Infant-Directed Singing for At-Risk Mothers and Infants

NCT05483153 | Completed

• 1 other identifier: 20220297
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Maternal Behavior; Infant Behavior

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Infant-Directed Singing Coaching Group

EXPERIMENTAL

At-risk mothers and infants will receive four, 30-minute sessions of an infant-directed singing coaching intervention.

Behavioral: Infant-Directed Singing Coaching

Interventions

Infant-Directed Singing Coaching BEHAVIORAL

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.

Infant-Directed Singing Coaching Group

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Participants who are not enrolled at the Linda Ray Intervention Center (LRIC).

Sponsors & Collaborators

• University of Miami: lead
• GRAMMY Museum Grant Program: collaborator

Study Sites (1)

University of Miami, Linda Ray Intervention Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Infant Behavior

Condition Hierarchy (Ancestors)

Child Behavior; Behavior

Study Officials

• Shannon K de l'Etoile, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean of Graduate Studies, Professor, Music Therapy

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 1, 2022
• Study Start: September 14, 2022
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)