Music and Child Health and Development

September 3, 2025 updated by: Kai Ling Kong, Children's Mercy Hospital Kansas City

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

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

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • ChildrensMHC

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

  • Child

Accepts Healthy Volunteers

Yes

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music Together
Behavioral: Music Together
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.
Placebo Comparator: Play Group
Behavioral: Play Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Mid (8 weeks), Post (16 weeks)
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.
Baseline and Post (16 weeks)
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.
Baseline, Mid (8 weeks), Post (16 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Collaborators

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

Investigators

  • Principal Investigator: Kai Ling Kong, PhD, Children's Mercy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 16, 2023

Primary Completion (Actual)

February 13, 2024

Study Completion (Actual)

February 13, 2024

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002451
  • UL1TR002366 (U.S. NIH Grant/Contract)

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

product manufactured in and exported from the U.S.

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.

Subscribe