Feasibility of a Psychoeducational Group Intervention to Improve Parental Reflective Functioning and Bonding in Prenatal Depression
Phase: NA
Conditions: Depression, Pregnancy
Sponsor: King's College London

 
 
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PROTOCOL TITLE: 
Feasibility of a psychoeducational group intervention to improve parental 
reflective functioning and bonding in prenatal depression 
 
NCT05628675 
 
Document Date: 05/05/2022 
Sponsor/s 
Name of organisation: South London and Maudsley NHS Foundation Trust and Institute 
of Psychiatry, Psychology & Neuroscience 
Address: Research & Development Office, Box P005, Institute of Psychiatry, Psychology 
& Neuroscience, King's College London, Denmark Hill Campus, 16 De Crespigny Park, 
London, SE5 8AF 
Telephone: 020 7848 0790 
Email: slam-ioppn.research@kcl.ac.uk 
Chief Investigator  
Name: Dr Fiona Challacombe 
Address: Health Service and Population Research Department (PO31), Institute of 
Psychiatry, Psychology & Neuroscience, De Crespigny Park, London, SE5 8AF 
Telephone: 020 3228 2101 
Email: fiona.challacombe@kcl.ac.uk 
Name and address of Principal Investigator(s), Co-Investigator(s), Statistician, 
Laboratories etc 
Name: Rebecca Cockburn 
Address: Department of Psychology (PO78), Institute of Psychiatry, Psychology & 
Neuroscience, Addiction Sciences Building, 4 Windsor Walk, King's College London, 
SE5 8BB 
Telephone: 07860 704 627 
Email: rebecca.cockburn@kcl.ac.uk 
 
 
 

 
 
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CONTENTS 
1. Introduction 
2 Study Objectives and Design  
2.1. Study Objectives 
2.2 Study Design & Flowchart 
2.3 Study Flowchart 
3. Sample Size, Statistics, Selection and Withdrawal of Subjects 
4. Study procedures 
5.  Sample Handling and Laboratories 
6. Assessment of Safety 
7. Study oversight arrangements 
8. Ethics and Regulatory Approvals 
9. Data Handling 
10. Finance & Publication Policy 
 
 
 
 
 

 
 
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Study Synopsis 
 
Full Title   
 
Feasibility of a psychoeducational group intervention 
to improve parental reflective functioning and 
bonding in prenatal depression 
Short Title/Acronym  
A prenatal bonding intervention for pregnant women 
with depression 
Protocol Version number and Date 
 
 
Version 1 05/05/2022 
 
Study Duration  
 
 
12 months 
Study Design 
 
 
Feasibility trial 
Sponsor/Co-sponsors  
 
 
South London & Maudsley NHS Foundation Trust 
and Institute of Psychiatry, Psychology & 
Neuroscience 
Chief Investigator 
 
 
Dr Fiona Challacombe 
IRAS number 
 
 
302132 
Primary objective 
 
 
To assess the acceptability and feasibility of a 
single-session psychoeducational group intervention, 
Baby CHAT, in women experiencing depression 
during pregnancy 
Secondary objective (s) 
 
 
To provide preliminary evidence for Baby CHAT’s 
effect on parental reflective functioning and prenatal 
bonding. To further develop the intervention from 
participants’ feedback and running of the group. 
Number of Subject  
N=24 
 
Main Inclusion Criteria 
 
 
Women aged ≥18 years who are pregnant, between 
20- and 34-weeks’ gestation, and currently 
experiencing depressive symptoms as identified by 
the Edinburgh Postnatal Depression Scale (EPDS). 
All participants must be resident in or accessing 
services in a London borough served by South 
London & Maudsley NHS Foundation Trust. 
Statistical Methodology and Analysis 
 
 
Quantitative feasibility and acceptability outcomes 
will be summarised descriptively. Qualitative data 
from the open-ended questions on the feedback 
form will be analysed using content analysis. Effect 
sizes for primary and secondary outcome measures 
will be calculated using Cohen’s d.  
 
 

 
 
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Glossary of Terms and Abbreviations 
 
AE 
 
 
Adverse Event 
 
 
AR 
 
 
Adverse Reaction 
ASR 
 
 
Annual Safety Report 
CA 
 
 
Competent Authority 
CI 
 
 
Chief Investigator 
CRF 
 
 
Case Report Form 
CRO  
 
Contract Research Organisation 
DMC  
 
Data Monitoring Committee 
EC 
 
 
European Commission 
GAfREC 
Governance Arrangements for NHS Research Ethics Committees 
ICF 
 
 
Informed Consent Form 
ISRCTN 
 
International Standard Randomised Controlled Trial Number 
MA 
 
 
Marketing Authorisation 
MS 
 
 
Member State 
Main REC 
 
Main Research Ethics Committee 
NHS R&D 
 
National Health Service Research & Development   
PI 
 
 
Principal Investigator 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
Subject 
 
An individual who takes part in a clinical trial 
RCT 
 
 
Randomised Controlled Trial 
REC 
 
 
Research Ethics Committee 
SAE 
 
 
Serious Adverse Event 
SDV 
 
 
Source Document Verification 
SOP 
 
 
Standard Operating Procedure  
SSA 
 
 
Site Specific Assessment 
TMG  
 
Trial Management Group 
TSC 
 
 
Trial Steering Committee 
 
 

 
 
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1. Introduction 
 
Depression is a significant public health problem in the United Kingdom and perinatal 
depression represents a particular concern. Prenatal or antenatal depression, that is, 
depression during pregnancy, is estimated to affect approximately 10-15% of pregnant women 
(Gavin et al., 2005). Meanwhile there is evidence that prevalence of prenatal depression may be 
increasing in the UK (Pearson et al., 2018). Depressive symptoms during pregnancy often 
persist into the postpartum period, where there is evidence that depression has a detrimental 
effect on the early mother-infant interaction (Field, 2011). Mothers may feel less confident in 
their role as a parent and show less sensitivity to infants’ needs and behaviour, which can 
substantially interfere with optimal child development. Maternal depression in pregnancy has 
been associated with a range of adverse emotional, behavioural and cognitive outcomes during 
childhood (Stein et al., 2014).    
 
