Maternal BehaviorNCT05483153
Infant-Directed Singing for At-Risk Mothers and Infants
A study testing Infant-Directed Singing Coaching in people with Maternal Behavior and Infant Behavior, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to figure out if mothers can learn how to use singing to help their babies. Singing can help babies calm down or encourage them to play, both of which are needed for learning. Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Maternal Behavior, Infant Behavior
- What is being tested?
- Infant-Directed Singing Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 21 Jul 2023
- 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 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers:
- must have infants enrolled at the Linda Ray Intervention Center (LRIC).
- must be 18 years of age or older
- must be able to read and write in English
- Infants:
- must be enrolled at the Linda Ray Intervention Center (LRIC).
- must be at least 3 months and no older than 12 months.
Who cannot join
- Participants who are not enrolled at the Linda Ray Intervention Center (LRIC).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami, Linda Ray Intervention Center
Miami, Florida, 33136
About this study
Official title: Infant-Directed Singing (IDS) for Maternal Sensitivity and Infant Self-Regulation in an At-Risk Population
The purpose of this study is to figure out if mothers can learn how to use singing to help their babies. Singing can help babies calm down or encourage them to play, both of which are needed for learning.
- Conditions
- Maternal Behavior, Infant Behavior
- Being tested
- Infant-Directed Singing Coaching
- Medical subject headings
- Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant-Directed Singing CoachingBehavioural
At-risk mothers will receive four, 30-minute, in-person infant-directed singing coaching intervention sessions that take place over two weeks. Mothers will learn how to better read infant cues and respond with sensitive singing. Infants will gain experience in self-regulation of arousal states.
| Study group | Role | What they receive |
|---|---|---|
| Infant-Directed Singing Coaching Group | Experimental | At-risk mothers and infants will receive four, 30-minute sessions of an infant-directed singing coaching intervention. Receives: Behavioral: Infant-Directed Singing Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maternal Perceived Self-Efficacy as measured by Karitane Parenting Confidence Scale
Change in maternal perceived self-efficacy will be measured by using the Karitane Parenting Confidence Scale. This is a 15-item self-report measure, with scores ranging from 0- 45. Lower scores reflect lower perceived self-efficacy, and higher scores indicate higher levels of perceived self-efficacy.
Measured: 1 week prior to intervention, 1 week after intervention
Change in Acoustic Parameters of Mothers' Singing
Change in the acoustic parameter of mothers evaluated by data mining of recording of mother's voices using a microphone
Measured: 1 week prior to intervention, week 2 of intervention, 1 week after intervention
Change in percentage of time Infant displays gaze type
Change in percentage of time infant displays gaze type will be measured by a video recording of the infant gaze. Videos will be coded to determine the percentage of time infants demonstrate a gaze type. Types of gaze include and range from roaming (most negative), averted, neutral, intermittent, to sustained (most positive).
Measured: 1 week prior to intervention, week 2 of intervention, 1 week after intervention
Change in percentage of time Infant displays affect type
Change in percentage of time infant displays affect type will be measured by a video recording of Infant's affect. Videos will be coded to determine the percentage of time infants demonstrate affect type. Types of affect include and range from large grimace (most negative), frown, neutral, smile, to large smile (most positive).
Measured: 1 week prior to intervention, week 2 of intervention, 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start14 Sep 2022
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal BehaviorStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- GRAMMY Museum Grant Program
- Responsible party
- Principal investigator, Shannon Kay de l'Etoile, University of Miami
- Investigators
- Shannon K de l'Etoile, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483153
- Sponsor's protocol ID
- 20220297
- Status last verified
- Aug 2023
- First submitted
- 29 Jul 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant-Directed Singing (IDS) for Maternal Sensitivity and Infant Self-Regulation in an At-Risk Population
- ClinicalTrials.gov ID
- NCT05483153
- Acronym / sponsor ID
- 20220297
- Conditions
- Maternal Behavior, Infant Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- GRAMMY Museum Grant Program
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 1 Aug 2022 (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.
The purpose of this study is to figure out if mothers can learn how to use singing to help their babies. Singing can help babies calm down or encourage them to play, both of which are needed for learning.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infant-Directed Singing Coaching Group | Experimental | Behavioral: Infant-Directed Singing CoachingAt-risk mothers and infants will receive four, 30-minute sessions of an infant-directed singing coaching intervention. |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- must have infants enrolled at the Linda Ray Intervention Center (LRIC).
- must be 18 years of age or older
- must be able to read and write in English
- must be enrolled at the Linda Ray Intervention Center (LRIC).
- must be at least 3 months and no older than 12 months.
Key exclusion criteria (1 listed)
- Participants who are not enrolled at the Linda Ray Intervention Center (LRIC).
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 |
|---|---|---|
| Infant-Directed Singing CoachingAt-risk mothers will receive four, 30-minute, in-person infant-directed singing coaching intervention sessions that take place over two weeks. Mothers will learn how to better read infant cues and respond with sensitive singing. Infants will gain experience in self-regulation of arousal states. | Behavioural | Infant-Directed Singing Coaching Group |
Primary outcome
Change in Maternal Perceived Self-Efficacy as measured by Karitane Parenting Confidence Scale
Time frame: 1 week prior to intervention, 1 week after intervention
Change in maternal perceived self-efficacy will be measured by using the Karitane Parenting Confidence Scale. This is a 15-item self-report measure, with scores ranging from 0- 45. Lower scores reflect lower perceived self-efficacy, and higher scores indicate higher levels of perceived self-efficacy.
Change in Acoustic Parameters of Mothers' Singing
Time frame: 1 week prior to intervention, week 2 of intervention, 1 week after intervention
Change in the acoustic parameter of mothers evaluated by data mining of recording of mother's voices using a microphone
Change in percentage of time Infant displays gaze type
Time frame: 1 week prior to intervention, week 2 of intervention, 1 week after intervention
Change in percentage of time infant displays gaze type will be measured by a video recording of the infant gaze. Videos will be coded to determine the percentage of time infants demonstrate a gaze type. Types of gaze include and range from roaming (most negative), averted, neutral, intermittent, to sustained (most positive).
Change in percentage of time Infant displays affect type
Time frame: 1 week prior to intervention, week 2 of intervention, 1 week after intervention
Change in percentage of time infant displays affect type will be measured by a video recording of Infant's affect. Videos will be coded to determine the percentage of time infants demonstrate affect type. Types of affect include and range from large grimace (most negative), frown, neutral, smile, to large smile (most positive).
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 14 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Shannon K de l'Etoile, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant-Directed Singing Coaching in people with Maternal Behavior and Infant Behavior, run by University of Miami 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 7 inclusion and 1 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 14 Aug 2023. 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?
Change in Maternal Perceived Self-Efficacy as measured by Karitane Parenting Confidence Scale (time frame: 1 week prior to intervention, 1 week after intervention). The study lists 4 primary outcomes in all. 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 14 Aug 2023.