 |
| Health condition(s) or problem(s) studied | Mental health of expectant parents |
| Intervention | The intervention Parenting with Awareness and Compassion consists of four group meetings, led by a midwife and is supported by a homepage with short informative texts and videos as well as audio files with practices. It includes the traditional elements of parental support from maternal healthcare such as preparation for childbirth, parenting, breastfeeding and alternative feeding, infant care and the couple relationship. These elements are woven together with mindfulness-based practices that strengthen emotional self-regulation, interoceptive awareness, meta-cognition, relational responsiveness, and compassion. Simply put, the practices, including peer support and reflective conversations give parents tools to decrease stress, anxiety and negative moods and increase their ability to reevaluate and see wider perspectives as well as become more sensitive and kind with themselves, each other and their child. Randomisation lists are made for each site using 'sealed envelope', with random blocks of 2-4. An administrator external to this project has the lists. Half of the participants will receive the new support and the other half (the control group) will receive the standard support given in maternal healthcare. The participants will fill out questionnaires about their quality of life, mental health and how it feels to be a parent. They will fill out the questionnaires three times: Around the middle of the pregnancy (gestational week 20-25), toward the end of the pregnancy (gestational week 32-34) and 3 months after their baby is born. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Self-compassion is measured using the Self-Compassion Scale Short Form at baseline, 2 months (around gestational week 34) and 5 months (around 3 months postpartum) 2. Quality of life is measured using Assessment of Quality of Life 8-Dimension at baseline, 2 months (around gestational week 34) and 5 months (around 3 months postpartum) |
| Secondary outcome measures | 1. Fear of birth is measured using the visual analogue score fear of birth at baseline and 2 months (around gestational week 34). 2. Depressive symptoms are measured using the Edinburgh Postpartum Depression Scale at baseline, 2 months (around gestational week 34) and 5 months (around 3 months postpartum) 3. Anxiety is measured using the General Anxiety Disorder form at baseline, 2 months (around gestational week 34) and 5 months (around 3 months postpartum) 4. Prenatal attachment is measured using the Prenatal Attachment Inventory at baseline and 2 months (around gestational week 34) 5. Postpartum bonding is measured using the Postpartum Bonding Questionnaire at 5 months (around 3 months postpartum) |
| Overall study start date | 01/04/2022 |
| Completion date | 31/10/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 374 |
| Total final enrolment | 159 |
| Key inclusion criteria | 1. Expectant primiparous mother or partner of expectant primiparous mother 2. In pregnancy weeks 18 to 30 3. Patient enlisted in one of seven participating maternal health clinics 4. Swedish speaking 5. 18 years of age or over |
| Key exclusion criteria | 1. Previous or active psychosis, personality disorders |
| Date of first enrolment | 09/12/2014 |
| Date of final enrolment | 08/05/2025 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Norrtälje
761 32
Sweden
Täby
183 34
Sweden
Stockholm
117 94
Sweden
Stockholm
136 40
Sweden
Sponsor information
University/education
Institutionen för folkhälso- och vårdvetenskap
Husargatan 3, Box 564
Uppsala
752 37
Sweden
| Phone | +46 (0)18 471 00 00 |
|---|---|
| karin.nordin@uu.se | |
| Website | https://www.uu.se/en/ |
"ROR" |
https://ror.org/048a87296 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Kamprad Family Foundation
- Location
- Sweden
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to ethical reasons and the handling of personal sensitive information. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | 18/09/2024 | 16/05/2025 | No | No |
Additional files
Editorial Notes
16/05/2025: The following changes were made to the trial record:
1. The statistical analysis plan was uploaded as an additional file.
2. The total final enrolment was added.
3. The participant level data sharing statement was added.
17/04/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 30/04/2025 to 08/05/2025.
2. The overall study end date was changed from 31/07/2025 to 31/10/2026.
3. Mamma Mia Nacka Barnmorskemottagning and Aleris Ultragyn Barnmorskemottagning på Sabbatsberg Sjukhus were removed from the study participating centres.
06/12/2024: Study's existence confirmed by Familjen Kamprads Stiftelse.
