NCT05868811

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. 1.Does participation in a music enrichment program improve the quality of parent-child interactions?
  2. 2.Does participation in a music enrichment program reduce motivation for food
  3. 3.Does participation in a music enrichment program improve the quality of the language environment?
  4. 4.Be randomly assigned to participate in either 2, 8-week semesters of weekly music enrichment classes or play group sessions.
  5. 5.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:
  6. 6.be video recorded during 10 minutes of playtime and meal time.
  7. 7.fill out questionnaires
  8. 8.wear a small wearable language recorder for 16 hours
  9. 9.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:
  10. 10.Play a computer game to test motivation for food
  11. 11.have height and weight measurements collected

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2024

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 3, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

April 20, 2023

Results QC Date

July 9, 2025

Last Update Submit

September 3, 2025

Conditions

Obesity, InfantLanguage DevelopmentParent-Child Relations

Outcome Measures

Primary Outcomes (3)

  • Relative Reinforcing Value of Food (RRV) Task

    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

    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

    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)

Study Arms (2)

Music Together

EXPERIMENTAL
Behavioral: Music Together

Play Group

PLACEBO COMPARATOR
Behavioral: Play Group

Interventions

Music TogetherBEHAVIORAL

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.

Music Together
Play GroupBEHAVIORAL

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.

Play Group

Eligibility Criteria

Age9 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChildrensMHC

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

  • 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.

    PMID: 39457194DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

As a pilot study, we did not power this study to detect effects on the RRVfood and home environment enrichment measures. Instead, our larger goal for this study was feasibility and acceptability. As such, our findings should be interpreted with caution and replicated in a larger sample.

Results Point of Contact

Title
Dr. Kai Ling Kong
Organization
Children's Mercy Hospital
kkong@cmh.edu
5157712880

Study Officials

  • Kai Ling Kong, PhD

    Children's Mercy

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Research Faculty, PhD

Study Record Dates

First Submitted

April 20, 2023

First Posted

May 22, 2023

Study Start

January 16, 2023

Primary Completion

February 13, 2024

Study Completion

February 13, 2024

Last Updated

September 23, 2025

Results First Posted

September 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)