Mamas in Harmony: a Feasibility Study With Pilot Randomised Controlled Trial and Process Evaluation of a Music and Social Support Group Intervention for Postnatal Mothers and Their Infants
Phase: NA
Conditions: Anxiety
Sponsor: Queen's University, Belfast

 
 
 
STUDY PROTOCOL AND  
INFORMED CONSENT FORM 
 
 
Mamas in Harmony: a feasibility study and pilot randomised controlled 
trial and process evaluation of a music and social support group 
intervention for postnatal mothers and their infants  
 
 
13.2.2023 

 
13-02-2023 Vn (1.3) 
1 
 
 
 
Mamas in Harmony: a feasibility study and pilot randomised 
controlled trial and process evaluation of a music and social 
support group intervention for postnatal mothers and their infants  
 
 
PROTOCOL 
 
 
 
Contact: Corinna Colella / Dr Fiona Lynn / Dr Jenny McNeill 
School of Nursing Midwifery 
Queen’s University Belfast (QUB) 
Medical Biology Centre 
97 Lisburn Road 
Belfast 
BT9 7BL 
Email: ccolella01@qub.ac.uk / f.lynn@qub.ac.uk / j.mcneill@qub.ac.uk 
 
 
 
 
Investigators: 
Corinna Colella (PhD student), Dr Fiona Lynn (Chief Investigator), Dr Jenny McNeill (Co-
investigator) and Una McCann (Non-QUB Co-Investigator) 
 
 

 
13-02-2023 Vn (1.3) 
2 
 
 
Background 
Perinatal mental health problems have the potential to lead to multiple negative outcomes for both 
mother and child, and mental health in the perinatal period is a current leading public health issue 
with significant economic burden if untreated (Dennis et al., 2017). The perinatal period lasts for the 
duration of pregnancy and for 1 year after the birth of the child (NICE, 2022). Symptoms of low 
mood, anxiety, stress, feeling isolated, and difficulties with mother-infant attachment are frequently 
experienced by both antenatal and postnatal mothers. Obsessive compulsive disorder (OCD), 
psychosis and post-traumatic stress disorder (PTSD) are conditions perinatal mothers can also 
develop (MIND, 2022). Factors such as lack of family or social support, poor housing, relationship 
breakdown, financial difficulty or previous traumatic life events may further increase the risk of 
experiencing poor perinatal mental health (MIND, 2020). 
It is reported that anxiety is often overlooked in the perinatal period, with limited research carried 
out in relation to perinatal anxiety compared to depression. With little knowledge around 
epidemiology or effectiveness of interventions for perinatal mental health conditions other than 
postnatal depression (PND) (Howard et al., 2014). This is despite the associations found between 
maternal anxiety and adverse outcomes for the child (Dennis et al., 2017). 
A systematic review conducted in 2016 of observational studies, including 221,974 women across 34 
countries, showed prevalence of anxiety symptoms as 22.9% across the three trimesters of 
pregnancy, and 17.8% in the first 4 weeks following childbirth, decreasing only slightly to 15% 
thereafter (Dennis et al., 2017). Overall findings from the review showed a significantly higher rate 
of anxiety among the maternal population compared to the adult population in general. No 
differences in prevalence rates were found between studies published before 2010 compared to 
those published afterwards (Dennis et al., 2017), indicating that perinatal anxiety is an ongoing 
concern. 
Associations between maternal anxiety and decreased coping strategies (George et al., 2013) and 
increased rates of suicide have been found (Farias et al., 2013). Studies investigating the effect of 
poor postnatal mental health have found an adverse impact on mother-infant attachment 
(McMahon et al., 2006), bonding, self-regulation and empathy (Rossen et al., 2016). Consequently, 
mothers find it difficult to engage with their infants both emotionally and behaviourally resulting in 
reducing their physical contact (Holt et al., 2021). Provision by the mother of a less stimulating 
environment, being less attuned to their infant (Brummelte and Galea, 2016) and reduced 
competence and low mood in the mother (Beebe et al., 2011) are also reported effects.  
Poor child development outcomes in the longer term, involving behavioural and emotional problems 
in children aged 4 years (O'CONNOR et al., 2002) and attention deficit hyperactivity disorder 
symptoms at age 8-9, were also shown when mothers experienced high levels of maternal anxiety 
(Van den Bergh and Marcoen, 2004). Children of mothers with postnatal depression were more 
likely to be underweight and have poor social, emotional and cognitive development (Yang et al., 
2019). Long lasting significant effects on the mother can occur if mental health issues are left 
untreated (Bauer et al., 2014). 

 
13-02-2023 Vn (1.3) 
3 
 
Restrictions were introduced by the UK government in March 2020 to reduce the spread of 
Coronavirus (Covid 19). The impact of measures at that time such as requiring people to stay at 
home, social distancing and closure of non-essential businesses and activities (GOV.UK, 2020) had 
far reaching consequences for perinatal women’s psychological state and social interaction (Fallon et 
al., 2021). Qualitative research conducted with women in Australia found becoming a mother during 
the pandemic was reported as an isolating experience, having increased desire for social support, 
and needing to manage the stress and anxiety caused by constant unknowns and the limited access 
to health and support services (Sweet et al., 2021). Similar findings were noted from a UK study and 
in addition reported the prevalence rates during the pandemic of clinically relevant maternal 
depression and anxiety in the UK being much higher than pre-pandemic (Fallon et al., 2021). 
Together, this indicates a heightened need for attention and intervention to improve mental health 
among mothers and the associated outcomes beyond the existing vulnerability they experience 
during the perinatal period. While government restrictions have now been removed since the start 
of the pandemic, it is reasonable to maintain an ongoing awareness of the additional impact posed 
to future perinatal mothers should restrictions return due to Covid 19 or similar crises (PHA, 2022). 
Regular screening for perinatal depression and anxiety disorders by health professionals is 
recommended by National Institute for Health and Care Excellence (NICE) guidelines from the first 
contact with the mother, throughout pregnancy and the postnatal period using assessment tools. 
These include Edinburgh Postnatal Depression Scale (EPDS) and Generalised Anxiety Disorder 7 Scale 
(GAD-7)  (NICE, 2020). However postnatal mental health problems often go unidentified, 
undiagnosed, and untreated for many women or they do not meet the eligibility threshold for 
specialist mental health services after the birth of their baby (Coates et al., 2015). Women may fear 
stigma and negative perceptions if they disclose a mental health problem in pregnancy or the 
postnatal period. It is further acknowledged that there are individuals who are pregnant or who 
have given birth, that may not identify as women, so the terms ‘woman’ or ‘mother’ should be taken 
to be inclusive of those individuals in accordance with NICE guidelines. In addition, where the term 
‘parents’ is used , this should be taken to include anyone who has main responsibility for caring for a 
baby (NICE, 2021). 
The NHS Long term Plan identified that the consequences of not receiving high quality perinatal 
mental health care is estimated to cost the NHS and social care £1.2 billion per year (NHS, 2019). 
Perinatal anxiety is shown to cost approximately £35,000 per case of which £14,000 relates to the 
impact on the child. While this is just under half of the estimated cost for perinatal depression at 
£74,000 in total, there is a high degree of overlap and therefore the cost of anxiety is likely to 
already be accounted for in those costs for depression (Bauer et al., 2014). 
Current pharmacological treatment options offered by health professionals involved in the care of 
mothers often have potential for side effects and low uptake and adherence, especially for 
breastfeeding mothers (Yang et al., 2019). Psychotherapy has presented challenges of mixed results, 
and short-lived improvements (Morrell et al., 2009); (Cooper et al., 2003). Consequently there has 
been an increase in interest in non-pharmacological interventions, such as arts in health 
programmes (Fancourt, 2017).  
A systematic review published in 2015 investigating the effect of interventions for PND that focused 
on the mother-infant dyad relationship, found promoting maternal responsiveness had the greatest 
efficacy when reducing symptoms of PND (Tsivos et al., 2015). It has been suggested that 
interventions focusing solely on maternal depression may not be enough to reduce the risks to 

