Abusive Head Trauma Clinical Trial
— EarlyABCsOfficial 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.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| United States | Women & Infants' Hospital | Providence | Rhode Island |
| Lead Sponsor | Collaborator |
|---|---|
| Women and Infants Hospital of Rhode Island | Lifespan |
United States,
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. — View Citation
Barr RG. The normal crying curve: what do we really know? Dev Med Child Neurol. 1990 Apr;32(4):356-62. — View Citation
Berkule SB, Dreyer BP, Huberman HS, Fierman AH, Mendelsohn AL. Attitudes about shared reading among at-risk mothers of newborn babies. Ambul Pediatr. 2007 Jan-Feb;7(1):45-50. — View Citation
Duursma E, Augustyn M, Zuckerman B. Reading aloud to children: the evidence. Arch Dis Child. 2008 Jul;93(7):554-7. doi: 10.1136/adc.2006.106336. Epub 2008 May 13. Review. — View Citation
Evanoo G. Infant crying: a clinical conundrum. J Pediatr Health Care. 2007 Sep-Oct;21(5):333-8. Review. — View 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. — View Citation
Golova N, Alario AJ, Vivier PM, Rodriguez M, High PC. Literacy promotion for Hispanic families in a primary care setting: a randomized, controlled trial. Pediatrics. 1999 May;103(5 Pt 1):993-7. — View Citation
High PC, LaGasse L, Becker S, Ahlgren I, Gardner A. Literacy promotion in primary care pediatrics: can we make a difference? Pediatrics. 2000 Apr;105(4 Pt 2):927-34. — View Citation
Keeton CP, Perry-Jenkins M, Sayer AG. Sense of control predicts depressive and anxious symptoms across the transition to parenthood. J Fam Psychol. 2008 Apr;22(2):212-21. doi: 10.1037/0893-3200.22.2.212. — View Citation
Lee C, Barr RG, Catherine N, Wicks A. Age-related incidence of publicly reported shaken baby syndrome cases: is crying a trigger for shaking? J Dev Behav Pediatr. 2007 Aug;28(4):288-93. — View Citation
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* Note: There are 14 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Other caregivers are reading with baby | 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 | 2-5 months | No |
| Other | DVD/Booklet promotes reading, playing or talking with baby | 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 | 2-5 months | No |
| Other | DVD/Booklet teaches how to calm baby or self | 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 | 2-5 months | No |
| Primary | Days/week mothers report reading with their infants | Mothers are asked how many days/week they read with their babies at 2-5 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. | 2-5 months | No |
| Primary | Reading with their baby is one of mother's favorite shared activities | 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. | 2-5 months | No |
| Primary | Knowledge of the typical peak of infant crying | 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. | 2-5 months | No |
| Primary | Having heard what can happen if a baby is shaken | 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. | 2-5 months | Yes |
| Secondary | Reading together is one of the baby's 3 favorite activities. | 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. | 2-5 months | No |
| Secondary | Number of children's books in the home | 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. | 2-5 months | No |
| Secondary | Reading with their baby is identified as a way of preparing him/her for school | 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. | 2-5 months | No |
| Secondary | Talking, singing and/or playing with their babies is identified as a favorite shared activity | 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. | 2-5 months | No |
| Secondary | Number of calming strategies for parenting stress identified | 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. | 2-5 months | No |
| Secondary | Number of soothing strategies to calm fussy babies identified | 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. | 2-5 months | No |
| Secondary | Knowledge that responding to babies younger than 6 months of age whenever they cry won't spoil them | 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. | 2-5 months | No |
| Secondary | Knowledge that shaking a baby can cause brain damage or death | 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 | 2-5 months | Yes |