Infant-Directed Singing for At-Risk Mothers and Infants

Maternal Behavior Clinical Trial

Official title:

Infant-Directed Singing (IDS) for Maternal Sensitivity and Infant Self-Regulation in an At-Risk Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05483153
• Other study ID #: 20220297
• Status: Completed
• Phase: N/A
• Start date: September 14, 2022
• Est. completion date: July 21, 2023

Study information

• Verified date: August 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 21, 2023
• Est. primary completion date: July 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months and older

Eligibility

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).

Related Conditions & MeSH terms

• Infant Behavior
• Maternal Behavior

Intervention

Behavioral:
• Infant-Directed Singing Coaching
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.

Locations

Country	Name	City	State
United States	University of Miami, Linda Ray Intervention Center	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	GRAMMY Museum Grant Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week prior to intervention, 1 week after intervention
Primary	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	1 week prior to intervention, week 2 of intervention, 1 week after intervention
Primary	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).	1 week prior to intervention, week 2 of intervention, 1 week after intervention
Primary	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).	1 week prior to intervention, week 2 of intervention, 1 week after intervention