NICE guidelines for treating prenatal depression depend on the severity of difficulties and 
include psychological treatment for depression and/or antidepressant medication, or a period of 
watchful waiting. However, evidence from studies with postnatal depression suggests that 
reducing mothers’ depressive symptoms is insufficient to also improve the mother-infant 
relationship and mitigate the impact on child development (Forman et al., 2007; Tsivos et al., 
2015). It is therefore important to consider mechanisms for the association between maternal 
depression and the mother-infant interaction, and how these may be targeted in interventions.  
 
Prenatal bonding, or maternal-foetal attachment, describes the emotional connection a woman 
develops with her foetus during pregnancy (Salisbury et al., 2003). Prenatal bonding has been 
shown to predict postnatal maternal involvement and can identify women who may have 
difficulties with the mother-child interaction after birth (Siddiqui and Hägglöf, 2000). McFarland 
and colleagues (2011) found an association between a clinical diagnosis of major depressive 
disorder during pregnancy and significantly lower levels of maternal-foetal attachment during the 
second and third trimesters, consistent with the clinical picture that depression is associated 
with social difficulties across a range of relationships. In a recent study in at-risk groups of 
women, prenatal depressive symptoms were again associated with poorer maternal-foetal 
bonding (Røhder et al., 2020). Taken together, the mother-infant relationship appears to play an 
important role in the widespread negative impacts of perinatal depression. Bonding between 
mother and foetus before birth could therefore be an important target for treatment.   
 
During pregnancy, mothers usually create a mental representation of their baby as a growing 
person, with their own social and emotional characteristics. The ability of a person to notice and 
describe feelings, thoughts and intentions underlying one’s own and others’ behaviour is known 
as mentalisation (Fonagy et al., 1991), operationalised in research as reflective functioning 
(RF). Parental RF is particularly important during a child’s early years, when children are entirely 
dependent on their caregiver to meet their needs. Developing RF during the prenatal period 
may therefore enable expectant mothers to prepare for parenthood. Research by Smaling and 
colleagues (2016) demonstrated that high prenatal RF predicted quality of the mother-child 
interaction and ameliorated some of the negative consequences of perinatal risk factors 
(including psychiatric disorders) on parent-child interactions.  
 
Evidence from the non-perinatal population suggests that psychological disorders, including 
depression, can affect a person’s capacity for RF (Katznelson, 2014; Luyton et al., 2012; 
Fischer-Kern et al., 2013). Studies have not consistently supported this relationship in maternal 
depression (e.g. Cordes et al., 2017). However, in a recent study in an Iranian community 

 
 
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sample (Khoshroo & Seyed Mousavi, 2021), maternal depression was found to be associated 
with poorer parental RF, as well as with greater internalising and externalising problems in the 
mothers’ children. Moreover, children of mothers with lower RF exhibited more internalising and 
externalising problems than children of mothers with higher RF. Therefore, despite the limited 
research on depression and RF in the prenatal period, interventions aimed at developing RF in 
pregnant women with depression have the potential to will ameliorate some of the negative 
consequences of depression and low parental RF for both mother and child.  
 
A variety of parenting interventions have been developed to promote prenatal bonding, 
postnatal attachment or RF. These include ultrasound scans (e.g. deJong-Pleij et al., 2013), 
psychoeducational sessions (e.g. Family Minds; Bammens, Adkins & Badger, 2015), and 
psychotherapy (e.g. the Mothers and Toddlers Programme; Suchman et al., 2012). Formats of 
these interventions have varied, including one-to-one sessions and groups. However, many 
existing interventions are conducted post-birth, are time-consuming for participants, or costly to 
facilitate. 
 
Therefore, a novel intervention, ‘Baby CHAT’, has been designed as a single-session group 
antenatal intervention, targeting both prenatal bonding and RF. The group incorporates 4D 
ultrasound footage of foetuses at 32 and 36 weeks of gestation showing imitation of mouth 
movements when hearing specific sounds, which indicates that foetuses react to stimulation and 
are preparing to interact socially before birth (Reissland et al., 2016). The clear, baby-like 
movements and facial expressions seen in 4D ultrasounds could aid attachment (Campbell, 
2006), and creating a meaningful narrative while viewing an ultrasound scan has been 
associated with good maternal-foetal bonding (Roberts, 2012). Baby CHAT aims to develop 
parents’ personal narratives and feelings of closeness with the baby by encouraging them to 
think about the social experience of their unborn baby and to engage socially with their baby 
before birth.  
 
There is promising early evidence that Baby CHAT is acceptable to participants and has the 
potential to improve prenatal bonding and RF in a non-clinical sample of expecting parents (Cox 
et al., 2020). Given these encouraging findings, the present study aims to examine the 
acceptability and feasibility of this intervention with a sample of pregnant women with 
depression, who are more likely to experience difficulties with bonding and RF. As Baby CHAT 
is a novel intervention, the study will also examine the feasibility of conducting research with 
Baby CHAT with this population. 
 
Terminology 
 
In the interests of brevity, the term ‘pregnant women’ will be used in the rest of this protocol to 
refer to all pregnant/birthing people, including women, non-binary people and transgender men, 
who will all be eligible to participate in this study. 
2 Study Objectives and Design 
2.1. Study Objectives 
 
The primary objective of the study is as follows: 
• 
To assess the acceptability and feasibility of a single-session psychoeducational group 
intervention, Baby CHAT, in women experiencing mild-to-moderate depression during 
pregnancy 
 

 
 
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Further, secondary objectives, are: 
• 
To provide preliminary evidence for Baby CHAT’s effect on parental RF and prenatal 
bonding in pregnant women with depression 
• 
To further develop the intervention from participants’ feedback and running of the group 
 
The study’s primary end point is as follows: 
• 
The study will be completed once Baby CHAT has been run enough times for 24 
participants to attend and the last participant has completed their outcome 
questionnaires 1 month after attending the final group 
2.2 Study Design & Flowchart 
 
Baby CHAT is a novel intervention and, to our knowledge, has never been trialled with pregnant 
women with depression. Therefore, a feasibility design is appropriate to explore whether Baby 
CHAT is acceptable to participants, if they experience the intervention as helpful, and to 
understand whether it is possible to recruit for and complete research on Baby CHAT with this 
group. Feasibility studies vary in scope but include assessing how practical it is to deliver the 
intervention, what the demand for the intervention is and how participants respond to it (Bowen 
et al., 2009). The findings of feasibility studies can then inform subsequent, larger-scale trials on 
the efficacy of the intervention.  
 
