The Early ABCs Study

Completed · Not applicable

Conditions studied: Abusive Head Trauma, Early Literacy

In brief

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.

Key facts

Study ID

NCT02055573

Run by

Women and Infants Hospital of Rhode Island

People needed

300

Starts

2014-02-01

Expected to finish

2015-01-01

Last updated by the study team

2015-06-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Women & Infants' Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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