The Effects on Children and Parents of Educating Parents About Ways to Play With Babies

University of Delaware2 个研究点分布在 1 个国家目标入组 49 人开始时间: 2022年4月1日最近更新: 2024年5月16日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Delaware
入组人数: 49
试验地点: 2
主要终点: Change in Parental Play Behaviors: Toys

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether educating parents about how to play with infants affects infant development or caregiver characteristics.

The project will comparatively evaluate the effects of two different play education programs on infants' development and on caregiver characteristics in a sample of infants with typical development and a sample of infants with/at risk for developmental delay.

详细描述

Parents are the primary source of interaction for their infants; they determine their infants' daily experiences and provide opportunities for growth and learning that have cascading, longitudinal effects. Early experiences may be even more important for infants who are at risk of developmental delays. In the United States, one out of every six children ages 3-17 will be diagnosed with one or multiple developmental disabilities, and the prevalence is growing. While some children with developmental disabilities or delays benefit from early intervention (EI) services in this critical period, enrollment rates for eligible children are disturbingly low, with only 5-10% of children with delays receiving EI services at 24 months of age. For these children who do not receive EI services during this critical window for neuroplasticity and learning, parents are the primary persons tasked with independently creating opportunities for their infants' developmental growth. The purpose of this study is to improve our understanding of early parent education and to determine whether or how parent education changes child outcomes (i.e., developmental scores) and parental characteristics (i.e., physical and social setting, customs, parent psychology). The investigators will conduct a pilot randomized controlled trial with a parallel design enrolling parents and infants ages 1-6 months with typical development or with/at risk of developmental delays. The investigators will use blocked randomization to control for socioeconomic status, as this is a known factor that can impact infant development, to assign parent-infant dyads to receive either the Enriched Education Program (EEP) or the Typical Education Program (TEP). Parents will receive written, illustrated instructions describing nine play activities; they will be asked to perform three activities each day (5 minutes each, 15 minutes total per day), logging their activity for 4 weeks. EEP activities were designed to implement EI and developmental science principles, while TEP activities represent common activities described on parenting websites, books, and mobile applications. Participants will be evaluated longitudinally across five visits using a variety of measures of child development and parental characteristics: at pre-intervention (baseline), post-intervention (1 month), and at follow-up visits (1-, 2-, and 5-month follow-up). In addition, infants' motor milestone development will be tracked through the onset of walking. The effect of the interventions on child developmental outcomes and parental characteristics will be evaluated for infants with typical development and infants at risk/with developmental delays. Usability of the educational programs will also be evaluated. The results of this study may help inform future parent education interventions.

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: Double (Investigator, Outcomes Assessor)

盲法说明

Participants will not be aware of their group assignment as all families will receive education about nine play activities. Sealed envelopes created prior to enrollment will conceal assignments (i.e., appropriate educational materials) and the next envelope for the correct block [Block 1: typical development (TD), low SES; Block 2: TD, mid-high SES; Block 3 developmental delay (DD), low SES; Block 4: DD, mid-high SES] will be handed to families by the blind assessor at in-person visits or emailed to virtual participants by a team member not engaged in the blind assessments.

入排标准

年龄范围: 1 Month 至 24 Months（Child）
性别: All
接受健康志愿者: 是

入选标准

•Able to engage in the data collection activities and be available for either in-person or virtual visits
•Parent participating in the study must be at least 18 years of age
•Parent must be able to speak and read in English
•Parent must be physically capable of performing the play activities with their infant (i.e., able to carry the infant and play on the floor with the infant).
•If parents choose to participate virtually, they must report having a device with a camera and microphone for the use of Zoom and access to the internet.
•Infants must be between the ages of 1 month and 6 months at enrollment
•Infants must not be legally blind
•Infants who meet the criteria for the State of Delaware Early Intervention Inclusion Criteria will be included in the at-risk group. These criteria are: 1) established conditions, such as chromosomal disorders, genetic disorders, and neurologic disorders; or 2) developmental delay measured via a standardized developmental assessment (e.g., the DAY-C).

排除标准

•None beyond inclusion criteria