A single-arm repeated measures mixed-methods design will be utilised to provide rich feedback 
on the acceptability and feasibility of Baby CHAT. The aims of the quantitative arm of the study 
will be to gather descriptive statistics on the feasibility of the intervention, including uptake and 
retention of participants and whether the intervention can feasibly be delivered during the given 
time frame. Effect sizes will also be calculated to inform sample size calculations for a larger-
scale clinical trial in the future.  
 
The qualitative arm of the study will gain participants’ feedback on the content and impact of the 
intervention, including their opinions on use of the 4D scan footage, level of adaptation for low 
mood and any suggested improvements. This qualitative data will provide rich information about 
participant’s experiences of Baby CHAT, that will inform the next stage of the intervention’s 
development.   
2.3 Study Flowchart 
 
 
Screening 
Baseline 
Intervention 
Post-
intervention 
1-month 
follow-up 
Written informed consent 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
EPDS 
X 
 
 
X 
X 
MAAS 
 
X 
 
X 
X 
P-PRFQ 
 
X 
 
X 
X 
Baby CHAT intervention 
 
 
X 
 
 
Feedback form 
 
 
 
X 
 
Adverse events 
 
X 

 
 
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3.  Sample Size, Statistics, Selection and Withdrawal of Subjects 
 
Sample size 
 
This study is concerned with generating descriptive statistics to assess the feasibility of the 
proposed methods, rather than establishing effectiveness or generalisability of the intervention. 
There has been disagreement in the literature on appropriate sample sizes for feasibility 
studies, but sample sizes between 24 and 50 have been recommended (Lancaster, Dodd & 
Williamson, 2004; Sim & Lewis, 2012; Julious, 2005). To further aid decision-making regarding 
an appropriate sample size for the current project, sample sizes of similar studies in the field 
were also reviewed. These included N=24 in the treatment arm for the intervention Nurture and 
Play (Salo et al., 2019), and N=25 for a feasibility trial of the Beating the Blues Before Birth 
intervention (Milgrom et al., 2015).  
 
In qualitative studies, there is often less rigour in the choice and justification of the sample sizes 
used (Marshall et al., 2013). Qualitative research often concerns developing a depth of 
understanding, and therefore data saturation, that is, the point at which including more 
participants no longer contributes additional perspectives, is often suggested as a guide for 
ending recruitment (Glaser & Strauss, 1967). However, this provides little guidance for 
estimating sample sizes prior to data collection. Determination of appropriate sample sizes in 
advance will depend on the context and scientific paradigm of the research (Boddy, 2016). This 
study involves a brief qualitative component designed to generate a breadth of feedback on the 
intervention. Meanwhile, it is feasible to ask all participants to provide qualitative feedback, 
using the questionnaire following completion of the intervention. 
 
Taken together, a sample size of N=24 is estimated as appropriate for both the quantitative and 
qualitative components of the study. This is expected to be achievable based on current 
recruitment rates in a similar study with women with prenatal depression (the DAWN trial; 
Trevillion et al., 2020) and given that in 2020, around 925 babies were born in Southwark, 
Lambeth and Lewisham each month (Office for National Statistics, 2020). 
 
Participant selection 
 
An opportunity sample of participants will be recruited through their clinician or self-referral. This 
study will recruit participants from South London and Maudsley NHS Foundation Trust (SLaM) 
who are receiving care within the primary care Improving Access to Psychological Therapies 
(IAPT) services and secondary care perinatal services in Lambeth, Southwark, Lewisham and 
Croydon. The student researcher will have no prior relationship with the participants. The 
research team will share information with clinicians about Baby CHAT and the study 
procedures, so that they have a good understanding of the study before they are asked to give 
their patients information about the research. Clinicians will provide eligible clients with a flyer 
(see Appendix 2 for flyer) and, if a client is interested, will ask for verbal consent for the student 
researcher to contact them by phone (just name and phone number provided at this stage). To 
enable self-referral, posters will be placed in the waiting areas of relevant services. Posters will 
also be placed in maternity scanning clinics at King’s College Hospital and St Thomas’ Hospital, 
for participants to self-refer. The study will also be advertised through carefully selected online 
groups, social media channels and the King’s College London research participation email 
circular. 
 

 
 
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Once a potential participant has self-referred or consented to be contacted via their clinician, the 
student researcher will contact them to check eligibility, introduce the project, provide the 
information sheet and to answer any questions. Participants will have sufficient time to consider 
whether they consent to take part. Participants will be offered £20 in reimbursement for taking 
part in the study. 
 
Inclusion criteria 
 
Participants eligible to take part in the project will be women aged ≥18 years who are pregnant, 
between 20- and 34-weeks’ gestation, and currently experiencing depressive symptoms as 
identified by the EPDS. Those scoring >13 will be eligible to take part in the study. Both first-
time and experienced parents will be eligible to participate. 
 
Given the study involves the participation of potentially vulnerable individuals, all participants 
must be resident in or accessing services in a London borough served by SLaM, in order to 
facilitate access to local mental health services if needed. 
 
Exclusion criteria 
 
Women will be excluded if they are experiencing severe depression or current severe co-morbid 
diagnoses (e.g. psychosis), if they endorse ‘yes, quite often’ or ‘sometimes’ on question ten of 
the EPDS (in the past 7 days, ‘the thought of harming myself has occurred to me’), or if they are 
unable to complete informed consent and the questionnaires in English. Participants must be 
able to sufficiently understand the psychoeducational materials and group discussions during 
the intervention, so that all participants experience a ‘high feedback’, interactive intervention. 
 
There will be clear signposting to NHS and third sector organisations (including the general 
practitioner, midwifery team, local psychological therapies service, and other online resources) 
for all included and excluded participants, given that women interested in the study will be 
experiencing subjective low mood and may not be accessing treatment. 
 
