The Early ABCs Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Dyads will be excluded if the infant: Is born premature (<37 wks G.A) Is born at low birth weight (<5 pounds or 2500 grams at birth) 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 Data Collection/Management and Analysis: 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 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 Health Communications, INC) 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 in each arm. 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 blinded to the intervention status at 2-5 months post-partum containing similar questions. Data will be entered into Excel and transferred into STATA for analysis. Sample Size calculation: For power analysis, we used categorical (behavioral) outcomes to arrive at conservative estimates of sample sizes with a 0.05 significance level. Effect sizes for differences in proportions are based on Cohen's h statistic (Cohen, 1988), computed for 80% power and Two-tailed significance test at alpha = 0.05 with equal numbers of participants in the intervention and control groups and a Confidence Interval of 95%. From a previous study of the All Babies Cry intervention at 5 weeks postpartum 36% of control group answered similar knowledge questions correctly, compared to 47% of those receiving the All Babies Cry Intervention. This resulted in a difference of 11% and SD of 18 in the control group and 19 in the intervention group. Based on this using Open Epi for sample size calculation we arrived at a group size of 45 subjects in each branch of the study. Althouhg in the original All Babies Cry Intervention we had a follow up rate of 77% at 17 weeks, our current estimates are closer to 40-45%. To account for a possible loss to follow up of 60% of subjects we will increase the sample size from 45 to 75 individuals in each group for a total of 150 subjects in each branch of the study. Previous studies of Early Literacy interventions in low income families have shown larger differences in similar literacy outcomes to ours. We are therefore basing our calculations on a more conservative data assumption. Statistical 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 baseline and at both follow up interviews.

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

Conditions
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Abusive Head Trauma, Early Literacy

Intervention / Treatment
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* Other: Ready To Learn (RTL)
* Other: All Babies Cry (ABC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mothers of healthy Singleton, full term infants Born at Women & Infants Hospital Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ready To Learn<br>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. | Other: Ready To Learn (RTL)<br>* See arm description<br>|
| Experimental: All Babies Cry<br>2) The All Babies Cry (ABC) arm will receive a DVD in both, Spanish and English and a bilingual booklet (both produced by VIDA Health Communications, INC) explaining crying as part of normal infant behavior, highlighting signs of parental distress and providing strategies to sooth parents and their children | Other: All Babies Cry (ABC)<br>* See arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days/week mothers report reading with their infants | 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. | 2-5 months | 
| Reading with their baby is one of mother's favorite shared activities | 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. | 2-5 months | 
| Knowledge of the typical peak of infant crying | 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. | 2-5 months | 
| Having heard what can happen if a baby is shaken | 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. | 2-5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reading together is one of the baby's 3 favorite activities. | At follow-up, mothers are asked what their baby's 3 favorite things to do are. We hypothesize that more mothers in the RTL Arm will spontaneously mention reading books with their parents as one of the baby's 3 favorite activities, compared to ABC arm mothers. | 2-5 months | 
| Number of children's books in the home | At follow-up mothers are asked how many children's books are in their home. We hypothesize that mothers in the RTL arm will report having more children's books in their homes compared to the numbers of children's books in the homes of ABC arm mothers. | 2-5 months | 
| Reading with their baby is identified as a way of preparing him/her for school | Mothers are asked if there is anything they plan to do with their child to help the child do well when he/she goes to school. We hypothesize that more RTL mothers compared to ABC mothers will spontaneously mention reading together or books as a way of promoting their child's readiness for school. | 2-5 months | 
| Talking, singing and/or playing with their babies is identified as a favorite shared activity | 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 talking, singing and/or playing together as a favorite shared activity compared to ABC Arm mothers. | 2-5 months | 
| Number of calming strategies for parenting stress identified | At follow-up mothers are asked to identify ways of calming themselves if their baby is crying inconsolably. We hypothesize that mothers in the ABC arm will identify more strategies for calming themselves if their baby is crying, compared to RTL arm mothers. | 2-5 months | 
| Number of soothing strategies to calm fussy babies identified | At follow-up mothers are asked to identify ways of soothing their babies if they are crying inconsolably. We hypothesize that mothers in the ABC arm will identify more strategies for soothing their babies if they are crying inconsolably, compared to RTL arm mothers. | 2-5 months | 
| Knowledge that responding to babies younger than 6 months of age whenever they cry won't spoil them | At follow-up interview mothers are asked if they believe that by responding to a baby in the first 6 months of life every time he/she starts to cry he/she can get spoiled. We hypothesize that more mothers in the ABC Arm of the study will know that they can't spoil a baby less than 6 months old by responding to all their cries, as compared to RTL arm mothers. | 2-5 months | 
| Knowledge that shaking a baby can cause brain damage or death | At follow-up interview mothers are asked if they have heard what could happen if a baby is shaken. We hypothesize that more mothers in the ABC Arm of the study will correctly identify that babies can sustain brain damage or die if they are shaken compared to RTL Arm mothers | 2-5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parental Education, Low Income, Abusive Head Trauma, Early Literacy