Music and Child Health and Development

Study Overview
=================
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.

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

Conditions
-----------------
Obesity, Infant, Language Development, Parent-Child Relations

Intervention / Treatment
-----------------
* Behavioral: Music Together
* Behavioral: Play Group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 9 Months
Maximum Age: 24 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Together<br> | Behavioral: Music Together<br>* 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.<br>|
| Placebo Comparator: Play Group<br> | Behavioral: Play Group<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, 8-weeks, 16-weeks | 
| 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 | Baseline, 8-weeks, 16-weeks | 
| 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 | Baseline, after semester 1, after semester 2 |