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The Early ABCs Study (EarlyABCs)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Women and Infants Hospital of Rhode Island
Sponsor:
Collaborator:
Lifespan
Information provided by (Responsible Party):
Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT02055573
First received: January 10, 2014
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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 400 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 100 mothers who speak Spanish primarily at home in each intervention group, as well as 100 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 2-4 months post-partum and then at 5-6 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.


Condition Intervention
Abusive Head Trauma
Early Literacy
Other: Ready To Learn (RTL)
Other: All Babies Cry (ABC)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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.

Resource links provided by NLM:


Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • Days/week mothers report reading with their infants [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
    Mothers are asked how many days/week they read with their babies at 2-4 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.

  • Reading with their baby is one of mother's favorite shared activities [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
    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.

  • Knowledge of the typical peak of infant crying [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
    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.

  • Having heard what can happen if a baby is shaken [ Time Frame: 2-4 months ] [ Designated as safety issue: Yes ]
    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.

  • Days/week mothers report reading with their infants [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
    Mothers are asked how many days/week they read with their babies at 5-6 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.

  • Reading with their baby is one of mother's favorite shared activities [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
    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.

  • Knowledge of the typical peak of infant crying [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
    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.

  • Having heard what can happen if a baby is shaken [ Time Frame: 5-6 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Reading together is one of the baby's 3 favorite activities. [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
    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.

  • Number of children's books in the home [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
    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.

  • Reading with their baby is identified as a way of preparing him/her for school [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
    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.

  • Talking, singing and/or playing with their babies is identified as a favorite shared activity [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
    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.

  • Number of calming strategies for parenting stress identified [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
    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.

  • Number of soothing strategies to calm fussy babies identified [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
    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.

  • Knowledge that responding to babies younger than 6 months of age whenever they cry won't spoil them [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
    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.

  • Knowledge that shaking a baby can cause brain damage or death [ Time Frame: 2-4 months ] [ Designated as safety issue: Yes ]
    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

  • Reading together is one of the baby's 3 favorite activities. [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
    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.

  • Number of children's books in the home [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
    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.

  • Reading with their baby is identified as a way of preparing him/her for school [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
    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.

  • Talking, singing and/or playing with their babies is identified as a favorite shared activity [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
    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.

  • Number of calming strategies for parenting stress identified [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
    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.

  • Number of soothing strategies to calm fussy babies identified [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
    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.

  • Knowledge that responding to babies younger than 6 months of age whenever they cry won't spoil them [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
    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.

  • Knowledge that shaking a baby can cause brain damage or death [ Time Frame: 5-6 months ] [ Designated as safety issue: Yes ]
    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


Other Outcome Measures:
  • Other caregivers are reading with baby [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
    Mothers will be asked who if anyone else reads with their baby?. We hypothesize that mothers in the RTL arm will be more likely to report that someone else reads with their baby as compared to mothers in the ABC arm

  • Other caregivers are reading with baby [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
    Mothers will be asked who if anyone else reads with their baby?. We hypothesize that mothers in the RTL arm will be more likely to report that someone else reads with their baby as compared to mothers in the ABC arm

  • DVD/Booklet promotes reading, playing or talking with baby [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
    At follow up interview mothers will be asked which parts of the DVD/Booklet they found helpful?. We hypothesize that RTL arm mothers will be more likely to report guidance around reading, playing or talking with baby was helpful compared to ABC arm mothers

  • DVD/Booklet promotes reading, talking or playing with baby [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
    At follow up interview mothers will be asked which parts of the DVD/Booklet they found helpful?. We hypothesize that RTL arm mothers will be more likely to report guidance around reading, playing or talking with baby was helpful compared to ABC arm mothers

  • DVD/Booklet teaches how to calm baby or self [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
    At follow up interview mothers will be asked which parts of the DVD/Booklet they found helpful?. We hypothesize that ABC arm mothers will be more likely to report guidance around how to sooth a baby and/or handle parenting stress was helpful compared to RTL arm mothers

  • DVD/Booklet teaches how to calm baby or self [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
    At follow up interview mothers will be asked which parts of the DVD/Booklet they found helpful?. We hypothesize that ABC arm mothers will be more likely to report guidance around how to sooth a baby and/or handle parenting stress was helpful compared to RTL arm mothers


Estimated Enrollment: 400
Study Start Date: February 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ready To Learn
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)
See arm description
Experimental: All Babies Cry
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)
See arm description

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02055573

Contacts
Contact: Marcia W VanVleet, MD, MPH 401-274-1122 ext 47470 MVanvleet@wihri.org
Contact: Luisa F Cala Cala, MD 401-444-4648 lcalacala@lifespan.org

Locations
United States, Rhode Island
Women & Infants' Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Marcia W VanVleet, MD, MPH    401-274-1122 ext 47470    MVanvleet@wihri.org   
Principal Investigator: Marcia W VanVleet, MD, MPH         
Sub-Investigator: Pamela C High, MD         
Sub-Investigator: Luisa F Cala Cala, MD         
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Lifespan
Investigators
Principal Investigator: Marcia W VanVleet, MD, MPH Women & Infants' Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT02055573     History of Changes
Other Study ID Numbers: WIH 13-0080
Study First Received: January 10, 2014
Last Updated: February 21, 2014
Health Authority: United States: Women and Infants' Hospital IRB

Keywords provided by Women and Infants Hospital of Rhode Island:
Abusive Head Trauma
Early Literacy
Parental Education
Low Income

Additional relevant MeSH terms:
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014