Withdrawal of subjects 
 
Participants have the right to withdraw from the study at any time for any reason. If participants 
drop out during the study their data will be included in the analysis, unless they also withdraw 
consent for this. No further data will be collected from them. Their pseudonymised data will be 
destroyed after a period of 5 years following completion of the study, consistent with Clinical 
Trials Regulations and in line with the rest of the data collected in this study. Efforts will be 
made to report reasons for withdrawal. Withdrawn participants will not be replaced. Withdrawn 
participants will receive signposting information to local mental health and other support 
services, as outlined above (see Exclusion criteria). 
 
Statistics 
 
The following quantitative feasibility and acceptability outcomes will be collected: rates of 
eligible participants, uptake and retention of participants, scores on the feedback form, rates of 
missing data, and scores on the fidelity checklist (to monitor intervention delivery). For the 
qualitative arm of the study, participants will complete the open-ended questions on the 
feedback form. Descriptive data on participant demographic characteristics will also be 
collected. 
 

 
 
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The quantitative feasibility and acceptability outcomes outlined above will be summarised 
descriptively. Qualitative data from the open-ended questions on the feedback form will be 
analysed using content analysis. 
 
Although this study is exploratory due to the novelty of the intervention, within feasibility 
research it is appropriate to set a priori thresholds for the main feasibility and acceptability 
outcomes. Feasibility thresholds will be as follows: 30 or more potential participants express 
interest in the study (participant uptake); 20 or more participants attend Baby CHAT (participant 
retention); and at least 70% of participants complete the study measures (missing data). The 
acceptability of Baby CHAT will be assessed by the feedback form, which consists mostly of 
open-ended questions. These will be analysed qualitatively and therefore no specific 
acceptability thresholds will be set. 
 
Effect sizes for primary and secondary outcome measures will be calculated using Cohen’s d.  
These effect sizes will inform the sample size calculations of future larger-scale studies on Baby 
CHAT. 
 
Items on the outcome questionnaires will be designated as mandatory on the online survey 
portal, Qualtrics, to minimise missing data. Participants will be contacted to attempt to complete 
any missing items from other forms. Therefore, no statistical imputation methods will be required 
to correct for missing data. 
 
Any deviations from the original statistical analysis plan will be reported in a protocol 
amendment. 
4.   Study procedures 
 
Informed consent procedure 
 
All interested participants, whether they self-referred to the study or consented to be contacted 
via their clinician, will have an initial contact with the research team to ask any questions about 
the project. Participants will be sent a full Participant Information Sheet by email to read and 
consider. The information in the Participant Information Sheet and opportunity for further 
discussion with the research team will allow detailed explanation of the aims, methods, 
anticipated benefits and potential harms of the study, as well as the participants’ right to refuse 
involvement in the study and to withdraw consent at any time. The research team will ensure 
adequate time for each participant to consider their consent to take part. Individuals who agree 
to take part will then be asked to complete and return a signed consent form. All participants will 
receive a copy of their signed consent form. 
 
Potential participants who either do not meet the eligibility criteria or decide not to consent will 
be provided with information signposting them to appropriate sources of psychological support, 
as outlined in previous sections (see Section 3, Exclusion criteria). 
 
Risks/burdens 
 
Ethical approval will be sought from an NHS REC via the Health Research Authority. The 
sample will be recruited from a potentially vulnerable population of women with depression 
during pregnancy and therefore several steps will be taken to reduce risk of distress and harm. 
 

 
 
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Anticipated ethical implications include increasing participants’ feelings of guilt about their 
current behaviours or behaviours during a previous pregnancy. Baby CHAT is a psycho-
educational, rather than therapeutic, intervention which focuses on ways to develop women’s 
feelings of bonding towards their unborn baby. However, it is possible that some participants 
could experience distressing thoughts and feelings during the group; for example, if they feel 
they are not bonding well with their baby, not engaging in attachment-promoting behaviours, or 
are engaging in risky health behaviours such as drinking alcohol or smoking. Negative thoughts 
are a symptom of depression and therefore this is more likely with this group when compared to 
the general population. 
 
Full informed consent will be gained from each participant, including adequate description of the 
intervention and the opportunity to further discuss the potential for distress. The group facilitator 
will be sensitive to the difficulties experienced by pregnant women with low mood and present 
the group content with a validating, non-blaming approach. Ground rules will be set at the start 
of each group to encourage participants to engage in their preferred coping strategies if they 
experience any distress during the group. Limits of confidentiality will also be outlined at the 
start of the group i.e. the need to discuss information with a third party if there are risk concerns. 
 
The facilitator will monitor participants’ reactions, contributions and emotional state throughout 
the group. The clinician will facilitate a sensitive and validating environment if a participant 
experiences a low level of distress during the group. If required, the facilitator will sensitively 
raise any concerns about emotional wellbeing with the participant after the group in private and 
attempt to resolve this in collaboration with the participant. If appropriate, consent will be sought 
to inform their midwife of their distress. If a participant leaves the online meeting in distress, the 
facilitator will attempt to contact them after the group to debrief. A more senior member of the 
research team will be available for supervision during the times that Baby CHAT is running. See 
Appendix 3 for the distress pathway. 
 
Participants will be able to contact the research team following the group for a debrief. All 
participants will be signposted to further information and support, including their general 
practitioner, midwife, local psychological therapies service, and other online resources. 
Information on participants’ experiences of the intervention will be collected via the feedback 
form to support detection of adverse events. 
 
If there is a potential safeguarding concern at any point during the study and the research team 
believes there may be imminent risk to the participant or another person, appropriate action will 
be taken (see Appendix 4 for the study safeguarding pathway). Safeguarding issues may arise 
during the main group, for example, if a participant mentions something concerning about 
themselves, their unborn baby or someone else. If this occurs, a facilitator will attempt to contact 
the participant after the group to gain further information and remind them of the limits of 
confidentiality. Risk concerns will be escalated to an appropriate member of the research team 
or the participant’s clinical team if applicable. Some participants will already be under the care of 
a mental health team, while some pregnant women with a history of mental health problems 
may be well-known to their midwife and have more frequent contacts with the midwifery team 
throughout their pregnancy. If there is felt to be an imminent and serious risk to the participant 
or someone else, crisis or emergency services will be contacted. 
 
Screening procedure 
 
Following informed consent, the depression screening measure (the EPDS) will be conducted. 
Participants will be informed in a timely and sensitive manner whether they have met the criteria 

 
 
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to be included in the study. Participants who consent but do not score above the threshold on 
the screening questionnaire will be signposted to appropriate sources of support (as above, see 
Exclusion criteria). 
 
