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Completed

NCT Number: NCT05868811

Music and Child Health and Development

The goal of this clinical trial is to learn about the effects of a music enrichment program on the quality of parent child interactions, a child's motivation to eat, and a child's language environment in 9 to 24 month-old children from low-income families. The main questions it aims to answer are:

1. Does participation in a music enrichment program improve the quality of parent-child interactions? 2. Does participation in a music enrichment program reduce motivation for food 3. Does participation in a music enrichment program improve the quality of the language environment?

Participants will:

1. Be randomly assigned to participate in either 2, 8-week semesters of weekly music enrichment classes or play group sessions. 2. At the beginning, after the first 8 weeks and after the second 8 weeks, a researcher will come to the participants house and parent-child pairs will:

1. be video recorded during 10 minutes of playtime and meal time. 2. fill out questionnaires 3. wear a small wearable language recorder for 16 hours 3. At the beginning, after the first 8 weeks and after the second 8 weeks, the parent and child will come to the baby lab and will:

1. Play a computer game to test motivation for food 2. have height and weight measurements collected

Researchers will compare the music and play groups to see if there is a difference in the quality of parent child interaction, food motivation or language environment.

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Key information

Conditions

Obesity, Infant Body Weight Language Development Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Parent-Child Relations Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

9 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ChildrensMHC

Kansas City, Missouri, 64108, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Family income meets criteria for the National Women, Infant, and Children (WIC) program
  • Family is able and willing to commit to a 6-month program

Exclusion criteria

  • Mother <18 years old at the time of delivery
  • During pregnancy:
  • Mother smoked >10 cigarettes/day
  • Mother used >1 marijuana joint/day
  • Mother used any other illicit drugs
  • Mother drank > 3 standard drinks on a single occasion or >1 standard drink on a daily basis
  • Preterm birth <37 weeks gestation
  • Child with significant health issues, and/or genetic conditions (e.g., cerebral palsy, down's syndrome)
  • Mother with major health concerns during pregnancy (e.g., gestational diabetes, pre-eclampsia, etc)
  • Parent/child who do not speak English

Treatment and study plan

Music Together

Behavioral

The intervention consists of 45-minute weekly classes for 16 weeks. Each class is delivered by a trained Music Together facilitator and includes music activities such as singing, dancing, moving and playing musical instruments. At the start of the program, participants receive materials for home use that consist of a song book and online access code for song recordings used in the class.

Play group

Behavioral

The play group consists of 45-minute weekly classes for 16 weeks. During each class parents are encouraged to play with their child and interact with other participants using the provided age appropriate toys. At the start of the program participants receive an age appropriate toy for use at home.

Primary outcomes

  1. Relative Reinforcing Value of Food (RRV) Task

    Time frame: Baseline, Mid (8 weeks), Post (16 weeks)

    RRVfood is a proximal measure of obesity risk. It measures how motivated one is to work to gain access to food versus non-food activity.

    RRVfood is the score for food divided by the total score (food + music). Scale range is 0-1. Lower number is the better outcome.

    The score for food is determined by a computer game to test motivation for food.

    The score for music is determined by a computer game to test motivation for music.

  2. Use of Music at Home

    Time frame: Baseline and Post (16 weeks)

    The Music @ Home Questionnaire was used to quantitatively assess the range of musical behaviors occurring in the home environment of families with young children.

    Participant score is based on a questionnaire with 18 questions each with a range of 1-7. Total score range of the questionnaire is 7- 126. The higher outcome is better.

  3. Conversational Turns

    Time frame: Baseline, Mid (8 weeks), Post (16 weeks)

    Back-and-forth vocalizations between a parent and child, even with pre-linguistic children, are considered a pivotal component of a high-quality early language environment because they associate with growth in specific brain regions responsible for language and cognitive development.

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • University of Kansas
  • University of Kansas Medical Center

Registry information

Official study title

A Feasibility Study of Music and Play to Enhance Health and Developmental Outcomes in Infants From Low-income Families

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 22, 2023
Registry last updated
Sep 23, 2025

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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