Abusive Head Trauma Clinical Trial
Official title:
Can we Promote Early Literacy and Prevent Shaken Baby Syndrome in the Well Child Nursery?.A Randomized Controlled Study, The Early ABC Study.
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)