Clinical trial NCT05868811: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Infant
Language Development
Parent-Child Relations
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: University of Kansas Medical Center
name: Jackson County Missouri
First posted: 2023-05-22
Enrollment: 18
Sex: ALL
Minimum age (years): 9
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change from Baseline infant food reinforcing ratio at 8 weeks and 16 weeks
timeFrame: Baseline, 8-weeks, 16-weeks
measure: Change from Baseline conversational turns at 8 weeks and 16 weeks
timeFrame: Baseline, 8-weeks, 16-weeks
measure: Change from Baseline Quality of parent-child interactions at 8-weeks and 16-weeks
timeFrame: Baseline, after semester 1, after semester 2
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: ChildrensMHC
state: Missouri
Study officials:
affiliation: Children's Mercy
name: Kai Ling Kong, PhD
role: PRINCIPAL_INVESTIGATOR
References: