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临床试验/NCT02055573
NCT02055573已完成不适用

Can we Promote Early Literacy and Prevent Shaken Baby Syndrome in the Well Child Nursery?.A Randomized Controlled Study, The Early ABC Study.

Women and Infants Hospital of Rhode Island2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
2
主要终点
Days/week mothers report reading with their infants

研究概览

简要总结

Regular reading with young children strengthens the parent-child relationship and builds their language, literacy and social emotional skills. Parent knowledge of normal variation of infant crying and of the dangers of shaking a baby as well as their ability to cope with infant irritability are likely factors in their successful adjustment to parenthood and the prevention of this tragic act.

Purpose: Identify easily implementable interventions for economically disadvantaged mothers in the newborn period which 1) Promote early literacy behaviors and early nurturing parent-child relationships and 2) Increase mother's knowledge of normal crying patterns, the dangers of shaking a baby and her ability to cope with parenting stresses.

Design/Methods: A convenience sample of 300 low income (insured by Medicaid) new mothers of healthy singleton, full term infants in the level 1 mother/baby unit at Women & Infants Hospital will be invited to participate in a Randomized Controlled Trial study of educational videos and materials for parents. They will be randomized into one of two intervention groups. 1) The Ready to Learn (RTL) arm will receive a DVD in both Spanish and English and a bilingual booklet (both produced by Parents' action for Children) addressing the benefits of reading, talking and playing with young children, as well as a new children's board book. 2) The All Babies Cry (ABC) arm will receive a DVD in both, Spanish and English and a bilingual booklet (both produced by VIDA) explaining crying as part of normal infant behavior, highlighting signs of parental distress and providing strategies to sooth parents and their children. We will enroll 75 mothers who speak Spanish primarily at home in each intervention group, as well as 75 mothers who speak primarily English. The RTL mothers will serve as controls for the ABC mothers and vice versa. Before reviewing the materials, mothers will be asked to respond to a baseline interview with socio-demographic information, questions regarding Early Literacy promotion, reading with children and their own reading habits as well as general knowledge on the prevention of shaking a baby and handling their own stress. Follow up phone interviews will be conducted by a bilingual research assistant blind to the intervention status at 2-5 months post-partum containing similar questions. Consenting mothers will receive a bag of diapers at the completion of enrollment interview as an incentive for participating in the study. Data will be entered into Excel and transferred into STATA for analysis. Frequency counts will be generated for demographic, literacy related and parental knowledge and stress variables in the two intervention arms. Chi-Square and T-tests will be used to compare literacy and parental knowledge outcomes for each intervention group at both follow up interviews.

Hypotheses: 1) Mothers in the RTL branch will recognize the importance of reading to their babies, initiating this activity at earlier ages and reading more often with them. 2) Mothers in the ABC branch will gain an understanding of crying as part of normal infant behavior and build strategies to sooth themselves and their newborns.

详细描述

Quality assurance Plan: The PI and collaborators will be overseen collection and processing of data.

Standard Operating Procedures:

Recruitment: A bilingual Research Assistant will review mother's records at Women & Infants' Hospital mother-baby unit to identify eligible mothers.

Dyads will be excluded if the mother:

  • Is not insured by Medicaid, Ritecare, or Neighborhood Health Plan.
  • Is not fluent in either English or Spanish.
  • Is younger than 18 years of age.
  • Will not be taking the baby home at hospital discharge.
  • Will be leaving USA within the following 6 months for longer than two weeks.
  • Is discharged from the hospital prior to being approached or scheduling interview.
  • Does not have access to DVD player
  • Refuses to participate in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Mothers of healthy Singleton, full term infants
  • Born at Women & Infants Hospital

排除标准

  • Mothers will be excluded if they:
  • Are not insured by Medicaid, Ritecare, or Neighborhood Health Plan.
  • Are not fluent in either English or Spanish.
  • Are younger than 18 years of age.
  • Will not be taking the baby home at hospital discharge.
  • Will be leaving USA within the following 6 months for longer than two weeks.
  • Is discharged from the hospital prior to being approached or scheduling interview.
  • Do not have access to DVD player
  • Refuse to participate in the study.
  • Mothers will be excluded if the infant:
  • Is born premature (<37 wks G.A)
  • Is born at low birth weight (<5 pounds at birth or 2500 grams)
  • Spent >24 hours in the Neonatal Intensive Care Unit
  • Was born with a significant anomaly or genetic syndrome associated with delay
  • Has a P.R.E with a hold with DCYF

结局指标

主要结局

Days/week mothers report reading with their infants

时间窗: 2-5 months

Mothers are asked how many days/week they read with their babies at 2-5 months. We hypothesize that mothers in the RTL Arm will report that they read with their babies more days/week compared to ABC Arm mothers.

Reading with their baby is one of mother's favorite shared activities

时间窗: 2-5 months

Mothers are asked what their 3 favorite things to do with their babies are. We hypothesize that more mothers in the RTL Arm will spontaneously mention reading books together.

Knowledge of the typical peak of infant crying

时间窗: 2-5 months

At follow-up interview mothers are asked if they know at what age infants tend to cry the most and they are given 7 options. We hypothesize that more mothers in the ABC Arm of the study will correctly identify 6-8 weeks as the peak of infant crying compared to RTL Arm mothers.

Having heard what can happen if a baby is shaken

时间窗: 2-5 months

At follow-up mothers are asked if they have heard or read what could happen if a baby is shaken. We hypothesize that more mothers in the ABC arm of the study will report having heard of what could happen if a baby is shaken.

次要结局

  • Reading together is one of the baby's 3 favorite activities.(2-5 months)
  • Number of children's books in the home(2-5 months)
  • Reading with their baby is identified as a way of preparing him/her for school(2-5 months)
  • Talking, singing and/or playing with their babies is identified as a favorite shared activity(2-5 months)
  • Number of calming strategies for parenting stress identified(2-5 months)
  • Number of soothing strategies to calm fussy babies identified(2-5 months)
  • Knowledge that responding to babies younger than 6 months of age whenever they cry won't spoil them(2-5 months)
  • Knowledge that shaking a baby can cause brain damage or death(2-5 months)

研究者

发起方
Women and Infants Hospital of Rhode Island
申办方类型
Other
责任方
Sponsor

研究点 (2)

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