A Feasibility Study of Music and Play to Enhance Health and Developmental Outcomes in Infants From Low-income Families
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Relative Reinforcing Value of Food (RRV) Task
研究概览
简要总结
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:
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Be randomly assigned to participate in either 2, 8-week semesters of weekly music enrichment classes or play group sessions.
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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:
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be video recorded during 10 minutes of playtime and meal time.
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fill out questionnaires
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wear a small wearable language recorder for 16 hours
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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:
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Play a computer game to test motivation for food
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Relative Reinforcing Value of Food (RRV) Task
时间窗: Baseline, Mid (8 weeks), Post (16 weeks)
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.
Use of Music at Home
时间窗: Baseline and Post (16 weeks)
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.
Conversational Turns
时间窗: Baseline, Mid (8 weeks), Post (16 weeks)
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.
次要结局
未报告次要终点
研究者
Kai Ling Kong
Doctoral Research Faculty, PhD
Children's Mercy Hospital Kansas City