Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
300 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-02-28
Study Completion Date
2015-01-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Abusive Head Trauma
Early Literacy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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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.
Group Type
EXPERIMENTAL
Ready To Learn (RTL)
Intervention Type
OTHER
See arm description
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
Group Type
EXPERIMENTAL
All Babies Cry (ABC)
Intervention Type
OTHER
See arm description
Interventions
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Ready To Learn (RTL)
See arm description
Intervention Type
OTHER
All Babies Cry (ABC)
See arm description
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Mothers of healthy Singleton, full term infants
* Born at Women \& Infants Hospital
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Lifespan
OTHER
Sponsor Role
collaborator
Women and Infants Hospital of Rhode Island
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Marcia W VanVleet, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Women & Infants' Hospital
Locations
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Women & Infants' Hospital
Providence, Rhode Island, United States
Site Status
Countries
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United States
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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. No abstract available.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Lewin L. Shaken baby syndrome: facts, education, and advocacy. Nurs Womens Health. 2008 Jun;12(3):235-9. doi: 10.1111/j.1751-486X.2008.00328.x. No abstract available.
Reference Type
BACKGROUND
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. doi: 10.1097/DBP.0b013e3180327b55.
Reference Type
BACKGROUND
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. doi: 10.1016/j.ambp.2006.10.004.
Reference Type
BACKGROUND
Evanoo G. Infant crying: a clinical conundrum. J Pediatr Health Care. 2007 Sep-Oct;21(5):333-8. doi: 10.1016/j.pedhc.2007.06.014. No abstract available.
Reference Type
BACKGROUND
Tomopoulos S, Dreyer BP, Tamis-LeMonda C, Flynn V, Rovira I, Tineo W, Mendelsohn AL. Books, toys, parent-child interaction, and development in young Latino children. Ambul Pediatr. 2006 Mar-Apr;6(2):72-8. doi: 10.1016/j.ambp.2005.10.001.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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. doi: 10.1542/peds.103.5.993.
Reference Type
BACKGROUND
Barr RG. The normal crying curve: what do we really know? Dev Med Child Neurol. 1990 Apr;32(4):356-62. doi: 10.1111/j.1469-8749.1990.tb16949.x. No abstract available.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Needlman R, Toker KH, Dreyer BP, Klass P, Mendelsohn AL. Effectiveness of a primary care intervention to support reading aloud: a multicenter evaluation. Ambul Pediatr. 2005 Jul-Aug;5(4):209-15. doi: 10.1367/A04-110R.1.
Reference Type
BACKGROUND
Related Links
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http://lincs.ed.gov/publications/pdf/NELPReport09.pdf
4\. National Institute for Literacy. 2008. Developing early literacy: Report of the National Early Literacy Panel.
Other Identifiers
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WIH 13-0080
Identifier Type: -
Identifier Source: org_study_id
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