 
13-02-2023 Vn (1.3) 
4 
 
infant development and further research is needed to assess outcomes relevant to both mother and 
infant (Tsivos et al., 2015). It is acknowledged that women with PND may have difficulty adhering to 
interventions that are dyadic due to the nature of their symptoms (Nylen et al., 2006). An 
intervention that has a strong focus on direct physical face to face stimulation and interaction 
between mother and infant would be well placed to not only protect against the potentially 
damaging effects of PND but strengthen the mother-infant relationship at the same time. The 
mother-infant relationship is reliant on reciprocity of the interaction between them and the intimate 
relationship between mother and infant is nurtured by the mutual satisfaction expressed during 
these moments (Vlismas et al., 2013). A mothers sensitivity and affection are communicated to her 
infant through her voice, gestures and rhythmical movement (Vlismas et al., 2013). 
Arts in Health 
The field of arts in health is rapidly expanding with evidence reporting a plethora of benefits from 
arts based initiatives in primary and secondary care. Strong evidence supports the arts in improving 
wellbeing and quality of life among adults (Fancourt et al., 2020). Arts in health activities are wide 
ranging and, in particular, include performing arts, which comprises of music, dance and theatre and 
visual arts and crafts such as drawing, woodwork, painting, ceramics and photography. Music, as a 
user friendly and low cost activity, is further used in the literature to refer to a wide spectrum of 
activities including singing, playing instruments and listening to music (Dingle et al., 2021a). A 
number of systematic reviews have shown a variety of benefits of singing among different 
populations (Reagon et al., 2016; Williams et al., 2018; Irons et al., 2020). Participants with mental 
health conditions, across the UK and Australia, showed improvements in depression, quality of life, 
and mental wellbeing following singing interventions lasting at least 8 weeks (Williams et al., 2018). 
Irons and colleagues reviewed the effect of singing among people with long term health conditions 
associated with persistent pain, which showed some potential to reduce pain intensity and 
interference; however, the findings from the review were limited by included studies having variable 
quality (Irons et al., 2020). When investigating health-related quality of life, in adults with a chronic 
health condition, singing interventions conducted primarily in the UK or Australia were found to 
either maintain or improve health-related quality of life and mood (Reagon et al., 2016). Despite this 
evidence, limitations persist within and between experimental studies with a high level of 
heterogeneity present, including differences in study participants, differences in frequency, setting 
and duration of the intervention and outcome measures (Reagon et al., 2016). A high or unclear risk 
of bias concerning random sequence allocation and treatment allocation concealment was found in 
experimental studies of singing interventions for individuals with mental health conditions (Williams 
et al., 2018).  
A recent systematic review, developed by the current project team, set out to assess the effect of 
mother-infant group music classes (any type of music as the primary component) on a range of 
maternal outcomes, including postnatal depression and maternal anxiety (Colella et al., 2021). The 
review has since been conducted and identified 2 studies from the UK and Australia, both measuring 
depression following 10 weekly sessions with a total sample of 123 mothers. Results from a meta-
analysis did not show a statistically significant reduction in depression post intervention. However, 
the point estimate favoured the music intervention (SMD: -1.61; 95%CI: -4.09, 0.87). Further meta-
analyses could not be performed. A narrative synthesis reported that secondary outcomes of anxiety 
and stress showed a statistically significant reduction in both outcomes and also statistically 
significant improvement in maternal self-efficacy post intervention (Colella et al., 2021). Findings 

 
13-02-2023 Vn (1.3) 
5 
 
from this review suggest potential for effect of music-based mother-infant group interventions on 
maternal anxiety, stress and self-efficacy.  
Qualitative synthesis of a process evaluation of a singing intervention, which was included in the 
review, found postnatal mothers reported that it provided an opportunity for mothers to interact 
socially after the sessions (Fancourt and Perkins, 2019). Receiving social support was shown to be a 
welcome service for postnatal mothers (Fancourt and Perkins, 2019). A variety of community 
organisations recognise this need and provide 1 to 1 or group based social support in the postnatal 
period. Considering a risk factor for postnatal depression is low, or a lack of, social support (Brugha 
et al., 1998), a key ingredient of group interventions should include the provision of social support 
and cohesion (Dingle et al., 2021b).  
The gap that remains in current literature is an arts in health based group intervention for mother-
infant dyads, supporting the reduction in symptoms of anxiety and stress, promoting social support 
and targeting an improvement in the mother-infant relationship (Estevao et al., 2021). This study will 
seek to explore the feasibility and the potential benefit of a new mother-infant group intervention, 
Mamas in Harmony, that combines group music classes with social support. 
A common finding among systematic reviews is the high risk of bias (Williams et al., 2018) and high 
heterogeneity (Yang et al., 2019) between included studies. More high quality randomised 
controlled trials are required. Intervention-based research should involve robust methodologies and 
transparent reporting especially in the underpinning theory of change, a detailed description of the 
content of the intervention and the intervention facilitator including their training and experience. 
The MRC framework will be utilised to underpin this study. There is a need for feasibility work before 
a full phase 3 trial so to pilot the study design, recruitment, intervention and data collection 
methods and allow any challenges to be identified and amendments to be made. 
Study aim 
This study aims to explore the feasibility of Mamas in Harmony, a novel 8 week combined music and 
social support community based group intervention for postnatal mothers and their infants. 
Study objectives 
• 
Test the feasibility of conducting a randomised controlled trial (RCT) of Mamas in Harmony 
in comparison to usual care, in terms of recruitment and retention rates, acceptability of 
outcome measures, and promise of effect on symptoms of anxiety, depression, perceived 
stress, perceived social support, postnatal attachment, health related quality of life and cost-
effectiveness 
• 
Establish feasibility of the Mamas in Harmony intervention in terms of acceptability, 
adherence and maternal satisfaction 
• 
Understand the experiences of mothers who received the Mamas in Harmony intervention 
and intervention facilitators delivering Mamas in Harmony 
• 
To explore quality of implementation, potential mechanisms of change and context  
 
 
 
 
 

