The Lullaby Project: A Musical Intervention for Pregnant Women

This study will evaluate the potential impact of a brief musical intervention, the Lullaby Project, in a sample of pregnant women. The study aims are:

1. To determine the potential effect of the Lullaby Project on maternal-fetal attachment.
2. To evaluate the potential impact of the Lullaby Project on maternal mental health.
3. To characterize the potential impact of the Lullaby Project on perceived maternal stress.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Behavioral: Lullaby Project

Detailed Description

Music has the power to build a sense of community and belonging - a crucial process in a U.S. that is steadily becoming more diverse. In America, there is no more pressing issue for children's development than their families' access to basic needs: housing, food, safety and health, as well as education. While music may seem a long way from living wages or immigration reform, the arts, including music, have a substantial role to play in building healthy families.

Over the last three years, musicians from Carnegie Hall's Weill Music Institute have developed the Lullaby Project, in which mothers living in challenging circumstances have the opportunity to write and record a song for their babies or very young children. As of spring 2015, more than 150 lullabies have been created in hospitals, correctional facilities, shelters, programs for teen parents, and other settings where young families face challenges every day. The purpose of this music-based intervention is to initiate or encourage and support the bonding process, to support parents' aspirations to create the family they want for their children, and to harness their creativity as a tool for imagining and building future possibilities.

This study proposes an arts-based intervention to improve maternal-child attachment. Based on theory from the arts and evidence from psychology and pediatrics, this intervention will test the ability of music creation to stimulate maternal attitudes regarding parenting, scores for attachment, and symptoms of anxiety, depression, and stress. In addition, the intervention will focus on at-risk women and their families with a goal of providing a healthier start for their children and preventing transition of these parents and children into the high-risk group.

Patients who consent to participate will be randomly assigned in a 1:1 ratio to participate in an intervention or control group. Each participant will be asked to complete a self-report battery of questionnaires pertaining to their pregnancy, mental health, and perceived stress. At the completion of the questionnaires, referral information for mental health support will be provided to all participants.

Women randomized to the intervention will participate in the three group sessions described below with approximately 8-10 other pregnant women at Virginia Commonwealth University.

i. Session 1: (5 hours) Participants collaborate with project musicians to compose an original lullaby. Efforts will be made to have a 1:1 musician-participant ratio, however, depending on group size, two participants may be paired with one musician.

ii. Session 2: (5 hours) Participants collaborate with project musicians to refine and record their lullaby. The recorded lullaby will not be collecting as data, nor will it be stored as such for this study. No other recordings will be made during the course of this study.

iii. Session 3: (2 hours) Participants listen to each recorded lullaby and are invited to informally reflect on their experience, both individually with one research staff member (study or project coordinator), and within the group.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age: at least 18 years of age.
• Must be able to read and understand English, and provide informed consent.
• Must be in the second or third trimester of pregnancy.

Exclusion Criteria:

• Age: Under the age of 18.
• Unable to read and understand English, and provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Lullaby Project	Behavioral: Lullaby Project; Pregnant women will participate in 3 group sessions. They will write and record a lullaby, and then listen to each recorded lullaby and reflect on their experience.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Fetal Attachment	As assessed by the Maternal Fetal Attachment Scale (MFAS)	End of Study (2 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental Health	General psychiatric distress as assessed by the Symptom Checklist (SCL-27)	End of Study (2 months)
Perceived Maternal Stress	As assessed by the Perceived Stress Scale (PSS)	End of Study (2 months)

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Jennifer L Hinesley, Psy. D, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2016
• Primary Completion (Actual): May 15, 2017
• Study Completion (Actual): May 15, 2017

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: maternal health; maternal-fetal attachment; maternal stress; Lullaby Project
• Other Study ID Numbers: HM20008253

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No