Clinical trial NCT02055573: The Early ABCs Study
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abusive Head Trauma
Early Literacy
Keywords: Abusive Head Trauma
Early Literacy
Parental Education
Low Income
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: Lifespan
First posted: 2014-02-05
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Days/week mothers report reading with their infants
timeFrame: 2-5 months
measure: Reading with their baby is one of mother's favorite shared activities
timeFrame: 2-5 months
measure: Knowledge of the typical peak of infant crying
timeFrame: 2-5 months
measure: Having heard what can happen if a baby is shaken
timeFrame: 2-5 months
Secondary outcomes:
measure: Reading together is one of the baby's 3 favorite activities.
timeFrame: 2-5 months
measure: Number of children's books in the home
timeFrame: 2-5 months
measure: Reading with their baby is identified as a way of preparing him/her for school
timeFrame: 2-5 months
measure: Talking, singing and/or playing with their babies is identified as a favorite shared activity
timeFrame: 2-5 months
measure: Number of calming strategies for parenting stress identified
timeFrame: 2-5 months
measure: Number of soothing strategies to calm fussy babies identified
timeFrame: 2-5 months
measure: Knowledge that responding to babies younger than 6 months of age whenever they cry won't spoil them
timeFrame: 2-5 months
measure: Knowledge that shaking a baby can cause brain damage or death
timeFrame: 2-5 months
Other outcomes:
measure: Other caregivers are reading with baby
timeFrame: 2-5 months
measure: DVD/Booklet promotes reading, playing or talking with baby
timeFrame: 2-5 months
measure: DVD/Booklet teaches how to calm baby or self
timeFrame: 2-5 months
Locations:
city: Providence
country: United States
facility: Women & Infants' Hospital
state: Rhode Island
Study officials:
affiliation: Women & Infants' Hospital
name: Marcia W VanVleet, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garner AS, Shonkoff JP; Committee on Psychosocial Aspects of Child and Family Health; Committee on Early Childhood, Adoption, and Dependent Care; Section on Developmental and Behavioral Pediatrics. Early childhood adversity, toxic stress, and the role of the pediatrician: translating developmental science into lifelong health. Pediatrics. 2012 Jan;129(1):e224-31. doi: 10.1542/peds.2011-2662. Epub 2011 Dec 26.
citation: Barr RG, Barr M, Fujiwara T, Conway J, Catherine N, Brant R. Do educational materials change knowledge and behaviour about crying and shaken baby syndrome? A randomized controlled trial. CMAJ. 2009 Mar 31;180(7):727-33. doi: 10.1503/cmaj.081419. Epub 2009 Mar 2.
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citation: Mendelsohn AL, Mogilner LN, Dreyer BP, Forman JA, Weinstein SC, Broderick M, Cheng KJ, Magloire T, Moore T, Napier C. The impact of a clinic-based literacy intervention on language development in inner-city preschool children. Pediatrics. 2001 Jan;107(1):130-4. doi: 10.1542/peds.107.1.130.
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