AzTrials
AzTrials

Pregnancy RelatedNCT03207919

The Lullaby Project: A Musical Intervention for Pregnant Women

A study testing Lullaby Project in people with Pregnancy Related, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy Related
What is being tested?
Lullaby Project
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
4 Nov 2016to 15 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

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.
Read the 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.

  1. 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.
Being tested
Lullaby Project
Keywords
maternal-fetal attachment, maternal health, maternal stress, Lullaby Project

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lullaby ProjectBehavioural

    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.

Study groups in NCT03207919
Study groupRoleWhat they receive
Lullaby ProjectExperimentalNot described
Receives: Behavioral: Lullaby Project
Control GroupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal Fetal Attachment

    As assessed by the Maternal Fetal Attachment Scale (MFAS)

    Measured: End of Study (2 months)

Secondary outcomes (2)
  1. Mental Health

    General psychiatric distress as assessed by the Symptom Checklist (SCL-27)

    Measured: End of Study (2 months)

  2. Perceived Maternal Stress

    As assessed by the Perceived Stress Scale (PSS)

    Measured: End of Study (2 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2017
  2. Study start4 Nov 2016
  3. Primary completion15 May 2017
  4. Study completion15 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03207919
Sponsor's protocol ID
HM20008253
Status last verified
Apr 2018
First submitted
29 Jun 2017
Last updated
24 Apr 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Lullaby Project in people with Pregnancy Related, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal Fetal Attachment (time frame: End of Study (2 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in