Study schedule 
 
Following inclusion in the study (i.e. having completed informed consent and scored over the 
screening threshold), participants will be asked to complete the baseline set of outcome 
questionnaires via Qualtrics (Time 1). Once completed, the participant will be booked into an 
upcoming session of the Baby CHAT group.  
 
Participants will attend an online Baby CHAT group at a time that is convenient for them. Up to 
eight women will be invited to each group, to facilitate optimal group dynamics and engagement 
with the group content. See below for further details of the intervention. 
 
After attending Baby CHAT, participants will be asked to complete the post-intervention 
outcome questionnaires and feedback form within 48 hours of the group (Time 2). One month 
later, participants will be contacted to complete the final follow-up questionnaires (Time 3).  
 
Measures 
 
The primary clinical outcome will be prenatal bonding as measured using the Maternal 
Antenatal Attachment Scale (MAAS). Secondary clinical outcomes of RF and depressive 
symptomology will be measured using the Prenatal Parental Reflective Functioning 
Questionnaire (P-PRFQ) and the Edinburgh Postnatal Depression Scale (EPDS). Feedback 
forms, containing both qualitative and quantitative components, will also be administered after 
participants have attended Baby CHAT in order to gather feedback on experience of the 
intervention (including group format, content and perceived usefulness). 
 
Edinburgh Postnatal Depression Scale 
The EPDS (Cox, Holden & Sagovsky, 1987) is a 10-item self-report measure used to identify 
depression in women during the perinatal period. The scale was initially developed to screen for 
postnatal depression but has also been validated for use in antenatal populations (Murray & 
Cox, 1990). Women are asked to rate on a 4-point scale how much they have experienced 
symptoms over the last week. Total scores are calculated, with higher scores indicating more 
severe symptoms, and a score of 13 or greater indicating likely depressive illness. The final item 
on the scale “the thought of harming myself has occurred to me” indicates the presence of 
thoughts of self-harm or suicide. The EPDS has been shown to have satisfactory sensitivity and 
specificity (Cox, Holden & Sagovsky, 1987; Gibson et al., 2009). 
 
Maternal Antenatal Attachment Scale 
The MAAS (Condon, 1993) is a self-report questionnaire for expectant mothers, designed to 
assess the maternal-foetal attachment during pregnancy. The scale consists of 19 items on a 5-
point Likert scale assessing women’s attitudes, feelings and behaviours towards their foetus. 
Most items evaluate experiences over the last two weeks, as well as imagined feelings towards 
the baby when they are born. An overall attachment score is calculated, as well as two subscale 
scores for ‘quality of attachment’ and ‘time spent in attachment mode (or intensity of 
preoccupation)’, for example, time spent thinking about the baby. Higher scores indicate 
stronger maternal-foetal attachment. The MAAS has been shown to have good construct validity 
(Condon & Corkindale, 1997), internal consistency and split-half reliability (Condon, 1993).  
 

 
 
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Prenatal Parental Reflective Functioning Questionnaire 
The P-PRFQ (Pajulo et al., 2015) is a 14-item self-report questionnaire assessing expectant 
parents’ abilities to think of their foetus as a separate individual with a developing temperament, 
personality and needs. The scale can be used during the second and third trimester of 
pregnancy. The 14-item measure asks expectant parents to rate several statements on a 7-
point Likert scale, with higher total scores indicating higher prenatal RF. The P-PRFQ has good 
construct validity and showed strong concurrent validity with an established interview of prenatal 
parental RF (Pajulo et al., 2015), and therefore shows promising use in both clinical and 
research settings as a brief, cost-effective measure of prenatal parental RF. 
 
Baby CHAT Feedback Form 
The feedback questionnaire (Appendix 5) was developed as part of the initial trial on Baby 
CHAT with the general population (Cox et al., 2020). The form has been adapted for the 
purpose of this study and contains eight items, consisting of eight open-ended questions, two of 
which additionally have closed question components. The feedback form aims to gather 
participants’ views on their experience of the group in order to develop it for future use, including 
what they liked about Baby CHAT, how helpful they found the inclusion of the 4D scan footage 
and anything they felt could have improved the group. 
 
A brief, follow-up feedback form was developed for the purposes of this study’s longitudinal 
component (Appendix 6). The form consists of four open-ended questions, one of which also 
contains a closed question component. The items aim to evaluate participants’ experiences of 
the impact of the intervention over time, including anything they felt could improve the 
longitudinal impact and whether they have noticed any subjective changes in their mood. 
 
Intervention 
 
Baby CHAT is an approximately 90-minute group intervention to be delivered during pregnancy. 
The group is comprised of psychoeducational material about a baby’s social development after 
birth and while the baby is growing in the womb. Attendees are encouraged to think about when 
an infant’s social development begins and consider whether this occurs before or after birth. 
Participants are then shown a video clip of Reissland et al.’s (2016) study showing 4D 
ultrasound images of foetuses mouthing in response to sounds that are presented to them 
outside the womb. Reissland’s research suggests that babies’ social development may begin to 
occur as early as 32 weeks. During Baby CHAT, parents are encouraged to reflect on this 
information in the context of their own baby’s development, including their likes and dislikes, 
routine and personality. The final section of the group involves generating ideas for social 
activities that parents can try with their baby prior to birth, such as singing to, massaging or 
reading to their baby. At the end, participants are asked to think about a positive take-home 
message from the session and, if they feel comfortable, to share this with the group. A Baby 
CHAT handout will be provided for participants to work through during the group and to refer to 
at home. See Appendix 7 for the full session plan. 
 
No significant changes will be made to the Baby CHAT group content for the purposes of this 
study. Baby CHAT was designed as a standalone session, that could be used as an add-on to 
existing treatments, and therefore does not target symptoms of depression specifically. 
However, the nature of the group discussions may naturally differ given that all participants will 
be experiencing depression during their pregnancy. Group facilitators will present the Baby 
CHAT content in a sensitive and non-blaming manner, validating participants’ experiences. The 
facilitators will also sensitively facilitate discussions during the group around the group content, 
for example, anticipated difficulties engaging in new activities while experiencing depression. 

