跳至主要内容
临床试验/NCT04289168
NCT04289168已完成不适用

Infant Peer Interaction Study by Examining the Effect of a 6-week Music Enhancement Program

State University of New York at Buffalo0 个研究点目标入组 49 人开始时间: 2014年8月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
主要终点
The primary study outcome is the food reinforcing ratio (FRR)

研究概览

简要总结

The overall purpose of this study is to better understand food reinforcement in infants. The results of this study should help to further our understanding of how individuals relate to food and how an enriched environment can change this behavior.

详细描述

The study will be a between subject design with a Music Together intervention group and a play date active control group. All subjects will complete the orientation and pre-screening intervention assessment sessions.

All infant-mother dyads in the Music together group will attend a 6 weekly, 45-minute classes as a group. Infant-mother dyads will also receive an illustrated songbook with family activities to practice and enjoy at home along with the CD. The program provides CD with a collection of songs, rhythm chants, "play-alongs", tonal and rhythm patterns, which will be used in classes.

All infant-mother dyads in the play date control group will attend 6 weekly, 45-minute organized play dates as a group. These play dates will be planned and led by DBM research staff members. Variety of age-appropriate toys (i.e. puzzles, shape sorters, books) will be provided for the play date. Each family in the play date group will receive a toy from us to practice and play at home with their baby.

Families in both groups are asked to report their home practice with the song or toy with their babies by filling out the Daily Home Practice Survey.

Both groups will attend a post-intervention training assessment session at the conclusion of the 6 week intervention period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
9 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • single birth
  • between 9-18 months
  • not allergic to puffed grains or cheerios

排除标准

  • Your child was premature/preterm at birth (< 37 weeks of gestation)
  • Your child had a low birth weight (<2500 grams)
  • Your child had any medical problems at birth
  • Your child showed signs of developmental delay based on his/her developmental milestones recorded when he/she was 6 to 9 months old
  • Infant who are currently participating or previously participated in Music Together® program or similar music program
  • Maternal age was less than 18 years at the time of your child's birth
  • Mother smoked, used controlled substances (i.e. opiates, cocaine, marijuana) or consumed excessive alcohol during pregnancy
  • Mother had a high-risk pregnancy
  • Infant who could not complete a food/social interaction reward task during the further screening/pre-intervention assessment
  • Your child is not overweight

结局指标

主要结局

The primary study outcome is the food reinforcing ratio (FRR)

时间窗: through study completion, an average 13 months

Infant completed the pre- and post-intervention's FRR task in the lab

次要结局

  • Infant weight(through study completion, an average 13 months)
  • Infant height(through study completion, on average 13 months)
  • Infant zWFL(through study completion, on average 13 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kai Ling Kong

Assistant Professor

State University of New York at Buffalo

相似试验