 
13-02-2023 Vn (1.3) 
6 
 
 
Methods 
Study design 
The study will consist of two sequential phases. Phase 1 will involve a feasibility study with a pilot 
randomised controlled trial and economic evaluation. Phase 2 will involve a process evaluation with 
a survey evaluation and semi-structured interviews. The UK National Institute for Health and Care 
Research (NIHR) describe feasibility studies as occurring early in the research process and pilot 
studies then test whether the main components can all work together (Eldridge et al., 2016). The 
literature appears to have little consensus on the appropriate sample size for feasibility and pilot 
studies, and suggested sample sizes can range from 12 (Julious, 2005) to 50 (Sim and Lewis, 2012). 
Therefore for this study a sample size of 40 mother-infant dyads for the intervention group and 20 
mother-infant dyads for the control group has been chosen. It is acknowledged this allocation 
favouring the intervention group may influence mothers participating compared to a 1:1 allocation. 
However, it ensures only the number of participants required are recruited, it is sufficient for a 
feasibility study and increases the pool of potential participants for process evaluation interviews. It 
is anticipated that between 10-12 mother-infant dyads will participate in a Mamas in Harmony 
group at a time for 8 weeks and then repeated 3-4 times to reach the required sample size receiving 
the intervention. 
Participants 
Inclusion criteria: 
• 
Mothers who have a baby aged ≥14 days to ≤4 months at time of consent 
• 
Aged 16 years or over 
• 
Able and willing to provide consent identified by having a satisfactory understanding of 
English and comprehension of the participant information sheet and consent form 
Exclusion criteria: 
• 
Mothers who have given birth in the last 14 days 
• 
Infants >4 months at time of consent 
• 
Identified as not having satisfactory understanding of English and comprehension of the 
participant information sheet and consent form 
• 
Mothers who have received a diagnosis of, or being treated for, severe mental illness 
including Bipolar disorder, Psychoses or Schizophrenia within the past 6 months (discovered 
through self-report at time of eligibility screening). This is due to the existing evidence 
supporting the use of singing interventions on mild-moderate symptoms of 
anxiety/depression (Fancourt & Perkins 2018; Williams et al. 2018) and not as a treatment 
for severe mental health conditions. 
For the delivery of the intervention, sessions will be held in a suitable meeting room with the 
required capacity at a Queens University Sport facility in Belfast, Northern Ireland. This venue is 
accessible by public and private transport as well as being suitable to access on foot and has free 
parking, with pram storage and baby changing facilities available. Sessions will be held on Tuesdays 
at 11am to allow for any older siblings to be dropped off to school or childcare and mothers to have 

 
13-02-2023 Vn (1.3) 
7 
 
sufficient time to travel to the venue. This fits into the current scheduled timetable at the venue for 
the room and parking.  
Recruitment and randomisation  
The recruitment strategy to identify and approach potential participants will involve the use of social 
media, websites and email contact lists of relevant parenting support organisations, along with 
posters/flyers in local community centres.   
Recruitment will be pursued via social media using a post on Twitter and Facebook groups for local 
mothers (Recruitment material 15-01-2023 Vn 1.1). National Childbirth Trust (NCT) groups, 
HomeStart, the Junior Academy for Music at QUB and the wider University and community choir 
audience will be asked to distribute the recruitment flyer (Recruitment material15-01-2023 Vn 1.1) 
via email to relevant contact lists of mothers/other interested individuals, display recruitment 
posters on communal/public facing noticeboards (Recruitment material 15-01-2023 Vn 1.1) and 
share social media content created by the researchers (Recruitment material 15-01-2023 Vn 1.1) on 
their social media platforms. Local Women’s and Community Centres, community mother and baby 
classes, social support organisations, SureStart Children’s Centres (Department of Education 
funded), and newborn photographers will be asked to display posters/flyers (Recruitment material 
15-01-2023 Vn 1.1) and share social media content created by the researchers (Recruitment material 
15-01-2023 Vn 1.1) on their social media platforms (if used). 
Mothers will be invited to make contact for further information about the study via the poster/flyer, 
email and social media posts, and will contain an email address for contacting the PhD researcher. A 
QR code will be included in all communication, which, when scanned, directs mothers to a webpage 
containing an introduction to the study (Webpage content 21-08-2022 Vn 1.0), a link to download 
the participant information sheet (PIS for pilot study 15-01-2023 Vn 1.2) and online contact form to 
complete if they are interested in hearing more (Online contact form 21-08-2022 Vn 1.0). If a 
potential participant contacts the QUB researcher via email, they will be directed to the webpage 
and online contact form. If the contact form is completed by the mother, telephone details will be 
received by the QUB researcher (Contact details for mothers 21-08-2022 Vn 1.0), who will make 
contact. Contact details will be saved and stored securely on QUB OneDrive. The mobile phone used 
by the researcher to call participants will be password protected however no participant telephone 
numbers will be saved on the phone and numbers will be deleted from the call list on the phone 
immediately after the call. During the telephone call, the researcher will describe the study and 
establish eligibility to participate. If the potential participant is eligible, further information will be 
provided about the study (Dialogue for eligibility screening 15-01-2023). If interested in 
participating, mothers will be emailed or posted (depending on preference of the mother) the 
participant information sheet (PIS) (PIS for pilot study 15-01-2023 Vn1.2) and copy of the consent 
form (Consent form for study for mother 15-01-2023 Vn 1.1). Additional contact details of postal 
address or email address will be requested depending on preference of contact (Contact details for 
mothers 21-08-2022 Vn 1.0). The researcher will provide each mother at least 48 hours to consider 
participation before making contact again by telephone (Dialogue for obtaining consent for study 21-
08-2022 Vn 1.0). This will be an opportunity for the researcher to answer any further questions the 
mother may have and confirm they are happy to consent. If a mother wishes to participate, they will 
be asked to sign and return a consent form (Consent form for study for mother 15-01-2023 Vn 1.1) 
to the researcher who will countersign and return a copy to them. Electronic copies will be 
generated in MS Forms and stored securely and separately in QUB SharePoint. A stamped addressed 

 
13-02-2023 Vn (1.3) 
8 
 
envelope will be supplied to be returned to QUB, if paper copies are preferred. Paper copies will be 
stored securely on university premises in a locked filing cabinet accessible only by the research team 
behind a locked door. Screening logs will be used to record the number of mothers who get in 
contact, how they heard about the study, number who are screened as eligible or not, number who 
are interested in participating, and any reasons for non-participation, if disclosed on request, 
consented to first approach, recruited to study, accepted to participate and any reasons for non-
acceptance, if disclosed on request (Screening log 21-08-2022 Vn 1.0). 
The baseline questionnaire (Baseline questionnaire 13-02-2023 Vn 1.2) will then be provided via an 
electronic link in an email from the online Qualtrics survey platform and completed questionnaires 
saved within the Qualtrics platform. A stamped addressed envelope will be supplied to be returned 
to QUB, if paper copies are preferred. Paper copies will be stored securely on university premises in 
a locked filing cabinet accessible only by the research team behind a locked door. All data will be 
stored in accordance with the Data Protection legislation and will be destroyed 5 years following 
completion of the study. 
Following completion of the baseline questionnaire, participants will be randomised, with their 
babies, on a 2:1 allocation to the intervention (Mamas in Harmony plus usual care) and control 
group (usual care alone). This allocation ratio was chosen to increase data available on the 
intervention, owing to it being a feasibility pilot RCT. The focus is not on effect size and so, for the 
purposes of this study, a power calculation has not been estimated. The recruitment, baseline data 
collection and randomisation process will be repeated with the aim of recruiting 60 participants in 
total, 40 allocated to the intervention group and 20 to the control group. The sequence generation 
for randomisation of study participants will be carried out using a computer-generated random 
allocation sequence completed by a 3rd party researcher within the School of Nursing & Midwifery, 
QUB to test feasibility of the process for concealment of allocations from the research team. The 3rd 
party will inform the participant, via their preferred form of communication (email or telephone) 
(Dialogue from 3rd party for allocation 21-08-2022 Vn 1.0), of their allocation. They will inform those 
in the intervention group of the start date for the group sessions, with the aim of there being 1-2 
weeks notice before sessions commence. The 3rd party will inform those in the control group that 
they will be contacted by the QUB researcher in 3 months for follow up data collection. The 
intervention group will also be provided with information giving directions and accessibility details 
for the venue (Directions to venue 21-08-2022 Vn 1.0). Intervention delivery will then commence. 
Four waves of recruitment and delivery of Mamas in Harmony are planned over an 18-month period. 
During intervention delivery, the QUB researcher will send mothers a text message as a reminder for 
attendance the day before each weekly session (Text message reminder 21-08-2022 Vn 1.0).  
All mothers in the intervention and control group will have been advised during the recruitment 
process that they will be contacted by the research team at approximately 3 months and 6 months 
post randomisation (for further data collection with questionnaires provided in the same way as the 
baseline assessment). The recruitment, randomisation and data collection process flow diagram is 
presented below: 