 
 
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While Baby CHAT was originally designed to be delivered face-to-face, in this study all sessions 
will be held virtually using video conferencing software. This will facilitate participants’ access to 
the group and enable greater safety relating to the risk of Covid-19. Groups will be offered at a 
mixture of times, including weekdays and evenings. 
 
End of study definition 
 
The study will be considered completed once participants of the last Baby CHAT group have 
completed 1-month follow-up questionnaires. The REC will be informed once the study has 
ended. 
6. Assessment of Safety  
 
Adverse event reporting will take place following the intervention via the Baby CHAT feedback 
form. Participants will be asked if they experienced any negative effects from attending the 
group. These will be recorded and reported in the Annual Progress Report and copied to the 
sponsor. 
 
SAEs are defined in this study as any adverse event which: results in death; is life-threatening; 
requires hospitalisation or prolongation of existing hospitalisation; results in persistent or 
significant disability or incapacity; or consists of a congenital anomaly or birth defect. SAEs are 
not anticipated to occur due to any of the study procedures. However, it is expected that SAEs 
may occur during the study for other reasons. Hospitalisation, likely due to complications with 
participants’ pregnancies, will be considered an unrelated but expected SAE. Where SAEs are 
made known to the research team, these will be documented. Suspected unexpected serious 
adverse reactions (SUSARs) will be reported to the REC within 15 days of the Chief Investigator 
becoming aware. 
 
See Appendix 1 for further information on adverse event reporting in non-CTIMP (Clinical Trial 
of an Investigational Medicinal Product) research. 
7. Study oversight arrangements  
 
The joint Research & Development Office for the Institute of Psychiatry, Psychology & 
Neuroscience and South London and Maudsley NHS Foundation Trust will sponsor this study 
and provide advice when required. 
8. Ethics & Regulatory Approvals 
 
The study protocol and all other documentation will be submitted to the NHS Health Research 
Authority (HRA) REC. 
9. Data Handling 
 
Confidentiality 
 
Participant’s names, demographics, details of their pregnancy and past pregnancies, and 
contact details will be collected. Access to this information will be limited to the Chief 
Investigator and Co-Investigators named in this protocol. No participant-identifiable information 

 
 
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will be transferred outside of King’s College London and South London and Maudsley NHS 
Foundation trust, nor outside of the EU. Participants have the right to revoke their authorisation 
for the use of their identifiable information. In the write-up and publication of this research, all 
participants will be anonymised. 
 
Case Report Form 
 
The Case Report Form (CRF) will record the following for each participant: unique participant 
identifier, confirmation of consent, demographics, eligibility criteria checklist, screening 
questionnaire, study procedure dates, follow-up outcome dates, any study interventional delays, 
AEs log, SAE form, withdrawal from study form (if applicable) and trial completion form. The Co-
Investigators named in this protocol will be responsible for the completion of the CRF at the 
point of participant registration to the study and after each trial procedure. The CRF will be 
stored electronically on a secure computer network and archived after study completion as 
outlined below. 
 
Record Retention and Archiving 
 
Participants’ details and consent forms will be stored electronically on a secure computer 
network. A unique participant ID number will be assigned to each participant, which can only be 
decoded by a member of the research team. This data will be password protected for additional 
security. Participant information collected via Qualtrics (demographics, details of pregnancy, 
outcome questionnaires and feedback form) will be password protected and only accessible to 
the research team. 
 
Upon completion of the study, participants will be given the option to receive a report 
summarising the outcome of the project. In this instance, participants will be asked to agree for 
researchers to retain their contact details to contact them to disseminate the study findings. 
Researchers will not access the contact information for those who do not consent to be 
contacted. All identifiable information will be stored in a password-protected file on a secure 
computer network and destroyed at the point of dissemination. 
 
Following completion of the study, pseudonymised data will be destroyed after a period of 5 
years, in line with Clinical Trial Regulations and to allow for publication of study findings. The 
Chief Investigator will act as custodian of the data and keep a fully anonymised dataset in a 
secure location indefinitely. 
 
If a participant wishes to withdraw from the study, the research team will ask how they would 
like any information provided so far to be dealt with and whether they consent to it still being 
used in the study analysis. 
 
Compliance 
 
The Chief Investigator will ensure that the trial is conducted in compliance with the principles of 
the Declaration of Helsinki (1996), and in accordance with all applicable regulatory requirements 
including but not limited to the UK policy framework for health and social care research, Trust 
and Research Office policies and procedures and any subsequent amendments. 
 
10. Finance and Publication Policy 
 
 

 
 
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Financial considerations 
 
A research budget of up to £1000 is provided for the conduct of this study by the Doctorate in 
Clinical Psychology at the Institute of Psychiatry, Psychology & Neuroscience, King’s College 
London. 
 
Publication 
 
This project will be disseminated to staff and trainees completing the Doctorate in Clinical 
Psychology at the Institute of Psychiatry, Psychology & Neuroscience, King’s College London. 
Write-up of the findings will be submitted to the course team as part of a doctoral thesis and will 
also be submitted to a peer-reviewed journal for publication. 
 
An overall findings report will be provided for participants and participating mental health and 
maternity services. 
 
The study will be registered on the following public database: www.clinicaltrials.gov 
 
 

 
 
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References 
 
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C. M. (2013). Three‐dimensional ultrasound and maternal bonding, a third trimester study and a 
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Forman, D. R., O'Hara, M. W., Stuart, S., Gorman, L. L., Larsen, K. E., & Coy, K. C. (2007). 
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Gavin, N. I., Gaynes, B. N., Lohr, K. N., Meltzer-Brody, S., Gartlehner, G., & Swinson, T. (2005). 
Perinatal depression: a systematic review of prevalence and incidence. Obstetrics & 
Gynecology, 106(5 Part 1), 1071-1083. 
 
Gibson, J., McKenzie‐McHarg, K., Shakespeare, J., Price, J., & Gray, R. (2009). A systematic 
review of studies validating the Edinburgh Postnatal Depression Scale in antepartum and 
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qualitative research. Piscataway, New Jersey: Transaction. 
 
Julious, S. A. (2005). Sample size of 12 per group rule of thumb for a pilot 
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Industry, 4(4), 287-291.  
 
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Recommendations for good practice. Journal of Evaluation in Clinical Practice, 10(2), 307-312 
 
Luyten, P., Fonagy, P., Lemma, A., and Target, M. (2012). Depression. In A. W. Bateman & P. 
Fonagy (Eds.), Handbook of mentalizing. American Psychiatric Publishing. 
 
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qualitative research?: A review of qualitative interviews in IS research. Journal of computer 
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McFarland, J., Salisbury, A. L., Battle, C. L., Hawes, K., Halloran, K., & Lester, B. M. (2011). 
Major depressive disorder during pregnancy and emotional attachment to the fetus. Archives of 
Women's Mental Health, 14(5), 425-434. 
 
Milgrom, J., Holt, C., Holt, C. J., Ross, J., Ericksen, J., & Gemmill, A. W. (2015). Feasibility 
study and pilot randomised trial of an antenatal depression treatment with infant follow-
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Murray, D., & Cox, J. L. (1990). Screening for depression during pregnancy with the Edinburgh 
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https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/livebirths/dat
asets/birthsummarytables 

 
 
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Pajulo, M., Tolvanen, M., Karlsson, L., Halme-Chowdhury, E., Öst, C., Luyten, P., Mayes, L., & 
Karlsson, H. (2015). The Prenatal Parental Reflective Functioning Questionnaire: Exploring 
factor structure and construct validity of a new measure in the Finn Brain Birth Cohort pilot 
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Pearson, R. M., Carnegie, R. E., Cree, C., Rollings, C., Rena-Jones, L., Evans, J., Stein, A., 
Tilling, K., Lewcock, M., & Lawlor, D. A. (2018). Prevalence of prenatal depression symptoms 
among 2 generations of pregnant mothers: the Avon longitudinal study of parents and 
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their lips to the sound that they hear? An observational feasibility study on auditory stimulation 
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Trevillion, K., Ryan, E. G., Pickles, A., Heslin, M., Byford, S., Nath, S., Bick, D., Milgrom, J., 
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depression assessing the mother–infant relationship and child developmental outcomes: a 
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Appendix 1 – Information with regards to Safety Reporting in Non-CTIMP Research 
 
 
 
Who 
When 
How 
To Whom 
SAE 
Chief 
Investigator 
Within 15 days of CI 
becoming aware of the 
event 
 
SAE Report form for Non-
CTIMPs, available from 
NRES website. 
Main REC with a 
copy to the sponsor 
Urgent Safety 
Measures  
Chief 
Investigator  
Immediately 
 
Within 3 days  
By phone 
 
Notice in writing setting 
out reasons for the urgent 
safety measures and the 
plan for future action. 
Main REC  
 
Main REC with a 
copy sent to the 
sponsor. The MREC 
will acknowledge 
this within 30 days of 
receipt.  
Progress 
Reports  
Chief 
Investigator  
Annually (starting 12 
months after the date 
of favourable opinion) 
Annual Progress Report 
Form (non-CTIMPs) 
available from the NRES 
website 
Main REC with a 
copy to the sponsor 
Declaration of 
the 
conclusion or 
early 
termination of 
the study 
Chief 
Investigator  
Within 90 days 
(conclusion) 
 
Within 15 days (early 
termination) 
 
The end of study 
should be defined in 
the protocol 
End of Study Declaration 
form available from the 
NRES website 
Main REC with a 
copy to the sponsor  
Summary of 
final Report  
Chief 
Investigator 
Within one year of 
conclusion of the 
Research 
No Standard Format 
However, the following 
Information should be 
included:- 
Where the study has met 
its objectives, the main 
findings and 
arrangements for 
publication or 
dissemination including 
feedback to subjects 
Main REC with a 
copy to be sent to 
the sponsor 
 
 
 

 
 
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Appendix 2 – Study Poster 
 
 

 
 
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Appendix 3 – Distress Pathway 
 
Group facilitators will remain vigilant to signs of emotional distress in participants during the 
group. The content and methods of Baby CHAT allow for sensitive and validating group 
conversations regarding participants’ emotional reactions during the group and therefore low 
levels of distress can be managed sensitively within the group setting. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participant identified as moderately distressed during the group 
Gain details from participant of the distress in a sensitive manner 
If yes: 
Provide information sheet signposting 
to psychological support. 
If appropriate, inform participant’s 
midwife and/or clinical team of any 
issues. 
 
Group facilitator contacts group member after the group to debrief 
and provide a confidential space for participant to talk about 
distressing issue 
Able to resolve?  
If facilitator is concerned about 
imminent risk issue: 
Contact crisis services on 0800 731 
2864 or call 999 
If no: 
Inform participant’s midwife and/or 
clinical team. 
Provide information sheet signposting 
to psychological support. 
Escalate to supervising member of 
research team for advice. 
 

 
 
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Appendix 4 – Safeguarding pathway 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Contact emergency 
services e.g. police or 
ambulance 
Need for Safeguarding Adults alert 
confirmed? 
Ensure the immediate safety of person at risk: 
Is the Adult at Risk in immediate danger or in need 
of emergency assistance?  
Has a crime been committed/is there a need to 
protect forensic evidence?  
Consult with supervisor/ 
participant’s midwife/ clinical team/ 
safeguarding lead to discuss 
whether safeguarding alert indicated 
Complete Datix and ePJS 
safeguarding event 
Alert midwife and/or clinical 
team and hand over details for 
them to follow up 
No further action  
Record details of concern and 
consider if other processes apply 
(e.g. Datix reporting/complaint/ 
other investigation)  
Inform midwife and/or clinical 
team if appropriate 
Yes 
No 
Yes 
No 
Concern or allegation regarding potential or actual harm/abuse 

 
 
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Appendix 5 – Feedback Form 
 
Participant ID: …………….. 
Baby CHAT Group Feedback  
 
Thank you for coming to Baby CHAT.  
 
We would really like your feedback on Baby CHAT. Please let us know anything that you 
enjoyed as well as anything you think we could do to improve Baby CHAT. 
 
Your feedback will add to our Baby CHAT research. We would like to include your feedback in 
our report about Baby CHAT.  When we do this, we make sure that the feedback is completely 
anonymous so no one will know who has written the comments.  
 
Date you attended Baby CHAT: …………………………………………………………. 
 
