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Completed

NCT Number: NCT05483153

Infant-Directed Singing for At-Risk Mothers and Infants

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.

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Key information

Conditions

Maternal Behavior Behavior Child Behavior Infant Behavior

Age range

3 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami, Linda Ray Intervention Center

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • GRAMMY Museum Grant Program

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2022
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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