跳至主要内容
临床试验/NCT05930990
NCT05930990已完成不适用

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

Queen's University, Belfast2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
主要终点
Rates of recruitment and retention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Rates of recruitment and retention

时间窗: 6 months

Rates of participant flow through each stage of the pilot RCT, from participant invite for eligibility assessment through to outcome assessment at 6-month follow-up, using screening logs and study registers. Data supplemented with reasons for non-participation, if disclosed.

次要结局

  • Completion rate of the Perceived Stress Scale (PSS)(3 months and 6 months post randomisation)
  • Completion rate of the EuroQol EQ-5D-5L(3 months and 6 months post randomisation)
  • Completion rate of the Social Support Survey (SSS)(3 months and 6 months post randomisation)
  • Satisfaction of Mamas in Harmony intervention(8 weeks)
  • Perspectives on barriers and facilitators to intervention delivery(6 months)
  • Acceptability of Mamas in Harmony intervention(6 months)
  • Completion rate of the Karitane Parenting Confidence Scale (KPCS)(3 months and 6 months post randomisation)
  • Completion rate of the Maternal Postnatal Attachment Scale (MPAS)(3 months and 6 months post randomisation)
  • Completion rate of service and resource use log(3 and 6 months)
  • Perspectives on barriers and facilitators to study participation(6 months)
  • Perspectives on intervention fidelity(6 months)
  • Rate of attendance to Mamas in Harmony intervention sessions(8 weeks)
  • Rate of adherence to the study protocol(6 months)
  • Completion rate of the Generalised Anxiety Disorder-7 scale (GAD-7)(3 months and 6 months post randomisation)
  • Completion rate of the Edinburgh Postnatal Depression Scale (EPDS)(3 months and 6 months post randomisation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fiona Lynn

Principal Investigator

Queen's University, Belfast

研究点 (2)

Loading locations...

相似试验