 
1. Did you think the timing of the group in your pregnancy was (please circle): 
 
Too early 
 
 
About right 
 
 
Too late 
 
Please explain your answer: ……………………………………………………… 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
 
 
2. Was the length of the group (please circle): 
 
Too long 
 
 
About right 
 
 
Too short 
 
Please explain your answer: ……………………………………………………… 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
 
 
3. What did you enjoy about the group? 
 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
 
 
 
 
 

 
 
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4. What information did you find most useful from the group? Why? 
 
…………………………………………………………………………………………… 
…………………………………………………………………………………………… 
…………………………………………………………………………………………… 
…………………………………………………………………………………………… 
 
 
5. Is there anything we can do to improve Baby CHAT? 
 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
 
 
6. Was the group relevant to people with low mood? Why/why not? 
 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
 
7. What did you think about the 4D scan video footage? Did this give you any ideas 
about how your own baby is developing? 
 
 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
 
8. Do you have any other comments or feedback on the group? 
 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
 
 
 
Thank you for taking the time to complete this questionnaire. 
 
 
 
 
 

 
 
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Appendix 6 – Feedback Form – Follow-Up 
 
Participant ID: …………….. 
Baby CHAT Group Feedback – Follow-Up 
 
We would really like your feedback on whether Baby CHAT has been helpful over the weeks 
since you attended. Please let us know anything that you have noticed or remembered over the 
last few weeks. 
 
Your feedback will add to our Baby CHAT research. We would like to include your feedback in 
our report about Baby CHAT.  When we do this, we make sure that the feedback is completely 
anonymous so no one will know who has written the comments.  
 
Date you attended Baby CHAT: …………………………………………………………. 
 
 
1. How much have you thought about Baby CHAT since attending (please circle): 
 
A lot 
 
 
 
Sometimes 
 
 
Rarely/never 
 
Please explain your answer: ……………………………………………………… 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
 
2. What have been the lasting impacts of Baby CHAT, if any: 
 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
 
 
3. Do you think attending Baby CHAT has helped your mood? Why/why not? 
 
…………………………………………………………………………………………… 
…………………………………………………………………………………………… 
…………………………………………………………………………………………… 
…………………………………………………………………………………………… 
 
 
4. Do you have any other comments or suggestions about the impact of Baby CHAT 
over time? Is there anything else that might be helpful? 
 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
………………………………………………………………………………………….. 
 
Thank you for taking the time to complete this questionnaire. 
 
 

 
 
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Appendix 7 – Baby CHAT Session Plan 
 
1. (10 mins) Welcome 
- 
Group facilitators introduce themselves and welcome to Baby CHAT, overview of Baby 
CHAT 
- 
Confidentiality explained as well as limits to confidentiality (i.e. if we hear something that 
is of concern over group members safety or the safety of someone they know this would 
be shared with a third party – most likely their midwife and/or safeguarding lead). 
- 
Ask every member of the group to write down on a post-it something they are looking 
forward to about meeting their baby. 
- 
Ask every member of the group to say their name and if they feel comfortable share 
aloud what they wrote on their post-it.  
 
 
2. (10 mins) Social and Unique baby (page 2 handout) 
- 
Show pictures/videos of babies after birth - Trying to get people thinking about the 
uniqueness of babies and their developing social skills after they are born 
e.g. video clip of Megan an 8-week old baby shown interacting first with her father, then 
with her mother. The video clip shows that an 8-week old baby is capable of reciprocal 
interaction with parents – when parents speak in high pitched tone, Megan kicks legs 
and makes noises (e.g. squealing with delight, laughing and babbling). Also shows 
Megan able to follow her mother with her head as her mother moves from side to side in 
front of her.  
- 
*All babies develop at slightly different times so this will not be the same for all 
babies* 
- 
Discussion in pairs – what do people already know about a baby’s social development 
and personality after birth? (Think about pictures/video clip/babies they know – try and 
think just after birth to about 6 months) 
- 
Use flip chart paper/interactive white board to ask the group to feedback some of things 
they have been discussing. Feedback to group – flip chart paper/interactive whiteboard 
 
The aim of this discussion is to get people thinking about baby’s:  
Personality  
Temperament 
Getting needs met 
Smiling 
Babbling 
Crying – the purpose of this 
Recognition- Moving head towards sounds/voice of mother/father 
Preferences 
Attention 
Concentration 
Awareness/baby cycles 
Learning 
  
Prompts for discussion if needed – draw attention to developmental timeline on page 
2 of handout  
 
Question for the group: When do you think this development of personality/social skills 
develops? Does it just happen as soon as the baby is born? Brief ideas about when this 
begin to occur i.e. before or after birth 

 
 
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3. (10 mins) Your own baby (page 3/4 handout) 
- 
What have you learnt about your baby so far? (work through work sheet in pack)  
- 
Temperament and personality 
 
4. (10 mins) New research in this area – would you like to see some new images of babies 
being social in the womb? 
 
- 
Social responsiveness of baby in womb - Show Video clip from Nadja’s research 
- 
Suggests that babies are developing their social skills while they are waiting to be born - 
not only are they getting physically ready for life after birth but they are developing the 
necessary social skills that they need to survive and interact with their caregivers. 
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Getting ready for when they meet you! 
 
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What do you think your baby is doing in the womb? (page 5 handout) 
 
5. (15 mins) Implications of this for your pregnancy 
 
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How can you make the most of this new information? What would help your baby to 
begin to develop social skills before they are born? (pages 5-12 handout) 
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*Important to emphasise to parents that there are no right or wrong answers when 
interacting with baby* 
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So… what activities can you do? 
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*Important that these activities are sensitively stimulating i.e. finding a volume of 
music that is right for parent and baby* (page 6-12 handout)  
 
Think about baby’s temperament/personality/routine 
Pet name 
Singing 
Talking 
Reading 
Playing music 
Massage 
Relax/Mindfulness 
 
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Work through at least one example 
e.g. Give mindfulness meditation practice (on page 10 of handout) 
 
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Plan when/where/how parents will have a go at one or more of these activities (page 12 
handout) 
 
 
 
 
 
 
 
6. (5mins) Ending – Ask everyone to write on a post-it something positive they will take away 
from the session about their baby’s development.  
 
Aim- to reinforce key messages and hopefully leave parents with positive feelings at the end of 
the group.