Clinical trial NCT05930990: Feasibility Study of a Music and Social Support Intervention for Postnatal Mothers/Infants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Depression
Stress
Parenting confidence
Social support
Mother-infant attachment
Health related quality of life
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 72
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research study aims to assess the feasibility of conducting a full scale trial of Mamas in Harmony, a group music and social support class delivered by a professional musician for mothers and their babies. Classes for Mamas in Harmony run for 1 hour each week for 8 weeks at a community venue with 10-12 mothers and babies in each class.

The aim of this study is to conduct a pilot randomised controlled trial and process evaluation to assess recruitment rate, retention rate, adherence rate to the study protocol, attendance rate for the intervention, completion rate of outcome measurement tools, acceptability of the intervention, and barriers/facilitators for study participation and intervention delivery.

This feasibility study aims to recruit 60 mothers and babies. Forty will be randomly allocated to the intervention group of Mamas in Harmony and receive standard postnatal care and twenty will receive standard postnatal care only, as the control group.

All mothers will be asked to complete study questionnaires at three time points over a 6 month period to assess their mental health and wellbeing and bonding with their baby.

Mothers will also be asked if they wish to share their opinions and experiences about the research study and Mamas in Harmony classes (if they were allocated to that group) in an interview, to provide their thoughts, whether anything made it easy/difficult for them to participate and whether they have any suggestions on how to improve the study procedure.

The musician will also be asked for their experiences on the barriers and facilitators of intervention delivery.

Detailed description: 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. The perinatal period lasts for the duration of pregnancy and for 1 year after the birth of the child. Symptoms of low mood, anxiety, stress, feeling isolated, and difficulties with mother-infant attachment are frequently experienced by both antenatal and postnatal mothers. 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). This is despite associations found between maternal anxiety and adverse outcomes for the child.

Studies investigating the effect of poor postnatal mental health have found an adverse impact on mother-infant attachment, bonding, self-regulation and empathy. Consequently, mothers find it difficult to engage with their infants both emotionally and behaviourally resulting in reducing their physical contact.

Regular screening for perinatal depression and anxiety disorders by health professionals is recommended in the UK 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. 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.

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. Psychotherapy has presented challenges of mixed results, and short-lived improvements. Consequently there has been an increase in interest in non-pharmacological interventions, such as arts in health programmes.

Strong evidence supports the arts in improving wellbeing and quality of life among adults. Arts in health activities are wide ranging and, in particular, include performing arts, such as music. 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.

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 using a pilot randomised controlled trial and process evaluation.

Sixty mother-infant dyads aim to be recruited via social media, including Facebook and Twitter, and recruitment posters on communal/public facing noticeboards. Local Women's and Community Centres, community mother and baby classes, social support organisations and SureStart Children's Centres (Department for Education funded) will be asked to display posters/flyers. Following informed consent and baseline data collection, mothers will be randomly allocated using a 2:1 ratio to the intervention or control group. Mamas in Harmony sessions will be delivered by a professional musician/choir leader in a community venue face to face in groups of 10-12 mother-infant dyads, for 1 hour each week for 8 weeks along with their usual postnatal care from health and social care services. The control group receive usual postnatal care only.

All mothers will be invited to complete questionnaires at baseline (prior to randomisation), 3 months and 6 months post-randomisation either online or posted in paper format to assess completion rates of measurement tools for anxiety, depression, perceived stress, parenting confidence, perceived social support, mother-infant attachment, health related quality of life and service and resource use.

Study registers will be used to assess recruitment rate, retention rate, adherence to the study protocol and attendance rate for the intervention.

Evaluation forms will be administered to the intervention group in week 8 and semi structured interviews completed online with a subset of 8 mothers from intervention and control groups at the end of the study to establish acceptability, and maternal satisfaction with the intervention and/or research study, as applicable. Semi structured interview/s will be conducted with the intervention facilitator/s to allow an understanding of the facilitators' perspectives of barriers and facilitators for intervention delivery.

Eligibility criteria: Inclusion Criteria:

* Mothers who have a baby aged ≥14 days to ≤4 months at time of consent.
* 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).

Primary outcomes:
measure: Rates of recruitment and retention
timeFrame: 6 months
Secondary outcomes:
measure: Rate of adherence to the study protocol
timeFrame: 6 months
measure: Rate of attendance to Mamas in Harmony intervention sessions
timeFrame: 8 weeks
measure: Completion rate of the Generalised Anxiety Disorder-7 scale (GAD-7)
timeFrame: 3 months and 6 months post randomisation
measure: Completion rate of the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 3 months and 6 months post randomisation
measure: Completion rate of the Perceived Stress Scale (PSS)
timeFrame: 3 months and 6 months post randomisation
measure: Completion rate of the Karitane Parenting Confidence Scale (KPCS)
timeFrame: 3 months and 6 months post randomisation
measure: Completion rate of the Social Support Survey (SSS)
timeFrame: 3 months and 6 months post randomisation
measure: Completion rate of the Maternal Postnatal Attachment Scale (MPAS)
timeFrame: 3 months and 6 months post randomisation
measure: Completion rate of the EuroQol EQ-5D-5L
timeFrame: 3 months and 6 months post randomisation
measure: Completion rate of service and resource use log
timeFrame: 3 and 6 months
measure: Satisfaction of Mamas in Harmony intervention
timeFrame: 8 weeks
measure: Acceptability of Mamas in Harmony intervention
timeFrame: 6 months
measure: Perspectives on barriers and facilitators to intervention delivery
timeFrame: 6 months
measure: Perspectives on barriers and facilitators to study participation
timeFrame: 6 months
measure: Perspectives on intervention fidelity
timeFrame: 6 months
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Queen's University
state: County Antrim
Study officials:
affiliation: Queen's University, Belfast
name: Fiona A Lynn, PhD
role: PRINCIPAL_INVESTIGATOR
References: