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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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:
- To determine the potential effect of the Lullaby Project on maternal-fetal attachment.
- To evaluate the potential impact of the Lullaby Project on maternal mental health.
- 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.
- 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.
- Conditions
- Pregnancy Related
- 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 group | Role | What they receive |
|---|---|---|
| Lullaby Project | Experimental | Not described Receives: Behavioral: Lullaby Project |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Fetal Attachment
As assessed by the Maternal Fetal Attachment Scale (MFAS)
Measured: End of Study (2 months)
Secondary outcomes (2)
Mental Health
General psychiatric distress as assessed by the Symptom Checklist (SCL-27)
Measured: End of Study (2 months)
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.
- First posted5 Jul 2017
- Study start4 Nov 2016
- Primary completion15 May 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer L Hinesley, Psy. D, Principal investigator, Virginia Commonwealth University
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lullaby Project: A Musical Intervention for Pregnant Women
- ClinicalTrials.gov ID
- NCT03207919
- Acronym / sponsor ID
- HM20008253
- Conditions
- Pregnancy Related
- Keywords
- maternal-fetal attachment, maternal health, maternal stress, Lullaby Project
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 4 Nov 2016 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the potential effect of the Lullaby Project on maternal-fetal attachment.
- To evaluate the potential impact of the Lullaby Project on maternal mental health.
- To characterize the potential impact of the Lullaby Project on perceived maternal stress.
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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lullaby Project | Experimental | Behavioral: Lullaby Project |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Age: Under the age of 18.
- Unable to read and understand English, and provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lullaby ProjectPregnant 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. | Behavioural | Lullaby Project |
Primary outcome
Maternal Fetal Attachment
Time frame: End of Study (2 months)
As assessed by the Maternal Fetal Attachment Scale (MFAS)
2 secondary outcomes
Mental Health
Time frame: End of Study (2 months)
Perceived Maternal Stress
Time frame: End of Study (2 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Hinesley, Psy. D principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
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.