 
13-02-2023 Vn (1.3) 
9 
 
 
 
 
PHASE 1: RECRUITMENT 
Mothers see recruitment material and use QR code or email to contact the research team 
T3 (6 months) DATA COLLECTION 
Mother completes T3 questionnaire 
BASELINE DATA COLLECTION 
 
Mother completes baseline questionnaire and indicates interest in interview 
T2 (3 months) DATA COLLECTION 
Mother completes T2 questionnaire 
YES – willing to participate 
Consent obtained 
INTERVENTION GROUP 
Mother receives 8x weekly Mamas in Harmony sessions + 
usual care. 
Mother completes evaluation form in week 8 
Research team contact mother to establish eligibility and 
provide participant information sheet and consent form 
Research team establish if mother willing to participate 
NO – not willing to participate 
Thank mother for interest 
Mother continues with usual care 
CONTROL GROUP 
Mother receives usual care 
T2 (3 months) DATA COLLECTION 
Mother completes T2 questionnaire 
T3 (6 months) DATA COLLECTION 
Mother completes T3 questionnaire 
RANDOMISATION 
Mother randomised on a 2:1 allocation 
PHASE 2: Research team review mothers who indicated interest in interview at baseline 
MOTHER INDICATED INTEREST 
MOTHER DID NOT INDICATE 
INTEREST 
END OF STUDY 
Research team contact mother to provide participant 
information sheet and consent form 
YES – willing to participate 
Consent obtained 
NO – not willing to participate 
Thank mother for interest 
END OF STUDY 
SEMI STRUCTURED INTERVIEWS WITH MOTHERS 
SEMI STRUCTURED INTERVIEW WITH 
INTERVENTION FACILITATOR/S 
END OF STUDY 

 
13-02-2023 Vn (1.3) 
10 
 
The schedule for enrolment, delivery of intervention and assessment of outcomes for all phases has 
been created and illustrated in a Standard Protocol Items: Recommendations for Interventional 
Trials (SPIRIT) diagram (Appendix A). 
Mamas in Harmony intervention 
This novel music and social support intervention is delivered to mother-infant dyads in a group 
format in a community setting. Sessions will be delivered by a professional individual experienced in 
delivering music based community groups to a varied population. Mothers will attend with their 
babies and be invited to sit upon soft cushioned play mats. Small colourful age and developmentally 
appropriate toys and sensory objects will be available for baby to look at and touch. Mothers will 
have been requested to bring a blanket for their baby to lie on or this will be supplied, if required. 
Mothers and babies will be encouraged to create a circle formation. The singing component will last 
40 minutes and begin with a welcome song sung by the intervention facilitator, mothers will be 
encouraged to join in, feel connected to each other through the song and will involve some gentle 
bouncing/rocking movements with baby. This song will remain the same each week to promote 
familiarity and confidence building for the mother.  
The middle section involves the facilitator introducing a mix of songs that are easy to learn and 
pleasing to listen to without the need for lyric sheets. Mothers will be encouraged to sing along. 
Mothers will be encouraged to interact with their baby through various sensory stimuli involving 
touch, sound and visual, for example; tickling fingers, gentle massage and humming sounds close to 
baby’s ear.  
The end of each singing session involves a short period of quiet time, where room lights are dimmed, 
and calming lighting effects are turned on. Soothing sounds are provided by the intervention 
facilitator using voice and instruments, and mothers are encouraged to sit or lie with their babies 
and enjoy a period of bonding time together with minimal distraction.  
Mothers are then invited to stay for informal social support with refreshments. This is facilitated by 
the intervention facilitator and assisted by the QUB researcher. Mothers will be encouraged to 
interact with other mothers to promote social connection. Acknowledging the potential for 
successful interaction occurring between mothers, the facilitator and assistant will step back after 20 
minutes and allow mothers to continue without their direct involvement for up to an additional 30 
minutes. This time will allow social support to be given and received. Mothers will be invited to sit 
and relax, to feel comfortable in attending to any of their babies needs as they chat and/or listen to 
others.  
In addition to Mamas in Harmony sessions, mothers and infants in the intervention group will also 
receive usual postnatal care from health and social care services. 
Usual care for control group 
Mothers in the control group will not receive the music and social support sessions but will receive 
usual postnatal care offered by Health and Social Care (HSC) services in Northern Ireland provided by 
their community midwife, GP and health visitor. This usually comprises of mother and infant health 
and wellbeing checks, infant weighing, infant feeding advice and support, developmental 
assessments and additional visits based on need and capacity (DHSSPS, 2010).  
 

 
13-02-2023 Vn (1.3) 
11 
 
 
Phase 1 - Feasibility study with a pilot randomised controlled trial (RCT) 
Data collection  
Baseline data will be gathered in the baseline questionnaire (Baseline questionnaire 13-02-2023 Vn 
1.2) and will include sociodemographic details on age of mother and infant, marital status, number 
of children living with them, ethnicity, educational attainment, and average household income.  
Further questionnaires will be administered at T2 (3 months post randomisation) (T2 questionnaire 
15-01-2023 Vn 1.1) and T3 (6 months post randomisation) (T3 questionnaire 15-01-2023 Vn 1.1). All 
questionnaires will be administered via an electronic link in an email from the online Qualtrics 
survey platform and completed questionnaires saved within the Qualtrics platform. A stamped 
addressed envelope will be supplied to be returned to QUB, if paper copies are preferred. Paper 
copies will be stored securely on university premises in a locked filing cabinet accessible only by the 
research team behind a locked door. All data will be stored in accordance with the Data Protection 
legislation and will be destroyed 5 years following completion of the study. 
 
Feasibility outcomes 
The feasibility outcomes of the study will be:  
1. The recruitment rate of study participants  
2. Reasons for non-participation (if disclosed) 
3. Adherence and retention of participants, including reasons (if disclosed) for attrition during 
the intervention.  
4. Attrition rate of mothers at the follow up timepoints at 3 months and 6 months post 
randomisation 
5. Acceptability of outcome measures for anxiety, postnatal depression, perceived stress, 
perceived social support, maternal postnatal attachment, health-related quality of life, and 
service use.  
6. Quality of implementation, potential mechanisms of change and context  
 
Outcome measurement 
Recruitment and allocation of participants will be collected and then reported and presented in a 
CONSORT flow diagram (Schulz et al., 2010). Screening logs will be used by the researcher during 
recruitment to record numbers of mothers who agreed to participate and those who declined to 
participate and reason (if given) (Screening log 21-08-2022 Vn 1.0) and may be used to discover 
influences over recruitment and/or retention of mothers. Mothers will have the option to declare 
that they prefer not to say. An attendance register (Attendance register 15-01-2023 Vn 1.1) will be 
used at each session to gather information on mothers attendance at the group music component 
and social support component and if any further information was provided by mothers such as their 
late arrival or early departure from sessions. This will be used to establish retention of participants 
and adherence to the intervention. 

