The baby sleep project: evaluation of support for families to follow safer sleep advice.
| ISRCTN | ISRCTN73364337 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73364337 |
| IRAS number | 329961 |
| Secondary identifying numbers | CPMS 58215, NIHR300820, IRAS 329961 |
- Submission date
- 06/02/2024
- Registration date
- 09/02/2024
- Last edited
- 09/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Every year in the UK, about 300 babies under a year die suddenly and unexpectedly, and most of these deaths remain unexplained. ‘Safer Sleep’ messages (e.g. Back is best) have worked for lots of families, but the deaths that now happen mostly occur within families experiencing poverty. Many of the deaths in these families could be prevented as they almost always have known, avoidable risks present, like sleeping on a sofa with a baby. We have developed some resources and tools for health professionals and families that we hope will help, but we need to test them to see how they work, for whom and under what circumstances.
Who can participate?
The study will recruit health professionals (neonatal staff, health visitors and family nurse partnership nurses) and families with new babies.
What does the study involve?
The health professionals will get some training in how to use the new resources and start to use them with families. They will fill out some questionnaires about using the new resources and we will interview some of them to find out how the new resources have been embedded into their work practices. We will ask families to complete questionnaires about their baby's sleeping habits and how they feel about being a parent. We will ask some parents who have not seen the new resources and some who have seen the new resources and look for any differences in their responses. We will also invite some of the parents to be interviewed by us to find out more about their experiences with the resources and what may have changed for them as a result of using them. We will use all of this information to develop our theory about how these new resources work, including working out where and when they work best, and what the underlying mechanisms might be for any changes we see as a result of using them.
What are the possible benefits and risks of participating?
There are no direct benefits to taking part, although we will say thank you for caregivers time by offering them a shopping voucher for taking part. There are no risks to taking part as using the resources will not replace any standard care or information that families receive.
Where is the study run from?
The study is led by a team of researchers based at the University of Bristol (UK)
When is the study starting and how long is it expected to run for?
June 2023 to March 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Dr Anna Pease, a.pease@bristol.ac.uk
Contact information
Scientific
Level D
St Micheals Hospital
Southwell St
Bristol
BS2 8EG
United Kingdom
| Phone | +44 117 342 5144 |
|---|---|
| a.pease@bristol.ac.uk |
Study information
| Study design | Interventional non-randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, Home, Internet/virtual, Telephone |
| Study type | Other |
| Participant information sheet | https://babysleepresearch.co.uk/baby-sleep-project/ |
| Scientific title | Supporting families with infants at risk of sudden unexpected death in infancy: co-production and realist evaluation of intervention to support safer infant sleep for families with infants at increased risk. |
| Study acronym | The Baby Sleep Project Part 2 |
| Study objectives | When the baby sleep project resources are integrated into conversations with families about safer sleep (context), families will be more likely to implement safer sleep advice (outcome) because they understand the risks to their own infant, understand how safer sleep works to protect their baby and have made a plan for safety during times when the routine is disrupted (mechanisms). |
| Ethics approval(s) |
Approved 07/12/2023, South West - Frenchay Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, United Kingdom; +44 207 104 8184; frenchay.rec@hra.nhs.uk), ref: 23/SW/0119 |
| Health condition(s) or problem(s) studied | Supporting families with infants at risk of sudden unexpected death in infancy |
| Intervention | A realist evaluation study involving before and after mixed methods data collection as follows: 1. Pre-intervention baseline data collection from families completing surveys at approximately 4 and 8 weeks after the birth of the baby 2. Training for health professionals using the baby sleep project resources 3. Post-intervention follow-up data collection from families completing surveys at approximately 4 and 8 weeks after the birth of the baby 4. Post-intervention Nomad questionnaires for health professionals 5. Qualitative interviews will take place when quantitative surveys have been completed with health professionals and family members |
| Intervention type | Behavioural |
| Primary outcome measure | Safer sleep adherence is measured using infant sleep diaries at 4 weeks and 8 weeks post birth |
| Secondary outcome measures | Current secondary outcome measures: 1. Parental self-efficacy is measured using the 13-item two-factor Uppsala Parental Self-Efficacy about Infant Sleep Instrument (UPPSEISI) at 4 weeks and 8 weeks post birth 2. Implementation processes are measured using the 23-item Nomad questionnaires at baseline, 2 months and 4 months Previous secondary outcome measures: 1. Parental self-efficacy is measured using the TOPSE-baby questionnaire at 4 weeks and 8 weeks post birth 2. Implementation processes are measured using the 23-item Nomad questionnaires at baseline, 2 months and 4 months |
| Overall study start date | 01/06/2023 |
| Completion date | 01/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 220; UK Sample Size: 220 |
| Key inclusion criteria | 1. Health professionals (teams of health visitors, neonatal nurses, midwives and specialist nurses (family nurse partnerships) working with families experiencing poverty. 2. Parents/caregivers of infants, either still pregnant or with infants under 2 weeks old, receiving services from recruited health professional teams, can take part in the evaluation. |
| Key exclusion criteria | 1. Individuals under 16 years of age 2. Anyone who lacks cognitive capacity to consent 3. Anyone unable to complete an interview in English |
| Date of first enrolment | 01/04/2024 |
| Date of final enrolment | 01/09/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Leicester
LE5 4PW
United Kingdom
Bristol
BS2 8EG
United Kingdom
Church Road
Birkenhead
CH42 0LQ
United Kingdom
Runcorn
WA7 4QX
United Kingdom
Clara Cross Lane
Bath
BA2 5RP
United Kingdom
Coopers End Road
Stansted
CM24 1SJ
United Kingdom
Holt
Trowbridge
BA14 6RL
United Kingdom
Sponsor information
University/education
Senate House, Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
| Phone | +44 1173940177 |
|---|---|
| research-governance@bristol.ac.uk | |
| Website | http://bristol.ac.uk/ |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | The results of this study will be shared with other health staff and parents by reports in medical and health journals, newsletters, and talking about the results at conferences. |
| IPD sharing plan | The data will be made available on the University of Bristol Research Data Repository (https://data.bris.ac.uk/data/). Access will only be granted to researchers with appropriate ethical approval. Consent for this will be obtained from participants. All data will be anonymised. Data will be available by the end of January 2026 indefinitely. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3 | 07/02/2024 | 09/02/2024 | No | No |
| Protocol file | version 5 | 21/02/2024 | 09/04/2024 | No | No |
Additional files
Editorial Notes
09/04/2024: The following changes were made:
1. Protocol (not peer reviewed) was added as an additional file.
2. The secondary outcome measures were changed.
11/03/2024: The recruitment start date was changed from 01/03/2024 to 01/04/2024.
04/03/2024: Internal review.
12/02/2024: Internal review.
06/02/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
