Feasibility Study of a Music and Social Support Intervention for Postnatal Mothers/Infants

NCT05930990 | Completed

• 1 other identifier: MHLS 22_168
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Depression; Stress; Parenting confidence; Social support; Mother-infant attachment; Health related quality of life

Outcome Measures

Primary Outcomes (1)

• Rates of recruitment and retention

  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.

  6 months

Secondary Outcomes (15)

• Rate of adherence to the study protocol

  6 months

• Rate of attendance to Mamas in Harmony intervention sessions

  8 weeks

• 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

• Completion rate of the Perceived Stress Scale (PSS)

  3 months and 6 months post randomisation

Study Arms (2)

Mamas in Harmony (and usual care)

EXPERIMENTAL

Mamas in Harmony is a 1 hour face to face intervention for mothers and their infants, delivered in groups of 10-12 mother-infant dyads, every week for 8 weeks. Mothers and infants also receive usual postnatal care from health and social care services.

Behavioral: Mamas in Harmony

Control (usual care only)

NO INTERVENTION

Mothers and infants receive usual postnatal care from health and social care services.

Interventions

Mamas in Harmony BEHAVIORAL

Mothers attend 8x 1 hour weekly classes with their infant. Classes take place in a community venue. Mothers sit with their infant on the floor in circle formation on cushioned mats. Group singing facilitated for 40 minutes by the intervention facilitator, a professional musician/choir leader. A mix of songs are introduced that are easy to learn without the need for lyric sheets. Mothers will be encouraged to sing along. Mothers will be encouraged to interact with their infant through various sensory stimuli involving touch, sound and visual. The end of each singing session involves a short period of quiet time, soothing sounds are provided by the intervention facilitator using voice and instruments. 20 minutes of facilitated social support will follow and mothers will be provided with refreshments. Mothers will be encouraged to interact with other mothers to promote social connection.

Mamas in Harmony (and usual care)

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Individuals who have given birth, who may not identify as women.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

Queen's University

Belfast, County Antrim, BT9 7BL, United Kingdom

Location

Related Publications (1)

• Colella CA, McNeill J, McCann U, Lynn FA. Mamas in Harmony: protocol for a pilot RCT and process evaluation of a music and social support intervention establishing the feasibility of reducing anxiety and stress in postnatal mothers. Pilot Feasibility Stud. 2025 Apr 10;11(1):44. doi: 10.1186/s40814-025-01629-1.

  PMID: 40211322 DERIVED

Related Links

• Study webpage

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Fiona A Lynn, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: July 5, 2023
• Study Start: March 16, 2023
• Primary Completion: April 12, 2024
• Study Completion: April 12, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)