 
13-02-2023 Vn (1.3) 
12 
 
Attrition rates from the research study will be recorded and analysed to assess feasibility of follow 
up immediately post-intervention and longitudinal follow up ≥6 months in duration within a full trial. 
Acceptability of outcome measures will be assessed from completion rates of outcome measures, 
missing data and promise of effect on outcome. A standardised service use log will be provided at 
baseline, one to be collected at 3 months (post randomisation) (3 month service use log 15-01-2023 
Vn 1.1) and one to be collected at 6 months (post randomisation) (6 month service use log 15-01-
2023 Vn 1.1) to establish completion rates.  
Implementation components of dose, reach, context, fidelity and challenges for intervention 
delivery will be reported on using data from attendance registers (dose), screening logs for 
discovering how mothers heard about the study (reach), semi-structured interviews during process 
evaluation (context, fidelity and challenges). Also use of evaluation forms (fidelity). The INNATE 
framework (Warran et al., 2022) used to support the design and implementation of the intervention 
will then be utilised following the process evaluation as a guide to attempt to identify potential 
causal mechanisms that may have led to an effect on outcomes.  
Data analysis  
Quantitative data will be analysed with descriptive statistics using SPSS version 27. Continuous data 
will be presented as means and standard deviations and categorical and dichotomous data 
presented as frequencies and percentages. Baseline comparisons between groups will be made 
using one-way ANOVAs, Kruskal-Wallis test and Chi-square test for linear, ordinal and categorical 
data respectively. Differences in (Generalised Anxiety Disorder 7 Scale) GAD-7, Edinburgh Postnatal 
Depression Scale (EPDS), Perceived Stress Scale (PSS), Social Support Survey (SSS), Maternal 
Postnatal Attachment Scale (MPAS) and EQ-5D-5L scores between groups at 3 months and 6 months 
(post randomisation) will be assessed using two way ANOVAs, with baseline scores included as co-
variates where collected. Any differences in score between groups on follow up will be of interest as 
evidence of promise. Mothers who dropped out versus retained at 3 months and mothers dropped 
out versus retained at 6 months will be reported on in terms of maternal characteristics at baseline 
across the two groups. 
 
Phase 2 – Process evaluation 
The aim of the process evaluation is to understand mothers’ experiences and opinions of the Mamas 
in Harmony intervention using evaluation forms and semi structured interviews completed by 
mothers from the intervention group. Insight will be sought as to the acceptability of the 
intervention in terms of being liked or disliked, appropriate, benefits gained, to identify any barriers 
to attendance and/or engagement that exist and recommendations for improvement. Responses 
from evaluation forms collected will be analysed and be used as prompts for further enquiry during 
the interview. 
Semi structured interviews will also be conducted with mothers from the control group to provide 
insight on the acceptability of the research study by gaining a broader understanding of recruitment 
methods, attrition of mothers during study and completion rates of outcome measures. 

 
13-02-2023 Vn (1.3) 
13 
 
Finally semi structured interviews will be conducted with the intervention facilitator/s to allow them 
to provide their professional opinion on the implementation of the intervention and to advise on 
challenges/improvements to facilitation to inform future research. 
 
Recruitment 
Potential participants will be identified from both intervention and control group mothers who 
indicate their interest in participating in an interview at the baseline data collection timepoint. A 
separate participant information sheet (PIS for interview for mothers 15-01-2023 Vn 1.1) and 
consent form (Consent form for interview for mothers 15-01-2023 Vn 1.1) have been developed for 
this phase and will be provided either by email or post depending on the mother’s preference (as 
indicated at recruitment for the pilot RCT) after completion of the pilot study when interviews are 
due to be scheduled. Mothers who indicated an interest in taking part in an interview will have their 
study ID entered into a MS Excel file where a random number generator will be used to compile a 
random list of all the study IDs. It is anticipated that 12 (20%) will indicate they will be interested in 
an interview and that on invite, 8 of these will agree, consent and participate. In the first instance, 
the mothers of the first eight randomly generated study IDs will be approached by the researcher 
through the participant’s preferred mode of contact, informed of this component of the study and 
invited to participate (Dialogue for interest in interview 21-08-2022 Vn 1.0). Recruitment will 
continue, by contacting the mother assigned to sequential Study IDs on the list. 
If interested in participating, mothers will be emailed or posted (depending on preference of the 
mother) the participant information sheet (PIS) (PIS for interview for mothers 15-01-2023 Vn 1.1) 
and copy of the consent form (Consent form for interview for mothers 15-01-2023 Vn 1.1). The 
researcher will provide each mother at least 48 hours to consider participation before making 
contact again by telephone (Dialogue for obtaining consent for interview 21-08-2022 Vn 1.0). This 
will be an opportunity for the researcher to answer any further questions the mother may have and 
confirm they are happy to consent. If a mother wishes to participate, they will be asked to sign and 
return consent forms to the researcher who will countersign and return a copy to them. Electronic 
copies will be generated in MS Forms and stored securely and separately in QUB SharePoint. A 
stamped addressed envelope will be supplied to be returned to QUB, if paper copies are preferred. 
Paper copies will be stored securely on university premises in a locked filing cabinet accessible only 
by the research team behind a locked door. All data will be stored in accordance with the Data 
Protection legislation and will be destroyed 5 years following completion of the study. Then mothers 
will be contacted by telephone (Dialogue for arranging interview 21-08-2022 Vn 1.0) to arrange a 
suitable date and time for interview and to confirm preference (face to face or Microsoft Teams).  
The intervention facilitator/s will be invited to attend an interview and will receive an electronic 
copy of the participant information sheet (PIS for interview for facilitators15-01-2023 Vn 1.1) and 
consent form (Consent form for interview for facilitators 15-01-2023 Vn 1.1), or paper copy if 
preferred, and will be stored as described above. 
Data collection  
The following processes will be undertaken: 

 
13-02-2023 Vn (1.3) 
14 
 
1. Evaluation forms (Evaluation form 21/08/2022 Vn 1.0) will be administered to mothers 
allocated to the intervention group in person in week 8 at the end of the final session of the 
intervention. A box will be provided at the side of the room for mothers to place their 
completed forms. Mothers will be reminded that all thoughts on the intervention will be 
valued and used to help improve the intervention content and delivery. They will be 
informed that they do not have to complete the form if they do not wish to, and that the 
forms are anonymous. The facilitator and researcher will leave the room while mothers 
complete the forms. The researcher will collect the box with the completed evaluation forms 
after the session has closed and all mothers have departed. The forms will be used to 
explore expectations of and satisfaction with the intervention and ideas for improvement. 
 
2. Semi structured interviews will be carried out with a subset of participants from the 
intervention group and will take place after completion of the pilot study so not to impact 
upon outcome assessment at 6 month follow up. Semi structured interviews were chosen as 
the preference over focus groups for participants, and an outline interview schedule has 
been created (Interview schedule for mothers 21-08-2022 Vn 1.0). The interview schedule 
will comprise of questions for mothers from both the intervention and control groups and  
questions specific to each group. The interview schedule was informed by using 
prompts/questions which are existing benefits/implementation characteristics of similar 
interventions in similar populations and also developed to advise on enablers/barriers to 
participation to inform future research. Socio-demographic characteristics of participants 
will be collected at the start of the interview to establish a profile of the participants taking 
part in the interviews (Demographics for interview 13-02-2023 Vn 1.1). While interviews are 
more time consuming for the researcher, they are more convenient to the mother and allow 
confidentiality for the mother in the discussion and so more likely to have higher 
participation rates and anticipated to provide rich data in relation to the depth of 
understanding gained of the mothers’ experiences. A previous study conducting a process 
evaluation with mothers and infants following a singing intervention, found low uptake in 
their focus groups likely due to the logistic challenges of the mother sitting and talking while 
having a young infant to attend to (Perkins et al., 2018). While this will still be the case for 
the mother regardless of method, it is planned that semi-structured interviews will be 
conducted face to face in person or virtually via Microsoft Teams, at a date and time 
convenient to the mother to allow as much flexibility as possible. Interviews will be digitally 
recorded via Microsoft Teams, then saved and stored securely on QUB SharePoint. If 
completed face to face, recording will take place using two digital voice recorders in the 
event of technical failure and saved and stored securely on QUB OneDrive. Transcription of 
audio recordings will take place as soon after data collection as possible. Transcripts will be 
identified by study ID only. Recordings will be destroyed after transcripts have been checked 
for accuracy.  
 
3. Semi structured interviews will be carried out with a subset of participants from the control 
group and will take place after completion of the pilot study so not to impact upon outcome 
assessment at 6 month follow up. Interviews will be conducted, recorded and data handled 
and stored as described in (2). The interview schedule (Interview schedule for mothers 21-
08-2022 Vn 1.0) was informed by using questions based on feasibility outcomes to gain a 
broader understanding of recruitment methods, attrition of mothers during study and 

 
13-02-2023 Vn (1.3) 
15 
 
completion rates of outcome measures. Socio-demographic characteristics of participants 
will be collected at the start of the interview to establish a profile of the participants taking 
part in the interviews (Demographics for interview 13-02-2023 Vn 1.1).  
 
4. A single interview will take place with the intervention facilitator/s following completion of 
all cycles of sessions. The interview will be conducted, recorded and data handled and 
stored as described in (2). The interview schedule (Interview schedule for facilitators 21-08-
2022 Vn 1.0) was informed by implementation characteristics of similar interventions in 
similar populations. Also to allow the facilitators to provide their professional opinion on the 
implementation of the intervention and to advise on challenges/improvements to 
facilitation to inform future research. 
Data analysis 
1. 
Evaluation forms will enable expectations and satisfaction of the intervention to be 
reported on and ideas for improvement to be made. 
2. 
Semi structured interviews with the intervention group will allow acceptability of the 
intervention to be reported on.  
3. 
Semi structured interviews with the control group will allow acceptability of the research 
study to be reported on.  
4. 
Semi structured interviews with the intervention facilitator/s will allow an understanding 
of the facilitators’ experiences of their involvement with the intervention to be gained. 
All recordings from the interviews will be transcribed verbatim by the researcher and 
pseudonymised transcripts will be uploaded to NVivo and analysed using an interpretive qualitative 
approach based on the principles of thematic analysis (Braun et al., 2014). This type of analysis 
focuses on identifying themes throughout the data and then be coded by identifying persistent 
words, phrases, experiences or concepts. Data will then be grouped according to topic, allowing 
further identification of sub-themes. Following coding, the data will be categorised to reflect the 
overall picture of the data and relationships between categories. Related categories will be merged 
into themes (Green and Thorogood, 2018). Reflexivity will be practiced through individual analysis 
conducted by the research team, then discussion and agreement. This allows any biases or 
assumptions about the content to be examined and for the researchers to undergo a process of self-
examination (Campbell et al., 2021). These themes will be used to gain an understanding of the 
experiences of mothers participating in the intervention. 
 
Ethical considerations 
Ethical approval will be sought from the Faculty of Medicine, Health and Life Sciences Research 
Ethics Committee at QUB prior to commencing the study. 
Confidentiality is paramount and will be maintained during and after the study. All information 
collected about participants during the course of the research will be kept strictly confidential with 
the exception that if they disclose information that indicates that they or someone they mention is at 
risk of harm, the researcher is legally obliged to pass on this information in accordance with 
professional guidelines. Participants are advised that all information shared within group discussions 

 
13-02-2023 Vn (1.3) 
16 
 
will be treated confidentially. Any personally identifiable information entered by participants within 
questionnaires will be removed, anonymised or pseudonymised as appropriate. 
A study advisory group will be formed, comprising of local and national professionals, 
paraprofessionals and parents to provide ongoing insight and expertise as the study progresses. The 
group will meet online at key milestones of the study, expected to be on a 6-monthly basis.  
 
Potential risks to the study participants 
Physical harm: No significant physical risks are expected to be associated with the participation in 
this study. A health and safety assessment of the venue for its suitability for mother and infant 
classes will be conducted prior to commencement of the study and on an ongoing basis during the 
study in accordance with QUB health and safety policy. 
Psychological harm: The risk of psychological harm is expected to be minimal. Previous research 
using a similar intervention has shown no adverse events to study participants (Fancourt and 
Perkins, 2018). The intervention facilitator and assistant facilitator will be vigilant during delivery of 
the intervention, process evaluation interviews and during any other contacts with study 
participants for any sign of distress observed or verbalised by the mother. If this occurs, the 
researcher will take appropriate action as set out in the distress protocols for both the Mamas in 
Harmony sessions and interviews (Distress protocol – study 21-08-2022 Vn 1.0; Distress protocol – 
interview 21-08-2022 Vn 1.0).  
It is acknowledged that outcome data provided at post intervention and follow up timepoints by 
mothers during the study would not normally be analysed until completion. However, due to 
completion of outcome measurement tools for anxiety and depression (EPDS and GAD-7) having the 
potential to identify scores above the recognised clinical threshold for the tool representing 
significant symptoms and/or risk to the mother and infant, these data will be analysed by the 
researcher within one week of receipt of the completed questionnaire from the mother. This will 
enable the researcher to signpost the mother to her GP and other appropriate supports as per the 
distress protocol (Distress protocol – study 21-08-2022 Vn 1.0). Contact will be made with the  
mother by the research team immediately in the event that the research team identify the mother’s 
score as being on/above the threshold indicating the potential need for follow up care, as per the 
measurement tool’s guidelines. A letter will be forwarded to the mother by email or post depending 
on preference to present to her GP providing the context for the contact (GP letter 13-02-2023 Vn 
1.0). In addition to these measures, should a mother express to the intervention facilitator and/or 
assistant facilitator that they, their infant, or someone else may be at risk of harm, consent will be 
sought from the mother for the researcher to contact her health visitor and/or GP within 24 hours of 
disclosure to share the information. Health visitor/GP contact details will be requested directly from 
the mother. Safeguarding advice will be sought by the researcher from the QUB designated 
safeguarding officer as required. 
Mothers may feel they are experiencing a level of inconvenience due to the required number of 
questionnaires administered. Each questionnaire will take approximately 25 minutes to complete, of 
which the participant will be made aware of in the participant information sheet and at the 
beginning of each questionnaire. Data collection at all three timepoints will take place via the 
Qualtrics survey platform, or by post if preferred, in order to be less intrusive to the mothers home 

 
13-02-2023 Vn (1.3) 
17 
 
life and potentially be more convenient. They will be able to complete the questionnaires at a time 
to suit their needs and that of their infant and can be saved and returned to before submitting. 
Covid 19 
The researcher will be following Public Health Agency guidance regarding Covid 19 at the time of the 
individual stages of the intervention and follow up. The researcher will complete health and safety 
documentation as required to identify and reduce risk. 
Benefits 
The benefits to the intervention and control groups will be the opportunity to participate in research 
and contribute knowledge to the evidence base. The intervention group may further benefit by 
taking part in group based activities with their infant. All participants will receive a £15 Amazon gift 
card as a thank you and to acknowledge their time in taking part at the end of the study.  
Dissemination 
Research findings will be disseminated to audiences through academic conferences and stakeholder-
related event presentations, as well as peer-reviewed academic journal publications. A study 
webpage will be created to disseminate progress of the study and findings to study participants and 
the wider public. Social media will also be used to disseminate findings to reach a wider audience 
and maximise impact. 
The study results will be implemented to decide on progression to a definitive RCT, using data on 
acceptability of the intervention and recruitment and attrition rates. The process evaluation will 
assist in exploring the quality of implementation, potential mechanisms of change and context, 
allowing for the intervention and conduct of the trial to be optimised and refined as required. 
Project Timetable 
A Gantt chart presents the anticipated schedule of recruitment, delivery of the intervention, data 
collection, data analysis and dissemination (See attached). 
 
