search
Back to results

Music and Child Health and Development

Primary Purpose

Obesity, Infant, Language Development, Parent-Child Relations

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Together
Play Group
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Infant

Eligibility Criteria

9 Months - 24 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ChildrensMHC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Music Together

Play Group

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline infant food reinforcing ratio at 8 weeks and 16 weeks
Infant will potentially change their food reinforcing ratio (FRR) based on the randomized class. Name of the measurement: Food reinforcing ratio (FRR) Unit of measure: ratio
Change from Baseline conversational turns at 8 weeks and 16 weeks
Parent-child dyads will potentially change their frequency of conversational turns based on the randomized class. Name of measurement: Conversational turns Unit of measure: frequency count
Change from Baseline Quality of parent-child interactions at 8-weeks and 16-weeks
Parent-child dyads will potentially change their quality of interactions based on the randomized class. Name of measurement: The parent child early relational assessment (PCERA) Unit of measure: 5-point global rating scale

Secondary Outcome Measures

Full Information

First Posted
April 20, 2023
Last Updated
May 11, 2023
Sponsor
Children's Mercy Hospital Kansas City
Collaborators
University of Kansas Medical Center, Jackson County Missouri
search

1. Study Identification

Unique Protocol Identification Number
NCT05868811
Brief Title
Music and Child Health and Development
Official Title
A Feasibility Study of Music and Play to Enhance Health and Developmental Outcomes in Infants From Low-income Families
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City
Collaborators
University of Kansas Medical Center, Jackson County Missouri

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Infant, Language Development, Parent-Child Relations

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music Together
Arm Type
Experimental
Arm Title
Play Group
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Music Together
Intervention Description
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
Intervention Name(s)
Play Group
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline infant food reinforcing ratio at 8 weeks and 16 weeks
Description
Infant will potentially change their food reinforcing ratio (FRR) based on the randomized class. Name of the measurement: Food reinforcing ratio (FRR) Unit of measure: ratio
Time Frame
Baseline, 8-weeks, 16-weeks
Title
Change from Baseline conversational turns at 8 weeks and 16 weeks
Description
Parent-child dyads will potentially change their frequency of conversational turns based on the randomized class. Name of measurement: Conversational turns Unit of measure: frequency count
Time Frame
Baseline, 8-weeks, 16-weeks
Title
Change from Baseline Quality of parent-child interactions at 8-weeks and 16-weeks
Description
Parent-child dyads will potentially change their quality of interactions based on the randomized class. Name of measurement: The parent child early relational assessment (PCERA) Unit of measure: 5-point global rating scale
Time Frame
Baseline, after semester 1, after semester 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Ling Kong, PhD
Organizational Affiliation
Children's Mercy
Official's Role
Principal Investigator
Facility Information:
Facility Name
ChildrensMHC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Music and Child Health and Development

We'll reach out to this number within 24 hrs