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临床试验/NCT04576481
NCT04576481已完成不适用

Literary Promotion Using Automated Hovering to Improve Development in Young Low-Income Children

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年11月17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
55
试验地点
2
主要终点
Acceptability Survey

研究概览

简要总结

The purpose of this study is to incorporate behavioral economics (BE) approaches to determine whether 3 novel interventions of varying intensity improve the frequency of parent-child reading behaviors among low-income families. In the first phase, 10 parents will be recruited to participate in rapid cycle interviews to determine the appropriateness of text messages. In the second phase, 45 participants will be randomized to comparative groups to test the effects of automated hovering and other BE approaches on frequency of parent-child shared reading. Investigators long-term goal is to test the effects of these approaches to promote child language and socio-emotional development.

详细描述

Early childhood is a sensitive period in which young children develop language and socio-emotional skills foundational for school readiness. Unfortunately, poor vulnerable children experience disparities in these critical areas of development. Parent-child shared reading can help ameliorate these disparities, yet low-income parents do not consistently engage in this activity. Behavioral economics approaches utilizing automated hovering (AH) have the potential to increase parent-child shared reading through text messages and financial inducements.

The study design is a two-phase study consisting of a qualitative component followed by a prospective, randomized comparative group trial to test the effects of AH approaches to increase parent-child shared reading. A total of 55 eligible children and their parents will be recruited from participating practices to achieve a diverse sample of children.

In the first phase, 10 parents will be recruited to participate in brief rapid cycle interviews to assess the appropriateness of text message reminders. In the second phase, forty-five participants will be randomized 1:1:1 to receive one of the 3 AH interventions: 1) daily text message reminders (texting), 2) daily text message reminders with social comparisons (regret) or 3) daily text message reminders with social comparisons and weekly lottery entries (lottery). All interventions are related to principles of behavioral economics in order to provide external motivation. There will be 15 participants per group to adequately assess feasibility and acceptability, the primary outcome.

Descriptive statistics for demographic, home reading environment, and parenting stress measured at baseline will be examined across the three groups to assess the success of the randomization. To assess feasibility and acceptability, Investigators will assess the proportion of participants who receive and report a daily reading behavior each week across all groups, the proportion of participants who access coaching content in group 2 & 3, and the proportion of participants who participate in the weekly lottery in group 3, and satisfaction scores in all groups. Secondary outcomes including differences between groups in weekly reading frequency, home reading environment, and child socio-emotional scores between groups will be assessed using standard inferential statistics and intention-to-treat analysis.

The results of this study may assist health care providers and researchers in testing the feasibility of AH approaches to improve parent-child shared reading and prepare for a larger efficacy trial.

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)

盲法说明

Participants will not be blinded to their treatment assignment. However, research staff will be blinded to treatment assignment when collecting study data.

入排标准

年龄范围
6 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Parents who:
  • Have an infant aged 6-24 months
  • Have access to a smart phone with text messaging capabilities
  • Have completed an informed consent
  • Children who:
  • Are aged 6-24 months old

排除标准

  • Parents who:
  • Non-English speaking
  • Children who:
  • Were born premature (estimated gestational age < 35 weeks)
  • Have been diagnosed with congenital malformations or genetic syndromes which place them at risk for developmental delays

结局指标

主要结局

Acceptability Survey

时间窗: 2 months

To determine acceptability, participants will be assessed on their overall satisfaction (5-point Likert scale 1=strong disagree, 2=disagree, 3=not sure, 4=agree and 5= strongly agree) with the study delivery intervention and answered survey questions regarding likes and dislikes concerning the intervention group they received following the intervention period.

Feasibility of Study

时间窗: 2 months

Percentage of study participants who completed the 2-month follow-up

次要结局

  • Change in Score of Cognitive Stimulation Provided in the Home Measure - (StimQ-Read)(2 months)
  • Change in Score for The Parenting Stress Index - Short Form (PSI-SF)(2 months)
  • Change in Weekly Parent-Child Shared Reading Frequency(2 months)
  • Measure of Child Socio-Emotional Development Using Devereux Early Childhood Assessment (DECA)(2 months)
  • Measure of Child Language Development Using MacArthur Communicative Development Inventory (CDI) - Percentiles(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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