References 
BAUER, A., PARSONAGE, M., KNAPP, M., LEMMI, V. & ADELAJA, B. 2014. The costs of perinatal 
mental health problems. London: Centre for Mental Health. 
BEEBE, B., STEELE, M., JAFFE, J., BUCK, K. A., CHEN, H., COHEN, P., KAITZ, M., MARKESE, S., 
ANDREWS, H., MARGOLIS, A. & FELDSTEIN, S. 2011. Maternal Anxiety Symptoms and 
Mother-Infant Self- and Interactive Contingency. Infant Mental Health Journal, 32, 174-206. 
BRAUN, V., CLARKE, V., TERRY, G., ROHLEDER, P. & LYONS, A. 2014. Qualitative research in clinical 
and health psychology. London, England: Palgrave Macmillan. 
BRUGHA, T. S., SHARP, H. M., COOPER, S. A., WEISENDER, C., BRITTO, D., SHINKWIN, R., SHERRIF, T. 
& KIRWAN, P. H. 1998. The Leicester 500 Project. Social support and the development of 
postnatal depressive symptoms, a prospective cohort survey. Psychological Medicine, 28, 63-
79. 
BRUMMELTE, S. & GALEA, L. A. 2016. Postpartum depression: Etiology, treatment and consequences 
for maternal care. Hormones & Behavior, 77, 153-66. 

 
13-02-2023 Vn (1.3) 
18 
 
CAMPBELL, K. A., ORR, E., DUREPOS, P., NGUYEN, L., LI, L., WHITMORE, C., GEHRKE, P., GRAHAM, L. 
& JACK, S. M. 2021. Reflexive thematic analysis for applied qualitative health research. The 
Qualitative Report, 26, 2011-2028. 
COATES, R., DE VISSER, R. & AYERS, S. 2015. Not identifying with postnatal depression: a qualitative 
study of women's postnatal symptoms of distress and need for support. Journal of 
Psychosomatic Obstetrics & Gynecology, 36, 114-21. 
COLELLA, C., LYNN, F. & MCNEILL, J. 2021. The effect of mother-infant group music interventions on 
postnatal depression – a systematic review. Queen's University Belfast. 
COOPER, P. J., MURRAY, L., WILSON, A. & ROMANIUK, H. 2003. Controlled trial of the short- and 
long-term effect of psychological treatment of post-partum depression: I. Impact on 
maternal mood. British Journal of Psychiatry, 182, 412-419. 
DENNIS, C.-L., FALAH-HASSANI, K. & SHIRI, R. 2017. Prevalence of antenatal and postnatal anxiety: 
Systematic review and meta-analysis. British Journal of Psychiatry, 210, 315-323. 
DHSSPS 2010. Healthy Child, Health Future. A Framework for the Universal Child Health Promotion 
Programme in Northern Ireland. 
DINGLE, G. A., SHARMAN, L. S., BAUER, Z., BECKMAN, E., BROUGHTON, M., BUNZLI, E., DAVIDSON, 
R., DRAPER, G., FAIRLEY, S., FARRELL, C., FLYNN, L. M., GOMERSALL, S., HONG, M., 
LARWOOD, J., LEE, C., LEE, J., NITSCHINSK, L., PELUSO, N., REEDMAN, S. E., VIDAS, D., 
WALTER, Z. C. & WRIGHT, O. R. L. 2021a. How Do Music Activities Affect Health and Well-
Being? A Scoping Review of Studies Examining Psychosocial Mechanisms. Frontiers in 
Psychology, 12. 
DINGLE, G. A., SHARMAN, L. S., HASLAM, C., DONALD, M., TURNER, C., PARTANEN, R., LYNCH, J., 
DRAPER, G. & VAN DRIEL, M. L. 2021b. The effects of social group interventions for 
depression: Systematic review. Journal of Affective Disorders, 281, 67-81. 
ELDRIDGE, S. M., LANCASTER, G. A., CAMPBELL, M. J., THABANE, L., HOPEWELL, S., COLEMAN, C. L. & 
BOND, C. M. 2016. Defining Feasibility and Pilot Studies in Preparation for Randomised 
Controlled Trials: Development of a Conceptual Framework. PLOS ONE, 11, e0150205. 
ESTEVAO, C., BIND, R., FANCOURT, D., SAWYER, K., DAZZAN, P., SEVDALIS, N., WOODS, A., CRANE, 
N., REBECCHINI, L., HAZELGROVE, K., MANOHARAN, M., BURTON, A., DYE, H., OSBORN, T., 
GREENWOOD, L., DAVIS, R. E., SOUKUP, T., ARIAS DE LA TORRE, J., BAKOLIS, I., HEALEY, A., 
PERKINS, R. & PARIANTE, C. 2021. SHAPER-PND trial: clinical effectiveness protocol of a 
community singing intervention for postnatal depression. BMJ Open, 11, e052133. 
FALLON, V., DAVIES, S. M., SILVERIO, S. A., JACKSON, L., DE PASCALIS, L. & HARROLD, J. A. 2021. 
Psychosocial experiences of postnatal women during the COVID-19 pandemic. A UK-wide 
study of prevalence rates and risk factors for clinically relevant depression and anxiety. 
Journal of Psychiatric Research, 136, 157-166. 
FANCOURT, D. 2017. Arts in Health Designing and Researching Interventions, Oxford, Oxford 
University Press. 
FANCOURT, D. & PERKINS, R. 2018. Effect of singing interventions on symptoms of postnatal 
depression: three-arm randomised controlled trial. British Journal of Psychiatry, 212, 119-
121. 
FANCOURT, D. & PERKINS, R. 2019. Creative interventions for symptoms of postnatal depression: a 
process evaluation of implementation. Arts & Health, 11, 38-53. 
FANCOURT, D., WARRAN, K. & AUGHTERSON, H. 2020. Evidence Summary for Policy: The role of arts 
in improving health and wellbeing: Report to the Department for Digital, Culture, Media & 
Sport. 
FARIAS, D. R., PINTO, T. D. J. P., TEOFILO, M. M. A., VILELA, A. A. F., DOS SANTOS VAZ, J., NARDI, A. E. 
& KAC, G. 2013. Prevalence of psychiatric disorders in the first trimester of pregnancy and 
factors associated with current suicide risk. Psychiatry research, 210, 962-968. 

