Ignite Creation Date:
2024-05-06 @ 2:28 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02055573
Status:
COMPLETED
Last Update Posted:
2015-06-04
First Post:
2014-01-10
Brief Title:
The Early ABCs Study
Sponsor:
Women and Infants Hospital of Rhode Island
Organization:
Women and Infants Hospital of Rhode Island
Study Overview
Official Title:
Can we Promote Early Literacy and Prevent Shaken Baby Syndrome in the Well Child NurseryA Randomized Controlled Study The Early ABC Study
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EarlyABCs
Brief 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 mothers knowledge of normal crying patterns the dangers of shaking a baby and her ability to cope with parenting stresses
DesignMethods A convenience sample of 300 low income insured by Medicaid new mothers of healthy singleton full term infants in the level 1 motherbaby 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 childrens 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 mothers knowledge of normal crying patterns the dangers of shaking a baby and her ability to cope with parenting stresses
DesignMethods A convenience sample of 300 low income insured by Medicaid new mothers of healthy singleton full term infants in the level 1 motherbaby 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 childrens 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
Detailed Description:
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 mothers 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 GA
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 PRE with a hold with DCYF
Data CollectionManagement and Analysis
A convenience sample of 300 low income insured by Medicaid new mothers of healthy singleton full term infants in the level 1 motherbaby 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 childrens 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 005 significance level Effect sizes for differences in proportions are based on Cohens h statistic Cohen 1988 computed for 80 power and Two-tailed significance test at alpha 005 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 mothers 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 GA
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 PRE with a hold with DCYF
Data CollectionManagement and Analysis
A convenience sample of 300 low income insured by Medicaid new mothers of healthy singleton full term infants in the level 1 motherbaby 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 childrens 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 005 significance level Effect sizes for differences in proportions are based on Cohens h statistic Cohen 1988 computed for 80 power and Two-tailed significance test at alpha 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None