Music and Child Health and Development

NCT ID: NCT05868811

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-16
• Study Completion Date: 2024-02-13

Brief Summary

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.

Conditions

Obesity, Infant; Language Development; Parent-Child Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Music Together

Group Type: EXPERIMENTAL

Music Together

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Play Group

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: lead

University of Kansas Medical Center

OTHER

Sponsor Role: collaborator

University of Kansas

OTHER

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Responsible Party

Kai Ling Kong

Doctoral Research Faculty, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kai Ling Kong, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy

Locations

ChildrensMHC

Kansas City, Missouri, United States

Countries

United States

References

Kong KL, Smith AR, Salley B, Hanson-Abromeit D, Engel H, Serwatka CA. A Feasibility Study of a Music Enrichment Program on Relative Reinforcing Value of Food and Home Environmental Enrichment among Families of Low Socioeconomic Status. Children (Basel). 2024 Oct 11;11(10):1229. doi: 10.3390/children11101229.

Reference Type: DERIVED

PMID: 39457194 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UL1TR002366

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002451

Identifier Type: -

Identifier Source: org_study_id