 
13-02-2023 Vn (1.3) 
19 
 
GEORGE, A., LUZ, R. F., DE TYCHEY, C., THILLY, N. & SPITZ, E. 2013. Anxiety symptoms and coping 
strategies in the perinatal period. BMC pregnancy and childbirth, 13, 1-6. 
GOV.UK. 2020. Staying at home and away from others (social distancing) (guidance withdrawn 11 
May 2020) [Online]. Available: https://www.gov.uk/government/publications/full-guidance-
on-staying-at-home-and-away-from-others/full-guidance-on-staying-at-home-and-away-
from-others [Accessed 16 March 2022]. 
GREEN, J. & THOROGOOD, N. 2018. Qualitative Methods for Health Research, London, SAGE. 
HOLT, C., GENTILLEAU, C., GEMMILL, A. W. & MILGROM, J. 2021. Improving the mother-infant 
relationship following postnatal depression: a randomised controlled trial of a brief 
intervention (HUGS). Archives of Women's Mental Health, 19, 19. 
HOWARD, L. M., MOLYNEAUX, E., DENNIS, C.-L., ROCHAT, T., STEIN, A. & MILGROM, J. 2014. Non-
psychotic mental disorders in the perinatal period. The Lancet, 384, 1775-1788. 
IRONS, J. Y., SHEFFIELD, D., BALLINGTON, F. & STEWART, D. E. 2020. A systematic review on the 
effects of group singing on persistent pain in people with long‐term health conditions. 
European Journal of Pain, 24, 71-90. 
JULIOUS, S. A. 2005. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical 
Statistics, 4, 287-291. 
MCMAHON, C. A., BARNETT, B., KOWALENKO, N. M. & TENNANT, C. C. 2006. Maternal attachment 
state of mind moderates the impact of postnatal depression on infant attachment. J Child 
Psychol Psychiatry, 47, 660-9. 
MIND. 2020. Postnatal depression and perinatal mental health [Online]. Available: 
https://www.mind.org.uk/information-support/types-of-mental-health-problems/postnatal-
depression-and-perinatal-mental-health/causes/ [Accessed 29 April 2021]. 
MIND. 2022. Postnatal depression and perinatal mental health [Online]. MIND. Available: 
https://www.mind.org.uk/information-support/types-of-mental-health-problems/postnatal-
depression-and-perinatal-mental-health/about-maternal-mental-health-problems/ 
[Accessed 11 August 2022]. 
MORRELL, C. J., WARNER, R., SLADE, P., DIXON, S., WALTERS, S., PALEY, G. & BRUGHA, T. 2009. 
Psychological interventions for postnatal depression: cluster randomised trial and economic 
evaluation. The PoNDER trial. Health Technol Assess, 13, 1-153. 
NHS 2019. The NHS Long Term Plan. 
NICE. 2020. Antenatal and postnatal mental health: clinical management and service guidance 
[Online]. NICE. Available: 
https://www.nice.org.uk/guidance/cg192/chapter/recommendations#anxiety-disorders 
[Accessed 19 August 2022]. 
NICE. 2021. Postnatal Care [Online]. Available: https://www.nice.org.uk/guidance/ng194 [Accessed 
15 January 2023]. 
NICE. 2022. Maternity and mental health [Online]. NICE. Available: 
https://www.nice.org.uk/about/what-we-do/into-practice/measuring-the-use-of-nice-
guidance/impact-of-our-guidance/niceimpact-maternity/ch2-maternity-and-mental-health 
[Accessed 11 August 2022]. 
NYLEN, K. J., MORAN, T. E., FRANKLIN, C. L. & O'HARA, M. W. 2006. Maternal depression: A review of 
relevant treatment approaches for mothers and infants. Infant Mental Health Journal, 27, 
327-343. 
O'CONNOR, T. G., HERON, J., GLOVER, V. & TEAM, A. S. 2002. Antenatal anxiety predicts child 
behavioral/emotional problems independently of postnatal depression. Journal of the 
American Academy of Child & Adolescent Psychiatry, 41, 1470-1477. 

 
13-02-2023 Vn (1.3) 
20 
 
PERKINS, R., YORKE, S. & FANCOURT, D. 2018. How group singing facilitates recovery from the 
symptoms of postnatal depression: a comparative qualitative study. BMC psychology, 6, 1-
12. 
PHA. 2022. COVID-19 (coronavirus) [Online]. Available: https://www.publichealth.hscni.net/covid-
19-coronavirus [Accessed 26 September 2022]. 
REAGON, C., GALE, N., ENRIGHT, S., MANN, M. & VAN DEURSEN, R. 2016. A mixed-method 
systematic review to investigate the effect of group singing on health related quality of life. 
Complementary Therapies in Medicine, 27, 1-11. 
ROSSEN, L., HUTCHINSON, D., WILSON, J., BURNS, L., C, A. O., ALLSOP, S., E, J. E., JACOBS, S., 
MACDONALD, J. A. & MATTICK, R. P. 2016. Predictors of postnatal mother-infant bonding: 
the role of antenatal bonding, maternal substance use and mental health. Archives of 
Women's Mental Health, 19, 609-22. 
SCHULZ, K. F., ALTMAN, D. G., MOHER, D. & THE, C. G. 2010. CONSORT 2010 Statement: updated 
guidelines for reporting parallel group randomised trials. Trials, 11, 32. 
SIM, J. & LEWIS, M. 2012. The size of a pilot study for a clinical trial should be calculated in relation 
to considerations of precision and efficiency. Journal of Clinical Epidemiology, 65, 301-308. 
SWEET, L., BRADFIELD, Z., VASILEVSKI, V., WYNTER, K., HAUCK, Y., KULIUKAS, L., HOMER, C. S. E., 
SZABO, R. A. & WILSON, A. N. 2021. Becoming a mother in the ‘new’ social world in Australia 
during the first wave of the COVID-19 pandemic. Midwifery, 98, 102996. 
TSIVOS, Z.-L., CALAM, R., SANDERS, M. R. & WITTKOWSKI, A. 2015. Interventions for postnatal 
depression assessing the mother-infant relationship and child developmental outcomes: a 
systematic review. International journal of women's health, 7, 429-447. 
VAN DEN BERGH, B. R. & MARCOEN, A. 2004. High antenatal maternal anxiety is related to ADHD 
symptoms, externalizing problems, and anxiety in 8‐and 9‐year‐olds. Child development, 75, 
1085-1097. 
VLISMAS, W., MALLOCH, S. & BURNHAM, D. 2013. The effects of music and movement on mother–
infant interactions. Early Child Development and Care, 183, 1669-1688. 
WARRAN, K., BURTON, A. & FANCOURT, D. 2022. What are the active ingredients of ‘arts in 
health’activities? Development of the INgredients iN ArTs in hEalth (INNATE) Framework. 
Wellcome Open Research, 7. 
WILLIAMS, E., DINGLE, G. A. & CLIFT, S. 2018. A systematic review of mental health and wellbeing 
outcomes of group singing for adults with a mental health condition. European journal of 
public health, 28, 1035-1042. 
YANG, W.-J., BAI, Y.-M., QIN, L., XU, X.-L., BAO, K.-F., XIAO, J.-L. & DING, G.-W. 2019. The 
effectiveness of music therapy for postpartum depression: A systematic review and meta-
analysis. Complementary Therapies in Clinical Practice, 37, 93-101. 
 
Appendices 
A. SPIRIT diagram (separate document) 
B. GANTT chart (separate document) 
 
 
 
 
 
 
 

 
13-02-2023 Vn (1.3) 
21 
 
 
 
 
 
________________________  
_____________ 
 
_____________________ 
Name of Participant 
 
 
Date 
 
 
 
Signature          
 
________________________  
_____________ 
 
_____________________ 
Researcher 
 
 
 
Date 
 
 
 
Signature          
 
Consent form for Mamas in Harmony study 
STUDY ID __________ 
 
 
 
 
 
Please 
initial 
1.  I confirm that I have been given and have read and understand the Participant 
Information Sheet (15-01-2023 Version 1.1). I have had the opportunity to ask and 
receive answers to any questions I may have had. 
 
2. I understand that my participation is voluntary and that I am free to withdraw at any time, 
without giving any reason and without my legal rights being affected.  
 
 
3. I understand that the data provided until the point of withdrawal will be retained and used 
for analysis. 
 
 
4. I understand that my personal information will be held securely on university premises 
and should comply with relevant data protection legislation and data collected as part of 
the research may be looked at by authorised individuals from Queen’s University Belfast 
(QUB) where relevant and I give permission for these individuals to have access to this 
information. 
 
 
5. I understand what is discussed during the Mamas in Harmony study will be kept 
confidential by the research team with the exception that if I disclose information that 
indicates that I or someone I mention is at risk of harm, the researcher is legally obliged 
to pass on this information in accordance with professional guidelines. 
 
6. The research team cannot ensure confidentiality of information shared between, and/or 
by other mothers during or after Mamas in Harmony sessions 
   
 
7.  I understand that I will not be identifiable in any data published in relation to this project. 
 
8.  I agree to take part in the above study.