- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05483153
Infant-Directed Singing for At-Risk Mothers and Infants
August 10, 2023 updated by: Shannon Kay de l'Etoile, University of Miami
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami, Linda Ray Intervention Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- Participants who are not enrolled at the Linda Ray Intervention Center (LRIC).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Infant-Directed Singing Coaching Group
At-risk mothers and infants will receive four, 30-minute sessions of an infant-directed singing coaching intervention.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 week prior to intervention, 1 week after intervention
|
|
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
|
1 week prior to intervention, week 2 of intervention, 1 week after intervention
|
|
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).
|
1 week prior to intervention, week 2 of intervention, 1 week after intervention
|
|
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).
|
1 week prior to intervention, week 2 of intervention, 1 week after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shannon K de l'Etoile, PhD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2022
Primary Completion (Actual)
July 21, 2023
Study Completion (Actual)
July 21, 2023
Study Registration Dates
First Submitted
July 29, 2022
First Submitted That Met QC Criteria
July 29, 2022
First Posted (Actual)
August 1, 2022
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 10, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 20220297
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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