Boosting baby communication and play
| ISRCTN | ISRCTN64237883 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64237883 |
| IRAS number | 289896 |
| Secondary identifying numbers | IRAS 289896 |
- Submission date
- 10/09/2021
- Registration date
- 13/09/2021
- Last edited
- 07/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
When a new mother experiences mental illness, this can have negative effects not just on herself, but also on her relationship with her child and on her child’s future development and mental health. The NHS Long-Term plan states that increasing access to interventions to improve parent-infant relationships should be a priority. However, we have very little evidence on what parent-infant interventions actually work when implemented in real-world NHS services.
Our team has recently evaluated the video feedback for positive parenting intervention (VIPP) in perinatal mental health services for women experiencing mental illness in the first year of their child’s life. Mothers are videoed interacting with their babies, and given positive and non-judgemental feedback. We found potential benefits for mothers and children receiving VIPP, in how confident mothers felt and how they interacted with their children.
However, VIPP is currently designed for infants aged above 6 months. To help more women using perinatal mental health services, we have now adapted VIPP for younger babies and have also added tips on what strategies parents can use to feel calmer if they are feeling stressed while interacting with their child.
We now need to pilot the modified intervention with Mums using perinatal mental health services, to check it is feasible for clinicians to deliver, and to gain Mums' and clinicians' feedback. We will train clinicians in perinatal mental health services to deliver the modified intervention. We will evaluate how well perinatal mental health staff are able to deliver the intervention; mothers’ attendance and feedback; changes in mothers’ responses to their babies’ communication, parenting-related stress, parental self-confidence and bond with their baby. We will assess these using questionnaires and videos of the mothers playing with their babies, as well as by carrying out feedback interviews with mothers and clinicians.
Who can participate?
Mothers currently under the care of a perinatal mental health service who have a child aged 2 months 0 days to 3 months 31 days old.
What does the study involve?
Step 1. We will ask mothers about their current and past mental health, their feelings about being a Mum, and their baby’s development. We will film short clips of Mum and baby playing together.
Step 2. Mothers will then be offered six sessions of the video feedback intervention for positive parenting. The clinician will make film clips of Mum and baby playing together and then you will watch them back with the clinician so that you can talk together about what your baby’s behaviour means, their bond with you and what he/she is communicating.
Step 3. We will check in with the mothers again, to find out how they are doing in terms of their mental health, their feelings about being a Mum, and their baby’s development. We will again film short clips of Mum and baby playing together. We will also ask mothers to give us feedback about their experiences of the intervention.
What are the possible benefits and risks of participating?
We are in the early stages of this research and therefore we cannot say with certainty that taking part will be of benefit. However, the Baby Communication and Play sessions have been used in research studies previously and parents have found them helpful. Afterwards, mothers will be able to download their own copy of the clips of baby and themselves playing together. The disadvantages of taking part are likely to be small. Mothers will need to put some time aside for the video feedback visits. Some people can find it embarrassing to watch clips of themselves and can start to feel self-conscious, judge themselves or worry that others will judge them. The professionals conducting the visits are specially trained to be aware of this and to help participants deal with these feelings.
Where is the study run from?
City University of London (UK).
When is the study starting and how long it is expected to run for?
April 2021 to May 2022.
Who is funding the study?
The study is funded by City University of London and Central & North West London NHS Foundation Trust (UK).
Who is the main contact?
The main contact is Kirsten Barnicot at City University of London.
Contact information
Scientific
School of Health Sciences - Myddleton Street Building
Myddleton Street
London
EC1R 1UW
United Kingdom
 ORCID ID |
0000-0001-5083-5135 |
|---|---|
| Phone | +44 (0)20 7040 5060 |
| Kirsten.Barnicot@city.ac.uk |
Public
School of Health Sciences - Myddleton Street Building
Myddleton Street
London
EC1R 1UW
United Kingdom
| Phone | +44 (0)20 7040 5060 |
|---|---|
| Kirsten.Barnicot@city.ac.uk |
Study information
| Study design | Multi-centre interventional feasibility case series |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Video feedback for positive parenting in perinatal mental health services: Developing and piloting an optimised protocol |
| Study acronym | BOOST-2 |
| Study objectives | To evaluate the feasibility and acceptability of the adapted Video feedback intervention for Positive Parenting (VIPP), for mothers using perinatal mental health services and their 2 to 6 month old infants. |
| Ethics approval(s) | Approved 29/06/2021, East of England - Cambridge South Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; no telephone number provided; cambridgesouth.rec@hra.nhs.uk), ref: 21/EE/0139 |
| Health condition(s) or problem(s) studied | Mothers experiencing moderate to severe perinatal mental health difficulties |
| Intervention | Video feedback intervention for positive parenting. A 7 session intervention in which mothers and their child are filmed playing together and given positive feedback on the interaction from the child's perspective, with the aim of enhancing maternal sensitivity and parent-child relationships. The intervention sessions are scheduled every 2 weeks and the intervention thus lasts on average 3 months. Research follow-up will be at 5 months post-baseline. This is an uncontrolled case series; there is no control/ comparator intervention. |
| Intervention type | Behavioural |
| Primary outcome measure | Percentage of mothers initiating and completing the VIPP intervention measured using patient records at the end of the study |
| Secondary outcome measures | 1. Percentage of mothers invited to participate who give informed consent to do so measured using patient records at the end of the study 2. Mother and clinician ratings of the therapeutic alliance measured using the Helping Alliance Scale during VIPP at month 5 post-baseline 3. Participants’ own accounts of their experiences of the feasibility and acceptability of the intervention, assessed using qualitative interviews at month 5 post-baseline 4. Parental Stress Scale at month 5 post-baseline 5. Parent Expectations Survey at month 5 post-baseline 6. Mother Object Relations Scale – Short Form (MORS-SF) at month 5 post-baseline 7. Parental sensitivity measured using the Parent Infant Interaction Observation Scale at month 5 post-baseline 8. Difficulties in Emotion Regulation Scale at month 5 post-baseline |
| Overall study start date | 01/04/2021 |
| Completion date | 30/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 10 |
| Key inclusion criteria | 1. Are using community perinatal mental health services 2. Are a primary caregiver of a child aged 2 to 3 months 3. Are capable of giving informed consent 4. Are aged 16 to 65 years |
| Key exclusion criteria | 1. Families where a sibling or co-parent is participating in the trial 2. Families in which the eligible child has a clinical diagnosis of a learning difficulty, developmental disorder or sensory impairment. 3. Families in which the eligible parent has English language or learning difficulties that are sufficiently severe to prevent them completing study measures even with assistance. |
| Date of first enrolment | 13/09/2021 |
| Date of final enrolment | 30/11/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Regent's Place
London
NW1 3AX
United Kingdom
London
E1 8DE
United Kingdom
Pinewood Place
Dartford
DA2 7WG
United Kingdom
Sponsor information
University/education
Northampton Square
London
EC1V 0HB
England
United Kingdom
| Phone | +44 (0)20 7040 5060 |
|---|---|
| Anna.Ramberg.1@city.ac.uk | |
| Website | http://www.city.ac.uk |
"ROR" |
https://ror.org/04489at23 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 31/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We will publish the study in a peer-reviewed journal and disseminate the findings at conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. k.barnicot@imperial.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.1 | 22/06/2021 | 13/09/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 05/03/2024 | 07/03/2024 | Yes | No |
Additional files
Editorial Notes
07/03/2024: Publication reference added.
13/09/2021: Trial's existence confirmed by East of England - Cambridge South Research Ethics Committee
