The Early ABCs Study
NCT02055573 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2015-06-04
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.
Conditions
- Abusive Head Trauma
- Early Literacy
Interventions
- OTHER
-
Ready To Learn (RTL)
See arm description
- OTHER
-
All Babies Cry (ABC)
See arm description
Sponsors & Collaborators
-
Lifespan
collaborator OTHER -
Women and Infants Hospital of Rhode Island
lead OTHER
Principal Investigators
-
Marcia W VanVleet, MD, MPH · Women & Infants' Hospital
Study Design
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2015-01-31
- Completion
- 2015-01-31
Countries
- United States
Study Locations
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